Safety Assessment of Polyglyceryl Fatty Acid Esters as Used in Cosmetics

Transcription

1 Safety Assessmet of Polyglyceryl Fatty Acid Esters as Used i Cosmetics Status: Draft Fial eport for Pael eview elease Date: September, 06 Pael Meetig Date: September 6-7, 06 The 06 Cosmetic Igrediet eview Expert Pael members are: Chairma, Wilma F. Bergfeld, M.D., F.A.C.P.; Doald V. Belsito, M.D.; oald A. ill, Ph.D.; Curtis D. Klaasse, Ph.D.; Daiel C. Liebler, Ph.D.; James G. Marks, Jr., M.D., oald C. Shak, Ph.D.; Thomas J. Slaga, Ph.D.; ad Paul W. Syder, D.V.M., Ph.D. The CI Director is Lillia J. Gill, D.P.A. This safety assessmet was prepared by Moice M. Fiume, Assistat Director/Seior Scietific Aalyst/Writer ad Bart eldreth, Ph.D., Chemist. Cosmetic Igrediet eview 60 L Street, NW, Suite 00 Washigto, DC ph fax cirifo@cir-safety.org

2 Distributed for Commet ly -- Do Not Cite or Quote To: From: CI Expert Pael Members ad Liaisos Moice M. Fiume MMF Assistat Director/Seior Scietific Aalyst Memoradum Date: September, 06 Subject: Safety Assessmet of Polyglyceryl Fatty Acid Esters as Used i Cosmetics Commitmet & Credibility sice 976 Eclosed is the Draft Fial eport of the Safety Assessmet of Polyglyceryl Fatty Acid Esters as Used i Cosmetics (PGlyFE0906rep). At the March/April meetig, the Pael cocluded that this family of 74 igrediets, which comprises igrediets that are esterificatio products of polyglyceri chais ad fatty acids that vary i umbers of glyceri ad fatty-acid equivalets ad legths of the fatty acids, are safe as used i cosmetics whe formulated to be o-irritatig. A large submissio of upublished data was received, ad the data have bee icorporated ito the report (idicated usig gree highlightig). The results of these ew studies are cosistet with the existig data. Because of the size of the submissio, the followig data are icluded i a supplemet to the mai report package:. Iformatio o Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters (PGlyFE0906data_) a. 6 studies: dermal irritatio i rabbits; cliical patch test; ocular irritatio i rabbits; guiea pig maximizatio test; acute oral toxicity; Ames test. Iformatio o Macadamia Seed il Polyglyceryl-6 Esters Beheate (PGlyFE0906data_) a. 6 studies: acute oral toxicity; Ames test; cliical patch test; dermal irritatio i rabbits; guiea pig maximizatio test; ocular irritatio i rabbits 3. Iformatio o Polyglyceryl-8 Decabeheate/Caprate (PGlyFE0906data_3) a. 6 studies: Ames test; dermal irritatio i rabbits; cliical irritatio study; ocular irritatio i rabbits; guiea pig maximizatio test; acute oral toxicity 4. Iformatio o Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate (PGlyFE0906data_4) a. 5 studies: dermal irritatio i rabbits; guiea pig maximizatio test; ocular irritatio i rabbits; acute oral toxicity; Ames test 5. Iformatio o Polyglyceryl-0 Decaethylhexaoate (PGlyFE0906data_5) a. 5 studies: bacterial reverse mutatio assay; i vitro ocular irritatio; cliical patch test; i vitro ski irritatio; cliical sesitizatio test 6. Iformatio o Polyglyceryl-0 Petaisostearate (PGlyFE0906data_6) a. 5 studies: bacterial reverse mutatio assay; i vitro ocular irritatio; cliical patch test; i vitro ski irritatio; cliical sesitizatio test 7. Iformatio o Polyglyceryl-0 Noaisostearate (PGlyFE0906data_7; PGlyFE0906data_8) a. 9 studies: ocular irritatio i rabbits; acute oral toxicity; dermal irritatio i rabbits; cliical irritatio study; photosesitizatio i guiea pigs; dermal irritatio i guiea pigs; LLNA; Ames test; phototoxicity i guiea pigs. Additioally, the VCP data have bee updated to ow iclude 06 data (PGlyFE0306FDA). There were o sigificat chages i frequecy or types of use. Commets o the draft report (PGlyFE0906pcpc_) ad tetative report (PGlyFE0906pcpc_) were received from the Coucil ad have bee addressed. Please review the Discussio to esure that it captures the ratioale for the report coclusio. The Pael should be prepared to issue a Fial eport. 60 L Street, NW, Suite 00, Washigto, DC 0036 (Mai) (Fax) ( ) cirifo@cir-safety.org (Website)

3 Distributed for Commet ly -- Do Not Cite or Quote SAFETY ASSESSMENT FLW CAT INGEDIENT/FAMILY Polyglyceryl Fatty Acid Esters MEETING Sept 06 Public Commet CI Expert Pael Priority List INGEDIENT PIITY LIST SL Ja 9, 06 DAFT EPT 60 day public commet period Mar 06 Draft eport Table Table IDA Notice Draft T IDA T IDA DAFT TENTATIVE EPT Table Table Issue T Tetative eport Jue 0, 06 Draft F 60 day Public commet period DAFT FINAL EPT Sept 06 Table Table PUBLIS Fial eport Differet Coclusio Issue F eport Status

4 Distributed for Commet ly -- Do Not Cite or Quote PLYGLYCEYL FATTY ACID ESTES March 3 April, 06: Draft eport The Pael issued a tetative report for public commet with the coclusio that the followig 74 polyglyceryl fatty acid esters are safe as used i cosmetics whe formulated to be o-irritatig. Acacia Decurres/Jojoba/Suflower Seed Wax Polyglyceryl-3 Esters was removed from the report because the Pael previously foud the data isufficiet to support the safety of Acacia Decurres Extract i cosmetic formulatios. September 6-7, 06: draft Fial eport The followig upublished data were received ad added to the report: Iformatio o Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters a. 6 studies: dermal irritatio i rabbits; cliical patch test; ocular irritatio i rabbits; guiea pig maximizatio test; acute oral toxicity; Ames test Iformatio o Macadamia Seed il Polyglyceryl-6 Esters Beheate a. 6 studies: acute oral toxicity; Ames test; cliical patch test; dermal irritatio i rabbits; guiea pig maximizatio test; ocular irritatio i rabbits Iformatio o Polyglyceryl-8 Decabeheate/Caprate a. 6 studies: Ames test; dermal irritatio i rabbits; cliical irritatio study; ocular irritatio i rabbits; guiea pig maximizatio test; acute oral toxicity Iformatio o Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate a. 5 studies: dermal irritatio i rabbits; guiea pig maximizatio test; ocular irritatio i rabbits; acute oral toxicity; Ames test Iformatio o Polyglyceryl-0 Decaethylhexaoate a. 5 studies: bacterial reverse mutatio assay; i vitro ocular irritatio; cliical patch test; i vitro ski irritatio; cliical sesitizatio test Iformatio o Polyglyceryl-0 Petaisostearate a. 5 studies: bacterial reverse mutatio assay; i vitro ocular irritatio; cliical patch test; i vitro ski irritatio; cliical sesitizatio test Iformatio o Polyglyceryl-0 Noaisostearate a. 9 studies: ocular irritatio i rabbits; acute oral toxicity; dermal irritatio i rabbits; cliical irritatio study; photosesitizatio i guiea pigs; dermal irritatio i guiea pigs; LLNA; Ames test; phototoxicity i guiea pigs. VCP data were bee updated to ow iclude 06 data.

5 Distributed for Commet ly -- Do Not Cite or Quote Mucous Mem Irr cular Irritatio Case eports Photoses/Phototox Dermal Irr/Ses Carciogeicity Geotoxicity epro/dev Toxicity Aimal Tox ptd Dose, Ihalatio Aimal Tox, ptd Dose, ral Aimal Tox ptd Dose, Dermal Aimal Tox, Acute, Ihalatio Aimal Tox Acute, ral Toxicokietics Aimal Tox Acute, Dermal Impurities Dermal Peetratio Method of Mfg geeral Polyglyceryl Fatty Acid Esters geeral Polyglyceryl Stearate Polyglyceryl Mooesters Polyglyceryl- Caprate Polyglyceryl- Caprylate Polyglyceryl- Laurate Polyglyceryl- Myristate Polyglyceryl- Isopalmitate Polyglyceryl- Palmitate Polyglyceryl- Isostearate Polyglyceryl- leate Polyglyceryl- Stearate Polyglyceryl- Isopalmitate/Sebacate Polyglyceryl-3 Caprate Polyglyceryl-3 Caprylate Polyglyceryl-3 Laurate Polyglyceryl-3 Myristate Polyglyceryl-3 Palmitate Polyglyceryl-3 Isostearate Polyglyceryl-3 leate Polyglyceryl-3 Stearate Polyglyceryl-3 Stearate SE Polyglyceryl-3 icioleate Polyglyceryl-3 Beheate Apricot Kerel il Polyglyceryl-3 Esters Cadelilla/Jojoba/ice Bra Polyglyceryl-3 Esters live il Polyglyceryl-3 Esters Palm il Polyglyceryl-3 Esters Polyglyceryl-3 Beeswax Polyglyceryl-3 Cocoate Polyglyceryl-3 ice Braate Polyglyceryl-3 Soyate/Shea Butterate ice Bra il Polyglyceryl-3 Esters Shea Butter Polyglyceryl-3 Esters Suflower Seed il Polyglyceryl-3 Esters Polyglyceryl-4 Caprate Polyglyceryl-4 Caprylate Polyglyceryl-4 Laurate Polyglyceryl-4 Isostearate Polyglyceryl-4 leate Polyglyceryl-4 Stearate Fatty Acid Comp. eported Use Polyglyceryl Fatty Acid Esters Sept 06 Moice Fiume

6 Distributed for Commet ly -- Do Not Cite or Quote Apricot Kerel il Polyglyceryl-4 Esters Babassu il Polyglyceryl-4 Esters Borage Seed il Polyglyceryl-4 Esters Liseed il Polyglyceryl-4 Esters live il Polyglyceryl-4 Esters Palm Kerel il Polyglyceryl-4 Esters Palm il Polyglyceryl-4 Esters Polyglyceryl-4 Almodate/Shea Butterate Polyglyceryl-4 Caprylate/Caprate Polyglyceryl-4 Cocoate Polyglyceryl-4 azelutseedate Polyglyceryl-4 Isostearate/Laurate Polyglyceryl-4 Laurate/Sebacate Polyglyceryl-4 Laurate/Succiate Polyglyceryl-4 Puicate Polyglyceryl-4 Sweet Almodate Shea Butter Polyglyceryl-4 Esters Suflower Seed il Polyglyceryl-4 Esters Sweet Almod il Polyglyceryl-4 Esters Polyglyceryl-5 Caprate Polyglyceryl-5 Laurate Polyglyceryl-5 Myristate Polyglyceryl-5 Isostearate Polyglyceryl-5 leate Polyglyceryl-5 Stearate Polyglyceryl-5 icioleate Apricot Kerel il Polyglyceryl-5 Esters Palm il Polyglyceryl-5 Esters Suflower Seed il Polyglyceryl-5 Esters Polyglyceryl-6 Caprate Polyglyceryl-6 Caprylate Polyglyceryl-6 Udecyleate Polyglyceryl-6 Laurate Polyglyceryl-6 Myristate Polyglyceryl-6 Palmitate Polyglyceryl-6 Isostearate Polyglyceryl-6 leate Polyglyceryl-6 Stearate Polyglyceryl-6 icioleate Polyglyceryl-6 Beheate Adasoia Digitata Seed il Polyglyceryl-6 Esters Mucous Mem Irr cular Irritatio Case eports Photoses/Phototox Dermal Irr/Ses Carciogeicity Geotoxicity epro/dev Toxicity Aimal Tox ptd Dose, Ihalatio Aimal Tox, ptd Dose, ral Aimal Tox ptd Dose, Dermal Aimal Tox, Acute, Ihalatio Aimal Tox Acute, ral Aimal Tox Acute, Dermal Dermal Peetratio Toxicokietics Impurities Method of Mfg Fatty Acid Comp. eported Use Polyglyceryl Fatty Acid Esters Sept 06 Moice Fiume

7 Distributed for Commet ly -- Do Not Cite or Quote Apricot Kerel il Polyglyceryl-6 Esters Arga il Polyglyceryl-6 Esters Astrocaryum Vulgare il Polyglyceryl-6 Esters Avocado il Polyglyceryl-6 Esters Babassu il Polyglyceryl-6 Esters Bertholletia Excelsa Seed il Polyglyceryl-6 Esters Borage Seed il Polyglyceryl-6 Esters Carapa Guaiaesis il Polyglyceryl-6 Esters Castor il Polyglyceryl-6 Esters Cocoa Butter Polyglyceryl-6 Esters Cocout il Polyglyceryl-6 Esters Coffee Seed il Polyglyceryl-6 Esters Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters azelut Seed il Polyglyceryl-6 Esters Macadamia Seed il Polyglyceryl-6 Esters Mauritia Flexuosa Seed il Polyglyceryl-6 Esters live il Polyglyceryl-6 Esters Palm il Polyglyceryl-6 Esters Pariari Curatellifolia il Polyglyceryl-6 Esters Pius Sibirica Seed il Polyglyceryl-6 Esters Polyglyceryl-6 Adasoia Digitata Seedate Polyglyceryl-6 Apricot Kerelate Polyglyceryl-6 Arga Kerelate Polyglyceryl-6 Caprylate/Caprate Polyglyceryl-6 Citrullus Laatus Seedate Polyglyceryl-6 Palmitate/Succiate Polyglyceryl-6 Schiziophyto autaeii Kerelate Polyglyceryl-6 Sclerocarya Birrea Seedate Polyglyceryl-6 Trichilia Emetica Seedate Polyglyceryl-6 imeia Americaa Seedate osa ubigiosa Seed il Polyglyceryl-6 Esters Safflower Seed il Polyglyceryl-6 Esters Schiziophyto autaeii Kerel il Polyglyceryl6 Esters Sclerocarya Birrea Seed il Polyglyceryl-6 Esters Sesame il Polyglyceryl-6 Esters Shea Butter Polyglyceryl-6 Esters Soybea il Polyglyceryl-6 Esters Suflower Seed il Polyglyceryl-6 Esters Sweet Almod il Polyglyceryl-6 Esters Mucous Mem Irr cular Irritatio Case eports Photoses/Phototox Dermal Irr/Ses Carciogeicity Geotoxicity epro/dev Toxicity Aimal Tox ptd Dose, Ihalatio Aimal Tox, ptd Dose, ral Aimal Tox ptd Dose, Dermal Aimal Tox, Acute, Ihalatio Aimal Tox Acute, ral Aimal Tox Acute, Dermal Dermal Peetratio Toxicokietics Impurities Method of Mfg Fatty Acid Comp. eported Use Polyglyceryl Fatty Acid Esters Sept 06 Moice Fiume

8 Distributed for Commet ly -- Do Not Cite or Quote Theobroma Gradiflorum Seed Butter Polyglyceryl6 Esters Trichilia Emetica Seed il Polyglyceryl-6 Esters Watermelo Seed il Polyglyceryl-6 Esters imeia Americaa Seed il Polyglyceryl-6 Esters Polyglyceryl-8 leate Polyglyceryl-8 Stearate Polyglyceryl-8 C-0 Acid Ester Polyglyceryl-0 Caprate Polyglyceryl-0 Caprylate Polyglyceryl-0 Udecyleate Polyglyceryl-0 Laurate Polyglyceryl-0 Myristate Polyglyceryl-0 Palmitate Polyglyceryl-0 Isostearate Polyglyceryl-0 Lioleate Polyglyceryl-0 leate Polyglyceryl-0 Stearate Almod il/polyglyceryl-0 Esters Apricot Kerel il Polyglyceryl-0 Esters Caprylic/Capric Glycerides Polyglyceryl-0 Esters Polyglyceryl-0 Apricot Kerelate Polyglyceryl-0 Beheate/Eicosadioate Polyglyceryl-0 Caprylate/Caprate Polyglyceryl-0 Cocoate Polyglyceryl-0 Eicosaedioate/Tetradecaedioate Polyglyceryl-0 ydroxystearate/stearate/ Eicosadioate Polyglyceryl-0 Palmate Sclerocarya Birrea Seed il Polyglyceryl-0 Esters Suflower Seed il Polyglyceryl-0 Esters Watermelo Seed il Polyglyceryl-0 Esters Polyglyceryl Multi-Esters Polyglyceryl- Sesquicaprylate Polyglyceryl- Sesquiisostearate Polyglyceryl- Diisostearate Polyglyceryl- Triisostearate Polyglyceryl- Tetraisostearate Polyglyceryl- Dioleate Polyglyceryl- Sesquioleate Polyglyceryl- Tetraoleate Polyglyceryl- Sesquistearate Mucous Mem Irr cular Irritatio Case eports Photoses/Phototox Dermal Irr/Ses Carciogeicity Geotoxicity epro/dev Toxicity Aimal Tox ptd Dose, Ihalatio Aimal Tox, ptd Dose, ral Aimal Tox ptd Dose, Dermal Aimal Tox, Acute, Ihalatio Aimal Tox Acute, ral Aimal Tox Acute, Dermal Dermal Peetratio Toxicokietics Impurities Method of Mfg Fatty Acid Comp. eported Use Polyglyceryl Fatty Acid Esters Sept 06 Moice Fiume

9 Distributed for Commet ly -- Do Not Cite or Quote cular Irritatio Case eports Mucous Mem Irr Photoses/Phototox Dermal Irr/Ses Carciogeicity Aimal Tox ptd Dose, Ihalatio Aimal Tox, ptd Dose, ral Aimal Tox ptd Dose, Dermal Geotoxicity Aimal Tox, Acute, Ihalatio Aimal Tox Acute, ral Aimal Tox Acute, Dermal Dermal Peetratio Toxicokietics Impurities Method of Mfg epro/dev Toxicity Polyglyceryl- Distearate Polyglyceryl- Tetrastearate Polyglyceryl- Tetrabeheate/ Macadamiate/Sebacate Polyglyceryl-3 Dicaprate Polyglyceryl-3 Diisostearate Polyglyceryl-3 Triisostearate Polyglyceryl-3 Dioleate Polyglyceryl-3 Distearate Polyglyceryl-3 Di-ydroxystearate Polyglyceryl-3 Petaricioleate Diisostearoyl Polyglyceryl-3 Dimer Dilioleate Polyglyceryl-3 Dicitrate/Stearate Polyglyceryl-3 Dicocoate Polyglyceryl-3 Petacaprylate/Caprate Polyglyceryl-3 Petaolivate Polyglyceryl-3 Triolivate Triisostearoyl Polyglyceryl-3 Dimer Dilioleate Polyglyceryl-4 Dilaurate Polyglyceryl-4 Petaoleate Polyglyceryl-4 Distearate Polyglyceryl-4 Tristearate Polyglyceryl-4 Petastearate Polyglyceryl-4 Petapalmitate/Stearate Pumpki Seed il Polyglyceryl-4 Esters Pumpki Seed il Polyglyceryl-4 Esters Succiate Polyglyceryl-5 Dicaprylate Polyglyceryl-5 Dilaurate Polyglyceryl-5 Trimyristate Polyglyceryl-5 Petamyristate Polyglyceryl-5 Triisostearate Polyglyceryl-5 Dioleate Polyglyceryl-5 Trioleate Polyglyceryl-5 Tristearate Polyglyceryl-5 exastearate Polyglyceryl-5 Tribeheate Polyglyceryl-6 Sesquicaprylate Polyglyceryl-6 Dicaprate Polyglyceryl-6 Tricaprylate Polyglyceryl-6 Tetracaprylate Polyglyceryl-6 Petacaprylate Fatty Acid Comp. eported Use Polyglyceryl Fatty Acid Esters Sept 06 Moice Fiume

10 Distributed for Commet ly -- Do Not Cite or Quote Polyglyceryl-6 eptacaprylate Polyglyceryl-6 ctacaprylate Polyglyceryl-6 Dipalmitate Polyglyceryl-6 Sesquiisostearate Polyglyceryl-6 Diisostearate Polyglyceryl-6 Dioleate Polyglyceryl-6 Tetraoleate Polyglyceryl-6 Petaoleate Polyglyceryl-6 exaoleate Polyglyceryl-6 Sesquistearate Polyglyceryl-6 Distearate Polyglyceryl-6 Tristearate Polyglyceryl-6 Petastearate Polyglyceryl-6 exastearate Polyglyceryl-6 ctastearate Polyglyceryl-6 Petaricioleate Polyglyceryl-6 Tetrabeheate Macadamia Seed il Polyglyceryl-6 Esters Beheate Polyglyceryl-8 Decabeheate/Caprate Polyglyceryl-8 Decaerucate/Decaisostearate/ Decaricioleate Polyglyceryl-0 Decaethylhexaoate Polyglyceryl-0 Dodecacaprate Polyglyceryl-0 Petacaprylate Polyglyceryl-0 Dodecacaprylate Polyglyceryl-0 Tridecaoate Polyglyceryl-0 Dilaurate Polyglyceryl-0 Trilaurate Polyglyceryl-0 Tetralaurate Polyglyceryl-0 Petalaurate Polyglyceryl-0 Dimyristate Polyglyceryl-0 Dipalmitate Polyglyceryl-0 Diisostearate Polyglyceryl-0 Triisostearate Polyglyceryl-0 Petaisostearate Polyglyceryl-0 exaisostearate Polyglyceryl-0 Noaisostearate Polyglyceryl-0 Decaisostearate Polyglyceryl-0 Petalioleate Polyglyceryl-0 Decalioleate Polyglyceryl-0 Dioleate Mucous Mem Irr cular Irritatio Case eports Photoses/Phototox Dermal Irr/Ses Carciogeicity Geotoxicity epro/dev Toxicity Aimal Tox ptd Dose, Ihalatio Aimal Tox, ptd Dose, ral Aimal Tox ptd Dose, Dermal Aimal Tox, Acute, Ihalatio Aimal Tox Acute, ral Aimal Tox Acute, Dermal Dermal Peetratio Toxicokietics Impurities Method of Mfg Fatty Acid Comp. eported Use Polyglyceryl Fatty Acid Esters Sept 06 Moice Fiume

11 Distributed for Commet ly -- Do Not Cite or Quote Polyglyceryl-0 Trioleate Polyglyceryl-0 Tetraoleate Polyglyceryl-0 Petaoleate Polyglyceryl-0 Petaricioleate Polyglyceryl-0 exaoleate Polyglyceryl-0 eptaoleate Polyglyceryl-0 Decaoleate Polyglyceryl-0 Distearate Polyglyceryl-0 Tristearate Polyglyceryl-0 Petastearate Polyglyceryl-0 Petahydroxystearate Polyglyceryl-0 eptahydroxystearate Polyglyceryl-0 eptastearate Polyglyceryl-0 Decahydroxystearate Polyglyceryl-0 Decastearate Polyglyceryl-0 Dodecabeheate Polyglyceryl-0 Trierucate Polyglyceryl-0 exaerucate Polyglyceryl-0 Noaerucate Polyglyceryl-0 Decamacadamiate Polyglyceryl-0 Dicocoate Polyglyceryl-0 Didecaoate Polyglyceryl-0 Dodeca-Caprylate/ Caprate Polyglyceryl-0 epta(beheate/stearate) Polyglyceryl-0 Moo/Dioleate Polyglyceryl-0 Sesquistearate Polyglyceryl-0 Tetradecaedioate Polyglyceryl-0 Tricocoate Polyglyceryl-5 Diisostearate Polyglyceryl-0 exacaprylate Polyglyceryl-0 eptacaprylate Polyglyceryl-0 ctaisooaoate Polyglyceryl-0 Docosabeheate/Isostearate Polyglyceryl-0 Docosabeheate/Laurate Polyglyceryl-0 Docosabeheate/leate Polyglyceryl-0 eptadecabeheate/laurate Polyglyceryl-0 ctadecabeheate/laurate x Mucous Mem Irr cular Irritatio Case eports Photoses/Phototox Dermal Irr/Ses Carciogeicity Geotoxicity epro/dev Toxicity Aimal Tox ptd Dose, Ihalatio Aimal Tox, ptd Dose, ral Aimal Tox ptd Dose, Dermal Aimal Tox, Acute, Ihalatio Aimal Tox Acute, ral Aimal Tox Acute, Dermal Dermal Peetratio Toxicokietics Impurities Method of Mfg Fatty Acid Comp. eported Use Polyglyceryl Fatty Acid Esters Sept 06 Moice Fiume

12 Distributed for Commet ly -- Do Not Cite or Quote Polyglyceryl Fatty Acid Esters CAS # Geeric terms, Polyglyceryl Fatty Acid Esters, etc --Acacia Decurres/Jojoba/ Suflower Seed Wax Polyglyceryl 3 Esters --Adasoia Digitata Seed il Polyglyceryl 6 Esters --Almod il/polyglyceryl 0 Esters --Apricot Kerel il Polyglyceryl 0 Esters --Apricot Kerel il Polyglyceryl 3 Esters --Apricot Kerel il Polyglyceryl 4 Esters (Dub Aprilose +) --Apricot Kerel il Polyglyceryl 5 Esters --Apricot Kerel il Polyglyceryl 6 Esters --Arga il Polyglyceryl 6 Esters --Astrocaryum Vulgare il Polyglyceryl 6 Esters --Avocado il Polyglyceryl 6 Esters --Babassu il Polyglyceryl 4 Esters --Babassu il Polyglyceryl 6 Esters --Bertholletia Excelsa Seed il Polyglyceryl 6 Esters --Borage Seed il Polyglyceryl 4 Esters --Borage Seed il Polyglyceryl 6 Esters --Cadelilla/Jojoba/ice Bra Polyglyceryl 3 Esters --Caprylic/Capric Glycerides Polyglyceryl 0 Esters ( --Carapa Guaiaesis il Polyglyceryl 6 Esters ( --Castor il Polyglyceryl 6 Esters --Cocoa Butter Polyglyceryl 6 Esters --Cocout il Polyglyceryl 6 Esters --Coffee Seed il Polyglyceryl 6 Esters Diisostearoyl Polyglyceryl 3 Dimer Dilioleate --Glyceryl/Polyglyceryl 6 Isostearate/ Beheate Esters --azelut Seed il Polyglyceryl 6 Esters --Liseed il Polyglyceryl 4 Esters Macadamia Seed il Polyglyceryl 6 Esters Use IfoBase PubMed SciFider ChemID NTIS FDA ECA CF PV IUCLID/ SIDS W/ JEFCA EU NICNAS Web o r o r o r o r o r o r o r o r o r o r -- - o r o r o r o r o r o r o r o r o r o r o r o r o r o r -- o r o r o r o r -- --

13 Distributed for Commet ly -- Do Not Cite or Quote CAS # --Macadamia Seed il Polyglyceryl 6 Esters Beheate --Mauritia Flexuosa Seed il Polyglyceryl 6 Esters --live il Polyglyceryl 3 Esters --live il Polyglyceryl 4 Esters --live il Polyglyceryl 6 Esters --Palm Kerel il Polyglyceryl 4 Esters --Palm il Polyglyceryl 3 Esters --Palm il Polyglyceryl 4 Esters --Palm il Polyglyceryl 5 Esters --Palm il Polyglyceryl 6 Esters --Pariari Curatellifolia il Polyglyceryl 6 Esters --Pius Sibirica Seed il Polyglyceryl 6 Esters --Polyglyceryl 0 Apricot Kerelate Polyglyceryl 0 Beheate/Eicosadioate Polyglyceryl 0 Caprate Polyglyceryl 0 Caprylate Polyglyceryl 0 Caprylate/Caprate Polyglyceryl 0 Cocoate Polyglyceryl 0 Decaethylhexaoate Polyglyceryl 0 Decahydroxystearate Polyglyceryl 0 Decaisostearate Polyglyceryl 0 Decalioleate Polyglyceryl 0 Decamacadamiate Polyglyceryl 0 Decaoleate Polyglyceryl 0 Decastearate Polyglyceryl 0 Dicocoate Polyglyceryl 0 Didecaoate Polyglyceryl 0 Diisostearate Polyglyceryl 0 Dilaurate Polyglyceryl 0 Dimyristate Polyglyceryl 0 Dioleate Polyglyceryl 0 Dipalmitate Polyglyceryl 0 Distearate Polyglyceryl 0 Dodecabeheate Polyglyceryl 0 Dodecacaprate ; (geeric) Use IfoBase PubMed SciFider ChemID NTIS FDA ECA PV IUCLID/ SIDS W/ JEFCA CF NICNAS o r - EU -- o r o r o r o r o r o r o r o r o r -- - o r - - o r o r o r o r o r o r o r o r o r o r o r o r o r o r o r o r pre o r Web o r o r o r o r o r o r o r

14 Distributed for Commet ly -- Do Not Cite or Quote CAS # Polyglyceryl 0 Dodecacaprylate Polyglyceryl 0 Dodeca Caprylate/Caprate Polyglyceryl 0 Eicosaedioate/ Tetra decaedioate Polyglyceryl 0 epta(beheate/stearate) Polyglyceryl 0 eptahydroxystearate Polyglyceryl 0 eptaoleate Polyglyceryl 0 eptastearate Polyglyceryl 0 exaerucate Polyglyceryl 0 exaisostearate Polyglyceryl 0 exaoleate Polyglyceryl 0 ydroxystearate/ Stearate/Eicosadioate Polyglyceryl 0 Isostearate Polyglyceryl 0 Laurate Polyglyceryl 0 Lioleate Polyglyceryl 0 Moo/Dioleate Polyglyceryl 0 Myristate Polyglyceryl 0 Noaerucate Polyglyceryl 0 Noaisostearate Polyglyceryl 0 leate Polyglyceryl 0 Palmate Polyglyceryl 0 Palmitate Polyglyceryl 0 Petacaprylate Polyglyceryl 0 Petahydroxystearate Polyglyceryl 0 Petaisostearate Polyglyceryl 0 Petalaurate Polyglyceryl 0 Petalioleate Polyglyceryl 0 Petaoleate Polyglyceryl 0 Petaricioleate Polyglyceryl 0 Petastearate Polyglyceryl 0 Sesquistearate Polyglyceryl 0 Stearate Polyglyceryl 0 Tetradecaedioate Polyglyceryl 0 Tetralaurate Polyglyceryl 0 Tetraoleate Use IfoBase PubMed SciFider ChemID NTIS FDA ECA PV IUCLID/ SIDS W/ JEFCA EU NICNAS o r o r o r Web -- o r o r o r o r o r o r o r o r (geeric) o r o r pre o r o r o r o r o r o r pre pre o r o r o r o r o r o r o r o r o r o r o r o r o r o r o r ; (geeric)

15 Distributed for Commet ly -- Do Not Cite or Quote CAS # Polyglyceryl 0 Tricocoate Polyglyceryl 0 Tridecaoate Polyglyceryl 0 Trierucate Polyglyceryl 0 Triisostearate Polyglyceryl 0 Trilaurate Polyglyceryl 0 Trioleate Polyglyceryl 0 Tristearate Polyglyceryl 0 Udecyleate Polyglyceryl 5 Diisostearate Polyglyceryl Caprate Polyglyceryl Caprylate Polyglyceryl Diisostearate Polyglyceryl Dioleate Polyglyceryl Distearate Polyglyceryl Isopalmitate Polyglyceryl Isopalmitate/Sebacate Polyglyceryl Isostearate Polyglyceryl Laurate Polyglyceryl Myristate Polyglyceryl leate Polyglyceryl Palmitate Polyglyceryl Sesquicaprylate Polyglyceryl Sesquiisostearate (ostaceri DGI) Polyglyceryl Sesquioleate Polyglyceryl Sesquistearate Polyglyceryl Stearate Polyglyceryl Tetrabeheate/ Macadamiate/Sebacate Polyglyceryl Tetraisostearate Polyglyceryl Tetraoleate Polyglyceryl Tetrastearate Polyglyceryl Triisostearate Use IfoBase PubMed SciFider ChemID NTIS FDA ECA ; (geeric) ; ; (geeric) (geeric); Pre -- pre -- pre -Pre (geeric) IUCLID/ SIDS W/ JEFCA EU - -- o r o r o r o r o r o r o r o r o r o r o r o r -- - Pre pre -- PV NICNAS Web -- o r o r o r o r o r - o r -- o r o r -- - o r o r o r - -- o r o r o r o r pre pre - -- o r o r o r o r

16 Distributed for Commet ly -- Do Not Cite or Quote CAS # Use IfoBase PubMed SciFider ChemID NTIS FDA ECA PV IUCLID/ SIDS Polyglyceryl 0 Docosabeheate/ Isostearate Polyglyceryl 0 Docosabeheate/Laurate Polyglyceryl 0 Docosabeheate/leate Polyglyceryl 0 eptacaprylate Polyglyceryl 0 eptadecabeheate/ Laurate Polyglyceryl 0 exacaprylate Polyglyceryl 0 ctadecabeheate/laurate Polyglyceryl 0 ctaisooaoate Polyglyceryl 3 Beeswax Polyglyceryl 3 Beheate ; Polyglyceryl 3 Caprate ; Polyglyceryl 3 Caprylate Polyglyceryl 3 Cocoate Polyglyceryl 3 Di ydroxystearate Polyglyceryl 3 Dicaprate Polyglyceryl 3 Dicitrate/Stearate Polyglyceryl 3 Dicocoate Polyglyceryl 3 Diisostearate Polyglyceryl 3 Dioleate Polyglyceryl 3 Distearate Polyglyceryl 3 Isostearate Polyglyceryl 3 Laurate Polyglyceryl 3 Myristate Polyglyceryl 3 leate Polyglyceryl 3 Palmitate Polyglyceryl 3 Petacaprylate/Caprate Polyglyceryl 3 Petaolivate Polyglyceryl 3 Petaricioleate Polyglyceryl 3 ice Braate ; (geeric) ; (geeric) EU NICNAS Web o r o r o r o r o r -- o r o r o r o r o r o r o r o r o r -- o r pre - -- Pre - - o r o r o r o r Pre W/ JEFCA o o o o o o o o o o

17 Distributed for Commet ly -- Do Not Cite or Quote CAS # Polyglyceryl 3 icioleate Polyglyceryl 3 Soyate/Shea Butterate Polyglyceryl 3 Stearate Polyglyceryl 3 Stearate SE Polyglyceryl 3 Triisostearate Polyglyceryl 3 Triolivate Polyglyceryl 4 Almodate/Shea Butterate Polyglyceryl 4 Caprate Polyglyceryl 4 Caprylate Polyglyceryl 4 Caprylate/Caprate Polyglyceryl 4 Cocoate Polyglyceryl 4 Dilaurate Polyglyceryl 4 Distearate Polyglyceryl 4 azelutseedate Polyglyceryl 4 Isostearate Polyglyceryl 4 Isostearate/Laurate Polyglyceryl 4 Laurate Polyglyceryl 4 leate Polyglyceryl 4 Petaoleate Polyglyceryl 4 Petapalmitate/Stearate Polyglyceryl 4 Petastearate Polyglyceryl 4 Puicate Polyglyceryl 4 Stearate Polyglyceryl 4 Sweet Almodate Polyglyceryl 4 Tristearate Polyglyceryl 5 Caprate Polyglyceryl 5 Dicaprylate Polyglyceryl 5 Dilaurate Polyglyceryl 5 Dioleate Polyglyceryl 5 exastearate ; ; (geeric) Use IfoBase PubMed SciFider ChemID NTIS - FDA - ECA Pre *** pre PV -- IUCLID/ SIDS W/ JEFCA ; ; ; (geeric) ; ; (geeric) Web o o o -- o o o o Pre o o o o o o o o o o o -- o o o o o NICNAS EU pre- -- o o o o o o o

18 Distributed for Commet ly -- Do Not Cite or Quote CAS # Polyglyceryl 5 Isostearate Polyglyceryl 5 Laurate Polyglyceryl 5 Myristate Polyglyceryl 5 leate Polyglyceryl 5 Petamyristate Polyglyceryl 5 icioleate Polyglyceryl 5 Stearate Polyglyceryl 5 Tribeheate Polyglyceryl 5 Triisostearate Polyglyceryl 5 Trimyristate Polyglyceryl 5 Trioleate Polyglyceryl 5 Tristearate Polyglyceryl 6 Adasoia Digitata Seedate Polyglyceryl 6 Apricot Kerelate Polyglyceryl 6 Arga Kerelate Polyglyceryl 6 Beheate Polyglyceryl 6 Caprate Polyglyceryl 6 Caprylate Polyglyceryl 6 Caprylate/Caprate Polyglyceryl 6 Citrullus Laatus Seedate Polyglyceryl 6 Dicaprate Polyglyceryl 6 Diisostearate Polyglyceryl 6 Dioleate Polyglyceryl 6 Dipalmitate Polyglyceryl 6 Distearate Polyglyceryl 6 eptacaprylate Polyglyceryl 6 exaoleate Polyglyceryl 6 exastearate Polyglyceryl 6 Isostearate Polyglyceryl 6 Laurate Polyglyceryl 6 Myristate Polyglyceryl 6 ctacaprylate Polyglyceryl 6 ctastearate Polyglyceryl 6 leate Polyglyceryl 6 Palmitate Polyglyceryl 6 Palmitate/Succiate ; (geeric) (geeric) (geeric) Use IfoBase PubMed SciFider ChemID NTIS FDA ECA PV IUCLID/ SIDS W/ JEFCA EU NICNAS Web o o pre pre o o o o o o o o o o ; pre o r o r o r o o o o o o r o r o r o r o r o r o r o r o o o o r o r o - -- o o

19 Distributed for Commet ly -- Do Not Cite or Quote CAS # Polyglyceryl 6 Petacaprylate Polyglyceryl 6 Petaoleate Polyglyceryl 6 Petaricioleate Polyglyceryl 6 Petastearate Polyglyceryl 6 icioleate Polyglyceryl 6 Schiziophyto autaeii Kerelate Polyglyceryl 6 Sclerocarya Birrea Seedate Polyglyceryl 6 Sesquicaprylate Polyglyceryl 6 Sesquiisostearate Polyglyceryl 6 Sesquistearate Polyglyceryl 6 Stearate Polyglyceryl 6 Tetrabeheate Polyglyceryl 6 Tetracaprylate Polyglyceryl 6 Tetraoleate Polyglyceryl 6 Tricaprylate Polyglyceryl 6 Trichilia Emetica Seedate Polyglyceryl 6 Tristearate Polyglyceryl 6 Udecyleate Polyglyceryl 6 imeia Americaa Seedate Polyglyceryl 8 C 0 Acid Ester Polyglyceryl 8 Decabeheate/Caprate Polyglyceryl 8 Decaerucate/Decaiso stearate/ Decaricioleate Polyglyceryl 8 leate Polyglyceryl 8 Stearate Pumpki Seed il Polyglyceryl 4 Esters (Ecobod PK) Pumpki Seed il Polyglyceryl 4 Esters Succiate ice Bra il Polyglyceryl 3 Esters (Prolix ) osa ubigiosa Seed il Polyglyceryl 6 Esters (Viateza ose P6) Safflower Seed il Polyglyceryl 6 Esters (Viateza Safflower P6) Use IfoBase PubMed SciFider ChemID NTIS FDA ECA PV IUCLID/ SIDS W/ JEFCA o r o r o r o r o o r o r EU NICNAS Web o r ; ; o r o r o o r o r o r o r o r o r o o r o r o r o r ; ; o r o r o r o r o r o r o r

20 Distributed for Commet ly -- Do Not Cite or Quote CAS # Schiziophyto autaeii Kerel il Polyglyceryl 6 Esters (Viateza Mogogo P6) Sclerocarya Birrea Seed il Polyglyceryl Esters --Sclerocarya Birrea Seed il Polyglyceryl 6 Esters --Sesame il Polyglyceryl 6 Esters -Shea Butter Polyglyceryl 3 Esters --Shea Butter Polyglyceryl 4 Esters Shea Butter Polyglyceryl 6 Esters Soybea il Polyglyceryl 6 Esters Suflower Seed il Polyglyceryl 0 Esters --Suflower Seed il Polyglyceryl 3 Esters --Suflower Seed il Polyglyceryl 4 Esters --Suflower Seed il Polyglyceryl 5 Esters Suflower Seed il Polyglyceryl 6 Esters Sweet Almod il Polyglyceryl 4 Esters Sweet Almod il Polyglyceryl 6 Esters --Theobroma Gradiflorum Seed Butter Polyglyceryl 6 Esters Trichilia Emetica Seed il Polyglyceryl Esters Triisostearoyl Polyglyceryl 3 Dimer Dilioleate --Watermelo Seed il Polyglyceryl 0 Esters ) --Watermelo Seed il Polyglyceryl 6 Esters --imeia Americaa Seed il Polyglyceryl 6 Esters Use IfoBase PubMed SciFider ChemID NTIS FDA ECA PV IUCLID/ SIDS W/ JEFCA EU NICNAS Web o r o r o r - o r o r ot listed o r o r o r o r o r o r o r o r o r o r - -- o r o r o r o r o r

21 Distributed for Commet ly -- Do Not Cite or Quote SciFider : Polyglyceryl 99 hits/4 useful Esterificatio products of glyceri ad fatty acids 456 hits CAS # AND polyglycerol esters AND polyglyceri esters AND glycerol esters, without polyglyceryl 56 hits efie so oly Eglish 895 hits PubMed : Polyglyceryl 3 hits/ useful Polyglycerol ad ester# - 84 hits (glycerol AND ((fatty AND acid) ester)) AND (toxic# dermal sesitiz# sesitis# irita# carcioge# mutage# geotoxic# teratoge#) 508 ITS

22 Distributed for Commet ly -- Do Not Cite or Quote [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] [EC/N Number] 0 hits

23 Distributed for Commet ly -- Do Not Cite or Quote PLYGLYCEYL FATTY ACID ESTES TANSCIPTS Full Pael April, 06 D. BEGFELD: All of them. All right, movig o to the ext igrediet i this report advacig, polyglyceryl fatty acids, Dr. Belsito. D. BELSIT: So this is the first time we are lookig at this report of 75 igrediets. We are otified that of the 75, ufortuately acacia decurres has bee foud to be isufficiet previously by the pael so we felt that we could go ahead ad rule that all 74, except for acacia decurres jojoba suflower seed wax polyglyceral-3 esters were safe as used whe formulated to be o-irritatig ad i that i our discussio we would have peetratio ehacemet i the respiratory boiler plate. D. MAKS: Secod. D. BEGFELD: Would you also iclude the exclusio of your oe igrediet -D. BELSIT: Yes, that is isufficiet ad it was isufficiet based upo compositio. D. BEGFELD: ight, so is that goig to be i the discussio or the coclusio? D. BELSIT: Well we could elimiate it just from the list ad the have o commet o it. D. BEGFELD: kay, is that your preferece? D. BELSIT: Yes. D. BEGFELD: kay. D. MAKS: Agree. D. BEGFELD: Agree. Ay other commets regardig this movemet of goig safe? Seeig oe, I'll call for the questio; all those i favor? pposed? Abstaiig? (Motio passed uaimously) D. ILL: Yeah I just -- we had talked yesterday about we had some plat derived fatty acids that we did't have the acid compositio for ad the I was bothered by the idea of readig across without that iformatio so I thik we had come up with a list of about eight or ie that fell uder that category. D. BEGFELD: So we ca make a iformal request for that? For the compositio of some of these that are udefied? D. ILL: I would have preferred to leave those isufficiet util we got -D. BEGFELD: Well the vote has goe forward though so -D. ILL: I am aware of that. Yes, I am sorry; I tried to jump i but -D. BEGFELD: Well Carol, you heard us so i case we ca a iformal. Belsito Team March 3, 06 (st review) D. BELSIT: The ext oe is polyglyceryl fatty acid esters. So this is the first time we're lookig at these 75 igrediets ad they fuctio as ski coditioig igrediets. A lot of the data came out of the ECA website ad the questio we're beig asked is is this sufficiet ad if ot what do we eed. So my first questio always goes to Da ad I guess Bart is ot here so is the groupig appropriate? D. LIEBLE: Yes. It is big but yes. I did't have ay exclusios. D. BELSIT: There is oe of these ad I believe it is acacia decurres jojoba is that the oe where the flour wax was isufficiet? I ca't tell where my where my commet is whether it is acacia or adesoia. But oe of the flour waxes that is part of this group was isufficiet which brig us up to the issue we've always had with the arachidoic acid ad the do we wat to iclude it. MS. FIUME: It was acacia decurres flower wax. D. BELSIT: So ow we have acacia decurres suflower seed wax polyglyceryl three acids. Does that bother ayoe that the flower wax of acacia decurres was isufficiet ad we're icludig it i this groupig. D. LIEBLE: Do we kow why it was isufficiet? D. SNYDE: I'm guessig compositio ad impurities. D. LIEBLE: So we just do't kow what the fatty acid profile is basically? So you're worried about possibly havig a sigificat amout of arachidoic acid? That would be the thig he would like to verify that it does't.

24 Distributed for Commet ly -- Do Not Cite or Quote D. BELSIT: From my s I've bee away for the past week so I got through this but I did't look as to why it was isufficiet. D. LIEBLE: That's what I would be lookig for I thik ad I realize we do't ecessarily have i the report here fatty acid profiles for all the plat derived igrediets. Table 5 has some of them. D. BELSIT: So i goig through the report we have 60 uses i lipsticks to 39 per cet. But were told the diisostearyl polyglyceryl-3 was okayed for food use so I'm assumig o oe has problems with the igestio from all of those lipstick products? D. SNYDE: No. D. BELSIT: It is a peetratio ehacerso we have to put that ito the discussio. So there was this thig i the (iaudible) studies about a impact o light dark cycle disturbace ad they thought that is what caused some issues i those (iaudible) I'm assumig we just leave that off? D. SNYDE: Yes. D. BELSIT: So uder irritatio ad sesitizatio more tha adequately covered. It thik there were some issues where occasioally there was irritatio. I was't overwhelmed by it but if we wated to be safe we could go o formulated to be o irritatig to cover that aspect. I woder if ay of you had ay commets. D. SNYDE: Your memo said there were 75 igrediets but the report said 73. MS. FIUME: I'm sorry I tried to catch it i most places. There were two igrediets that we foud at the very ed so it was actually 75. I kow the itroductio has 75. D. SNYDE: kay thak you. D. LIEBLE: So Moice haded me the report ad it does look like simply that it was isufficiet for the compositio. That had appeared to be it. It just did't have the fatty acid profile. D. SNYDE: Would it be advatageous if we had a boiler plate for what we cosider data eeds ad issues for ail applicatios like we do for ihalatio ad other thigs? D. BELSIT: I thik creatig a boiler plate may be a little difficult because some compoets i the ail product is goig to be volatile ad the we talk about the fact that the amout i the breathig zoe is small or below the threshold of toxicologic cocer. There are may differet optios. D. LIEBLE: Well I was thik of that very issue whe we do that with oxidized ad o oxidized because our data eeds are differet for those. D. SNYDE: I do't thik it is the aswer to my problem. My issue is very simple is you've got to defie what the chemical substace is ad if we ask for impurities give impurities. Just because it goes o the ail does't chage the fact that you have't defied the impurities. You have to defie the chemical ature of the substace so I do't thik a boiler plate is goig to take care of that. D. BELSIT: Goig back to the polyglyceryl fatty acids Moice o page 3 of the PDF uder case reports it talks about a 80 year old female with a rash ad she was patch tested ad it says to go o this is the third lie ad the irritatio caused by this substace. MS. FIUME: I believe it was [iaudible]. D. BELSIT: I uderstad but is that the author's words because it is ot irritatio if it persisted it is sesitizatio. MS. FIUME: It was probably the author's words but I ca chage it too. D. BELSIT: Well if it's the author's words I would put it i quotatio marks ad put sic because that is ot a appropriate descriptio that patch test was positive. I thought overall these were all safe as used whe formulated to be o irritatig just to cover that small little bit of irritat data ad the the oly questio I had is are you okay with icludig that oe flower wax? D. LIEBLE: Not today. But I agree with you this is a large but straightforward family of igrediets ad you metioed the peetratio ehacemet eeds to be covered i the discussio. These are extesively metabolized to commo utriets ad physiologic itermediates. I see o issue with that. D. BELSIT: -- Moice o page 33 the paragraph with apricot kerel oil dow towards the bottom. So I would add here ad rechallege the resposes were see i both the cotrol ad the experimetal group because that's oe really fluky sesitizatio study where it looks like they're actually sesitized the (iaudible) or somethig else i the mixture because you're gettig positive reactios i both cotrol ad experimetal group. So I thought I did't really have a lot of issues with that. The I had a list of some of the discussio. We eed peetratio ehacemet, respiratory boiler plate. A lot of these are derived from plat substaces so do we eed the botaical boiler plate? So we eed the botaical boiler plate ad I do't

25 Distributed for Commet ly -- Do Not Cite or Quote eve kow if we wat to discuss that fluky repro study with the day ight issue where the fluky (iaudible) study do those eve require I mea I thik that is puttig to much emphasis o studies that are obviously flawed. D. LIEBLE: I agree. D. BELSIT: So really just peetratio, respiratory, botaical ad a coclusio of safe whe formulated to be o irritatig. MS. FIUME: With the pesticide ad heavy metal boiler plate as well? D. BELSIT: Yes. Ad the we will be elimiatig the flower wax. MS. FIUME: Dr. Belsito ca I ask for a clarificatio o the botaical boiler plate because we have the iformatio ow that says it is ot a costituet of cocer laguage that we've bee usig i the pure botaicals it is just the heavy metals? D. BELSIT: Yes I'm ot cocered about the costituets of cocer. There's othig that pops up at me at the levels these are used it is more just the pesticides heavy metals. MS. FIUME: Just for your iformatio so whe it comes back just earlier this week I did receive more iformatio o probably at least 0 to of these igrediets ad it was mostly acute talks ad irritatio sesitizatio ad oe or two photo cotact studies ad they were all egative. So just agreed with what was already there. D. BELSIT: Now i my discussio of my last poit do we wat to say aythig about the mucosal exposure i lipstick products ad that that product was cosidered for food as log as it was (iaudible) free or we do't eed to discuss that? D. SNYDE: I thik it is a o issue. D. LIEBLE: I agree. D. BELSIT: kay aythig else with this group? So we're goig to say discussio peetratio ehacemet, respiratory boiler plate, botaical boiler plate ot about costituets but about heavy metals ad pesticides, elimiate the acacia jojoba flower wax ad safe as used whe formulated for beig o irritatig. D. LIEBLE: Souds good. Marks Team April, 06 (st review) D. MAKS: Next -- Polyglyceryl fatty acid esters. This is a draft report, so it's the first time we've see these. A small list of igrediets, oly 75, so we previously reviewed compoets of these igrediets ad foud them safe. That's o page 68, so I guess goig back, is there, i this log, laudry list of igrediets of these polyglyceryl fatty acid esters, aythig we should remove? This is goig to be a first if we ca look at 75 igrediets ad say they all look good i this groupig. Where's Bart? MS. FIUME: e had to go over ad do -D. MAKS: Yeah, o, that's fie. I'm oly teasig here. So o, you say it looks fie. Tom, looks fie, the 75 ad o Shak are you fie with the 75? D. SANK: I split it i two, the simple polyglyceryl fatty acids, I foud were okay. But I eeded help from the chemists o the multi-esters. D. ILL: Are you talkig about, for example, the oes derived from plat? Plat derived fatty acid mixtures, is that what you're -D. SANK: Let's see -D. MAKS: Multi-ester, you refer to it. D. SANK: They are referred to here as multi- esters. MS. FIUME: PDF page 38. D. SANK: 38? Thak you. D. MAKS: Ad the help you eeded, o, i terms of, from the chemists, that's why Bart, actually I was teasig Bart, but it would be good to have Bart here i terms of clearig up the chemistry. D. ILL: Well, I get your poit. It's kid of a level -- this is sort of like mooglyceride, mooacylglycerols ad diacylglycerols, the way that these are made; I thik you ca't divorce the groups, because you get mixtures. That's my take o it.

26 Distributed for Commet ly -- Do Not Cite or Quote D. SANK: Ad I have here that we have the data for simple polyglyceryl fatty acids. Ca we use those stated to cover all of the multi-esters? I also have a questio, I'm ot sure why these compouds absorb UV light, somewhere i the report. D. MAKS: I do't see ay phototox data at all. D. SANK: ight. D. ILL: I would't predict that we'd eed it, uless there's some highly cojugated usaturated fatty acid that I'm missig here. But I was goig to brig up that we have a few plat derived fatty acids that are used for the esterificatio that, to my memory, ad I did't go back ad go through the 400 ad some oils that we had i the oil report, to my memory, we did't previously review it. Ad I wat to say fatty acid compositio wheever we actually do the safety assessmet. I'm missig iformatio right ow, I guess is the best way to put it. MS. FIUME: I brought the fatty acid compositio that was available from the oils report ito this report. D. ILL: ight. So there are some plats that were't i the oils report that are fatty acids that are used for these, I'm cofidet. I did't cout them. MS. FIUME: Ad I did look for fatty acid compositio o typical data sheets, so whatever I did fid, there is additioal i here that was ot i the oils. But whatever I could fid is i here. D. ILL: kay. So that meas there's still some missig oes I guess is -- but that does't mea we remove the igrediets. It oly meas we eed some iformatio. MS. FIUME: Dr. Shak, while you're lookig, if I could just -D. SANK: Sure. MS. FIUME: -- add some iformatio. So we had already received a lot of iformatio from idustry ad the last week, because it was still withi the 60-day commet period, we did receive aother large submissio. Most of the iformatio was acute, oral tox, ocular irritatio ad ski sesitizatio ad geotox o a umber of igrediets. It was all egative. But we also received some phototoxicity data o polyglyceryl-0 oaisostearate, ad it was ot phototoxic, so we have two studies i guiea pigs for that compoud. D. SANK: Thak you. D. MAKS: So it's at wave three, Moice. MS. FIUME: It is. D. MAKS: That's good to kow. I mea that's very helpful. MS. FIUME: Ad I've actually, if ayoe, I oly have oe copy, but I've marked i red o the data profile, if ayoe would like to see it, what the additioal data we received is. Differet tha what's i the report. D. MAKS: That'll -- you'll actually, whe we get the ext reditio of this report, you'll -- that'll be highlighted, this is ew. MS. FIUME: It'll all be highlighted. It's just there was a lot of iformatio. I kid of like to make sure I kew what we did receive. D. MAKS: So Bart is back here, o Shak. Did you wat to ask him about the chemistry? Ad you were sayig, ca we use the data from the simple esters to cover the multi- esters? D. SANK: Correct. D. MAKS: Ad how do you thik the chemists ca aswer that? Meaig, is this somethig that you say structurally this is similar, so we ca read across? r do you thik that's somethig we actually -- ow you got more data. I do't kow if that covered some of the multi-esters or ot. MS. FIUME: It did. D. MAKS: h it did. kay. D. ILL: So agai, my aswer was, that the way that these thigs are made, you're goig to get mixtures ad so eve if it says it's the moo-ester, it's a mixture of moo-esters ad -- udoubtedly cotamiated with some di ad tri. D. MAKS: kay. D. ILL: Ad so if it's marketed as the di, it's goig to have some moo ad a collectio of di ad so that I thik, my sese is at least, that they're all mixtures based o the way that they're made. Ad that really takig them apart would compromise ay read across. D. MAKS: So, o Shak, is that reassurig? D. SANK: Yes.

27 Distributed for Commet ly -- Do Not Cite or Quote D. MAKS: So we ca say ow all the 75 igrediets are okay i the report? kay, good, that's -- ay data eeds from -- ad I kow we have wave three there. But ay data eeds at this poit? No. Ad irritatio, sesitizatio was good? D. ILL: Just the fatty acid compositios o the plats that were't part of the vegetable oil report earlier. D. MAKS: But would that prohibit us from issuig a tetative report with a safe coclusio? D. ILL: Yes. D. SANK: I would like to say isufficiet o those. D. BEGFELD: I thought that you said you had some plat readigs. D. ILL: Some. D. BEGFELD: h, ot eough for you? I mea, we have't see these. MS. FIUME: It was i the report. D. BEGFELD: h was it? kay. I thought you said it was ew. D. ILL: Well that -- my poit is that's what eables read across or lack thereof. D. BEGFELD: I thik this deserves a big discussio, i the discussio. All this 00 plus, plus read across ad -D. ILL: What I was surprised to see is that these polyglyceryls are biotrasformed as if they were mooglycerides because, likig that, I was woderig how we eve, you have your mooglycerol, ad I apologize, I'll probably go i ad erase my commet but it was sort of, I ca't fathom how you'd thik that what we did o the mooacylglycerols has ay relatioship whatsoever to these. Because polyglyceryls are ot physiological, but at least it seems like we ca cleave freely ad, yeah, we geerate polyglyceryls, but o toxicology I ca suspect. But owhere, othig i evidece. D. MAKS: So I still have't, from the team, got a cosesus moved. I'll be secodig a motio. Is it goig to be safe or tetative or isufficiet data o those. Safe? D. SANK: Safe. D. MAKS: o Shak, safe. D. ILL: Disset. D. MAKS: Disset, okay. D. ILL: But I do't have a list, I should get the list. Actually, I do't have the beefit of wave three. So -MS. FIUME: h, wave three does't have fatty acid compositio. D. ILL: kay. MS. FIUME: I just was -- we eed to say that there were additioal fatty acid compositio i here, i additio to what was i the oil report. D. ILL: kay. So I just eed to go through ad look ad see what's missig. D. MAKS: Fatty acid compositio of plat. D. ILL: There are certai, where it's esterified with a plat-derived fatty acid, plat oil derived fatty acid ad there are some plats that appeared i here that were ot i our oils report. But I did't compile a list of those, there are ot may. D. MAKS: kay, well, I'll go ahead ad presumably secod the motio to ed the report with a safe coclusio. Ad the I'll let you, o ill, obviously, uh, coclusio. D. ILL: kay. D. MAKS: Ad the. o, you ca go ahead ad metio if you wat, the eed for fatty acid compositio of plat oil derived igrediets. kay. Ay other commets? D. ILL: Ay chace you could (iaudible) ad I keep gettig from her? I'll have to stay up half the ight fidig out which oes -- o I ca fid it. D. EISENMANN: I wat to look for oe that I did't fid ay data o. MS. FIUME: kay. All right. MS. FIUME: Dr. Marks? Before we move o, ca you give me some discussio items for the polyglyceryl fatty acid esters? What you would like to see i there. D. SLAGA: Well, sice you have all the related data it would be ice to have that discussed i the discussio sice they're all safe, ad the I thik that's a great policy to avoid discussio. I did't see aythig egative to put i the discussio.

28 Distributed for Commet ly -- Do Not Cite or Quote D. BEGFELD: I do't thik you have to put what's egative. You have to put what to do with the read across, what -- all these igrediets. D. SLAGA: Well, that would be, I guess, part of the discussio too. M. BEST: It certaily seems mysterious to a layperso. I mea (laughter) the read across, right. I kow that's goe before us or maybe halluciatig kid of what that meas ad etails why it's okay (iaudible) certaily. D. ILL: So except for the oes that we do't kow about, the fatty acids that are esterified oto the polyglyceryls are i commo with both the vegetable oil igrediets that we reviewed before ad also the acyl glycerols that we've reviewed before. So the differece is that we have polyglyceryl core istead of simple glycerol core. It appears that i terms of bio-hadlig -- I kow Dr. Liebler does't like that word but it's real -- i terms of bio- hadlig that we are able to freely remove the fatty acids from the polyglyceryls ad our idicatio from Toxicokietics is that we are able to metabolize these to fatty acids i polyglyceryls. The polyglyceryls are very hydrophilic ad effectively cleared from the body rapidly, ad there's o evidece from the data that we do have that the polyglyceryls geerated the way that i terms of systemic availability cause ay toxicological affects, ad I believe we have very high doses give orally, ad i that particular case we would expect absorptio ad the toxicology should be relevat to aythig dermal that I ca evisio. Does that help at all? D. MAKS: Moice? MS. FIUME: Yes, but if I could get somethig -- some additioal wordig writte i case it's i a capture. Just eve a ote of some terms ad I ca go with it from there. Thak you. D. MAKS: o Shak, did you wat to add aythig more i terms of the discussio? D. SANK: No. D. ILL: Are you hopig for that tomorrow morig, or ca you me ad I'll back what I just said? (laughter) D. SANK: Yes. MS. FIUME: Yes, I just eed to be able to have it to be -- if it goes out as tetative to be able to release it ext week. D. ILL: kay, hopefully it got captured somewhere here. MS. FIUME: I'm hopig the -D. MAKS: Well, it'll be i the recorded miutes. So, actually it will all be there. kay, ay other commets? MS. FIUME: Dr. Marks? Before we move o, ca you give me some discussio items for the polyglycerol fatty acid esters? What you would like to see i there. D. SLAGA: Well, sice you have all the related data it would be ice to have that discussed i the discussio sice they're all safe, ad the I thik that's a great policy to avoid discussio. I did't see aythig egative to put i the discussio. D. BEGFELD: I do't thik you have to put what's egative. You have to put what to do with the read across, what these igrediets. all D. SLAGA: Well, that would be, I guess, part of the discussio too. M. BEST: It certaily seems mysterious to a layperso. I mea (laughter) the read across, right. I kow that's goe before us or maybe halluciatig kid of what that meas ad etails why it's okay (iaudible) certaily. D. ILL: So except for the oes that we do't kow about, the fatty acids that are esterified oto the polyglycerols are i commo with both the vegetable oil igrediets that we reviewed before ad also the asoglycerols that we've reviewed before. So the differece is that we have polyglycerol core istead of simple glycerol core. It appears that i terms of bio hadlig I kow Dr. Liebler does't like that word but it's real i terms of bio hadlig that we are able to freely remove the fatty acids from the polyglycerols ad our idicatio from Toxicokietics is that we are able to metabolize these to fatty acids i polyglycerols. The polyglycerols are very hydrophilic ad effectively cleared from the body rapidly, ad there's o evidece from the data that we do have that the polyglycerols geerated the way that i terms of systemic availability cause ay toxicological affects, ad I believe we have very high doses give orally, ad i that particular case we would expect absorptio ad the toxicology should be relevat to aythig dermal that I ca evisio. Does that help at all? D. MAKS: Moice? MS. FIUME: Yes, but if I could get somethig some additioal wordig writte i case it's i a capture. Just eve a ote of ski terms ad I ca go with it from there. Thak you. D. MAKS: o Shak, did you wat to add aythig more i terms of the discussio?

29 Distributed for Commet ly -- Do Not Cite or Quote D. SANK: No. D. ILL: Are you hopig for that tomorrow morig, or ca you me ad I'll back what I just said? (laughter) D. SANK: Yes. MS. FIUME: Yes, I just eed to be able to have it to be if it goes out as tetative to be able to release it ext week. D. ILL: kay, hopefully it got captured somewhere here. MS. FIUME: I'm hopig the D. MAKS: Well, it'll be i the recorded miutes. So, actually it will all be there. kay, ay other commets?

30 Distributed for Commet ly -- Do Not Cite or Quote Safety Assessmet of Polyglyceryl Fatty Acid Esters as Used i Cosmetics Status: elease Date: Pael Meetig Date: Draft Fial eport for Pael eview September, 06 September 6-7, 06 The 06 Cosmetic Igrediet eview Expert Pael members are: Chairma, Wilma F. Bergfeld, M.D., F.A.C.P.; Doald V. Belsito, M.D.; oald A. ill, Ph.D.; Curtis D. Klaasse, Ph.D.; Daiel C. Liebler, Ph.D.; James G. Marks, Jr., M.D., oald C. Shak, Ph.D.; Thomas J. Slaga, Ph.D.; ad Paul W. Syder, D.V.M., Ph.D. The CI Director is Lillia J. Gill, D.P.A. This safety assessmet was prepared by Moice M. Fiume, Assistat Director/Seior Scietific Aalyst/Writer ad Bart eldreth, Ph.D., Chemist. Cosmetic Igrediet eview 60 L Street, NW, Suite 00 Washigto, DC ph fax cirifo@cir-safety.org

31 Distributed for Commet ly -- Do Not Cite or Quote ABSTACT The Cosmetic Igrediet eview (CI) Expert Pael (Pael) assessed the safety of 74 polyglyceryl fatty acid esters. Each of the esters i this group is a polyether comprisig to 0 glyceryl residues, ed-capped by esterificatio with simple carboxylic acids, such as fatty acids. Most of these igrediets are reported to fuctio i cosmetics as ski-coditioig agets ad/or surfactats. The Pael reviewed the available data ad cosidered coclusios from relevat previous CI reports, ad determied that these igrediets are safe i cosmetics i the preset practices of use ad cocetratio described i this safety assessmet whe formulated to be o-irritatig. INTDUCTIN This is a safety assessmet of the polyglyceryl fatty acid esters as used i cosmetic formulatios. Each of the esters i this group is a polyether comprisig to 0 glyceryl residues, ed-capped by esterificatio with simple carboxylic acids, such as fatty acids. The 74 igrediets icluded i this report are listed alphabetically i Table. Table ad Table 3 preset these igrediets based iitially by icreasig polyglyceryl chai legth ad secod by icreasig alkyl chai legth; however, whe there is a mixture of fatty acid costituets, those igrediets are preseted by chai legth for the polyglyceryl moiety ad alphabetically based o the fatty acid compoet. Test data are preseted based o icreasig chai legth (i.e., the order provided i Table ad Table 3). Accordig to the Iteratioal Cosmetic Igrediet Dictioary ad adbook, most of these igrediets are reported to fuctio i cosmetics as ski-coditioig agets ad/or surfactats (Table 3). Additioal fuctios have also bee reported. I 0, the Cosmetic Igrediet eview (CI) Expert Pael (Pael) published a safety assessmet of a family of igrediets that icluded Polyglyceryl-0 ctaisooaoate; the Pael cocluded that all of the igrediets amed i that report are safe i the preset practices of use ad cocetratio idetified i that assessmet. Because Polyglyceryl-0 ctaisooaoate is a polyglyceryl fatty acid ester ad is structurally related to the igrediets i this report, it is beig icluded i this safety assessmet. The Pael has recetly reviewed the safety of mooglyceryl mooesters, ad cocluded that the mooglyceryl mooesters are safe i cosmetics i the preset practices of use ad cocetratio described i that safety assessmet.3 Mooglyceryl mooesters ad the polyglyceryl fatty acid esters both cosist of the same startig materials, ad they have the same potetial metabolites. The differece betwee these two families of igrediets is that mooglyceryl mooesters are structurally costituted of the esterificatio products of oly oe equivalet of glyceri ad oe equivalet of a carboxylic acid, as opposed to the varyig umber of equivalets of glyceri ad fatty acids i the polyglyceryl esters. The Pael has previously reviewed the safety of igrediets that represet some of the startig materials of the polyglyceryl fatty acid esters that may persist as residual impurities i the polyglyceryl esters products, or may represet potetial metabolites (e.g., from the actio of esterases i the ski), such as glyceri ad free fatty acids. A list of relevat igrediets that have bee reviewed ad the associated coclusios are provided i Table 4. (The full reports ca be foud o the CI website: ther igrediets, such as dipropylee glycol ad polypropylee glycols (PPGs), have also bee reviewed ad are also icluded i Table 4 because they have similar properties ad fuctios. Much of the toxicity data icluded i this safety assessmet were foud o the Europea Chemicals Agecy (ECA) website.4 The ECA website provides summaries of iformatio geerated by idustry, ad it is the summary data that are reported i this safety assessmet whe ECA is cited. Also, whe deemed appropriate, read-across data from ECA are icluded i this report. I some ECA dossiers, such as i,,3-propaetriol, homopolymer, diisooctadecaoate, the umber of polyglyceryl chais is ot defied. Because the umber of polyglyceryl chais is ot defied, ad it therefore is uclear what specific igrediet is beig studied, the data are preseted as potetial read-across data. Several studies that are summarized i this safety assessmet examied the toxicity of a polyglyceryl ester. The exact compositio of the test material was ot idetified i may of the studies ad, geerally, very few details were provided. owever, this iformatio is icluded i this safety assessmet for completeess. CEMISTY Defiitio ad Structure The igrediets i this report are each structurally costituted of the esterificatio products of polyglyceri chais ad fatty acids. These igrediets vary i the umber of equivalets of glyceri ad fatty acids, ad the legth of those fatty acids (Figures ad ). The defiitios ad idealized structures of the polyglyceryl fatty acid esters are provided i Table 3.

32 Distributed for Commet ly -- Do Not Cite or Quote Figure. Geeric structure of polyglyceryl esters, wherei represets hydroge or the residue of certai fatty acids, ad varies from to 0 C3 Figure. Polyglyceryl- caprate (wherei, i the geeral structure i Figure, is hydroge i 3 istaces ad caprate i istace; ad is ) The polymerizatio process used to produce polyglycerol yields a distributio of differet oligomers that have a primarily liear structure.5 I additio to the liear cofiguratio, a sigificat part of the polyglycerol is of the brached types, e.g., origiatig from,- ad,--ether likages. Polyglyceryl esters of fatty acids have a hydrophilic polyglycerol group that cosists of a fiite umber of hydroxyethers of glycerol ad a hydrophobic fatty acid chai withi the same compoud.6 These igrediets are o-ioic compouds, ad a rage of polarities is possible because of the variatio of the degree of polymerizatio ad umber of fatty acids per headgroup. Physical ad Chemical Properties The physical properties ad appearace of polyglyceryl esters of fatty acids maily depeds o their molecular structure. Typically, the physical form of those with a higher degree of polymerizatio ad shorter or usaturated fatty acid chais rages from viscous liquids to plastic pastes, ad the polyglyceryl esters with a lower degree of polymerizatio ad loger, saturated fatty acid chais are geerally powders, flakes or small beads.6 The color of the esters is depedet o the source of the fatty acids, but the polyglycerol will cotribute to the color.5 The solubility of polyglyceryl esters i orgaic solvets depeds o the ature of the solvet ad the polarity of the ester but, geerally, the esters will show best solubility i protic ad polar aprotic solvets, such as lower alcohols ad dimethyl sulfoxide (DMS). Polyglyceryl esters of fatty acids are polar or amphiphilic lipids, ad the amphiphilic properties i water exhibit mesomorphic activities formig lyotropic liquid crystals.6 The polyglyceryl ester as a polar emulsifier will form aggregated bodies, such as micelles, at low cocetratios i water. Polyglyceryl esters of fatty acids become ustable with water ad high temperatures, ad the istability is ehaced i the presece of alkalie substaces. The presece of a alkali or acid results i the partial hydrolysis of fatty acids ad the formatio of free polyglycerol. Polyglyceryl esters are comparable to mooglycerides with respect to hydrolysis. I ezymatic systems, lipases will hydrolyze the polyglyceryl ester, as see i the case of other glycerides.5 The average fatty acid compositios (whe available) are described i Table 5, ad the physical ad chemical properties of may of the igrediets icluded i this safety assessmet are preseted i Table 6. Method of Maufacture The sythesis of polyglyceryl esters of fatty acids is achieved by the polymerizatio of a hydrophilic headgroup, ad the esterificatio of the headgroup with the hydrophobic tails.6 Polyglycerols are geerally prepared from a alkalie codesatio of glycerol molecules at elevated temperature, with the removal of water. Because oe glycerol molecule possesses 3 reactive sites ( secodary alcohol (ceter positio) ad primary alcohols (termial positios)), several kids of diglycerol molecules ca be formed. If the polymerizatio proceeds to tri-, tetra-, or higher glycerols, the the umber of possible liear or brached isomers icreases expoetially. Moreover, oce a dimer is formed, cyclic products ca result from itramolecular rig-closure reactios (Figure 3).

33 Distributed for Commet ly -- Do Not Cite or Quote Figure 3. Polymerizatio of glycerol7 Polyglycerols ca be used as produced, or they may be stripped of excess glycerol ad cyclic glycerols by steam distillatio at reduced pressure.7 Alteratively, strippig processes have bee developed usig mesoporous ad zeolite catalysts uder milder coditios. ther possible processes for productio of a polyglycerol use reactive petrochemical substaces such as epichlorohydrie (chloro-,3-dihydroxypropae), which is allowed to react with glycerol i a etherificatio process. owever, epichlorohydrie is a hazardous material, ad the purificatio of the polyglycerol complicates the process.5 Glycidol is also used for the productio of polyglycerol, ad the oxirae group easily reacts with glycerol or epichlorohydrie, depedig o the coditios of the reactio ad the type of polyglycerol required. owever, these processes use chemicals that make the process o-competitive i relatio to a glycerol based process. Accordig to the World ealth rgaizatio (W) Food ad Agriculture rgaizatio (FA), polyglyceryl esters of fatty acids (as used i foods) are formed by reactig polymerized glycerols with edible fats, oils (edible fats ad oils are primarily triglycerides), or fatty acids.8 The degree of polymerizatio varies, ad is specified by a umber (such as tri-) that is related to the average umber of glycerol residues per polyglycerol molecule. Polyglyceryl esters of fatty acids also ca be prepared by direct esterificatio betwee polyolethers ad fatty acids at elevated temperatures (T > 00 C) with the removal of water.5,6 The esterificatio is ormally carried out uder alkalie coditios ad ca be stopped by simply addig a acid ad lowerig the reactio temperature. To obtai a large amout of moo- ad diesters, the sythesis is geerally carried out with a excess of polyglycerol. Some ureacted polyglycerol ca be removed by simple gravimetric settlig, ad the remaiig fractio by extractio with water combied with salts i a charge-wise separatio process. Alteratively, polyglyceryl esters ca be prepared by a iter-esterificatio (or trasesterificatio) betwee polyglycerols ad triglycerides; this is a reactio carried out at a high temperature ad uder coditios similar to direct esterificatio, but the degree of polymerizatio is ot as high as obtaied with direct esterificatio. Trasesterificatio betwee polyglycerol ad alcohol esters of fatty acids is aother possible method of sythesis; usig this process, methaol is cotiuously removed from the reactor, ad the process icludes a secod step to reduce the remaiig ureacted oxirae oxyge. Compositio ad Impurities Joit FA/W Expert Committee o Food Additives (JECFA) specificatios for polyglyceryl esters of fatty acids used i foods state the polyglycerol moiety shall be composed of ot less tha 70% of di-, tri- ad tetraglycerols ad shall cotai ot more tha 0% of polyglycerols equal to or higher tha heptaglycerol ; that acids other tha fatty acids shall ot be detectable; ad that ot more tha mg/kg lead is detectable.8 Mior amouts of moo-, di-, ad triglycerides, free glycerol ad polyglycerols, free fatty acids, ad sodium salts of fatty acids may be preset. Trace amouts of ureacted glycerol ad fatty acid soaps ca be foud i polyglyceryl esters of fatty acids.6 Specificatios, impurities or costituets of some of the igrediets icluded i this report are provided i Table 7. USE Cosmetic The safety of the cosmetic igrediets icluded i this safety assessmet is evaluated based o data received from the U.S. Food ad Drug Admiistratio (FDA) ad the cosmetics idustry o the expected use of these igrediets i cosmetics. Use frequecies of idividual igrediets i cosmetics are collected from maufacturers ad reported by cosmetic product category i FDA s Volutary Cosmetic egistratio Program (VCP) database. Use cocetratio data are submitted by Idustry i respose to surveys, coducted by the Persoal Care Products Coucil (Coucil), of maximum reported use cocetratios by product category. Based o 056 VCP data ad the results of the Coucil surveys, 77 of the 74 igrediets icluded i this report are reported to be i use. Accordig to 06 VCP registratio data, Polyglyceryl-3 Diisostearate has the most reported uses of

34 Distributed for Commet ly -- Do Not Cite or Quote the igrediets icluded i this report; of the 37 reported uses, 363 are i leave-o formulatios, 6 of which are i lipsticks9 (Table 8). Polyglyceryl-4 Isostearate has the secod highest umber of reported uses; of the 80 uses, all but oe is i leave-o products. The results of the cocetratio of use surveys coducted by the Coucil idicate Polyglyceryl- Triisostearate ad Polyglyceryl-3 Diisostearate have the highest cocetratio of use i a leave-o formulatio; these igrediets are used at 40% ad 39% i lipsticks, respectively0-4 (Table 8). Additioally, supplier-recommeded use cocetratios are provided; most of the recommeded use levels are 0% (Table 9). Use cocetratios were reported for several igrediets that were ot reported as used i the VCP; it should be presumed there is at least oe use i every category for which a cocetratio is reported. Additioally, several igrediets have uses reported i the VCP, but cocetratio of use data were ot received. The 97 igrediets with o reported uses i both the VCP ad idustry survey are listed i Table 0. May of these polyglyceryl fatty acid esters are used i products applied to the eye area, products that ca result i icidetal igestio, or products that come ito cotact with mucous membraes. The highest reported cocetratios of use for these types of exposures are 4.% Polyglyceryl-4 Isostearate i other eye make-up preparatios ad 40% Polyglyceryl- Triisostearate i lipstick formulatios (resultig i icidetal igestio ad mucous membrae exposure). A few of the polyglyceryl fatty acid esters are reported to be used i baby products; Polyglyceryl-3 Diisostearate has the highest reported use i a baby product, i.e., % i baby lotios, oils, ad creams. Additioally, some of the polyglyceryl fatty acid esters are used i cosmetic sprays ad could possibly be ihaled; for example, Polyglyceryl-3 Distearate is reported to be used at 3% i spray body ad had creams. I practice, 95% to 99% of the droplets/particles released from cosmetic sprays have aerodyamic equivalet diameters >0 µm, with propellat sprays yieldig a greater fractio of droplets/particles <0 µm compared with pump sprays.5,6 Therefore, most droplets/particles icidetally ihaled from cosmetic sprays would be deposited i the asopharygeal ad thoracic regios of the respiratory tract ad would ot be respirable (i.e., they would ot eter the lugs) to ay appreciable amout.7,8 All of the polyglyceryl fatty acids amed i this report are listed i the Europea Uio ivetory of cosmetic igrediets, ad oe of the listed igrediets are restricted from use i ay way uder the rules goverig cosmetic products i the Europea Uio.9 I Australia, accordig to a Natioal Idustrial Chemicals Notificatio ad Assessmet Scheme (NICNAS), Polyglyceryl-0 Laurate (~60% pure, with ~40% polyglyceri-0 ad ~% sodium laurate) is ot cosidered to pose a ureasoable risk to public health whe used i the proposed maer (i.e., 3% i ski lotios), ad caot be classified accordig to the Globally armoised System for the Classificatio ad Labellig of Chemicals or the Approved Criteria for Classifyig azardous Substaces.0 No-Cosmetic Polyglyceryl esters of fatty acids, up to ad icludig the decaglycerol esters, are permitted as multipurpose direct food additives whe () they are prepared from cor oil, cottoseed oil, lard, palm oil from fruit, peaut oil, safflower oil, sesame oil, soybea oil, ad tallow ad the fatty acids derived from these substaces (hydrogeated ad o-hydrogeated) ad/or oleic acid derived from tall oil fatty acids; () they are used as emulsifiers i food, i amouts ot greater tha that required to produce the iteded physical or techical effect; (3) polyglyceryl esters of a mixture of stearic, oleic, ad cocout fatty acids are used as a cloud ihibitor i vegetable ad salad oils whe use is ot precluded by stadards of idetity, ad oleic acid derived from tall oil fatty acids may be used as a substitute for, or together with, the oleic acid; ad (4) polyglyceryl esters of butter oil fatty acids are used as emulsifiers i combiatio with other approved emulsifiers i dry, whipped toppig base, whe used at a level ot i excess of the amout required to perform their emulsifyig effect. [CF7.854] JECFA established a acceptable daily itake (ADI) of 0-5 mg/kg bw for polyglyceryl esters of fatty acids havig a average chai legth of up to 3 glycerol uits, ad a ADI of mg/kg bw for polyglyceryl esters of iteresterified ricioleic acid. I the EU, the esters are listed as food additives at cocetratios betwee 5000 ad 0,000 mg/kg i certai foods, ad up to 7% free glycerol/polyglycerol is allowed (i.e., 700 mg/kg).3 Polyglyceryl-0 Caprylate/Caprate4 ad Polyglyceryl0 leate5 are polysorbate replacers, dispersig agets, ad emulsifiers i foods. Several polyglyceryl oleates are allowed for use as iactive igrediets i approved drug products.6 Polyglyceryl-3 leate is approved as a iactive igrediet i topical, oral, ad vagial drug products. I oral products, maximum potecy is 0.87 mg i gelati-coated capsules, mg i soft gelati capsules, ad 30 mg/ml i oral solutios; i vagial products maximum potecy is.7% i regular ad sustaied-release emulsios ad creams. Approved dermal use is i topical sustaied release creams; a maximum potecy was ot specified. Polyglyceryl-4 leate is approved as a iactive igrediet i vagial emulsios ad creams at a maximum potecy of.7%. Polyglyceryl-0 leate is approved for use i oral soft gelati capsules ad i oral solutios; maximum potecy is 99.9 mg ad 90 mg/ml, respectively. Polyglyceryl-0 leate is used as a iteral lubricat for polyviyl chloride (PVC) sheet ad film ad as a ati-fog aget i plasticized PVC film formulatios.5

35 Distributed for Commet ly -- Do Not Cite or Quote TICKINETICS Peetratio Ehacemet Polyglyceryl-3 Diisostearate Polyglyceryl-3 Diisostearate was ot a peetratio ehacer i a study that evaluated the ski peetratio ehacig effects of several excipiets o the hydrophilic drug 5-fluorouracil.7 Figure 4. 5-Fluorouracil The ability to ehace ski peetratio was determied i vitro by measurig ski permeability coefficiets for huma abdomial ski samples. Polyglyceryl-3 Dioleate Polyglyceryl-3 Dioleate is reported to be a water-i-oil surfactat/solubilizer associated with ehaced drug peetratio.8 Polyglyceryl-4 Laurate ad Polyglyceryl-4 leate The effect of microemulsios o the rate ad extet of release ad peetratio of ceramide AP was evaluated usig a i vitro, multi-layer, membrae model with 4 layers of circular 40-mm membrae films arraged oe over the other.9 wherei m has a value ragig from 3 to 7 ad has a value ragig from to 0. Figure 5. Ceramide AP e test microemulsio, a o/w emulsio, cotaied 5% Polyglyceryl-4 Laurate, 5% Polyglyceryl-4 leate, ad 60% water-, petaediol (:9); the other, a w/o emulsio, cotaied 30% Polyglyceryl-4 Laurate, 5% isopropyl palmitate/lioleic acid (5:), ad 55% water-, petaediol (.5-8.5). Both test formulatios cotaied 0.4% ceramide AP. A o-ioic hydrophilic cream cotaiig 0.5% ceramide AP was used as a referece formulatio. Each test substace, i a amout that cotaied 50 µg ceramide AP, was spread evely over a 4 cm area. The formulatio was left i place for 580 mi; the uabsorbed test material was the removed ad the ceramide was extracted from the membraes. Whe compared to the referece cream, the microemulsios icreased the rate ad extet of peetratio of ceramide AP. Withi 5 mi, a higher percetage of ceramide AP was released from the microemulsios ad peetrated ito the deeper membrae layers; ceramide AP was ot detected i the 3rd ad 4th layers whe the referece cream was used. Also, the amout that peetrated ito each layer at each time poit was greater with the microemulsios tha with the cream. The total percet ceramide AP released ad peetrated was 93.4% with the microemulsio cotaiig 5% Polyglyceryl-4 Laurate ad 5% Polyglyceryl-4 leate, 84.% for the secod test formulatio, ad 73.3% with the referece formulatio. The effect of similar microemulsios ad microemulsio gels o the permeatio of ceramide NP was evaluated i huma thigh ski samples usig Fraz diffusio cells.30 Several microemulsios were evaluated; the formulatios were composed of 30 or 35% Polyglyceryl-4 Laurate/Polyglyceryl-4 leate (:), 0-5% isopropyl palmitate/lioleic acid (9:), 50-60% water/, petaediol (.5:8.5), 0.% ceramide AP, ad 0.% deuterated ceramide NP. The gels were prepared by dispersig.5% Carbopol 940 ito the microemulsio. Some of the formulatios were o/w, ad some were bicotiuous. A hydrophilic cream cotaiig 0.% deuterated ceramide NP was used as a referece formulatio. Twety mg of each formulatio was applied to the ski surface (3.46 cm) ad allowed to permeate for 300 mi. After 300 mi, the ski surface was wiped ad the stratum coreum layer was removed with 0 tape strips over a.06 cm area. Subsequetly, 3 ski puches were take ad the epidermal layer was removed. Permeatio was deeper from the microemulsios, as compared to the cream ad the microemulsio gels; additioally, peetratio was deeper with the o/w formulatios compared to the bicotiuous formulatios. Deuterated ceramide NP i the cream did ot permeate ito the deeper layers of the stratum coreum ad other ski layers. Permeatio from the gel was shallow due to its high viscosity.

36 Distributed for Commet ly -- Do Not Cite or Quote Polyglyceryl-0 Trioleate The effect of Polyglyceryl-0 Trioleate o the permeatio of teoxicam (a o-steroidal ati-iflammatory drug) i a propylee glycol solutio was examied i vitro usig dorsal ski from male artley strai guiea pigs.3 Figure 6. Teoxicam The test solutio was prepared by suspedig 0.3 g teoxicam i a mixed solutio of 3.0 g propylee glycol ad.5 g Polyglyceryl-0 Trioleate, ad the suspesio was adjusted to a p of 6.0. Usig a Fraz-type diffusio chamber, g of the resultig suspesio, which cotaied % teoxicam, 0% propylee glycol, ad 5% Polyglyceryl-0 Trioleate, was applied to the door ski, ad.0 ml of the receptor solutio was sampled every 3 h for 48 h. The flux of teoxicam was statistically sigificatly ehaced by the iclusio of Polyglyceryl-0 Trioleate, from 8. x 0-5 µg/s cm to 8.48 µg/s cm. Absorptio, Distributio, Metabolism, ad Excretio (ADME) ral Metabolic studies of polyglyceryl esters idicated that these esters are hydrolyzed i the gastroitestial (GI) tract, ad utilizatio ad digestibility studies supported the assumptio that the fatty acid moiety is metabolized i the ormal maer.3 Aalytical studies have produced o evidece of accumulatio of the polyglycerol moiety i body tissues. Albio Wistar rats were fed a diet cotaiig 5% or 0% polyglyceryl ester; the exact compositio of the ester was ot provided, but it was stated that the ester was mostly prepared with stearic ad oleic acids.33 Cotrol aimals were give utreated feed. The umber of aimals per group ad duratio of dosig also was ot specified, however some aimals were fed the test diet for up to 4 mos, ad some were maitaied through 3 geeratios. Feed cosumptio was determied for males ad females per group, ad feces were collected for these aimals for 4 days. Fecal lipids were icreased i the test groups whe compared to the cotrols; however, the researchers stated that at least 95-98% of the polyglyceryl esters were digested. Similarly, groups of Wistar rats were fed a diet cotaiig 5% polyglyceryl ester prepared with oleic acid or with liseed oil, ad feed cosumptio was measured ad feces collected for males ad females per group for 4 days.33 The polyglyceryl esters were almost completely utilized. Groups of 8 male Sherma rats were fed a restricted diet cosistig of g of a polyglyceryl ester i 5 g basic diet/day for 3 wks, followed by 8 wks feedig, ad libitum, of a diet cotaiig 8% of the test material.34 The esters used i the study raged i size from to 30 glyceryl radicals, with hydrogeated cottoseed oil or peaut oil. Fecal fat excretio, calculated as total lipid extract, absorptio, ad digestibility values, were determied durig the restricted ad ad libitum feedig periods. The fecal lipids from rats fed the polyglyceryl hydrogeated cottoseed oil esters were higher i palmitic, stearic, ad oleic acids, ad lower i lioleic acid, tha those the fed the polyglyceryl peaut oil esters. Gas-liquid chromatography (GLC) aalysis of the fatty acids of the extracted lipids from the epididymal fat pads determied that oly triglycerides were preset ad o appreciable amouts of polyglycerols were deposited. A study was coducted i which rats were fed a polyglyceryl ester with a high meltig poit for 8 mos.35 No residues were detected i depot fat, or i fat of muscle, liver, kidey or splee. (Details were ot provided.) Polyglyceryl leates ad Decaoleate The metabolism of Polyglyceryl-3 leate, Polyglyceryl-0 leate, ad Polyglyceryl-0 Decaoleate was ivestigated i male Sprague-Dawley rats.36 Groups of 4 rats were dosed with % Polyglyceryl-3 [4C]leate, Polyglyceryl-0 [4C]leate, [4C]Polyglyceryl-0 leate, Polyglyceryl-0 [4C]Decaoleate, ad [4C]Polyglyceryl-0 Decaoleate by stomach tube i a liquid diet; the diet cotaied 7-4 µci of 4C. The study also icluded polyglyceryl esters that are ot cosmetic igrediets, but are similar to igrediets reviewed i this report: triglycerol [4C]tetraoleate ad polyglyceri-0 [4C]mooeicosaoate. Catabolism studies were coducted by admiisterig the test diet, collectig expired C, feces, ad urie with the use of metabolism chambers, ad collectig GI tract cotets ad examiig the carcass of each aimal after 5 h. I additioal groups of 4 aimals, simultaeous catabolism-absorptio studies were coducted by isertig a thoracic duct caula i each aimal, dosig the aimals, ad the usig a metabolism chamber for the collectio of lymph, respiratory C, feces, ad

37 Distributed for Commet ly -- Do Not Cite or Quote urie (each as a sigle fractio) for 5 h. Lipids were extracted from the lymph of aimals dosed with fatty-acid labelled esters, ad the distributio of radioactivity amog the various lipid costituets of lymph was obtaied to determie whether ay itact polyglyceryl esters were preset i the lymph lipids. The metabolism of the esters was also compared to glycerol,3-[4c], [4C]polyglyceri-3, ad [4C]polyglyceri-0. The dispositio of radioactivity followig admiistratio of each compoud is preseted i Table. I the catabolism studies, total recovery of the radioactivity raged from 88-98% of the dose. The distributio of the absorbed [4C]Polyglyceryl0 leate ad [4C]Polyglyceryl-0 Decaoleate was cosiderably differet from that of glycerol. The absorbed polyglyceryls were excreted primarily i the urie ( %) with less tha 4% of the 4 C appearig i the respiratory C ad less tha 5.5% i the carcass; ~ % was foud i the GI cotets. ly small amouts of radioactivity from the [4C]oleic acid moiety were recovered i feces (~0.-0.9%) ad GI cotet (~.8-4.0%), ad the fatty acid appeared to be equally wellabsorbed as the polyceryl-3 ad the polyglyceryl-0 ester. adioactivity from labeled oleic acid moieties of the esters appeared i expired C at close to the same rates as that from glycerol; however, recovery of labeled polyglyceri-3 ad polyglyceri-0 i expired C was less tha 4% of the dose, with upolymerized glycerol accoutig for most of what was recovered. adioactivity from the eicosaoic acid-labeled ester was excreted i C at a lower rate (55.5%) tha that for the oleic acid-labeled compouds. I the catabolism-absorptio studies, 83-0% of the radioactivity was recovered. No more tha 5% of the radioactivity from glycerol-labeled esters were absorbed via the lymphatic system; however, ~ % of the radioactivity from the oleic acid-labeled polyglyceryl esters was recovered i the lymph, ad ~54% was recovered i the lymph of aimals give the eicosaoate-labeled polyglyceryl ester. Lipids from the oleate- (ad eicosaoate-) labeled compouds cotaied 97-99% of the total lymph radioactivity. I vitro hydrolysis studies cofirmed that the oleic acid ester bod i the polyglyceryl-3 ad polyglyceryl-0 esters was readily cleaved. Additioally, it was show that the eicosaoate bod was cleaved more slowly tha the oleate bod. The researchers cocluded that the polyglycerols were ot catabolized, the ether likages are iert to ormal ezymatic hydrolysis, ad the polyglycerols were absorbed ad rapidly excreted i the urie without beig catabolized. Groups of 0 male ad 0 female Sprague-Dawley rats were fed a diet cotaiig.5, 5.0, or 0.0% Polyglyceryl-0 Decaoleate for 90 days, ad the cotrol group was fed a diet cotaiig soybea oil as the dietary fat.37 The percetage of dietary fatty acids absorbed decreased as the levels of Polyglyceryl-0 Decaoleate i the diet icreased. Fat absorptio by males ad females of the 5 ad 0% test groups was statistically sigificatly less tha cotrols at wks 4 ad 0, ad was statistically sigificatly decreased i females of the.5% group at wk 4 ad males of the.5% group at wk 0. GLC aalysis of fecal fatty acids revealed excretio of oleic acid icreased i a dose-related maer; the icreased excretio of fatty acids i geeral, ad oleic acid i particular, idicated that the absorptio of dietary Polyglyceryl-0 Decaoleate was ot complete. The researchers stated that fecal oleic acid may have resulted from excretio of itact Polyglyceryl-0 Decaoleate or from hydrolyzed or partially hydrolyzed but uabsorbed material. I Vitro Polyglyceryl- Diisostearate The metabolism of Polyglyceryl- Diisostearate was evaluated usig a lipase assay; olive oil was used as a referece substace.38 Both Polyglyceryl- Diisostearate ad olive oil icreased the fatty acid cocetratio i all reactio vials i a time depedet maer, ad the speed of fatty acid formatio was comparable for both substrates. The i vitro experimetal results support the hypothesis that accumulatio of Polyglyceryl- Diisostearate i the gut is ulikely. TICLGICAL STUDIES Acute Toxicity Acute toxicity studies are summarized i Table.3,38-54 I a acute dermal toxicity study i rats, the LD50 of,,3-propaetriol, homopolymer, diisooctadecaoate was>5 g/kg. Low toxicity was reported i acute oral studies. I rats, the LD50 > g/kg for Polyglyceryl-3 Caprate, Polyglyceryl-3 Caprylate, Polyglyceryl-4 Caprate, Diisostearoyl Polyglyceryl-3 Dimer Dilioleate, ad Polyglyceryl-8 Decabeheate/Caprate, the LD50 was estimated to be >.5 g/kg for Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters, Macadamia Seed il Polyglyceryl-6 Esters Beheate, Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate, ad Polyglyceryl-0 Noaisostearate, ad the LD50 was >5 g/kg for Polyglyceryl-3 Isostearate, Polyglyceryl-3 leate, Polyglyceryl- Diisostearate ad Polyglyceryl-3 Diisostearate.

38 Distributed for Commet ly -- Do Not Cite or Quote Short-Term Toxicity Aimal ral Polyglyceryl Esters - geeral I rats, repeated oral dosig with 0 g/kg bw polyglyceryl ester daily over 5 days caused o deaths.3 (No details were provided.) The feedig of a restricted diet cosistig of g of a polyglyceryl ester i 5 g basic diet/day for 3 wks to Sherma rats, followed by 8 wks feedig, ad libitum, of a diet cotaiig 8% of the test material (8 males/group; study described i the ADME sectio) did ot result i ay microscopic abormalities i the liver, kideys, or ileum.34 Polyglyceryl Stearate Two groups of 4 male albio rats were admiistered a suspesio of g/kg bw/day of polyglyceryl stearate (glyceryl chai legth ot stated) i a aqueous solutio of 0.5% carboxymethylcellulose (CMC) ad 0.% Twee 80 for 0 wks; oe group was fed a basic diet, ad the other a diet supplemeted with 5% hydrogeated fat.55 Two utreated cotrol groups, oe fed a basal diet ad oe the fat-supplemeted diet, were used. Polyglyceryl stearate was ot toxic, ad it did ot have a effect o red blood cell cout, white blood cell cout, or hemoglobi values. Polyglyceryl- Diisostearate I a dietary study, 5 male ad 5 female rats per group were give feed cotaiig 0, 0.0, 0., or.% Polyglyceryl- Diisostearate (for a targeted dose of 0, 0, 00, or 000 mg/kg/day, respectively) for 8 days, ad a cotrol group was give utreated feed.38 There were o mortalities, cliical sigs of toxicity, effects o body weight, cliical pathology, or gross or histopathology alteratios that were cosidered related to the dietary admiistratio of the test substace ad/or cosidered to be of toxicological sigificace. The o observed adverse effect level (NAEL) was 845 mg/kg/day i males ad 9 mg/kg/day i females, correspodig to the highest dietary cocetratio tested. uma ral Polyglyceryl Esters - geeral For 3 wks, 37 subjects were fed -0 g/day polyglyceryl ester i their diet.3 No abormalities were detected i the hematology or cliical chemistry values or uriary or fecal parameters that were examied. Subchroic Toxicity Studies Aimal ral Polyglyceryl-0 Decaoleate Groups of 0 male ad 0 female Sprague-Dawley rats were fed a diet cotaiig.5, 5.0, or 0.0% Polyglyceryl-0 Decaoleate for 90 days, ad the cotrol group was fed a diet cotaiig soybea oil as the dietary fat.37 Urie was collected from each group durig wks 3 ad 9, total fatty acid absorptio was determied i feces collected durig wks 4 ad 0, ad hematological studies were coducted durig wks 5 ad, ad at study termiatio. No test article-related sigs of toxicity were observed. Gross ad microscopic examiatio of the testes ad ovaries ad other orgas did ot reveal ay sigs of toxicity or microscopic lesios, ad relative ad absolute orga weights were uremarkable. Chroic Toxicity Studies Aimal ral Polyglyceryl Esters - geeral Groups of 5 male ad 5 female mice were fed a diet with 5% polyglyceryl ester for 80 wks.3 No adverse effects o body weight, feed cosumptio, hematology values, or survival rate were oted. Carcass fat of the test group showed o polyglycerol residues. The levels of free fatty acids, usapoifiable material, ad the fatty acid compositio of carcass fat were the same for the test group compared to a cotrol group fed 5% groud ut oil i the diet. The oly differeces oted i orga weights were for the liver ad kideys of female mice, which were sigificatly higher. Microscopic examiatio of all major orgas showed othig remarkable. I a -yr study, 8 male ad 8 female rats were fed 5% polyglyceryl ester i the diet.3 No adverse effects o body weight, feed cosumptio, hematology values, or survival rate were oted. rga weights were similar i cotrol ad test groups. Liver fuctio tests ad real fuctio tests performed at 59 ad 04 wks of the study were comparable betwee the test group ad a cotrol group fed 5% groud ut oil. The carcass fat cotaied o polyglycerol, ad the levels of free fatty acid, usapoifiable residue ad fatty acid compositio of carcass fat were ot differet from the cotrols. A complete histological examiatio of major orgas showed othig remarkable.

39 Distributed for Commet ly -- Do Not Cite or Quote I the ADME study described previously, i which Wistar rats (umber of aimals per group ot specified) were fed a diet cotaiig 5 or 0% polyglyceryl ester (prepared mostly with stearic ad oleic acid; duratio of dosig ot specified, however some aimals were fed the test diet for up to 4 mos, ad some were maitaied through 3 geeratios), o abormalities were observed upo microscopic examiatio of tissues (details ot provided).33 DEVELPMENTAL AND EPDUCTIVE TICITY STUDIES ral Polyglyceryl Esters - geeral A test group of rats was fed a diet cotaiig.5% polyglyceryl ester for 3 geeratios.3 A group of 8 rats was used as a cotrol. The aimals were kept for over year without sigificat variatio i fertility or reproductive performace. Gross ad microscopic examiatio of the third geeratio revealed o cosistet abormality attributable to the test substace. No details were provided. Polyglyceryl-3 Diisostearate A combied repeated dose oral toxicity study with a reproductio/developmetal toxicity screeig test (ECD Guidelie 4) was coducted i Wistar rats.39 The aimals were dosed oce daily by gavage with 0, 00, 300, or 000 mg/kg bw/day,,3-propaetriol, homopolymer, diisooctadecaoate ( ot defied; this substace is most likely Polyglyceryl-3 Diisostearate) i cor oil. Iitially, the groups cosisted of males ad females. owever, because a disturbace of the light/dark cycle was believed to cause a reductio i matig rate of the females of the first delivery, additioal male ad female rats were added i a secod delivery for breedig to meet guidelie requiremets for the umber of gravid females per group. All (st ad d delivery) aimals were subjected to the same coditios of the study, with the exceptio that the males of the secod delivery were ecropsied o day 4 after matig, ot o day 6 of matig. Therefore, Polyglyceryl-3 Diisostearate was admiistered to male rats for up to 8 days (first delivery) ad up to 4 days (secod delivery) ad to female rats for 4 days prior to matig, through the matig ad gestatio periods, ad util the F geeratio reached day 4 post-partum. Because a impact caused by the light/dark cycle disturbace could ot be excluded (i.e., a prologed duratio of gestatio ad a icreased post-implatatio loss at the high dose), the study was repeated with a third delivery with cotrol ad highdose groups uder proper light coditios. The test article was admiistered to male rats/group for 33 days ad to female rats/group for 4 days prior to matig, through matig ad gestatio, ad util day 4 post-partum. Five males ad 5 females/group killed at the ed of the study were selected for hematology ad cliical chemistry examiatios, ad some additioal orgas were weighed. The NEL ad NAEL for systemic effects were 300 mg/kg bw/day ad 000 mg/kg bw/day,,3-propaetriol, homopolymer, diisooctadecaoate, respectively, i both males ad females. No adverse effects o body weights ad body weight gais, feed cosumptio, hematology, cliical chemistry, eurobehavior, or gross or microscopic lesios were observed. Statistically sigificat icreases i absolute ad relative liver ad kidey weights i males ad females of the 000 mg/kg bw/day were ot cosidered to be adverse effects because there was o evidece for a impairmet of orga fuctio by cliical pathology ad histopathology. Additioally, icreases i the absolute ad relative heart weights i high-dose females were without histopathological correlatio ad cosidered to be icidetal. GENTICITY STUDIES Geotoxicity studies are summarized i Table 3.0,38-44,46,48,56-65 Geerally, egative results were obtaied i geotoxicity tests. Polyglyceryl- leate, Polyglyceryl- Diisostearate, ad,,3-propaetriol, homopolymer, diisooctadecaoate were ot geotoxic i the Ames test, mammalia cell gee mutatio assay, or chromosomal aberratio assay, with or without metabolic activatio. Polyglyceryl-3 Caprate, Polyglyceryl-3 Caprylate, Polyglyceryl-3 Laurate, Polyglyceryl-3 Isostearate, Polyglyceryl-4 Caprate, Polyglyceryl-4 Isostearate, Polyglyceryl-4 Laurate/Succiate, Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters, Diisostearoyl Polyglyceryl-3 Dimer Dilioleate, Macadamia Seed il Polyglyceryl-6 Esters Beheate, Polyglyceryl-8 Decabeheate/Caprate, Polyglyceryl-8 Decaerucate/ Decaisostearate/Decaricioleate, Polyglyceryl-6 Decaethylhexaoate, Polyglyceryl-0 Petaisostearate, ad Polyglyceryl-0 Noaisostearate were egative i the Ames test. Polyglyceryl-6 Caprylate/CapratePolyglyceryl-0 Laurate (~60% pure) gave equivocal results i the absece ad positive results i the presece of metabolic activatio whe tested at cocetratios up to 5 ad 50 µg/ml, respectively, i a chromosomal aberratio assay usig Chiese hamster V79 cells, but was ot clastogeic i a chromosomal aberratio assay i huma peripheral lymphocytes, with or without activatio. Accordig to the Europea Food Safety Authority (EFSA) Pael, the impurities of polyglyceryl fatty acid esters, i.e. free fatty acids ad their esters, have o structural alerts for geotoxicity.3

40 Distributed for Commet ly -- Do Not Cite or Quote CACINGENICITY STUDIES ral I a -yr study (summarized previously i Chroic Toxicity ), 8 male ad 8 female rats were fed 5% polyglyceryl ester i the diet.3 Tumor icidece ad tumor distributio were similar i cotrol ad test groups. DEMAL IITATIN AND SENSITIZATIN STUDIES Dermal irritatio ad sesitizatio studies are summarized i Table 4.38,40-44,46-48,56,66-7,7-74,74-97 Apricot Kerel il Polyglyceryl-4 Esters ad Palm il Polyglyceryl-4 Esters were classified as o-irritat i the SkiEthicTM irritatio test, Polyglyceryl-4 Laurate/Sebacate, Polyglyceryl-4 Laurate/Succiate, ad Polyglyceryl-6 Caprylate/ Caprate were cosidered to be o-irritat i the EpiSkiTM model for ski irritatio, ad Polyglyceryl-0 Decaethylhexaoate. Polyglyceryl-0 Petaisostearate were cosidered o-irritatig usig the EpiDermTM model for ski irritatio. I rabbits, Polyglyceryl-3 Caprate, a polyglyceryl moo/diester of capric acid (read-across for Polyglyceryl-3 Caprylate), Polyglyceryl-4 Caprate, Polyglyceryl-3 Diisostearate,,,3-propaetriol, homopolymer, diisooctadecaoate, Macadamia Seed il Polyglyceryl-6 Esters Beheate, Polyglyceryl-8 Decabeheate/Caprate, ad Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate were ot irritatig to the ski. Polyglyceryl- Isostearate, Glyceryl/Polyglyceryl-6 Isostearate, ad Polyglyceryl-0 Noaisostearate were mildly irritatig, Polyglyceryl- Diisostearate was slightly irritatig, ad Polyglyceryl3 Isostearate ad Polyglyceryl-3 leate were moderate irritats i rabbit ski. Polyglyceryl-3 Caprate, Polyglyceryl-3 Caprylate, Polyglyceryl-3 Isostearate, Polyglyceryl-4 Caprate, Polyglyceryl-4 Isostearate, Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters, Polyglyceryl- Diisostearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate (read-across for Diisostearoyl Polyglyceryl-3 Dimer Dilioleate), Macadamia Seed il Polyglyceryl-6 Esters Beheate, Polyglyceryl-8 Decabeheate/Caprate, ad Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate were ot sesitizers i guiea pig studies; Polyglyceryl-0 Noaisostearate was ot a sesitizer i a local lymph ode assay. Polyglyceryl-3 Diisostearate was ot a sesitizer i guiea pigs i oe sesitizatio study (50% at iductio ad challege; 5% at rechallege), but results were icoclusive i a guiea pig maximizatio test (0.% or 0.% at itradermal iductio; 40% at epicutaeous iductio; 0 ad 5% at challege; 8 ad 4% at rechallege). I a cliical studies, 7% Polyglyceryl- Isostearate elicited slight irritatio, ad erythema was observed i 4-h occlusive patches tests of udiluted Polyglyceryl-0 Decaethylhexaoate (3/43 subjects ad 3 cotrols) ad Polyglyceryl-0 Petaisostearate (/43 subjects). Udiluted Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters, 5% Polyglyceryl-0 Laurate, 0% Polyglyceryl-0 Myristate, 5% Polyglyceryl-0 Isostearate, 5% Polyglyceryl-0 leate, 0% Polyglyceryl-0 Stearate, a mixture cotaiig 60% Polyglyceryl-0 Eicosaedioate/Tetradecaedioate/40% glyceri, udiluted Polyglyceryl- Sesquiisostearate, 0% active,,3-propaetriol, homopolymer, diisooctadecaoate, udiluted Macadamia See il Polyglyceryl-6 Esters Beheate, udiluted Polyglyceryl-8 Decabeheate/Caprate, 5% Polyglyceryl-0 Diisostearate, 50% Polyglyceryl-0 Petaisostearate, ad Polyglyceryl-0 Decaoleate (cocetratio ot give) were ot ski irritats. Udiluted Polyglyceryl-3 Laurate, Triisostearoyl Polyglyceryl-3 Dimer Dilioleate, Polyglyceryl-0 Decaethylhexaoate, ad Polyglyceryl-0 Petaisostearate were ot irritats or sesitizers. Photosesitizatio/Phototoxicity Aimal Polyglyceryl-0 Noaisostearate The phototoxicity ad photosesitizatio potetials of Polyglyceryl-0 Noaisostearate were evaluated i female albio Duki-artley guiea pigs. I the phototoxicity study, 0.5 ml udiluted Polyglyceryl-0 Noaisostearate was39,47 applied to the right flak of 0 guiea pigs.8 The aimals were exposed to the maximal o-erythematous dose of ultraviolet (UV) radiatio, ad exposure was first to 50 mj/cm UVB ad the to 7000 mj/cm UVA (source: Biotroic, Vilbert Lourmat). A o-irradiated test site served as a egative cotrol, ad 8-methoxypsorale was used as the positive cotrol. eactios were scored 4 ad 48 h after irradiatio. No cutaeous reactios were observed; Polyglyceryl-0 Noaisostearate was ot phototoxic i guiea pigs. I the photosesitizatio study, 3 iductio applicatios were made, with day itervals betwee applicatios, of 0.5 ml udiluted Polyglyceryl-0 Noaisostearate (determied to be the maximal o-irritat cocetratio i a prelimiary test) to a 5 cm area of iterscapular ski of aimals, ad the test sites were exposed to 7000 mj/cm UVA irradiatio 30 mi after applicatio.98 Prior to applicatio, pair of itradermal ijectios were made with 50% Freud s Complete Adjuvat/ physiological salie solutio. Six cotrol aimals were treated i a similar maer usig liquid paraffi. After a 6-day otreatmet period, the challege was performed by applyig 0.5 ml of udiluted Polyglyceryl-0 Noaisostearate to a 50 cm area o oe flak of the test ad cotrol aimals; 30 mi after applicatio, the treated site ad a utreated site o the opposite flak were exposed to 7 J/cm UVA irradiatio. Cutaeous reactios were evaluated 4 ad 48 h after challege. No cutaeous reactios were observed durig iductio or challege. Polyglyceryl-0 Noaisostearate was ot a photosesitizer.

41 Distributed for Commet ly -- Do Not Cite or Quote CULA IITATIN STUDIES cular irritatio studies are summarized i Table 5.0,30,38-44,47,86,99- Polyglyceryl-3 Laurate, a mixture cotaiig 60% Polyglyceryl-0 Eicosaedioate/Tetradecaedioate, Triisostearoyl Polyglyceryl-3 Dimer Dilioleate (0% i cor oil), udiluted Polyglyceryl-0 Decaethylhexaoate, ad udiluted Polyglyceryl0 Petaisostearate were classified as o-irritatig usig a EpicularTM tissue model. I the he s egg test chorioallatoic membrae (ET-CAM) assay, microemulsios cotaiig 30% or 40% Polyglyceryl-4 Laurate, Apricot Kerel il Polyglyceryl-4 Esters, Palm il Polyglyceryl-4 Esters, ad Polyglyceryl- Dioleate were classified as o-irritat, ad Diisostearoyl Polyglyceryl-3 Dimer Dilioleate produced mior irritatio. Polyglyceryl-4 Laurate/Sebacate, Polyglyceryl-4 Laurate/Succiate, ad Polyglyceryl-6 Caprylate/Caprate were cosidered o-irritat i the SkiEthicTM recostituted huma coreal epithelium model, ad Polyglyceryl-0 Laurate, Polyglyceryl-0 Myristate, ad Polyglyceryl-0 Isostearate were cosidered ulikely to cause irritatio whe evaluated i the rabbit eucleated eye test (EET). Polyglyceryl-0 Myristate, Polyglyceryl-0 Stearate, ad Polyglyceryl-0 Diisostearate were o-irritatig usig the SIC-eutral red () method. I rabbit eyes, Polyglyceryl-3 Caprate, a polyglyceryl moo/diester of capric acid (read-across for Polyglyceryl-3 Caprylate), Polyglyceryl-4 Caprate, Polyglyceryl- Diisostearate, Polyglyceryl- Dioleate, Polyglyceryl-3 Diisostearate, ad,,3-propaetriol, homopolymer, diisooctadecaoate were ot irritatig, ad Polyglyceryl-3 Isostearate ad Polyglyceryl-3 leate were slightly irritatig. Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters, Polyglyceryl-0 Laurate, Polyglyceryl-0 Myristate, Polyglyceryl-0 Isostearate, Macadamia See il Polyglyceryl-6 Esters Beheate, ad Polyglyceryl-8 Decabeheate Caprate caused miimal irritatio i rabbit eyes, ad Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate ad Polyglyceryl-0 Noaisostearate were mild irritats. Polyglyceryl-0 Laurate (~60% pure) was possibly slightly irritatig to the eyes of humas. CLINICAL EPTS Case eports A case report described the icidece of recurrig pruritic erythema over a 3-mo period i a 80-yr old female.3 A 48-h closed patch test with the subject s cosmetics was positive (++). Subsequet testig with the idividual igrediets was positive (+) with 0.5% aqueous (aq.) Polyglyceryl-0 Laurate, ad the positive reactio caused by this substace was still preset i this patiet 7 days after exposure. Positive reactios (+) were reported at all cocetratios with additioal testig of 0.05-% aq. Polyglyceryl-0 Laurate. After 6 mos, patch tests with 0.-% Polyglyceryl-0 Laurate (obtaied from several suppliers), ad 0.5-% Polyglyceryl-4 Laurate ad Polyglyceryl-6 Laurate, were positive. No reactios were reported with 0.-% aq. Polyglyceryl-0 Myristate, Polyglyceryl-0 Isostearate, Polyglyceryl-0 Stearate, ad Polyglyceryl-0 leate, or with the cotrol test materials. SUMMAY This assessmet reviews the safety of 74 polyglyceryl fatty acid esters as used i cosmetics. Each of the esters i this group is a polyether comprisig to 0 glyceryl residues, ed-capped by esterificatio with simple carboxylic acids, such as fatty acids. Most of these igrediets are reported to fuctio i cosmetics as ski-coditioig agets ad/or surfactats. Sevety-seve of the 74 igrediets icluded i this report are reported to be i use. Polyglyceryl-3 Diisostearate has the most reported uses (37, 6 of which are i lipsticks), ad Polyglyceryl-4 Isostearate has the secod highest umber of reported uses (80). Polyglyceryl- Triisostearate ad Polyglyceryl-3 Diisostearate have the highest cocetratio of use i a leave-o formulatio; these igrediets are used at 40% ad 39%, respectively. May of these polyglyceryl fatty acid esters are used i products applied to the eye area, products that ca result i icidetal igestio, or products that come ito cotact with mucous membraes, ad a few of the polyglyceryl fatty acid esters are reported to be used i baby products. Additioally, some of the polyglyceryl fatty acid esters are used i cosmetic sprays ad could possibly be ihaled. Polyglyceryl esters of fatty acids, up to ad icludig the decaglycerol esters, are permitted as multipurpose direct food additives. JECFA established a ADI of 0-5 mg/kg bw for polyglyceryl esters of fatty acids havig a average chai legth of up to 3 glycerol uits, ad a ADI of mg/kg bw for polyglyceryl esters of iteresterified ricioleic acid. I the EU, the esters are listed as food additives at levels betwee 5000 ad 0,000 mg/kg i certai foods, ad up to 7% free glycerol/polyglycerol is allowed (i.e., 700 mg/kg). Polyglyceryl esters are hydrolyzed i the GI tract, ad the fatty acid moiety is metabolized i a ormal maer. Aalytical studies have produced o evidece of accumulatio of the polyglycerol moiety i body tissues. The ability to ehace ski peetratio was examied for several of the polyglyceryl fatty acid esters. Polyglyceryl-3 Dioleate is reported to be a water-i-oil surfactat/solubilizer associated with ehaced drug peetratio. Polyglyceryl-0 Trioleate ehaced the flux of teoxicam i a i vitro study. Microemulsios cotaiig Polyglyceryl-4 Laurate ad Polyglyceryl-4 leate icreased ceramide permeatio ito ski.

42 Distributed for Commet ly -- Do Not Cite or Quote I a acute dermal toxicity study i rats, the LD50 of,,3-propaetriol, homopolymer, diisooctadecaoate was>5 g/kg. Low toxicity was reported i acute oral studies. I rats, the LD50 > g/kg for Polyglyceryl-3 Caprate, Polyglyceryl-3 Caprylate, Polyglyceryl-4 Caprate, Diisostearoyl Polyglyceryl-3 Dimer Dilioleate, ad Polyglyceryl-8 Decabeheate/Caprate, the LD50 was estimated to be >.5 g/kg for Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters, Macadamia Seed il Polyglyceryl-6 Esters Beheate, Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate, ad Polyglyceryl-0 Noaisostearate, ad the LD50 was >5 g/kg for Polyglyceryl-3 Isostearate, Polyglyceryl-3 leate, Polyglyceryl- Diisostearate ad Polyglyceryl-3 Diisostearate. Dietary studies with polyglyceryl ester, polyglyceryl stearate, Polyglyceryl- Diisostearate, ad Polyglyceryl-0 Decaoleate did ot produce ay remarkable effects. No test-article related adverse effects were observed i multi-geeratioal studies with polyglyceryl esters or,,3-propaetriol, homopolymer, diisooctadecaoate. Geerally, egative results were obtaied i geotoxicity tests. Polyglyceryl- leate, Polyglyceryl- Diisostearate, ad,,3-propaetriol, homopolymer, diisooctadecaoate were ot geotoxic i the Ames test, mammalia cell gee mutatio assay, or chromosomal aberratio assay, with or without metabolic activatio. Polyglyceryl-3 Caprate, Polyglyceryl-3 Caprylate, Polyglyceryl-3 Laurate, Polyglyceryl-3 Isostearate, Polyglyceryl-4 Caprate, Polyglyceryl-4 Isostearate, Polyglyceryl-4 Laurate/Succiate, Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters, Diisostearoyl Polyglyceryl-3 Dimer Dilioleate, Macadamia Seed il Polyglyceryl-6 Esters Beheate, Polyglyceryl-8 Decabeheate/Caprate, Polyglyceryl-8 Decaerucate/ Decaisostearate/Decaricioleate, Polyglyceryl-6 Decaethylhexaoate, Polyglyceryl-0 Petaisostearate, ad Polyglyceryl-0 Noaisostearate were egative i the Ames test. Polyglyceryl-6 Caprylate/Caprate ad Polyglyceryl-0 Laurate (~60% pure) gave equivocal results i the absece ad positive results i the presece of metabolic activatio whe tested at cocetratios up to 5 ad 50 µg/ml, respectively, i a chromosomal aberratio assay usig Chiese hamster V79 cells, but were ot clastogeic i a chromosomal aberratio assay i huma peripheral lymphocytes, with or without activatio. The impurities of polyglyceryl fatty acid esters, i.e. free fatty acids ad their esters, have o structural alerts for geotoxicity. I a -yr dietary study i rats, 5% polyglyceryl ester was ot carciogeic ad did ot produce ay adverse effects. Apricot Kerel il Polyglyceryl-4 Esters ad Palm il Polyglyceryl-4 Esters were classified as o-irritat i the SkiEthicTM irritatio test, Polyglyceryl-4 Laurate/Sebacate, Polyglyceryl-4 Laurate/Succiate, ad Polyglyceryl-6 Caprylate/ Caprate were cosidered to be o-irritat i the EpiSkiTM model for ski irritatio, ad Polyglyceryl-0 Decaethylhexaoate. Polyglyceryl-0 Petaisostearate was cosidered o-irritatig usig the EpiDermTM model for ski irritatio. I rabbits, Polyglyceryl-3 Caprate, a polyglyceryl moo/diester of capric acid (read-across for Polyglyceryl-3 Caprylate), Polyglyceryl-4 Caprate, Polyglyceryl-3 Diisostearate,,,3-propaetriol, homopolymer, diisooctadecaoate, Macadamia Seed il Polyglyceryl-6 Esters Beheate, Polyglyceryl-8 Decabeheate/Caprate, ad Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate were ot irritatig to the ski. Polyglyceryl- Isostearate, Glyceryl/Polyglyceryl-6 Isostearate, ad Polyglyceryl-0 Noaisostearate were mildly irritatig, Polyglyceryl- Diisostearate was slightly irritatig, ad Polyglyceryl3 Isostearate ad Polyglyceryl-3 leate were moderate irritats i rabbit ski. Polyglyceryl-3 Caprate, Polyglyceryl-3 Caprylate, Polyglyceryl-3 Isostearate, Polyglyceryl-4 Caprate, Polyglyceryl-4 Isostearate, Glyceryl/Polyglyceryl-6 Isostearate/ Beheate Esters, Polyglyceryl- Diisostearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate (read-across for Diisostearoyl Polyglyceryl-3 Dimer Dilioleate), Macadamia Seed il Polyglyceryl-6 Esters Beheate, Polyglyceryl-8 Decabeheate/Caprate, ad Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate were ot sesitizers i guiea pig studies; Polyglyceryl-0 Noaisostearate was ot a sesitizer i a local lymph ode assay. Polyglyceryl-3 Diisostearate was ot a sesitizer i guiea pigs i oe sesitizatio study (50% at iductio ad challege; 5% at rechallege), but results were icoclusive i a guiea pig maximizatio test (0.% or 0.% at itradermal iductio; 40% at epicutaeous iductio; 0 ad 5% at challege; 8 ad 4% at rechallege). I cliical studies, 7% Polyglyceryl- Isostearate elicited slight irritatio, ad erythema was observed i 4-h occlusive patches tests of udiluted Polyglyceryl-0 Decaethylhexaoate (3/43 subjects ad 3 cotrols) ad Polyglyceryl-0 Petaisostearate (/43 subjects). Udiluted Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters, 5% Polyglyceryl-0 Laurate, 0% Polyglyceryl-0 Myristate, 5% Polyglyceryl-0 Isostearate, 5% Polyglyceryl-0 leate, 0% Polyglyceryl-0 Stearate, a mixture cotaiig 60% Polyglyceryl-0 Eicosaedioate/Tetradecaedioate/40% glyceri, udiluted Polyglyceryl- Sesquiisostearate, 0% active,,3-propaetriol, homopolymer, diisooctadecaoate, udiluted Macadamia See il Polyglyceryl-6 Esters Beheate, udiluted Polyglyceryl-8 Decabeheate/Caprate, 5% Polyglyceryl-0 Diisostearate, 50% Polyglyceryl-0 Petaisostearate, ad Polyglyceryl-0 Decaoleate (cocetratio ot give) were ot ski irritats. Udiluted Polyglyceryl-3 Laurate, Triisostearoyl Polyglyceryl-3 Dimer Dilioleate, Polyglyceryl-0 Decaethylhexaoate, ad Polyglyceryl-0 Petaisostearate were ot irritats or sesitizers. Udiluted Polyglyceryl-0 Noaisostearate was ot phototoxic or a photosesitizer i guiea pigs. Polyglyceryl-3 Laurate, a mixture cotaiig 60% Polyglyceryl-0 Eicosaedioate/Tetradecaedioate, Triisostearoyl Polyglyceryl-3 Dimer Dilioleate (0% i cor oil), udiluted Polyglyceryl-0 Decaethylhexaoate, ad udiluted Polyglyceryl0 Petaisostearate were classified as o-irritatig usig a EpicularTM tissue model. I the ET-CAM assay, microemulsios cotaiig 30% or 40% Polyglyceryl-4 Laurate, Apricot Kerel il Polyglyceryl-4 Esters, Palm il Polyglyceryl-4

43 Distributed for Commet ly -- Do Not Cite or Quote Esters, ad Polyglyceryl- Dioleate were classified as o-irritat, ad Diisostearoyl Polyglyceryl-3 Dimer Dilioleate produced mior irritatio. Polyglyceryl-4 Laurate/Sebacate, Polyglyceryl-4 Laurate/Succiate, ad Polyglyceryl-6 Caprylate/ Caprate were cosidered o-irritat i the SkiEthicTM recostituted huma coreal epithelium model, ad Polyglyceryl-0 Laurate, Polyglyceryl-0 Myristate, ad Polyglyceryl-0 Isostearate were cosidered ulikely to cause irritatio whe evaluated i the EET. Polyglyceryl-0 Myristate, Polyglyceryl-0 Stearate, ad Polyglyceryl-0 Diisostearate were oirritatig usig the SIC- method. I rabbit eyes, Polyglyceryl-3 Caprate, a polyglyceryl moo/diester of capric acid (read-across for Polyglyceryl-3 Caprylate), Polyglyceryl-4 Caprate, Polyglyceryl- Diisostearate, Polyglyceryl- Dioleate, Polyglyceryl-3 Diisostearate, ad,,3-propaetriol, homopolymer, diisooctadecaoate were ot irritatig, ad Polyglyceryl-3 Isostearate ad Polyglyceryl-3 leate were slightly irritatig. Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters, Polyglyceryl-0 Laurate, Polyglyceryl-0 Myristate, Polyglyceryl-0 Isostearate, Macadamia See il Polyglyceryl-6 Esters Beheate, ad Polyglyceryl-8 Decabeheate Caprate caused miimal irritatio i rabbit eyes, ad Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate ad Polyglyceryl-0 Noaisostearate were mild irritats. Polyglyceryl-0 Laurate (~60% pure) was possibly slightly irritatig to the eyes of humas. DISCUSSIN The igrediets i this report are esterificatio products of polyglyceri chais ad fatty acids that vary i umbers of glyceri ad fatty-acid equivalets ad legths of the fatty acids. The polymerizatio process used to produce polyglycerol yields a distributio of oligomers with primarily liear structures. I additio to liear cofiguratios, brached polyglycerol cofiguratios, origiatig from,- ad,--ether likages, are also possible. The Pael ackowledged this is a very large group of igrediets; however these igrediets are extesively metabolized to commo utriets ad physiologic itermediates, therefore the Pael was satisfied that the data icluded i the report could be used to assess the safety of all the igrediets. Furthermore, the Pael has reviewed previously the safety of umerous igrediets that serve as startig materials for the sythesis of polyglyceryl fatty acid esters. These previously-reviewed igrediets, which ca be residual impurities i the polyglyceryl esters products or potetial metabolites (e.g., glyceri ad free fatty acids released by the actio of esterases i the ski), were foud safe as used (or safe whe formulated to be oirritatig) i cosmetic formulatios. Some of these igrediets ca ehace the peetratio of other igrediets through the ski. The Pael cautioed that care should be take i formulatig cosmetic products that may cotai these igrediets i combiatio with ay igrediets whose safety was based o their lack of dermal absorptio data, or whe dermal absorptio was a cocer. It was oted that some of these igrediets are derived from plats. The Pael expressed cocer about pesticide residues ad heavy metals that may be preset i botaical igrediets, ad stressed that the cosmetics idustry should cotiue to use the ecessary procedures to limit these impurities i the igrediet before bledig ito cosmetic formulatios. The Pael was cocered that the potetial exists for dermal irritatio with the use of products formulated usig some of the polyglyceryl fatty acid esters. The Pael specified that products cotaiig these igrediets must be formulated to be oirritatig. Additioally, the Pael discussed the issue of icidetal ihalatio exposure, as some of the polyglyceryl fatty acid esters are used i cosmetic sprays ad could possibly be ihaled. For example, Polyglyceryl-3 Distearate is reported to be used at 3% i spray body ad had creams. The Pael oted that droplets/particles from spray cosmetic products would ot be respirable to ay appreciable amout. Furthermore, droplets/particles deposited i the asopharygeal or brochial regios of the respiratory tract preset o toxicological cocers based o the chemical ad biological properties of these igrediets. Coupled with the small actual exposure i the breathig zoe ad the cocetratios at which the igrediets are used, the available iformatio idicates that icidetal ihalatio would ot be a sigificat route of exposure that might lead to local respiratory or systemic effects. A detailed discussio ad summary of the Pael s approach to evaluatig icidetal ihalatio exposures to igrediets i cosmetic products is available at CNCLUSIN The CI Expert Pael cocluded that the 74 polyglyceryl fatty acid esters listed below are safe i cosmetics i the preset practices of use ad cocetratio described i this safety assessmet whe formulated to be o-irritatig: Adasoia Digitata Seed il Polyglyceryl-6 Esters* Almod il/polyglyceryl-0 Esters* Apricot Kerel il Polyglyceryl-3 Esters* Apricot Kerel il Polyglyceryl-4 Esters* Apricot Kerel il Polyglyceryl-5 Esters* Apricot Kerel il Polyglyceryl-6 Esters* Apricot Kerel il Polyglyceryl-0 Esters* Arga il Polyglyceryl-6 Esters* Astrocaryum Vulgare il Polyglyceryl-6 Esters* Avocado il Polyglyceryl-6 Esters* Babassu il Polyglyceryl-4 Esters Babassu il Polyglyceryl-6 Esters

44 Distributed for Commet ly -- Do Not Cite or Quote Bertholletia Excelsa Seed il Polyglyceryl-6 Esters* Borage Seed il Polyglyceryl-4 Esters* Borage Seed il Polyglyceryl-6 Esters* Cadelilla/Jojoba/ice Bra Polyglyceryl-3 Esters Caprylic/Capric Glycerides Polyglyceryl-0 Esters Carapa Guaiaesis il Polyglyceryl-6 Esters* Castor il Polyglyceryl-6 Esters* Cocoa Butter Polyglyceryl-6 Esters* Cocout il Polyglyceryl-6 Esters Coffee Seed il Polyglyceryl-6 Esters* Diisostearoyl Polyglyceryl-3 Dimer Dilioleate Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters azelut Seed il Polyglyceryl-6 Esters* Liseed il Polyglyceryl-4 Esters* Macadamia Seed il Polyglyceryl 6 Esters* Macadamia Seed il Polyglyceryl 6 Esters Beheate Mauritia Flexuosa Seed il Polyglyceryl-6 Esters* live il Polyglyceryl-3 Esters* live il Polyglyceryl-4 Esters* live il Polyglyceryl-6 Esters* Palm Kerel il Polyglyceryl-4 Esters* Palm il Polyglyceryl-3 Esters* Palm il Polyglyceryl-4 Esters Palm il Polyglyceryl-5 Esters* Palm il Polyglyceryl-6 Esters* Pariari Curatellifolia il Polyglyceryl-6 Esters* Pius Sibirica Seed il Polyglyceryl-6 Esters* Polyglyceryl- Caprate Polyglyceryl- Caprylate* Polyglyceryl- Diisostearate Polyglyceryl- Dioleate* Polyglyceryl- Distearate* Polyglyceryl- Isopalmitate Polyglyceryl- Isopalmitate/Sebacate* Polyglyceryl- Isostearate Polyglyceryl- Laurate Polyglyceryl- Myristate* Polyglyceryl- leate Polyglyceryl- Palmitate* Polyglyceryl- Sesquicaprylate* Polyglyceryl- Sesquiisostearate Polyglyceryl- Sesquioleate* Polyglyceryl- Sesquistearate Polyglyceryl- Stearate Polyglyceryl- Tetrabeheate/ Macadamiate/Sebacate* Polyglyceryl- Tetraisostearate Polyglyceryl- Tetraoleate* Polyglyceryl- Tetrastearate* Polyglyceryl- Triisostearate Polyglyceryl-3 Beeswax Polyglyceryl-3 Beheate* Polyglyceryl-3 Caprate Polyglyceryl-3 Caprylate Polyglyceryl-3 Cocoate* Polyglyceryl-3 Dicaprate* Polyglyceryl-3 Dicitrate/Stearate Polyglyceryl-3 Dicocoate* Polyglyceryl-3 Di ydroxystearate* Polyglyceryl-3 Diisostearate Polyglyceryl-3 Dioleate* Polyglyceryl-3 Distearate Polyglyceryl-3 Isostearate Polyglyceryl-3 Laurate Polyglyceryl-3 Myristate* Polyglyceryl-3 leate Polyglyceryl-3 Palmitate Polyglyceryl-3 Petacaprylate/Caprate* Polyglyceryl-3 Petaolivate* Polyglyceryl-3 Petaricioleate Polyglyceryl-3 ice Braate* Polyglyceryl-3 icioleate Polyglyceryl-3 Soyate/Shea Butterate* Polyglyceryl-3 Stearate Polyglyceryl-3 Stearate SE* Polyglyceryl-3 Triisostearate* Polyglyceryl-3 Triolivate* Polyglyceryl-4 Almodate/Shea Butterate* Polyglyceryl-4 Caprate Polyglyceryl-4 Caprylate* Polyglyceryl-4 Caprylate/Caprate* Polyglyceryl-4 Cocoate Polyglyceryl-4 Dilaurate* Polyglyceryl-4 Distearate* Polyglyceryl-4 azelutseedate* Polyglyceryl-4 Isostearate Polyglyceryl-4 Isostearate/Laurate* Polyglyceryl-4 Laurate Polyglyceryl-4 Laurate/Sebacate* Polyglyceryl-4 Laurate/Succiate* Polyglyceryl-4 leate Polyglyceryl-4 Petaoleate* Polyglyceryl-4 Petapalmitate/Stearate* Polyglyceryl-4 Petastearate* Polyglyceryl-4 Puicate* Polyglyceryl-4 Stearate* Polyglyceryl-4 Sweet Almodate* Polyglyceryl-4 Tristearate* Polyglyceryl-5 Caprate* Polyglyceryl-5 Dicaprylate* Polyglyceryl-5 Dilaurate* Polyglyceryl-5 Dioleate Polyglyceryl-5 exastearate* Polyglyceryl-5 Isostearate Polyglyceryl-5 Laurate Polyglyceryl-5 Myristate* Polyglyceryl-5 leate Polyglyceryl-5 Petamyristate* Polyglyceryl-5 icioleate* Polyglyceryl-5 Stearate Polyglyceryl-5 Tribeheate* Polyglyceryl-5 Triisostearate Polyglyceryl-5 Trimyristate* Polyglyceryl-5 Trioleate Polyglyceryl-5 Tristearate* Polyglyceryl-6 Adasoia Digitata Seedate* Polyglyceryl-6 Apricot Kerelate* Polyglyceryl-6 Arga Kerelate* Polyglyceryl-6 Beheate*

45 Distributed for Commet ly -- Do Not Cite or Quote Polyglyceryl-6 Caprate* Polyglyceryl-6 Caprylate* Polyglyceryl-6 Caprylate/Caprate Polyglyceryl-6 Citrullus Laatus Seedate* Polyglyceryl-6 Dicaprate* Polyglyceryl-6 Diisostearate* Polyglyceryl-6 Dioleate Polyglyceryl-6 Dipalmitate* Polyglyceryl-6 Distearate Polyglyceryl-6 eptacaprylate* Polyglyceryl-6 exaoleate* Polyglyceryl-6 exastearate* Polyglyceryl-6 Isostearate Polyglyceryl-6 Laurate* Polyglyceryl-6 Myristate* Polyglyceryl-6 ctacaprylate* Polyglyceryl-6 ctastearate Polyglyceryl-6 leate Polyglyceryl-6 Palmitate* Polyglyceryl-6 Palmitate/Succiate* Polyglyceryl-6 Petacaprylate* Polyglyceryl-6 Petaoleate* Polyglyceryl-6 Petaricioleate* Polyglyceryl-6 Petastearate Polyglyceryl-6 icioleate Polyglyceryl-6 Schiziophyto autaeii Kerelate* Polyglyceryl-6 Sclerocarya Birrea Seedate* Polyglyceryl-6 Sesquicaprylate* Polyglyceryl-6 Sesquiisostearate* Polyglyceryl-6 Sesquistearate* Polyglyceryl-6 Stearate* Polyglyceryl-6 Tetrabeheate* Polyglyceryl-6 Tetracaprylate* Polyglyceryl-6 Tetraoleate* Polyglyceryl-6 Tricaprylate Polyglyceryl-6 Trichilia Emetica Seedate* Polyglyceryl-6 Tristearate* Polyglyceryl-6 Udecyleate* Polyglyceryl-6 imeia Americaa Seedate* Polyglyceryl-8 C-0 Acid Ester* Polyglyceryl-8 Decabeheate/Caprate Polyglyceryl-8 Decaerucate/Decaisostearate/ Decaricioleate Polyglyceryl-8 leate* Polyglyceryl-8 Stearate* Polyglyceryl-0 Apricot Kerelate* Polyglyceryl-0 Beheate/Eicosadioate Polyglyceryl-0 Caprate* Polyglyceryl-0 Caprylate* Polyglyceryl-0 Caprylate/Caprate Polyglyceryl-0 Cocoate* Polyglyceryl-0 Decaethylhexaoate* Polyglyceryl-0 Decahydroxystearate* Polyglyceryl-0 Decaisostearate Polyglyceryl-0 Decalioleate* Polyglyceryl-0 Decamacadamiate* Polyglyceryl-0 Decaoleate Polyglyceryl-0 Decastearate* Polyglyceryl-0 Dicocoate* Polyglyceryl-0 Didecaoate* Polyglyceryl-0 Diisostearate Polyglyceryl-0 Dilaurate* Polyglyceryl-0 Dimyristate* Polyglyceryl-0 Dioleate Polyglyceryl-0 Dipalmitate Polyglyceryl-0 Distearate Polyglyceryl-0 Dodecabeheate* Polyglyceryl-0 Dodecacaprate* Polyglyceryl-0 Dodecacaprylate* Polyglyceryl-0 Dodeca-Caprylate/ Caprate* Polyglyceryl-0 Eicosaedioate/Tetradecaedioate* Polyglyceryl-0 epta(beheate/stearate)* Polyglyceryl-0 eptahydroxystearate Polyglyceryl-0 eptaoleate* Polyglyceryl-0 eptastearate* Polyglyceryl-0 exaerucate* Polyglyceryl-0 exaisostearate* Polyglyceryl-0 exaoleate* Polyglyceryl-0 ydroxystearate/stearate/eicosadioate Polyglyceryl-0 Isostearate Polyglyceryl-0 Laurate Polyglyceryl-0 Lioleate* Polyglyceryl-0 Moo/Dioleate* Polyglyceryl-0 Myristate Polyglyceryl-0 Noaerucate* Polyglyceryl-0 Noaisostearate Polyglyceryl-0 leate Polyglyceryl-0 Palmate* Polyglyceryl-0 Palmitate* Polyglyceryl-0 Petacaprylate* Polyglyceryl-0 Petahydroxystearate Polyglyceryl-0 Petaisostearate Polyglyceryl-0 Petalaurate* Polyglyceryl-0 Petalioleate* Polyglyceryl-0 Petaoleate Polyglyceryl-0 Petaricioleate* Polyglyceryl-0 Petastearate Polyglyceryl-0 Sesquistearate* Polyglyceryl-0 Stearate Polyglyceryl-0 Tetradecaedioate* Polyglyceryl-0 Tetralaurate* Polyglyceryl-0 Tetraoleate* Polyglyceryl-0 Tricocoate* Polyglyceryl-0 Tridecaoate* Polyglyceryl-0 Trierucate* Polyglyceryl-0 Triisostearate* Polyglyceryl-0 Trilaurate* Polyglyceryl-0 Trioleate* Polyglyceryl-0 Tristearate Polyglyceryl-0 Udecyleate* Polyglyceryl-5 Diisostearate* Polyglyceryl-0 Docosabeheate/Isostearate* Polyglyceryl-0 Docosabeheate/Laurate* Polyglyceryl-0 Docosabeheate/leate* Polyglyceryl-0 eptacaprylate* Polyglyceryl-0 eptadecabeheate/laurate* Polyglyceryl-0 exacaprylate* Polyglyceryl-0 ctadecabeheate/laurate* Polyglyceryl-0 ctaisooaoate*

46 Distributed for Commet ly -- Do Not Cite or Quote Pumpki Seed il Polyglyceryl-4 Esters* Pumpki Seed il Polyglyceryl-4 Esters Succiate* ice Bra il Polyglyceryl-3 Esters* osa ubigiosa Seed il Polyglyceryl-6 Esters* Safflower Seed il Polyglyceryl-6 Esters* Schiziophyto autaeii Kerel il Polyglyceryl-6 Esters* Sclerocarya Birrea Seed il Polyglyceryl-6 Esters* Sclerocarya Birrea Seed il Polyglyceryl-0 Esters* Sesame il Polyglyceryl-6 Esters* Shea Butter Polyglyceryl-3 Esters* Shea Butter Polyglyceryl-4 Esters* Shea Butter Polyglyceryl-6 Esters* Soybea il Polyglyceryl-6 Esters* Suflower Seed il Polyglyceryl 3 Esters* Suflower Seed il Polyglyceryl-4 Esters* Suflower Seed il Polyglyceryl-5 Esters* Suflower Seed il Polyglyceryl 6 Esters* Suflower Seed il Polyglyceryl 0 Esters* Sweet Almod il Polyglyceryl-4 Esters* Sweet Almod il Polyglyceryl-6 Esters* Theobroma Gradiflorum Seed Butter Polyglyceryl-6 Esters* Trichilia Emetica Seed il Polyglyceryl-6 Esters* Triisostearoyl Polyglyceryl-3 Dimer Dilioleate Watermelo Seed il Polyglyceryl-6 Esters * Watermelo Seed il Polyglyceryl-0 Esters* imeia Americaa Seed il Polyglyceryl-6 Esters* *Not reported to be i curret use. Were igrediets i this group ot i curret use to be used i the future, the expectatio is that they would be used i product categories ad at cocetratios comparable to others i this group.

47 Distributed for Commet ly -- Do Not Cite or Quote TABLES Table. Polyglyceryl Fatty Acid Esters preseted alphabetically Adasoia Digitata Seed il Polyglyceryl-6 Esters Almod il/polyglyceryl-0 Esters Apricot Kerel il Polyglyceryl-3 Esters Apricot Kerel il Polyglyceryl-4 Esters Apricot Kerel il Polyglyceryl-5 Esters Apricot Kerel il Polyglyceryl-6 Esters Apricot Kerel il Polyglyceryl-0 Esters Arga il Polyglyceryl-6 Esters Astrocaryum Vulgare il Polyglyceryl-6 Esters Avocado il Polyglyceryl-6 Esters Babassu il Polyglyceryl-4 Esters Babassu il Polyglyceryl-6 Esters Bertholletia Excelsa Seed il Polyglyceryl-6 Esters Borage Seed il Polyglyceryl-4 Esters Borage Seed il Polyglyceryl-6 Esters Cadelilla/Jojoba/ice Bra Polyglyceryl-3 Esters Caprylic/Capric Glycerides Polyglyceryl-0 Esters Carapa Guaiaesis il Polyglyceryl-6 Esters Castor il Polyglyceryl-6 Esters Cocoa Butter Polyglyceryl-6 Esters Cocout il Polyglyceryl-6 Esters Coffee Seed il Polyglyceryl-6 Esters Diisostearoyl Polyglyceryl-3 Dimer Dilioleate Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters azelut Seed il Polyglyceryl-6 Esters Liseed il Polyglyceryl-4 Esters Macadamia Seed il Polyglyceryl-6 Esters Macadamia Seed il Polyglyceryl-6 Esters Beheate Mauritia Flexuosa Seed il Polyglyceryl-6 Esters live il Polyglyceryl-3 Esters live il Polyglyceryl-4 Esters live il Polyglyceryl-6 Esters Palm Kerel il Polyglyceryl-4 Esters Palm il Polyglyceryl-3 Esters Palm il Polyglyceryl-4 Esters Palm il Polyglyceryl-5 Esters Palm il Polyglyceryl-6 Esters Pariari Curatellifolia il Polyglyceryl-6 Esters Pius Sibirica Seed il Polyglyceryl-6 Esters Polyglyceryl- Caprate Polyglyceryl- Caprylate Polyglyceryl- Diisostearate Polyglyceryl- Dioleate Polyglyceryl- Distearate Polyglyceryl- Isopalmitate Polyglyceryl- Isopalmitate/Sebacate Polyglyceryl- Isostearate Polyglyceryl- Laurate Polyglyceryl- Myristate Polyglyceryl- leate Polyglyceryl- Palmitate Polyglyceryl- Sesquicaprylate Polyglyceryl- Sesquiisostearate Polyglyceryl- Sesquioleate Polyglyceryl- Sesquistearate Polyglyceryl- Stearate Polyglyceryl- Tetrabeheate/ Macadamiate/Sebacate Polyglyceryl- Tetraisostearate Polyglyceryl- Tetraoleate Polyglyceryl- Tetrastearate Polyglyceryl- Triisostearate Polyglyceryl-3 Beeswax Polyglyceryl-3 Beheate Polyglyceryl-3 Caprate Polyglyceryl-3 Caprylate Polyglyceryl-3 Cocoate Polyglyceryl-3 Dicaprate Polyglyceryl-3 Dicitrate/Stearate Polyglyceryl-3 Dicocoate Polyglyceryl-3 Di-ydroxystearate Polyglyceryl-3 Diisostearate Polyglyceryl-3 Dioleate Polyglyceryl-3 Distearate Polyglyceryl-3 Isostearate Polyglyceryl-3 Laurate Polyglyceryl-3 Myristate Polyglyceryl-3 leate Polyglyceryl-3 Palmitate Polyglyceryl-3 Petacaprylate/Caprate Polyglyceryl-3 Petaolivate Polyglyceryl-3 Petaricioleate Polyglyceryl-3 ice Braate Polyglyceryl-3 icioleate Polyglyceryl-3 Soyate/Shea Butterate Polyglyceryl-3 Stearate Polyglyceryl-3 Stearate SE Polyglyceryl-3 Triisostearate Polyglyceryl-3 Triolivate Polyglyceryl-4 Almodate/Shea Butterate Polyglyceryl-4 Caprate Polyglyceryl-4 Caprylate Polyglyceryl-4 Caprylate/Caprate Polyglyceryl-4 Cocoate Polyglyceryl-4 Dilaurate Polyglyceryl-4 Distearate Polyglyceryl-4 azelutseedate Polyglyceryl-4 Isostearate Polyglyceryl-4 Isostearate/Laurate Polyglyceryl-4 Laurate Polyglyceryl-4 Laurate/Sebacate Polyglyceryl-4 Laurate/Succiate Polyglyceryl-4 leate Polyglyceryl-4 Petaoleate Polyglyceryl-4 Petapalmitate/Stearate Polyglyceryl-4 Petastearate Polyglyceryl-4 Puicate Polyglyceryl-4 Stearate Polyglyceryl-4 Sweet Almodate Polyglyceryl-4 Tristearate Polyglyceryl-5 Caprate Polyglyceryl-5 Dicaprylate Polyglyceryl-5 Dilaurate Polyglyceryl-5 Dioleate Polyglyceryl-5 exastearate Polyglyceryl-5 Isostearate Polyglyceryl-5 Laurate Polyglyceryl-5 Myristate Polyglyceryl-5 leate Polyglyceryl-5 Petamyristate Polyglyceryl-5 icioleate Polyglyceryl-5 Stearate Polyglyceryl-5 Tribeheate Polyglyceryl-5 Triisostearate Polyglyceryl-5 Trimyristate Polyglyceryl-5 Trioleate Polyglyceryl-5 Tristearate Polyglyceryl-6 Adasoia Digitata Seedate Polyglyceryl-6 Apricot Kerelate Polyglyceryl-6 Arga Kerelate Polyglyceryl-6 Beheate Polyglyceryl-6 Caprate Polyglyceryl-6 Caprylate Polyglyceryl-6 Caprylate/Caprate Polyglyceryl-6 Citrullus Laatus Seedate Polyglyceryl-6 Dicaprate Polyglyceryl-6 Diisostearate Polyglyceryl-6 Dioleate Polyglyceryl-6 Dipalmitate

48 Distributed for Commet ly -- Do Not Cite or Quote Polyglyceryl-6 Distearate Polyglyceryl-6 eptacaprylate Polyglyceryl-6 exaoleate Polyglyceryl-6 exastearate Polyglyceryl-6 Isostearate Polyglyceryl-6 Laurate Polyglyceryl-6 Myristate Polyglyceryl-6 ctacaprylate Polyglyceryl-6 ctastearate Polyglyceryl-6 leate Polyglyceryl-6 Palmitate Polyglyceryl-6 Palmitate/Succiate Polyglyceryl-6 Petacaprylate Polyglyceryl-6 Petaoleate Polyglyceryl-6 Petaricioleate Polyglyceryl-6 Petastearate Polyglyceryl-6 icioleate Polyglyceryl-6 Schiziophyto autaeii Kerelate Polyglyceryl-6 Sclerocarya Birrea Seedate Polyglyceryl-6 Sesquicaprylate Polyglyceryl-6 Sesquiisostearate Polyglyceryl-6 Sesquistearate Polyglyceryl-6 Stearate Polyglyceryl-6 Tetrabeheate Polyglyceryl-6 Tetracaprylate Polyglyceryl-6 Tetraoleate Polyglyceryl-6 Tricaprylate Polyglyceryl-6 Trichilia Emetica Seedate Polyglyceryl-6 Tristearate Polyglyceryl-6 Udecyleate Polyglyceryl-6 imeia Americaa Seedate Polyglyceryl-8 C-0 Acid Ester Polyglyceryl-8 Decabeheate/Caprate Polyglyceryl-8 Decaerucate/Decaisostearate/ Decaricioleate Polyglyceryl-8 leate Polyglyceryl-8 Stearate Polyglyceryl-0 Apricot Kerelate Polyglyceryl-0 Beheate/Eicosadioate Polyglyceryl-0 Caprate Polyglyceryl-0 Caprylate Polyglyceryl-0 Caprylate/Caprate Polyglyceryl-0 Cocoate Polyglyceryl-0 Decaethylhexaoate Polyglyceryl-0 Decahydroxystearate Polyglyceryl-0 Decaisostearate Polyglyceryl-0 Decalioleate Polyglyceryl-0 Decamacadamiate Polyglyceryl-0 Decaoleate Polyglyceryl-0 Decastearate Polyglyceryl-0 Dicocoate Polyglyceryl-0 Didecaoate Polyglyceryl-0 Diisostearate Polyglyceryl-0 Dilaurate Polyglyceryl-0 Dimyristate Polyglyceryl-0 Dioleate Polyglyceryl-0 Dipalmitate Polyglyceryl-0 Distearate Polyglyceryl-0 Dodecabeheate Polyglyceryl-0 Dodecacaprate Polyglyceryl-0 Dodecacaprylate Polyglyceryl-0 Dodeca-Caprylate/ Caprate Polyglyceryl-0 Eicosaedioate/Tetradecaedioate Polyglyceryl-0 epta(beheate/stearate) Polyglyceryl-0 eptahydroxystearate Polyglyceryl-0 eptaoleate Polyglyceryl-0 eptastearate Polyglyceryl-0 exaerucate Polyglyceryl-0 exaisostearate Polyglyceryl-0 exaoleate Polyglyceryl-0 ydroxystearate/stearate/eicosadioate Polyglyceryl-0 Isostearate Polyglyceryl-0 Laurate Polyglyceryl-0 Lioleate Polyglyceryl-0 Moo/Dioleate Polyglyceryl-0 Myristate Polyglyceryl-0 Noaerucate Polyglyceryl-0 Noaisostearate Polyglyceryl-0 leate Polyglyceryl-0 Palmate Polyglyceryl-0 Palmitate Polyglyceryl-0 Petacaprylate Polyglyceryl-0 Petahydroxystearate Polyglyceryl-0 Petaisostearate Polyglyceryl-0 Petalaurate Polyglyceryl-0 Petalioleate Polyglyceryl-0 Petaoleate Polyglyceryl-0 Petaricioleate Polyglyceryl-0 Petastearate Polyglyceryl-0 Sesquistearate Polyglyceryl-0 Stearate Polyglyceryl-0 Tetradecaedioate Polyglyceryl-0 Tetralaurate Polyglyceryl-0 Tetraoleate Polyglyceryl-0 Tricocoate Polyglyceryl-0 Tridecaoate Polyglyceryl-0 Trierucate Polyglyceryl-0 Triisostearate Polyglyceryl-0 Trilaurate Polyglyceryl-0 Trioleate Polyglyceryl-0 Tristearate Polyglyceryl-0 Udecyleate Polyglyceryl-5 Diisostearate Polyglyceryl-0 Docosabeheate/Isostearate Polyglyceryl-0 Docosabeheate/Laurate Polyglyceryl-0 Docosabeheate/leate Polyglyceryl-0 eptacaprylate Polyglyceryl-0 eptadecabeheate/laurate Polyglyceryl-0 exacaprylate Polyglyceryl-0 ctadecabeheate/laurate Polyglyceryl-0 ctaisooaoate Pumpki Seed il Polyglyceryl-4 Esters Pumpki Seed il Polyglyceryl-4 Esters Succiate ice Bra il Polyglyceryl-3 Esters osa ubigiosa Seed il Polyglyceryl-6 Esters Safflower Seed il Polyglyceryl-6 Esters Schiziophyto autaeii Kerel il Polyglyceryl-6 Esters Sclerocarya Birrea Seed il Polyglyceryl-6 Esters Sclerocarya Birrea Seed il Polyglyceryl-0 Esters Sesame il Polyglyceryl-6 Esters Shea Butter Polyglyceryl-3 Esters Shea Butter Polyglyceryl-4 Esters Shea Butter Polyglyceryl-6 Esters Soybea il Polyglyceryl-6 Esters Suflower Seed il Polyglyceryl-3 Esters Suflower Seed il Polyglyceryl-4 Esters Suflower Seed il Polyglyceryl-5 Esters Suflower Seed il Polyglyceryl-6 Esters Suflower Seed il Polyglyceryl-0 Esters Sweet Almod il Polyglyceryl-4 Esters Sweet Almod il Polyglyceryl-6 Esters Theobroma Gradiflorum Seed Butter Polyglyceryl-6 Esters Trichilia Emetica Seed il Polyglyceryl-6 Esters Triisostearoyl Polyglyceryl-3 Dimer Dilioleate Watermelo Seed il Polyglyceryl-6 Esters Watermelo Seed il Polyglyceryl-0 Esters imeia Americaa Seed il Polyglyceryl-6 Esters

49 Distributed for Commet ly -- Do Not Cite or Quote Table. Polyglyceryl Fatty Acid Esters arraged by polyglyceryl chai legth Polyglyceryl- discrete esters Polyglyceryl- Caprate Polyglyceryl- Caprylate Polyglyceryl- Laurate Polyglyceryl- Myristate Polyglyceryl- Isopalmitate Polyglyceryl- Palmitate Polyglyceryl- Isostearate Polyglyceryl- leate Polyglyceryl- Stearate Polyglyceryl Mooesters Polyglyceryl-5 discrete esters Polyglyceryl-5 Caprate Polyglyceryl-5 Laurate Polyglyceryl-5 Myristate Polyglyceryl-5 Isostearate Polyglyceryl-5 leate Polyglyceryl-5 Stearate Polyglyceryl-5 icioleate Polyglyceryl- mixed esters Polyglyceryl- Isopalmitate/Sebacate Polyglyceryl-5 mixed esters Apricot Kerel il Polyglyceryl-5 Esters Palm il Polyglyceryl-5 Esters Suflower Seed il Polyglyceryl-5 Esters Polyglyceryl-3 discrete esters Polyglyceryl-3 Caprate Polyglyceryl-3 Caprylate Polyglyceryl-3 Laurate Polyglyceryl-3 Myristate Polyglyceryl-3 Palmitate Polyglyceryl-3 Isostearate Polyglyceryl-3 leate Polyglyceryl-3 Stearate Polyglyceryl-3 Stearate SE Polyglyceryl-3 icioleate Polyglyceryl-3 Beheate Polyglyceryl-6 discrete esters Polyglyceryl-6 Caprate Polyglyceryl-6 Caprylate Polyglyceryl-6 Udecyleate Polyglyceryl-6 Laurate Polyglyceryl-6 Myristate Polyglyceryl-6 Palmitate Polyglyceryl-6 Isostearate Polyglyceryl-6 leate Polyglyceryl-6 Stearate Polyglyceryl-6 icioleate Polyglyceryl-6 Beheate Polyglyceryl-3 mixed esters Apricot Kerel il Polyglyceryl-3 Esters Cadelilla/Jojoba/ice Bra Polyglyceryl-3 Esters live il Polyglyceryl-3 Esters Palm il Polyglyceryl-3 Esters Polyglyceryl-3 Beeswax Polyglyceryl-3 Cocoate Polyglyceryl-3 ice Braate Polyglyceryl-3 Soyate/Shea Butterate ice Bra il Polyglyceryl-3 Esters Shea Butter Polyglyceryl-3 Esters Suflower Seed il Polyglyceryl-3 Esters Polyglyceryl-6 mixed esters Adasoia Digitata Seed il Polyglyceryl-6 Esters Apricot Kerel il Polyglyceryl-6 Esters Arga il Polyglyceryl-6 Esters Astrocaryum Vulgare il Polyglyceryl-6 Esters Avocado il Polyglyceryl-6 Esters Babassu il Polyglyceryl-6 Esters Bertholletia Excelsa Seed il Polyglyceryl-6 Esters Borage Seed il Polyglyceryl-6 Esters Carapa Guaiaesis il Polyglyceryl-6 Esters Castor il Polyglyceryl-6 Esters Cocoa Butter Polyglyceryl-6 Esters Cocout il Polyglyceryl-6 Esters Coffee Seed il Polyglyceryl-6 Esters Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters azelut Seed il Polyglyceryl-6 Esters Macadamia Seed il Polyglyceryl-6 Esters Mauritia Flexuosa Seed il Polyglyceryl-6 Esters live il Polyglyceryl-6 Esters Palm il Polyglyceryl-6 Esters Pariari Curatellifolia il Polyglyceryl-6 Esters Pius Sibirica Seed il Polyglyceryl-6 Esters Polyglyceryl-6 Adasoia Digitata Seedate Polyglyceryl-6 Apricot Kerelate Polyglyceryl-6 Arga Kerelate Polyglyceryl-6 Caprylate/Caprate Polyglyceryl-6 Citrullus Laatus Seedate Polyglyceryl-6 Palmitate/Succiate Polyglyceryl-6 Schiziophyto autaeii Kerelate Polyglyceryl-6 Sclerocarya Birrea Seedate Polyglyceryl-6 Trichilia Emetica Seedate Polyglyceryl-6 imeia Americaa Seedate osa ubigiosa Seed il Polyglyceryl-6 Esters Safflower Seed il Polyglyceryl-6 Esters Schiziophyto autaeii Kerel il Polyglyceryl-6 Esters Sclerocarya Birrea Seed il Polyglyceryl-6 Esters Sesame il Polyglyceryl-6 Esters Shea Butter Polyglyceryl-6 Esters Polyglyceryl-4 discrete esters Polyglyceryl-4 Caprate Polyglyceryl-4 Caprylate Polyglyceryl-4 Laurate Polyglyceryl-4 Isostearate Polyglyceryl-4 leate Polyglyceryl-4 Stearate Polyglyceryl-4 mixed esters Apricot Kerel il Polyglyceryl-4 Esters Babassu il Polyglyceryl-4 Esters Borage Seed il Polyglyceryl-4 Esters Liseed il Polyglyceryl-4 Esters live il Polyglyceryl-4 Esters Palm Kerel il Polyglyceryl-4 Esters Palm il Polyglyceryl-4 Esters Polyglyceryl-4 Almodate/Shea Butterate Polyglyceryl-4 Caprylate/Caprate Polyglyceryl-4 Cocoate Polyglyceryl-4 azelutseedate Polyglyceryl-4 Isostearate/Laurate Polyglyceryl-4 Laurate/Sebacate Polyglyceryl-4 Laurate/Succiate Polyglyceryl-4 Puicate Polyglyceryl-4 Sweet Almodate Shea Butter Polyglyceryl-4 Esters Suflower Seed il Polyglyceryl-4 Esters Sweet Almod il Polyglyceryl-4 Esters Polyglyceryl-6 mixed esters (co t) Soybea il Polyglyceryl-6 Esters Suflower Seed il Polyglyceryl-6 Esters Sweet Almod il Polyglyceryl-6 Esters Theobroma Gradiflorum Seed Butter Polyglyceryl-6 Esters Trichilia Emetica Seed il Polyglyceryl-6 Esters Watermelo Seed il Polyglyceryl-6 Esters imeia Americaa Seed il Polyglyceryl-6 Esters Polyglyceryl-8 discrete esters Polyglyceryl-8 leate Polyglyceryl-8 Stearate Polyglyceryl-8 mixed esters Polyglyceryl-8 C-0 Acid Ester Polyglyceryl-0 discrete esters Polyglyceryl-0 Caprate Polyglyceryl-0 Caprylate Polyglyceryl-0 Udecyleate Polyglyceryl-0 Laurate Polyglyceryl-0 Myristate Polyglyceryl-0 Palmitate Polyglyceryl-0 Isostearate Polyglyceryl-0 Lioleate Polyglyceryl-0 leate Polyglyceryl-0 Stearate Polyglyceryl-0 mixed esters Almod il/polyglyceryl-0 Esters Apricot Kerel il Polyglyceryl-0 Esters Caprylic/Capric Glycerides Polyglyceryl-0 Esters Polyglyceryl-0 Apricot Kerelate Polyglyceryl-0 Beheate/Eicosadioate Polyglyceryl-0 Caprylate/Caprate Polyglyceryl-0 Cocoate Polyglyceryl-0 Eicosaedioate/Tetradecaedioate Polyglyceryl-0 ydroxystearate/stearate/ Eicosadioate Polyglyceryl-0 Palmate Sclerocarya Birrea Seed il Polyglyceryl-0 Esters Suflower Seed il Polyglyceryl-0 Esters Watermelo Seed il Polyglyceryl-0 Esters

50 Distributed for Commet ly -- Do Not Cite or Quote Table. Polyglyceryl Fatty Acid Esters arraged by polyglyceryl chai legth Polyglyceryl Multi-esters (i.e., ot moo-esters ad ot polyesters ) Polyglyceryl- discrete multi-esters Polyglyceryl- Sesquicaprylate Polyglyceryl- Sesquiisostearate Polyglyceryl- Diisostearate Polyglyceryl- Triisostearate Polyglyceryl- Tetraisostearate Polyglyceryl- Dioleate Polyglyceryl- Sesquioleate Polyglyceryl- Tetraoleate Polyglyceryl- Sesquistearate Polyglyceryl- Distearate Polyglyceryl- Tetrastearate Polyglyceryl- mixed multi-esters Polyglyceryl- Tetrabeheate/ Macadamiate/Sebacate Polyglyceryl-3 discrete multi-esters Polyglyceryl-3 Dicaprate Polyglyceryl-3 Diisostearate Polyglyceryl-3 Triisostearate Polyglyceryl-3 Dioleate Polyglyceryl-3 Distearate Polyglyceryl-3 Di-ydroxystearate Polyglyceryl-3 Petaricioleate Polyglyceryl-3 mixed multi-esters Diisostearoyl Polyglyceryl-3 Dimer Dilioleate Polyglyceryl-3 Dicitrate/Stearate Polyglyceryl-3 Dicocoate Polyglyceryl-3 Petacaprylate/Caprate Polyglyceryl-3 Petaolivate Polyglyceryl-3 Triolivate Triisostearoyl Polyglyceryl-3 Dimer Dilioleate Polyglyceryl-6 discrete multi-esters Polyglyceryl-6 Sesquicaprylate Polyglyceryl-6 Dicaprate Polyglyceryl-6 Tricaprylate Polyglyceryl-6 Tetracaprylate Polyglyceryl-6 Petacaprylate Polyglyceryl-6 eptacaprylate Polyglyceryl-6 ctacaprylate Polyglyceryl-6 Dipalmitate Polyglyceryl-6 Sesquiisostearate Polyglyceryl-6 Diisostearate Polyglyceryl-6 Dioleate Polyglyceryl-6 Tetraoleate Polyglyceryl-6 Petaoleate Polyglyceryl-6 exaoleate Polyglyceryl-6 Sesquistearate Polyglyceryl-6 Distearate Polyglyceryl-6 Tristearate Polyglyceryl-6 Petastearate Polyglyceryl-6 exastearate Polyglyceryl-6 ctastearate Polyglyceryl-6 Petaricioleate Polyglyceryl-6 Tetrabeheate Polyglyceryl-6 mixed multi-ester Macadamia Seed il Polyglyceryl-6 Esters Beheate Polyglyceryl-8 mixed multi-esters Polyglyceryl-8 Decabeheate/Caprate Polyglyceryl-8 Decaerucate/Decaisostearate/ Decaricioleate Polyglyceryl-0 discrete multi-esters Polyglyceryl-0 Decaethylhexaoate Polyglyceryl-4 discrete multi-esters Polyglyceryl-0 Dodecacaprate Polyglyceryl-4 Dilaurate Polyglyceryl-0 Petacaprylate Polyglyceryl-4 Petaoleate Polyglyceryl-0 Dodecacaprylate Polyglyceryl-4 Distearate Polyglyceryl-0 Tridecaoate Polyglyceryl-4 Tristearate Polyglyceryl-0 Dilaurate Polyglyceryl-4 Petastearate Polyglyceryl-0 Trilaurate Polyglyceryl-0 Tetralaurate Polyglyceryl-4 mixed multi-esters Polyglyceryl-0 Petalaurate Polyglyceryl-4 Petapalmitate/Stearate Polyglyceryl-0 Dimyristate Pumpki Seed il Polyglyceryl-4 Esters Polyglyceryl-0 Dipalmitate Pumpki Seed il Polyglyceryl-4 Esters Succiate Polyglyceryl-0 Diisostearate Polyglyceryl-0 Triisostearate Polyglyceryl-5 discrete multi-esters Polyglyceryl-0 Petaisostearate Polyglyceryl-5 Dicaprylate Polyglyceryl-0 exaisostearate Polyglyceryl-5 Dilaurate Polyglyceryl-0 Noaisostearate Polyglyceryl-5 Trimyristate Polyglyceryl-0 Decaisostearate Polyglyceryl-5 Petamyristate Polyglyceryl-0 Petalioleate Polyglyceryl-5 Triisostearate Polyglyceryl-0 Decalioleate Polyglyceryl-5 Dioleate Polyglyceryl-0 Dioleate Polyglyceryl-5 Trioleate Polyglyceryl-0 Trioleate Polyglyceryl-5 Tristearate Polyglyceryl-0 Tetraoleate Polyglyceryl-5 exastearate Polyglyceryl-0 Petaoleate Polyglyceryl-5 Tribeheate Polyglyceryl-0 discrete multi-esters (co t) Polyglyceryl-0 Petaricioleate Polyglyceryl-0 exaoleate Polyglyceryl-0 eptaoleate Polyglyceryl-0 Decaoleate Polyglyceryl-0 Distearate Polyglyceryl-0 Tristearate Polyglyceryl-0 Petastearate Polyglyceryl-0 Petahydroxystearate Polyglyceryl-0 eptahydroxystearate Polyglyceryl-0 eptastearate Polyglyceryl-0 Decahydroxystearate Polyglyceryl-0 Decastearate Polyglyceryl-0 Dodecabeheate Polyglyceryl-0 Trierucate Polyglyceryl-0 exaerucate Polyglyceryl-0 Noaerucate Polyglyceryl-0 mixed multi-esters Polyglyceryl-0 Decamacadamiate Polyglyceryl-0 Dicocoate Polyglyceryl-0 Didecaoate Polyglyceryl-0 Dodeca-Caprylate/ Caprate Polyglyceryl-0 epta(beheate/stearate) Polyglyceryl-0 Moo/Dioleate Polyglyceryl-0 Sesquistearate Polyglyceryl-0 Tetradecaedioate Polyglyceryl-0 Tricocoate Polyglyceryl-5 discrete multi-ester Polyglyceryl-5 Diisostearate Polyglyceryl-0 discrete multi-esters Polyglyceryl-0 exacaprylate Polyglyceryl-0 eptacaprylate Polyglyceryl-0 ctaisooaoate Polyglyceryl-0 mixed multi-esters Polyglyceryl-0 Docosabeheate/Isostearate Polyglyceryl-0 Docosabeheate/Laurate Polyglyceryl-0 Docosabeheate/leate Polyglyceryl-0 eptadecabeheate/laurate Polyglyceryl-0 ctadecabeheate/laurate

51 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl- discrete esters Polyglyceryl- Caprate ( CI Staff) Defiitio & Structure Polyglyceryl Mooesters Fuctio(s) the ester of capric acid ad diglyceri ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl- Caprylate C3 wherei is the ester of caprylic acid ad diglyceri ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl- Laurate C3 wherei is the ester of lauric acid ad diglyceri ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl- Myristate C3 wherei is the mooester of myristic acid ad diglycerol ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl- Isopalmitate C3 wherei is a ester of isopalmitic acid ad diglyceri ski-coditioig aget - emolliet; surfactat emulsifyig aget C3 Polyglyceryl- Palmitate C3 wherei is (oe example of a iso ) the mooester of palmitic acid ad diglycerol ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl- Isostearate wherei is the ester of isostearic acid ad diglyceri C3 C3 wherei is (oe example of a iso ) a ester of oleic acid ad diglyceri ski-coditioig aget - emolliet; surfactat emulsifyig aget C3 Polyglyceryl- Stearate (geeric) ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl- leate (geeric) C3 wherei is the ester of stearic acid ad diglyceri C3 ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei is Polyglyceryl- mixed esters Polyglyceryl- Isopalmitate/Sebacate the mixed ester of isopalmitic acid, sebacic acid ad diglyceri surfactat emulsifyig aget wherei C()- represets the residue of isopalmitic or sebacic acid, ad is Polyglyceryl-3 discrete esters Polyglyceryl-3 Caprate a ester of capric acid ad polyglyceri-3 C3 wherei is 3 ski-coditioig aget - emolliet; surfactat emulsifyig aget

52 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-3 Caprylate ( CI Staff) Defiitio & Structure the ester of caprylic acid ad polyglyceri-3 Fuctio(s) deodorat aget; surfactats emulsifyig aget Polyglyceryl-3 Laurate C3 wherei is 3 the ester of lauric acid ad polyglyceri-3 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-3 Myristate C3 wherei is 3 the ester of myristic acid ad polyglyceri-3 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-3 Palmitate C3 wherei is 3 a ester of palmitic acid ad polyglyceri-3 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-3 Isostearate C3 wherei is 3 the ester of isostearic acid ad polyglyceri-3 C3 Polyglyceryl-3 leate (geeric) wherei is 3 (oe example of a iso ) a ester of oleic acid ad polyglyceri-3 ski-coditioig aget - emolliet; surfactat emulsifyig aget C3 wherei is 3 a ester of stearic acid ad polyglyceri-3 C3 Polyglyceryl-3 Stearate SE C3 Polyglyceryl-3 Stearate (geeric) ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei is 3 a self-emulsifyig grade of polyglyceryl-3 stearate that cotais some sodium ad/or potassium stearate surfactat emulsifyig aget C3 wherei is 3 ad - M+ Polyglyceryl-3 icioleate (geeric) C3 wherei M is sodium or potassium a ester of ricioleic acid ad polyglyceri-3 C3 Polyglyceryl-3 Beheate ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei is 3 the ester of beheic acid ad polyglyceri-3 C3 wherei is 3 emulsio stabilizer; slip modifier; surface modifier

53 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-3 mixed esters Apricot Kerel il Polyglyceryl-3 Esters ( CI Staff) Defiitio & Structure the product obtaied by the trasesterificatio of pruus armeiaca (apricot) kerel oil ad polyglyceri-3 Cadelilla/Jojoba/ice Bra Polyglyceryl-3 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Fuctio(s) wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from pruus armeiaca (apricot) kerel oil, ad is 3 a product obtaied by the trasesterificatio of polyglyceri-3 ad euphorbia cerifera (cadelilla) wax, ad simmodsia chiesis (jojoba) seed wax ad oryza sativa (rice) bra wax emulsio stabilizer; surfactat emulsifyig aget live il Polyglyceryl-3 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from euphorbia cerifera (cadelilla) wax, ad simmodsia chiesis (jojoba) seed wax ad oryza sativa (rice) bra wax, ad is 3 the product obtaied by the trasesterificatio of polyglyceri-3 ad olea europaea (olive) fruit oil surfactat emulsifyig aget Palm il Polyglyceryl-3 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from olea europaea (olive) fruit oil, ad is 3 the product obtaied by the trasesterificatio of polyglyceri-3 ad elaeis guieesis (palm) oil Polyglyceryl-3 Beeswax ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from elaeis guieesis (palm) oil, ad is 3 a ester of beeswax fatty acids ad polyglyceri-3 surfactat emulsifyig aget Polyglyceryl-3 Cocoate wherei C()- represets the residue of beeswax fatty acids, ad is 3 the ester of cocout acid ad polyglyceri-3 surfactat emulsifyig aget Polyglyceryl-3 ice Braate wherei C()- represets the residue of cocout acid, ad is 3 the mooester of polyglyceri-3 ad rice bra acid surfactat emulsifyig aget wherei C()- represets the residue of rice bra acid, ad is 3 Polyglyceryl-3 Soyate/Shea Butterate a ester of a mixture of fatty acids derived from glycie soja (soybea) oil ad butyrospermum parkii (shea) butter with polyglyceri-3 wherei C()- represets the residue of the fatty acids obtaied from glycie soja (soybea) oil ad butyrospermum parkii (shea) butter, ad is 3 surfactat emulsifyig aget

54 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. ice Bra il Polyglyceryl-3 Esters ( CI Staff) Defiitio & Structure the product obtaied by the trasesterificatio of oryza sativa (rice) bra oil ad polyglyceri-3 Fuctio(s) surfactats emulsifyig aget Shea Butter Polyglyceryl-3 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from oryza sativa (rice) bra oil, ad is 3 the product obtaied by the trasesterificatio of polyglyceri-3 ad butyrospermum parkii (shea) butter wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from butyrospermum parkii (shea) butter, ad is 3 Suflower Seed il Polyglyceryl-3 Esters the product obtaied by the trasesterificatio of heliathus auus (suflower) seed oil ad polyglyceri-3 emulsio stabilizer; hair coditioig aget; ski-coditioig aget miscellaeous; surfactat emulsifyig aget; viscosity icreasig aget - aqueous ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from heliathus auus (suflower) seed oil, ad is 3 Polyglyceryl-4 discrete esters Polyglyceryl-4 Caprate the ester of capric acid ad polyglyceri-4 C3 Polyglyceryl-4 Caprylate ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei is 4 the mooester of caprylic acid ad polyglyceri-4 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-4 Laurate ; (geeric); C3 wherei is 4 the ester of lauric acid ad polyglyceri-4 wherei is 4 a ester of isostearic acid ad polyglyceri-4 C3 C3 wherei is 4 (oe example of a iso ) a ester of oleic acid ad polyglyceri-4 ski-coditioig aget - emolliet; surfactat emulsifyig aget C3 Polyglyceryl-4 Stearate (geeric) ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-4 leate (geeric) C3 Polyglyceryl-4 Isostearate ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei is 4 a ester of stearic acid ad polyglyceri-4 surfactat emulsifyig aget C3 wherei is 4

55 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-4 mixed esters Apricot Kerel il Polyglyceryl-4 Esters ( CI Staff) Defiitio & Structure the product obtaied by the trasesterificatio of pruus armeiaca (apricot) kerel oil ad polyglyceri-4 Babassu il Polyglyceryl-4 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Fuctio(s) wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from pruus armeiaca (apricot) kerel oil, ad is 4 the product of the trasesterificatio of orbigya oleifera seed oil ad polyglyceri-4 surfactat solubilizig aget Borage Seed il Polyglyceryl-4 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from orbigya oleifera seed oil, ad is 4 the product obtaied by the trasesterificatio of borago officialis seed oil ad polyglyceri-4 Liseed il Polyglyceryl-4 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from borago officialis seed oil, ad is 4 the product obtaied by the trasesterificatio of lium usitatissimum (liseed) seed oil ad polyglyceri-4 live il Polyglyceryl-4 Esters opacifyig aget; surfactat emulsifyig aget; surfactat solubilizig aget opacifyig aget; surfactat emulsifyig aget; surfactat solubilizig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from lium usitatissimum (liseed) seed oil, ad is 4 the product obtaied by the trasesterificatio of olea europaea (olive) fruit oil ad polyglyceri-4 surfactat solubilizig aget Palm Kerel il Polyglyceryl-4 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from olea europaea (olive) fruit oil, ad is 4 is the product obtaied by the trasesterificatio of elaeis guieesis (palm) kerel oil ad polyglyceri-4 Palm il Polyglyceryl-4 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from elaeis guieesis (palm) kerel oil, ad is 4 the product obtaied by the trasesterificatio of polyglyceri-4 ad elaeis guieesis (palm) oil wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from elaeis guieesis (palm) oil, ad is 4 a ester of a mixture of fatty acids derived from almod oil ad butyrospermum parkii (shea) butter with polyglyceri-4 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-4 Almodate/Shea Butterate opacifyig aget; surfactat emulsifyig aget; surfactat solubilizig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from butyrospermum parkii (shea) butter, ad is 4 surfactat emulsifyig aget

56 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-4 Caprylate/Caprate ( CI Staff) Defiitio & Structure the mooester of polyglyceri-4 ad a mixture of caprylic ad capric acids Polyglyceryl-4 Cocoate Fuctio(s) surfactat hydrotrope; surfactat solubilizig aget wherei C()- represets the residue of capric or caprylic acid, ad is 4 a ester of cocout acid ad polyglyceri-4 surfactat emulsifyig aget Polyglyceryl-4 azelutseedate wherei C()- represets the residue of cocout acid, ad is 4 a ester of the fatty acids derived from corylus avellaa (hazelut) seed oil with polyglyceri-4 surfactat emulsifyig aget Polyglyceryl-4 Isostearate/Laurate wherei C()- represets the residue of the fatty acids derived from corylus avellaa (hazelut) seed oil, ad is 4 the ester of a mixture of isostearic ad lauric acids with polyglyceri-4 wherei C()- represets the residue of isostearic or lauric acid, ad is 4 Polyglyceryl-4 Laurate/Sebacate the mooester of polyglyceri-4 ad a mixture of lauric ad sebacic acids Polyglyceryl-4 Laurate/Succiate dispersig aget osurfactat; emulsio stabilizer; surfactat emulsifyig aget; surfactat - foam booster surfactat hydrotrope; surfactat solubilizig aget wherei C()- represets the residue of lauric or sebacic acid, ad is 4 the mooester of polyglyceri-4 ad a mixture of lauric ad succiic acids surfactat emulsifyig aget Polyglyceryl-4 Puicate wherei C()- represets the residue of lauric or succiic acid, ad is 4 the ester of polyglyceri-4 ad puicic acid surfactat emulsifyig aget Polyglyceryl-4 Sweet Almodate wherei C()- represets the residue of puicic acid, ad is 4 a ester of the fatty acids derived from sweet almod oil ad polyglyceri-4 Shea Butter Polyglyceryl-4 Esters ski-coditioig aget - misc; surfactat emulsifyig aget wherei C()- represets the residue of the fatty acids obtaied from sweet almod oil, ad is 4 the product obtaied by the trasesterificatio of butyrospermum parkii (shea) butter ad polyglyceri-4 emulsio stabilizer; ski-coditioig aget emolliet Suflower Seed il Polyglyceryl-4 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from butyrospermum parkii (shea) butter, ad is 4 the product obtaied by the trasesterificatio of heliathus auus (suflower) seed oil ad polyglyceri-4 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from heliathus auus (suflower) seed oil, ad is 4 ski-coditioig aget - emolliet; surfactat emulsifyig aget

57 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Sweet Almod il Polyglyceryl-4 Esters (geeric) ( CI Staff) Defiitio & Structure the product obtaied by the trasesterificatio of pruus amygdalus dulcis (sweet almod) oil ad polyglyceri-4 Fuctio(s) surfactats solubilizig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from pruus amygdalus dulcis (sweet almod) oil, ad is 4 Polyglyceryl-5 discrete esters Polyglyceryl-5 Caprate the mooester of capric acid ad polyglyceri-5 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-5 Laurate ; (geeric) C3 wherei is 5 the ester of lauric acid ad a glyceri polymer cotaiig a average of 5 glyceri uits ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-5 Myristate C3 wherei is 5 the mooester of myristic acid ad a glyceri polymer cotaiig 5 uits of glyceri Polyglyceryl-5 Isostearate C3 wherei is 5 the ester of isostearic acid ad a glyceri polymer cotaiig a average of 5 glyceri uits C3 C3 wherei is 5 (oe example of a iso ) the ester of oleic acid ad a glyceri polymer cotaiig a average of 5 glyceri uits ski-coditioig aget - emolliet; surfactat emulsifyig aget C3 Polyglyceryl-5 Stearate (geeric) ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-5 leate (geeric) ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei is 5 the mooester of stearic acid ad a glyceri polymer cotaiig 5 uits of glyceri surfactat emulsifyig aget Polyglyceryl-5 icioleate C3 wherei is 5 is the product obtaied by the reactio of ricioleic acid with a glyceri polymer cotaiig 5 glyceri uits surfactat emulsifyig aget C3 wherei is 5 Polyglyceryl-5 mixed esters Apricot Kerel il Polyglyceryl-5 Esters the product obtaied by the trasesterificatio of pruus armeiaca (apricot) kerel oil ad polyglyceri-5 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from pruus armeiaca (apricot) kerel oil, ad is 5 ski-coditioig aget - emolliet; surfactat emulsifyig aget

58 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Palm il Polyglyceryl-5 Esters ( CI Staff) Defiitio & Structure the product obtaied by the trasesterificatio of a glyceri polymer cotaiig 5 uits of glyceri ad elaeis guieesis (palm) oil Suflower Seed il Polyglyceryl-5 Esters Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from elaeis guieesis (palm) oil, ad is 5 the product obtaied by the trasesterificatio of heliathus auus (suflower) seed oil ad a glyceri polymer cotaiig 5 uits of glyceri ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from heliathus auus (suflower) seed oil, ad is 5 Polyglyceryl-6 discrete esters Polyglyceryl-6 Caprate the mooester of capric acid ad polyglyceri-6 surfactat cleasig aget; surfactat emulsifyig aget Polyglyceryl-6 Caprylate C3 wherei is 6 the mooester of caprylic acid ad polyglyceri-6 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-6 Udecyleate C3 wherei is 6 a ester of udecyleic acid ad polyglyceri-6 surfactat emulsifyig aget C3 Polyglyceryl-6 Laurate ; (geeric) wherei is 6 the ester of lauric acid ad polyglyceri-6 C3 Polyglyceryl-6 Myristate ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei is 6 the mooester of myristic acid ad polyglyceri-6 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-6 Palmitate C3 wherei is 6 the ester of palmitic acid ad polyglyceri-6 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-6 Isostearate C3 wherei is 6 the ester of isostearic acid ad polyglyceri-6 C3 Polyglyceryl-6 leate (geeric) C3 wherei is 6 (oe example of a iso ) the ester of oleic acid ad polyglyceri-6 C3 wherei is 6 ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget

59 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-6 Stearate ( CI Staff) Defiitio & Structure the ester of stearic acid ad polyglyceri-6 Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget C3 Polyglyceryl-6 icioleate wherei is 6 the ester of polyglyceri-6 ad ricioleic acid C3 Polyglyceryl-6 Beheate ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei is 6 the mooester of beheic acid ad polyglyceri-6 C3 emulsio stabilizer; slip modifier; surface modifier wherei is 6 Polyglyceryl-6 mixed esters Adasoia Digitata Seed il Polyglyceryl-6 Esters the product obtaied by the trasesterificatio of adasoia digitata seed oil ad polyglyceri-6 Apricot Kerel il Polyglyceryl-6 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from adasoia digitata seed oil, ad is 6 the product obtaied by the trasesterificatio of pruus armeiaca (apricot) kerel oil ad polyglyceri-6 Arga il Polyglyceryl-6 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from pruus armeiaca (apricot) kerel oil, ad is 6 the product obtaied by the trasesterificatio of argaia spiosa kerel oil ad polyglyceri-6 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from argaia spiosa kerel oil, ad is 6 the product obtaied by the trasesterificatio of astrocaryum vulgare kerel oil ad polyglyceri-6 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from astrocaryum vulgare kerel oil, ad is 6 the product obtaied by the trasesterificatio of persea gratissima (avocado) oil ad polyglyceri-6 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from persea gratissima (avocado) oil, ad is 6 the product obtaied by the trasesterificatio of orbigya oleifera seed oil ad polyglyceri-6 ski-coditioig aget - emolliet; surfactat emulsifyig aget Babassu il Polyglyceryl-6 Esters ski-coditioig aget - misc; surfactat emulsifyig aget Avocado il Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Astrocaryum Vulgare il Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from orbigya oleifera seed oil, ad is 6 ski-coditioig aget - emolliet; surfactat emulsifyig aget

60 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Bertholletia Excelsa Seed il Polyglyceryl-6 Esters ( CI Staff) Defiitio & Structure the product obtaied by the trasesterificatio of bertholletia excelsa seed oil ad polyglyceri-6 Borage Seed il Polyglyceryl-6 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from bertholletia excelsa seed oil, ad is 6 the product obtaied by the trasesterificatio of borago officialis seed oil ad polyglyceri-6 Carapa Guaiaesis il Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from borago officialis seed oil, ad is 6 the product obtaied by the trasesterificatio of carapa guaiaesis seed oil ad polyglyceri-6 ski-coditioig aget - emolliet Castor il Polyglyceryl-6 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from carapa guaiaesis seed oil, ad is 6 the product obtaied by the trasesterificatio of ricius commuis (castor) seed oil ad polyglyceri-6 Cocoa Butter Polyglyceryl-6 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from ricius commuis (castor) seed oil, ad is 6 the product obtaied by the trasesterificatio of theobroma cacao (cocoa) seed butter ad polyglyceri-6 ski-coditioig aget - emolliet; ski coditioig aget misc; surfactat emulsifyig aget ski-coditioig aget - emolliet Cocout il Polyglyceryl-6 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from theobroma cacao (cocoa) seed butter, ad is 6 the product obtaied by the trasesterificatio of cocos ucifera (cocout) oil with polyglyceri-6 Coffee Seed il Polyglyceryl-6 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from cocos ucifera (cocout) oil, ad is 6 the product obtaied by the trasesterificatio of polyglyceri-6 ad coffea arabica (coffee) seed oil wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from coffea arabica (coffee) seed oil, ad is 6 the mixture of esters formed by the reactio of glyceri ad polyglyceri-6 with isostearic acid ad beheic acid ski-coditioig aget - emolliet; surfactat emulsifyig aget Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of isostearic or beheic acid, ad is or 6 ski-coditioig aget - emolliet

61 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. azelut Seed il Polyglyceryl-6 Esters ( CI Staff) Defiitio & Structure the product obtaied by the trasesterificatio of corylus avellaa (hazelut) seed oil ad polyglyceri-6 Macadamia Seed il Polyglyceryl-6 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from corylus avellaa (hazelut) seed oil, ad is 6 the product obtaied by the trasesterificatio of macadamia terifolia seed oil ad polyglyceri-6 Mauritia Flexuosa Seed il Polyglyceryl-6 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from macadamia terifolia seed oil, ad is 6 the product obtaied by the trasesterificatio of the oil obtaied from the seeds of Mauritia flexuosa ad polyglyceri-6 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from the seeds of Mauritia flexuosa, ad is 6 the product obtaied by the trasesterificatio of olea europaea (olive) fruit oil ad polyglyceri-6 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from olea europaea (olive) fruit oil, ad is 6 the product obtaied by the trasesterificatio of polyglyceri-6 ad elaeis guieesis (palm) oil wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from elaeis guieesis (palm) oil, ad is 6 the product of the trasesterificatio of the oil obtaied from the seeds of Pariari curatellifolia ad polyglyceri-6 ski-coditioig aget - emolliet; surfactat emulsifyig aget Pius Sibirica Seed il Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Pariari Curatellifolia il Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Palm il Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget live il Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from the seeds of Pariari curatellifolia, ad is 6 the product obtaied by the trasesterificatio of pius sibirica seed oil ad polyglyceri-6 surfactat emulsifyig aget Polyglyceryl-6 Adasoia Digitata Seedate wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from pius sibirica seed oil, ad is 6 the ester of the fatty acids obtaied from adasoia digitata seed oil ad polyglyceri-6 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from adasoia digitata seed oil, ad is 6 ski-coditioig aget - emolliet; surfactat emulsifyig aget

62 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-6 Apricot Kerelate ( CI Staff) Defiitio & Structure the ester of the fatty acids derived from pruus armeiaca (apricot) kerel oil ad polyglyceri-6 Polyglyceryl-6 Arga Kerelate wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from pruus armeiaca (apricot) kerel oil, ad is 6 the ester of polyglyceri-6 ad the fatty acids obtaied from argaia spiosa kerel oil Polyglyceryl-6 Caprylate/Caprate wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from argaia spiosa kerel oil, ad is 6 the mooester of polyglyceri-6 ad a mixture of caprylic ad capric acids Polyglyceryl-6 Citrullus Laatus Seedate ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-6 Palmitate/Succiate surfactat hydrotrope; surfactat solubilizig aget wherei C()- represets the residue of capric or caprylic acid, ad is 6 the ester of the fatty acids derived from citrullus laatus (watermelo) seed oil ad polyglyceri-6 ski-coditioig aget - emolliet; surfactat emulsifyig aget Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from citrullus laatus (watermelo) seed oil, ad is 6 the mooester of polyglyceri-6 ad a mixture of palmitic ad succiic acids surfactat emulsifyig aget Polyglyceryl-6 Schiziophyto autaeii Kerelate wherei C()- represets the residue of palmitic or succiic acid, ad is 6 the ester of polyglyceri-6 ad the fatty acids obtaied from schiziophyto rautaeii kerel oil Polyglyceryl-6 Sclerocarya Birrea Seedate wherei C()- represets the residue of the fatty acids obtaied from schiziophyto rautaeii kerel oil, ad is 6 the ester of polyglyceri-6 ad the fatty acids obtaied sclerocarya birrea seed oil wherei C()- represets the residue of the fatty acids obtaied from sclerocarya birrea seed oil, ad is 6 the ester of polyglyceri-6 ad the fatty acids obtaied from trichilia emetica seed butter Polyglyceryl-6 imeia Americaa Seedate wherei C()- represets the residue of the fatty acids obtaied from trichilia emetica seed butter, ad is 6 the ester of polyglyceri-6 ad the fatty acids obtaied from ximeia americaa seed oil ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-6 Trichilia Emetica Seedate ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of the fatty acids obtaied from ximeia americaa seed oil, ad is 6 ski-coditioig aget - emolliet; surfactat emulsifyig aget

63 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. osa ubigiosa Seed il Polyglyceryl-6 Esters ( CI Staff) Defiitio & Structure the product obtaied by the trasesterificatio of rosa rubigiosa seed oil ad polyglyceri-6 Safflower Seed il Polyglyceryl-6 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from rosa rubigiosa seed oil, ad is 6 the product obtaied by the trasesterificatio of carthamus tictorius (safflower) seed oil ad polyglyceri-6 Schiziophyto autaeii Kerel il Polyglyceryl-6 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from carthamus tictorius (safflower) seed oil, ad is 6 the product formed by the trasesterificatio of schiziophyto rautaeii kerel oil ad polyglyceri-6 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from schiziophyto rautaeii kerel oil, ad is 6 the product obtaied by the trasesterificatio of sclerocarya birrea seed oil with polyglyceri-6 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from sclerocarya birrea seed oil, ad is 6 the product obtaied by the trasesterificatio of sesamum idicum (sesame) oil ad polyglyceri-6 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from sesamum idicum (sesame) oil, ad is 6 the product obtaied by the trasesterificatio of butyrospermum parkii (shea) butter ad polyglyceri-6 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from butyrospermum parkii (shea) butter, ad is 6 the product of the trasesterificatio of glycie soja (soybea) oil ad polyglyceri-6 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from glycie soja (soybea) oil, ad is 6 the product obtaied by the trasesterificatio of heliathus auus (suflower) seed oil ad polyglyceri-6 ski-coditioig aget - emolliet; surfactat emulsifyig aget Suflower Seed il Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Soybea il Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Shea Butter Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Sesame il Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Sclerocarya Birrea Seed il Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Fuctio(s) ski-coditioig aget - emolliet; ski-coditioig aget miscellaeous; surfactat emulsifyig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from heliathus auus (suflower) seed oil, ad is 6 ski-coditioig aget - emolliet; surfactat emulsifyig aget

64 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Sweet Almod il Polyglyceryl-6 Esters ( CI Staff) Defiitio & Structure the product obtaied by the trasesterificatio of pruus amygdalus dulcis (sweet almod) oil ad polyglyceri-6 Theobroma Gradiflorum Seed Butter Polyglyceryl-6 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from pruus amygdalus dulcis (sweet almod) oil, ad is 6 the product obtaied by the trasesterificatio of theobroma gradiflorum seed butter ad polyglyceri-6 Trichilia Emetica Seed il Polyglyceryl-6 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from theobroma gradiflorum seed butter, ad is 6 the product obtaied by the trasesterificatio of trichilia emetica seed butter ad polyglyceri-6 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from trichilia emetica seed butter, ad is 6 the product obtaied by the trasesterificatio of citrullus laatus (watermelo) seed oil with polyglyceri-6 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from citrullus laatus (watermelo) seed oil, ad is 6 the product obtaied by the trasesterificatio of ximeia americaa seed oil ad polyglyceri-6 ski-coditioig aget - emolliet; surfactat emulsifyig aget imeia Americaa Seed il Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Watermelo Seed il Polyglyceryl-6 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from ximeia americaa seed oil, ad is 6 Polyglyceryl-8 discrete esters Polyglyceryl-8 leate (geeric) a ester of oleic acid ad a glyceri polymer cotaiig a average of 8 glyceri uits C3 ski-coditioig aget misc.; surfactat emulsifyig aget wherei is 8 a ester of stearic acid ad a glyceri polymer cotaiig a average of 8 glyceri uits surfactat emulsifyig aget Polyglyceryl-8 Stearate (geeric) C3 wherei is 8 Polyglyceryl-8 mixed esters Polyglyceryl-8 C-0 Acid Ester the ester of a glyceri polymer cotaiig 8 uits of glyceri ad a sythetic mixture of saturated acids cotaiig to 0 carbos i the alkyl chai wherei C()- represets the residue of a fatty acid cotaiig to 0 carbos i the alkyl chai, ad is 8 surfactat emulsifyig aget

65 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-0 discrete esters Polyglyceryl-0 Caprate ( CI Staff) Defiitio & Structure Fuctio(s) the ester of capric acid ad polyglyceri-0 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Caprylate C3 wherei is 0 the mooester of caprylic acid ad polyglyceri-0 surfactat emulsifyig aget Polyglyceryl-0 Udecyleate C3 wherei is 0 a ester of Udecyleic Acid ad polyglyceri-0 surfactat emulsifyig aget C3 Polyglyceryl-0 Laurate (geeric) wherei is 0 a ester of lauric acid ad polyglyceri-0 C3 Polyglyceryl-0 Myristate ski-coditioig aget - misc; surfactat emulsifyig aget wherei is 0 a ester of myristic acid ad polyglyceri-0 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Palmitate C3 wherei is 0 the ester of palmitic acid ad polyglyceri-0 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Isostearate C3 wherei is 0 the ester of isostearic acid ad polyglyceri-0 C3 Polyglyceryl-0 Lioleate ski-coditioig aget - emolliet; surfactat emulsifyig aget C3 wherei is 0 (oe example of a iso ) the mooester of lioleic acid ad polyglyceri-0 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 leate (geeric) wherei is 0 a ester of oleic acid ad polyglyceri-0 ski-coditioig aget - misc; surfactat emulsifyig aget C3 Polyglyceryl-0 Stearate (geeric) C3 wherei is 0 a ester of stearic acid ad polyglyceri-0 C3 wherei is 0 ski-coditioig aget - misc; surfactat emulsifyig aget

66 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-0 mixed esters Almod il/polyglyceryl-0 Esters ( CI Staff) Defiitio & Structure the product obtaied by the trasesterificatio of pruus amygdalus dulcis (sweet almod) oil ad polyglyceri-0 Fuctio(s) surfactat emulsifyig aget Apricot Kerel il Polyglyceryl-0 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from pruus amygdalus dulcis (sweet almod) oil, ad is 0 the product obtaied by the trasesterificatio of pruus armeiaca (apricot) kerel oil ad polyglyceri-0 Caprylic/Capric Glycerides Polyglyceryl-0 Esters wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from pruus armeiaca (apricot) kerel oil, ad is 0 the product obtaied by the trasesterificatio of caprylic/capric glycerides with polyglyceri-0 Polyglyceryl-0 Apricot Kerelate wherei C()- represets the residue of caprylic or capric acid, ad is 0 the ester of the fatty acids derived from pruus armeiaca (apricot) kerel oil ad polyglyceri-0 Polyglyceryl-0 Beheate/Eicosadioate wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from pruus armeiaca (apricot) kerel oil, ad is 0 the mooester of polyglyceri-0 ad a bled of beheic ad eicosadioic acids Polyglyceryl-0 Caprylate/Caprate Polyglyceryl-0 Eicosaedioate/Tetradecaedioate Polyglyceryl-0 ydroxystearate/ Stearate/Eicosadioate surfactatcleasig aget; surfactatemulsifyig aget hair coditioig aget; ski coditioig aget - occlusive wherei C()- represets the residue of eicosaedioic or tetradecaedioic acid, ad is 0 the mooester of polyglyceri-0 with a bled of hydroxystearic, stearic ad eicosadioic acids emulsio stabilizer; solvet; surfactat emulsifyig aget wherei C()- represets the residue of cocout acid, ad is 0 the ester of polyglyceri-0 with a mixture of eicosaedioic ad tetradecaedioic acids ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of capric or caprylic acid, ad is 0 the ester of cocout acid ad polyglyceri-0 ski-coditioig aget - emolliet; ski-coditioig aget miscellaeous; surfactat emulsifyig aget Polyglyceryl-0 Cocoate ski-coditioig aget - emolliet; surfactat emulsifyig aget; surfactat - solubilizig aget wherei C()- represets the residue of beheic or eicosadioic acid, ad is 0 the mooester of polyglyceri-0 ad a bled of caprylic ad capric acids ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of hydroxystearic, stearic ad eicosadioic acids, ad is 0 ski-coditioig aget - emolliet

67 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-0 Palmate ( CI Staff) Defiitio & Structure the ester of palm acid ad polyglyceri-0 Sclerocarya Birrea Seed il Polyglyceryl-0 Esters wherei C()- represets the residue of palm acid, ad is 0 the product obtaied by the trasesterificatio of sclerocarya birrea seed oil with polyglyceri-0 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from sclerocarya birrea seed oil, ad is 0 the product obtaied by the trasesterificatio of heliathus auus (suflower) seed oil ad polyglyceri-0 ski-coditioig aget - emolliet; surfactat emulsifyig aget Watermelo Seed il Polyglyceryl-0 Esters ski-coditioig aget - emolliet; surfactat emulsifyig aget Suflower Seed il Polyglyceryl-0 Esters Fuctio(s) ski-coditioig aget - misc; surfactat emulsifyig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from heliathus auus (suflower) seed oil, ad is 0 the product obtaied by the trasesterificatio of citrullus laatus (watermelo) seed oil with polyglyceri-0 ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from citrullus laatus (watermelo) seed oil, ad is 0 Polyglyceryl Multi-esters (i.e., ot moo-esters ad ot polyesters ) Polyglyceryl- discrete multi-esters Polyglyceryl- Sesquicaprylate a mixture of moo- ad diesters of caprylic acid ad diglyceri Polyglyceryl- Sesquiisostearate wherei - represets hydroge or the residue of caprylic acid, ad is a mixture of moo ad diesters of isostearic acid ad diglyceri Polyglyceryl- Diisostearate (geeric) wherei - represets hydroge or the residue of isostearic acid, ad is the diester of isostearic acid ad diglyceri Polyglyceryl- Triisostearate wherei - represets hydroge or the residue of isostearic acid, ad is the tetraester of isostearic acid ad a dimer of glyceri ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of isostearic acid, ad is the triester of isostearic acid ad diglyceri Polyglyceryl- Tetraisostearate ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl- Dioleate wherei C()- represets the residue of isostearic acid, ad is a diester of oleic acid ad diglyceri wherei C()- represets the residue of oleic acid, ad is ski-coditioig aget - emolliet; surfactat emulsifyig aget

68 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl- Sesquioleate ( CI Staff) Defiitio & Structure a mixture of moo ad diesters of oleic acid ad diglyceri Polyglyceryl- Tetraoleate wherei - represets hydroge or the residue of oleic acid, ad is the tetraester of oleic acid ad diglyceri Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - misc; surfactat emulsifyig aget Polyglyceryl- Sesquistearate (geeric) wherei C()- represets the residue of oleic acid, ad is a mixture of moo- ad diesters of stearic acid ad diglyceri Polyglyceryl- Distearate (geeric) wherei - represets hydroge or the residue of stearate acid, ad is the diester of stearic acid ad diglyceri Polyglyceryl- Tetrastearate (geeric) wherei C()- represets the residue of stearic acid, ad is the tetraester of stearic acid ad diglyceri surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of stearic acid, ad is Polyglyceryl- mixed multi-esters Polyglyceryl- Tetrabeheate/ Macadamiate/Sebacate the tetraester of a mixture of beheic, sebacic ad macadamia acids with a dimer of glyceri ski-coditioig aget - emolliet wherei C()- represets the residue of beheic, sebacic, or macadamia acid, ad is Polyglyceryl-3 discrete multi-esters Polyglyceryl-3 Dicaprate the diester of capric acid ad polyglyceri-3 Polyglyceryl-3 Diisostearate (geeric) wherei C()- represets the residue of capric acid, ad is 3 a diester of isostearic acid ad polyglyceri-3 wherei - represets hydroge or the residue of isostearic acid, ad is 3 a diester of oleic acid ad polyglyceri-3 ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of isostearic acid, ad is 3 the triester of isostearic acid ad polyglyceri-3 Polyglyceryl-3 Dioleate Polyglyceryl-3 Triisostearate ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of oleic acid, ad is 3 ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget

69 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-3 Distearate (geeric) (geeric) ( CI Staff) Defiitio & Structure the diester of stearic acid ad polyglyceri-3 Polyglyceryl-3 Di-ydroxystearate wherei C()- represets the residue of stearic acid, ad is 3 the diester of hydroxystearic acid ad polyglyceri-3 Polyglyceryl-3 Petaricioleate ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of hydroxystearic acid, ad is 3 the petaester of ricioleic acid ad polyglyceri-3 Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of ricioleic acid, ad is 3 Polyglyceryl-3 mixed multi-esters Diisostearoyl Polyglyceryl-3 Dimer Dilioleate the diester of dilioleic acid ad Polyglyceryl-3 Diisostearate Polyglyceryl-3 Dicitrate/Stearate wherei - represets the residue of isostearic acid or dilioleic acid, ad is 3 the diester of polyglyceri-3 with a mixture of citric acid ad stearic acid wherei C()- represets the residue of citric or stearic acid, ad is 3 the diester of cocout acid ad polyglyceri-3 wherei - represets hydroge or the residue of capric or caprylic acid, ad is 3 is the petaester of polyglyceri-3 ad olive acid ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of cocout acid, ad is 3 the petaester of a mixture of caprylic acid ad capric acid with polyglyceri-3 Polyglyceryl-3 Petaolivate Polyglyceryl-3 Petacaprylate/Caprate surfactat emulsifyig aget Polyglyceryl-3 Dicocoate ski-coditioig aget - emolliet ski-coditioig aget - emolliet; surfactat emulsifyig aget; surfactat solubilizig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-3 Triolivate wherei C()- represets the residue of olive acid, ad is 3 the triester of polyglyceri-3 ad olive acid Triisostearoyl Polyglyceryl-3 Dimer Dilioleate surfactat emulsifyig aget wherei - represets hydroge or the residue of olive acid, ad is 3 the diester of dilioleic acid ad polyglyceryl-3 triisostearate wherei - represets the residue of isostearic acid or dilioleic acid, ad is 3 ski-coditioig aget - emolliet

70 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-4 discrete multi-esters Polyglyceryl-4 Dilaurate ( CI Staff) Defiitio & Structure the diester of lauric acid ad polyglyceri-4 wherei - represets hydroge or the residue of oleic acid, ad is 4 a diester of polyglyceri-4 with stearic acid Polyglyceryl-4 Petastearate wherei - represets hydroge or the residue of stearic acid, ad is 4 the petaester of stearic acid ad polyglyceri-4 surfactat emulsifyig aget wherei C()- represets the residue of stearic acid, ad is 4 the triester of stearic acid ad polyglyceri-4 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-4 Tristearate ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of lauric acid, ad is 4 the petaester of oleic acid ad polyglyceri-4 Polyglyceryl-4 Distearate Polyglyceryl-4 Petaoleate Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei - represets hydroge or the residue of stearic acid, ad is 4 Polyglyceryl-4 mixed multi-esters Polyglyceryl-4 Petapalmitate/Stearate the petaester of a mixture of palmitic acid ad stearic acid with polyglyceri4 Pumpki Seed il Polyglyceryl-4 Esters wherei - represets hydroge or the residue of palmitic or stearic acid, ad is 4 the complex mixture of esters formed by the trasesterificatio of cucurbita pepo (pumpki) seed oil ad polyglyceri-4 emulsio stabilizer; surfactat emulsifyig aget Pumpki Seed il Polyglyceryl-4 Esters Succiate surfactat emulsifyig aget wherei - represets hydroge or the residue of the fatty acids derived from cucurbita pepo (pumpki) seed oil (via trasesterificatio), ad is 4 the complex mixture of esters formed by the trasesterificatio of cucurbita pepo (pumpki) seed oil ad polyglyceri-4 reacted with succiic acid emulsio stabilizer; surfactat emulsifyig aget wherei - represets hydroge or the residue of succiic acid or the fatty acids derived from cucurbita pepo (pumpki) seed oil (via trasesterificatio), ad is 4 Polyglyceryl-5 discrete multi-esters Polyglyceryl-5 Dicaprylate (geeric) the diester of caprylic acid with a glyceri polymer cotaiig 5 glyceri uits Polyglyceryl-5 Dilaurate wherei C()- represets the residue of caprylic acid, ad is 5 the diester of lauric acid ad a glyceri polymer cotaiig 5 uits of glyceri wherei C()- represets the residue of lauric acid, ad is 5 ski-coditioig aget - emolliet; surfactat cleasig aget; surfactat emulsifyig aget surfactat emulsifyig aget

71 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-5 Trimyristate ( CI Staff) Defiitio & Structure the triester of myristic acid ad a glyceri polymer cotaiig 5 uits of glyceri Polyglyceryl-5 Petamyristate wherei - represets hydroge or the residue of myristic acid, ad is 5 the petaester of myristic acid ad a glyceri polymer cotaiig 5 uits of glyceri wherei - represets hydroge or the residue of myristic acid, ad is 5 the triester of isostearic acid ad a glyceri polymer cotaiig 5 uits of glyceri Polyglyceryl-5 Dioleate wherei - represets hydroge or the residue of isostearic acid, ad is 5 the diester of oleic acid ad a glyceri polymer cotaiig 5 uits of glyceri Polyglyceryl-5 Tristearate (geeric) wherei - represets hydroge or the residue of oleic acid, ad is 5 the triester of stearic acid ad a glyceri polymer cotaiig 5 uits of glyceri wherei - represets hydroge or the residue of stearic acid, ad is 5 Polyglyceryl-5 exastearate the hexaester of stearic acid ad a glyceri polymer cotaiig 5 uits of glyceri wherei - represets hydroge or the residue of stearic acid, ad is 5 the triester of beheic acid ad a glyceri polymer cotaiig 5 uits of glyceri ski-coditioig aget - emolliet; surfactat emulsifyig aget surfactat cleasig aget; surfactat dispersig aget; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-5 Tribeheate surfactat emulsifyig aget wherei C()- represets the residue of oleic acid, ad is 5 the triester of oleic acid ad a glyceri polymer cotaiig 5 uits of glyceri surfactat cleasig aget; surfactat dispersig aget; surfactat emulsifyig aget Polyglyceryl-5 Trioleate ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-5 Triisostearate Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei - represets hydroge or the residue of beheic acid, ad is 5 Polyglyceryl-6 discrete multi-esters Polyglyceryl-6 Sesquicaprylate (geeric) (geeric) (geeric) a mixture of moo- ad diesters of caprylic acid ad polyglyceri-6 wherei - represets hydroge or the residue of caprylic acid, ad is 6 Polyglyceryl-6 Dicaprate the diester of capric acid ad polyglyceri-6 Polyglyceryl-6 Tricaprylate wherei C()- represets the residue of capric acid, ad is 6 the triester of caprylic acid ad polyglyceri-6 ski-coditioig aget - emolliet; surfactat cleasig aget; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei - represets hydroge or the residue of caprylic acid, ad is 6 surfactat cleasig aget

72 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-6 Tetracaprylate ( CI Staff) Defiitio & Structure the tetraester of caprylic acid ad polyglyceri-6 Polyglyceryl-6 Petacaprylate wherei - represets hydroge or the residue of caprylic acid, ad is 6 the petaester of caprylic acid ad polyglyceri-6 wherei - represets hydroge or the residue of caprylic acid, ad is 6 the heptaester of caprylic acid ad polyglyceri-6 wherei - represets hydroge or the residue of caprylic acid, ad is 6 the octaester of polyglyceri-6 ad caprylic acid surfactat emulsifyig aget Polyglyceryl-6 ctacaprylate surfactat cleasig aget Polyglyceryl-6 eptacaprylate Fuctio(s) surfactat cleasig aget ski-coditioig aget - emolliet Polyglyceryl-6 Dipalmitate wherei C()- represets the residue of caprylic acid, ad is 6 the diester of palmitic acid ad polyglyceri-6 Polyglyceryl-6 Sesquiisostearate wherei C()- represets the residue of palmitic acid, ad is 6 a mixture of moo- ad diesters of isostearic acid ad polyglyceri-6 wherei - represets hydroge or the residue of isostearic acid, ad is 6 the diester of isostearic acid ad polyglyceri-6 wherei - represets hydroge or the residue of oleic acid, ad is 6 the petaester of oleic acid ad polyglyceri-6 Polyglyceryl-6 exaoleate wherei - represets hydroge or the residue of oleic acid, ad is 6 a hexaester of oleic acid ad polyglyceri-6 Polyglyceryl-6 Sesquistearate wherei - represets hydroge or the residue of oleic acid, ad is 6 a mixture of moo- ad diesters of stearic acid ad polyglyceri-6 ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of oleic acid, ad is 6 the tetraester of leic Acid ad polyglyceri-6 Polyglyceryl-6 Petaoleate ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of isostearic acid, ad is 6 a diester of oleic acid ad polyglyceri-6 Polyglyceryl-6 Tetraoleate Polyglyceryl-6 Dioleate surfactat emulsifyig aget Polyglyceryl-6 Diisostearate ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei - represets hydroge or the residue of stearic acid, ad is 6 ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget surfactat emulsifyig aget

73 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-6 Distearate (geeric) ( CI Staff) Defiitio & Structure a diester of stearic acid ad polyglyceri-6 Polyglyceryl-6 Tristearate (geeric) wherei C()- represets the residue of stearic acid, ad is 6 the triester of stearic acid ad polyglyceri-6 wherei - represets hydroge or the residue of stearic acid, ad is 6 the petaester of stearic acid ad polyglyceri-6 Polyglyceryl-6 exastearate wherei - represets hydroge or the residue of stearic acid, ad is 6 the hexaester of stearic acid ad polyglyceri-6 Polyglyceryl-6 ctastearate wherei - represets hydroge or the residue of stearic acid, ad is 6 the octaester of stearic acid ad polyglyceri-6 surfactat emulsifyig aget Polyglyceryl-6 Petastearate (geeric) Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-6 Petaricioleate wherei C()- represets the residue of stearic acid, ad is 6 the petaester of ricioleic acid ad polyglyceri-6 Polyglyceryl-6 Tetrabeheate wherei - represets hydroge or the residue of ricioleic acid, ad is 6 the tetraester of beheic acid ad polyglyceri-6 ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei - represets hydroge or the residue of beheic acid, ad is 6 Polyglyceryl-6 mixed multi-ester Macadamia Seed il Polyglyceryl-6 Esters Beheate the beheic acid ester of the product obtaied by the trasesterificatio of macadamia seed oil ad polyglyceri-6 ski-coditioig aget - emolliet 3C 0 wherei C()- represets the residue of fatty acids derived (via trasesterificatio) from macadamia terifolia seed oil, ad is 6 Polyglyceryl-8 mixed multi-esters Polyglyceryl-8 Decabeheate/Caprate the decaester of a mixture of beheic acid ad capric acid with a glyceri polymer cotaiig 8 uits of glyceri viscosity icreasig aget - oaqueous Polyglyceryl-8 Decaerucate/Decaisostearate/ Decaricioleate wherei C()- represets the residue of capric or beheic acid, ad is 8 the decaester of a glyceri polymer cotaiig 8 uits of glyceri with a mixture of erucic acid, isostearic acid ad ricioleic acid wherei C()- represets the residue of erucic, isostearic, or ricioleic acid, ad is 8 ski-coditioig aget - emolliet

74 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-0 discrete multi-esters Polyglyceryl-0 Decaethylhexaoate ( CI Staff) Defiitio & Structure Fuctio(s) the decaester of -ethylhexaoic acid ad polyglyceri-0 ski coditioig aget - humectat Polyglyceryl-0 Dodecacaprate wherei C()- represets the residue of -ethylhexaoic acid, ad is 0 the dodecaester of capric acid ad polyglyceri-0 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Petacaprylate wherei C()- represets the residue of capric acid, ad is 0 the petaester of caprylic acid ad polyglyceri-0 wherei - represets hydroge or the residue of caprylic acid, ad is 0 Polyglyceryl-0 Dodecacaprylate the dodecaester of caprylic acid ad polyglyceri-0 surfactat cleasig aget; surfactat emulsifyig aget; surfactat solubilizig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Tridecaoate wherei C()- represets the residue of caprylic acid, ad is 0 the triester of decaoic acid ad polyglyceri-0 Polyglyceryl-0 Dilaurate wherei - represets hydroge or the residue of decaoic acid, ad is 0 the diester of lauric acid ad polyglyceri-0 Polyglyceryl-0 Trilaurate wherei C()- represets the residue of lauric acid, ad is 0 the triester of lauric acid ad polyglyceri-0 wherei - represets hydroge or the residue of lauric acid, ad is 0 the tetraester of lauric acid ad polyglyceri-0 wherei - represets hydroge or the residue of lauric acid, ad is 0 the petaester of lauric acid ad polyglyceri-0 Polyglyceryl-0 Dimyristate wherei - represets hydroge or the residue of lauric acid, ad is 0 the diester of myristic acid ad polyglyceri-0 surfactat cleasig aget Polyglyceryl-0 Petalaurate surfactat cleasig aget Polyglyceryl-0 Tetralaurate surfactat cleasig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of myristic acid, ad is 0 ski-coditioig aget - emolliet; surfactat emulsifyig aget surfactat emulsifyig aget

75 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-0 Dipalmitate ( CI Staff) Defiitio & Structure the diester of palmitic acid ad polyglyceri-0 Polyglyceryl-0 Diisostearate (geeric) wherei C()- represets the residue of palmitic acid, ad is 0 a diester of isostearic acid ad polyglyceri-0 wherei C()- represets the residue of isostearic acid, ad is 0 the triester of polyglyceri-0 ad isostearic acid wherei - represets hydroge or the residue of isostearic acid, ad is 0 the petaester of isostearic acid ad polyglyceri-0 wherei - represets hydroge or the residue of isostearic acid, ad is 0 the hexaester of polyglyceri-0 ad isostearic acid Polyglyceryl-0 Noaisostearate wherei - represets hydroge or the residue of isostearic acid, ad is 0 the oaester of polyglyceri-0 ad isostearic acid ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet wherei - represets hydroge or the residue of isostearic acid, ad is 0 the ester of polyglyceri-0 ad isostearic acid ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Decaisostearate surfactat emulsifyig aget Polyglyceryl-0 exaisostearate ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Petaisostearate Polyglyceryl-0 Triisostearate Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet Polyglyceryl-0 Petalioleate wherei C()- represets the residue of isostearic acid, ad is 0 the petaester of lioleic acid ad polyglyceri-0 Polyglyceryl-0 Decalioleate wherei - represets hydroge or the residue of lioleic acid, ad is 0 a decaester of lioleic acid ad polyglyceri-0 ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Dioleate wherei C()- represets the residue of lioleic acid, ad is 0 a diester of oleic acid ad polyglyceri-0 Polyglyceryl-0 Trioleate wherei C()- represets the residue of oleic acid, ad is 0 the triester of oleic acid ad polyglyceri-0 ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei - represets hydroge or the residue of oleic acid, ad is 0 surfactat emulsifyig aget

76 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-0 Tetraoleate ( CI Staff) Defiitio & Structure a tetraester of oleic acid ad polyglyceri-0 Polyglyceryl-0 Petaoleate wherei - represets hydroge or the residue of oleic acid, ad is 0 the petaester of oleic acid ad polyglyceri-0 Polyglyceryl-0 Petaricioleate wherei - represets hydroge or the residue of oleic acid, ad is 0 the petaester of ricioleic acid ad polyglyceri-0 Polyglyceryl-0 exaoleate wherei - represets hydroge or the residue of ricioleic acid, ad is 0 the hexaester of oleic acid ad polyglyceri-0 Polyglyceryl-0 eptaoleate wherei - represets hydroge or the residue of oleic acid, ad is 0 a heptaester of oleic acid ad polyglyceri-0 Polyglyceryl-0 Decaoleate wherei - represets hydroge or the residue of oleic acid, ad is 0 a decaester of oleic acid ad polyglyceri-0 Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Distearate (geeric) wherei C()- represets the residue of oleic acid, ad is 0 the diester of stearic acid ad polyglyceri-0 Polyglyceryl-0 Tristearate (geeric) wherei C()- represets the residue of stearic acid, ad is 0 the triester of stearic acid ad polyglyceri-0 Polyglyceryl-0 Petastearate (geeric) wherei - represets hydroge or the residue of stearic acid, ad is 0 a petaester of stearic acid ad polyglyceri-0 Polyglyceryl-0 Petahydroxystearate wherei - represets hydroge or the residue of stearic acid, ad is 0 the petaester of hydroxystearic acid ad polyglyceri-0 Polyglyceryl-0 eptahydroxystearate wherei - represets hydroge or the residue of hydroxystearic acid, ad is 0 a heptaester of hydroxystearic acid ad polyglyceri-0 Polyglyceryl-0 eptastearate (geeric) wherei - represets hydroge or the residue of hydroxystearic acid, ad is 0 the heptaester of stearic acid ad polyglyceri-0 ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei - represets hydroge or the residue of stearic acid, ad is 0 ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget

77 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-0 Decahydroxystearate ( CI Staff) Defiitio & Structure the decaester of hydroxystearic acid ad polyglyceri-0 Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Decastearate wherei C()- represets the residue of hydroxystearic acid, ad is 0 a decaester of stearic acid ad polyglyceri-0 ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Dodecabeheate wherei C()- represets the residue of stearic acid, ad is 0 the dodecaester of beheic acid ad polyglyceri-0 surfactat emulsifyig aget Polyglyceryl-0 Trierucate wherei C()- represets the residue of beheic, ad is 0 the triester of polyglyceri-0 ad erucic acid Polyglyceryl-0 exaerucate wherei - represets hydroge or the residue of erucic acid, ad is 0 the hexaester of polyglyceri-0 ad erucic acid Polyglyceryl-0 Noaerucate wherei - represets hydroge or the residue of erucic acid, ad is 0 the oaester of erucic acid ad polyglyceri-0 surfactat dispersig aget; surfactat emulsifyig aget surfactat dispersig aget; surfactat emulsifyig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei - represets hydroge or the residue of erucic acid, ad is 0 Polyglyceryl-0 mixed multi-esters Polyglyceryl-0 Decamacadamiate a decaester of polyglyceri-0 ad the fatty acids derived from macadamia ut oil ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Dicocoate wherei C()- represets the residue of the fatty acids derived from macadamia ut oil, ad is 0 the diester of cocout acid ad polyglyceri-0 Polyglyceryl-0 Didecaoate wherei C()- represets the residue of cocout acid, ad is 0 the diester of decaoic acid adppolyglyceri-0 Polyglyceryl-0 Dodeca-Caprylate/ Caprate ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei C()- represets the residue of decaoic acid, ad is 0 the dodecaester of a mixture of caprylic ad capric acids with polyglyceri-0 surfactat cleasig aget; surfactat emulsifyig aget wherei C()- represets the residue of capric or caprylic acid, ad is 0 ski-coditioig aget - occlusive

78 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-0 epta(beheate/stearate) ( CI Staff) Defiitio & Structure the heptaester of polyglyceri-0 with a mixture of beheic acid ad stearic acid Polyglyceryl-0 Moo/Dioleate wherei - represets hydroge or the residue of beheic acid ad stearic acid, ad is 0 a mixture of moo- ad diesters of oleic acid ad polyglyceri-0 Polyglyceryl-0 Sesquistearate wherei - represets hydroge or the residue of oleic acid, ad is 0 a mixture of moo- ad diesters of stearic acid ad polyglyceri-0 surfactat emulsifyig aget wherei - represets hydroge or the residue of stearate acid, ad is 0 the ester of tetradecaedioic acid ad polyglyceri-0 Polyglyceryl-0 Tricocoate ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Tetradecaedioate Fuctio(s) surfactat emulsifyig aget wherei - represets hydroge or the residue of tetradecaedioic acid, ad is 0 the triester of cocout acid ad polyglyceri-0 hair coditioig aget; ski coditioig aget - humectat surfactat cleasig aget; surfactat emulsifyig aget wherei - represets hydroge or the residue of cocout acid, ad is 0 Polyglyceryl-5 discrete multi-ester Polyglyceryl-5 Diisostearate a diester of isostearic acid ad a glyceri polymer cotaiig 5 glyceri uits hair coditioig aget; surfactat cleasig aget; surfactat emulsifyig aget wherei C()- represets the residue of isostearic acid, ad is 5 Polyglyceryl-0 discrete multi-esters Polyglyceryl-0 exacaprylate the hexaester of caprylic acid ad polyglyceri-0 wherei - represets hydroge or the residue of caprylic acid, ad is 0 Polyglyceryl-0 eptacaprylate the heptaester of caprylic acid ad polyglyceri-0 wherei - represets hydroge or the residue of caprylic acid, ad is 0 Polyglyceryl-0 ctaisooaoate the octaester of isooaoic acid ad polyglyceri-0 wherei - represets hydroge or the residue of isooaoic acid, ad is 0 Polyglyceryl-0 mixed multi-esters Polyglyceryl-0 Docosabeheate/Isostearate the docosaester of polyglyceri-0 with a mixture of beheic ad isostearic acids wherei C()- represets the residue of beheic or isostearic acid, ad is 0 surfactat cleasig aget; surfactat emulsifyig aget; surfactat solubilizig aget surfactat cleasig aget; surfactat emulsifyig aget; surfactat solubilizig aget surfactat cleasig aget; surfactat emulsifyig aget; surfactat solubilizig aget ski-coditioig aget - emolliet; surfactat emulsifyig aget

79 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Defiitios, idealized structures, ad fuctio Igrediet CAS No. Polyglyceryl-0 Docosabeheate/Laurate ( CI Staff) Defiitio & Structure the docosaester of polyglyceri-0 with a mixture of beheic ad lauric acids Fuctio(s) ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 Docosabeheate/leate wherei C()- represets the residue of beheic or lauric acid, ad is 0 the docosaester of polyglyceri-0 with a mixture of beheic ad oleic acids ski-coditioig aget - emolliet; surfactat emulsifyig aget Polyglyceryl-0 eptadecabeheate/laurate wherei C()- represets the residue of beheic or oleic acid, ad is 0 the heptadecaester of polyglyceri-0 with a mixture of beheic ad lauric acids Polyglyceryl-0 ctadecabeheate/laurate wherei - represets hydroge or the residue of beheic or lauric acid, ad is 0 the octadecaester of polyglyceri-0 ad a mixture of beheic ad lauric acids ski-coditioig aget - emolliet; surfactat emulsifyig aget wherei - represets hydroge or the residue of beheic or lauric acid, ad is 0 ski-coditioig aget - emolliet; surfactat emulsifyig aget

80 Distributed for Commet ly -- Do Not Cite or Quote Table 4. Previously eviewed Compoets ad elated Igrediets Compoet Coclusio eferece 5 Glyceri safe i cosmetics i the preset practices of use ad cocetratio (was used i 5,654 formulatios, 0,046 of which were leave-os; the maximum use cocetratios were 79.% i leave-o products, 99.4% i rise-off products, ad 47.9% i products diluted for the bath 6,7 Dipropylee Glycol Tripropylee Glycol Polypropylee Glycols (ad PPG 3) safe as used safe i the preset practices of use ad cocetratio whe formulated to be o-irritatig safe i the preset practices of use ad cocetratio whe formulated to be o-irritatig Mooglyceryl Mooesters Glyceryl Algiate Glyceryl Isostearate/Myristate Glyceryl Myristate safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio Citric Acid Cocout Acid ydroxystearic Acid Isostearic Acid Lauric Acid Myristic Acid leic Acid live Acid Palm Acid Palmitic Acid ice Bra Acid icioleic Acid safe i the preset practices of use ad cocetratio safe for use as a cosmetic igrediet safe as a cosmetic igrediet i the preset practices of use safe as a cosmetic igrediet i the preset practices of use safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio Sebacic Acid Stearic Acid Potassium Stearate Sodium Stearate safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio 8 Adasoia Digitata Seed il Argaia Spiosa Kerel il Beeswax Bertholletia Excelsa Seed il Borago fficialis Seed il Butyrospermum Parkii (Shea) Butter Caprylic/Capric/Coco Glycerides Carthamus Tictorius (Safflower) Seed il Citrullus Laatus (Watermelo) Seed il Cocos Nucifera (Cocout) il Cocoglycerides ydrogeated Coco-Glycerides Corylus Avellaa (azelut) Seed il Cucurbita Pepo (Pumpki) Seed il Elaeis Guieesis (Palm) il Elaeis Guieesis (Palm) Kerel il Euphorbia Cerifera (Cadelilla) Wax Glycie Soja (Soybea) il ydrogeated Soybea il eliathus Auus (Suflower) Seed il eliathus Auus (Suflower) Seed Wax Lium Usitatissimum (Liseed) Seed il Macadamia Itegrifolia Seed il Macadamia Terifolia Seed il lea Europaea (live) Fruit il rbigya leifera Seed il ryza Sativa (ice) Bra il ryza Sativa (ice) Bra Wax Persea Gratissima (Avocado) il Pruus Amygdalus Dulcis (Sweet Almod) il Pruus Armeiaca (Apricot) Kerel il icius Commuis (Castor) Seed il safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe for use as a cosmetic igrediet safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe for use as a cosmetic igrediet ,30 9, , safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio 6 safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio 3,3 safe i the preset practices of use ad cocetratio 6 safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio 6 safe i the preset practices of use ad cocetratio 6 safe i the preset practices of use ad cocetratio 33 safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio safe i the preset practices of use ad cocetratio

81 Distributed for Commet ly -- Do Not Cite or Quote Table 4. Previously eviewed Compoets ad elated Igrediets Compoet Coclusio ydrogeated Castor il Schiziophyto autaeii Kerel il safe i the preset practices of use ad cocetratio Sclerocarya Birrea Seed il safe i the preset practices of use ad cocetratio Simmodsia Chiesis (Jojoba) Seed Wax safe i the preset practices of use ad cocetratio Sesamum Idicum (Sesame) Seed il safe i the preset practices of use ad cocetratio Theobroma Cacao (Cocoa) Seed Butter safe i the preset practices of use ad cocetratio Theobroma Gradiflorum Seed Butter safe i the preset practices of use ad cocetratio eferece

82 Distributed for Commet ly -- Do Not Cite or Quote Table 5. Average fatty acid compositio of polyglyceryl fatty acid esters (%) Adasoia Digitata Apricot Kerel il Seed il PolyglycerylPolyglyceryl-6 Fatty Acids 6 Esters35 Esters36 Caproic (C6) Caprylic (C8) Capric (C0) Lauric (C)* Myristic (C4) Myristoleic (C4:) Palmitic (C6) <.5 Palmitoleic (C6:) eptadecaoic (C7:0) Stearic (C8) leic (C8:) Lioleic (C8:) -3 Lioleic (C8:3) < <.0 Arachidic (C0) <.0 Eicoseoic (C0:) Beheic (C) Erucic (C:) Ligoceric (C4) thers Arga il Polyglyceryl-6 Esters38,38 Babassu il Polyglyceryl-6 Esters39 Bertholletia Excelsa Seed il Polyglyceryl6 Esters Caprylic/Capric Glycerides Polyglyceryl-0 Esters4 < <3 < <0.5 < < < < Cocout oil Polyglyceryl-6 Esters43 < azelut Seed il Polyglyceryl-6 Esters44 Macadamia Seed il Polyglyceryl 6 Esters45 live il Polyglyceryl-6 Esters46 Polyglyceryl-0 Decaoleate < < < < <.5 < < <0. Cocoa Butter Polyglyceryl-6 Esters4 Caproic (C6) Caprylic (C8) Capric (C0) Lauric (C)* Myristic (C4) Myristoleic (C4:) Palmitic (C6) Palmitoleic (C6:) eptadecaoic (C7:0) Stearic (C8) leic (C8:) Lioleic (C8:) Lioleic (C8:3) Arachidic (C0) Eicoseoic (C0:) Beheic (C) Erucic (C:) Ligoceric (C4) thers Apricot Kerel il Polyglyceryl-0 Esters37 Safflower Seed il Polyglyceryl-6 Esters Total fatty acids are 83.%

83 Distributed for Commet ly -- Do Not Cite or Quote Table 5. Average fatty acid compositio of polyglyceryl fatty acid esters (%) Schiziophyto Sclerocarya Birrea autaeii Kerel il Seed il PolyglycerylPolyglyceryl-6 6 Esters49 Fatty Acids Esters48 Caproic (C6) Caprylic (C8) Capric (C0) Lauric (C)* <0. Myristic (C4) Myristoleic (C4:) Palmitic (C6) <0. Palmitoleic (C6:) eptadecaoic (C7:0) Stearic (C8) leic (C8:) Lioleic (C8:) 30-3 <0.7 Lioleic (C8:3) < Arachidic (C0) Eicoseoic (C0:) Beheic (C) Erucic (C:) Ligoceric (C4) thers Caproic (C6) Caprylic (C8) Capric (C0) Lauric (C)* Myristic (C4) Myristoleic (C4:) Palmitic (C6) Palmitoleic (C6:) eptadecaoic (C7:0) Stearic (C8) leic (C8:) Lioleic (C8:) Lioleic (C8:3) Arachidic (C0) Eicoseoic (C0:) Beheic (C) Erucic (C:) Ligoceric (C4) thers Sweet Almod il Polyglyceryl-6 Esters55 Trichilia Emetica Seed il Polyglyceryl-6 Esters < < < <.5 Sesame il Polyglyceryl-6 Esters50 Shea Butter Polyglyceryl-6 Esters5 Soybea il Polyglyceryl-6 Esters5 Suflower Seed il Polyglyceryl-6 Esters (high oleic acid)53 Suflower Seed il Polyglyceryl-0 Esters <. < < <.5 < < < <0.5 < <0. <

84 Distributed for Commet ly -- Do Not Cite or Quote Table 6. Physical ad Chemical Properties Adasoia Digitata Seed il Polyglyceryl6 Esters35 Property physical characteristics soft paste amber i color molecular wt solubility meltig poit ( C) desity (g/ml) specific gravity (g/ml) p refractive idex (0ºC) sapoificatio value acid value (mg K/g) hydroxyl value (mg K/g) peroxide value (meq of active oxyge/kg) iodie value (gi/00g) polarity LB physical characteristics molecular wt solubility meltig poit ( C) desity (g/ml) specific gravity (g/ml) p refractive idex (0ºC) sapoificatio value acid value (mg K/g) hydroxyl value (mg K/g) peroxide value (meq of active oxyge/kg) iodie value (gi/00g) polarity LB amber liquid (0ºC) amber (physical state ot specified) amber liquid soft paste with amber color Bertholletia Excelsa Seed il Polyglyceryl-6 Esters40 soft paste with amber color water dispersible water dispersible water soluble water dispersible water dispersible water dispersible < < > < < approx <5 approx <5 approx..47 <5 approx <5 approx <5 approx <5 <0 <0 <0 <0 <0 <0 o-ioic, amphiphilic o-ioic, amphiphilic o-ioic, amphiphilic o-ioic, amphiphilic 0-5 o-ioic, amphiphilic o-ioic, amphiphilic o-ioic, amphiphilic Cocoa Butter Polyglyceryl-6 Esters4 Cocout il Polyglyceryl-6 Esters43 beige solid soft paste, with amber color Diisostearoyl Polyglyceryl-3 Dimer Dilioleate viscous liquid 58 yellow liquid 59 ~6000 Glyceryl/Polyglyceryl6 Isostearate/Beheate Esters white waxy solid 45 azelut Seed il Polyglyceryl-6 Esters44 amber Macadamia Seed il Polyglyceryl-6 Esters45 amber liquid water dispersible < water dispersible < water dispersible water dispersible < < approx <5 approx...47 <5 approx <5 <5 ~ <5 <0 <0 <0 <0 <0 o-ioic, amphiphilic o-ioic, amphiphilic Caprylic/Capric Glycerides Polyglyceryl-0 Esters4 amber i color > approx..47 o-ioic, amphiphilic Apricot Kerel il Polyglyceryl-6 Esters o-ioic, amphiphilic Apricot Kerel il Arga il Polyglyceryl-6 Polyglyceryl-0 Esters37 Esters38, o-ioic, amphiphilic max58 Babassu il Polyglyceryl-6 Esters39 Borage Seed il Polyglyceryl-6 Esters57 water dispersible oil max ~559

85 Distributed for Commet ly -- Do Not Cite or Quote Table 6. Physical ad Chemical Properties Macadamia Seed il Polyglyceryl-6 Esters Beheate physical characteristics white waxy solid 5 molecular wt solubility meltig poit ( C) desity (g/ml) specific gravity (g/ml) p refractive idex (0ºC) sapoificatio value acid value (mg K/g) hydroxyl value (mg K/g) peroxide value (meq of active oxyge/kg) iodie value (gi/00g) polarity LB live il Polyglyceryl6 Esters46 Palm Kerel il Polyglyceryl-4 Esters60 amber liquid Polyglyceryl-3 Beeswax6 Polyglyceryl- Caprate 6 white to off-white Polyglyceryl-4 Caprate Polyglyceryl-3 Caprylate 63 trasparet, pale, yellow liquid with fait odor64 colorless to yellow, clear to slightly turbid, viscous liquid 65 high viscosity liquid 30.4 water dispersible water- ad oil- soluble soluble i water, ethaol,,propaediol, esters oil; isoluble i paraffi oi, isopropyl myristate, vegetable oil g/cm3 < ~ < max max64 < o-ioic, amphiphilic 4.564; ~4 65

86 Distributed for Commet ly -- Do Not Cite or Quote Table 6. Physical ad Chemical Properties Polyglyceryl-0 Polyglyceryl-8 Caprylate/Caprate 4,66 Decabeheate/Caprate physical characteristics molecular wt solubility meltig poit ( C) desity (g/ml) specific gravity (g/ml) p refractive idex (0ºC) sapoificatio value acid value (mg K/g) hydroxyl value (mg K/g) peroxide value (meq of active oxyge/kg) iodie value (gi/00g) polarity LB amber, viscous liquid pale yellow solid68 Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate pale yellow viscous liquid53,69 Polyglyceryl-0 Decaethylhexaoate Polyglyceryl-0 Decaisostearate67 Polyglyceryl-0 Decaoleate pale yellow viscous liquid70 fait yellow liquid solid isoluble i water slightly soluble i water (5 C) max ; ; max max Polyglyceryl-3 Diydroxystearate

87 Distributed for Commet ly -- Do Not Cite or Quote Table 6. Physical ad Chemical Properties physical characteristics Polyglyceryl- Diisostearate clear pale yellow, homogeous liquid38 molecular wt solubility meltig poit ( C) desity (g/ml) specific gravity (g/ml) p refractive idex (0ºC) sapoificatio value acid value (mg K/g) hydroxyl value (mg K/g) peroxide value (meq of active oxyge/kg) iodie value (gi/00g) polarity LB Polyglyceryl-3 Diisostearate)7 slightly yellowish, viscous liquid Polyglyceryl-6 Diisostearate 7 pale yellow liquid < 0.5 mg/l (water) g/cm³ Polyglyceryl-3 Dioleate 8,7 viscous yellow liquid Polyglyceryl-6 Dioleate dispersible i water; soluble i may orgaic solvets Polyglyceryl-0 Dipalmitate74,74 beads or waxy solids Polyglyceryl-3 Distearate 75 white or slightly yellowish powder at 0ºC: forms liquid crystals i water, ethaol, ad glyceri; isoluble i propylee glycol; forms a solid wax with wheat germ, avocado, ad paraffi oils, ad squalee; at 65ºC: dispersible i water, clearly soluble i ethaol, i wheat germ, avocado, ad paraffi oils, ad squalee; turbid solubility i glyceri; isoluble i propylee glycol (predicted) (predicted) 8 3

88 Distributed for Commet ly -- Do Not Cite or Quote Table 6. Physical ad Chemical Properties Polyglyceryl-6 Distearate physical characteristics waxy solid74 molecular weight solubility Polyglyceryl-4 Isostearate 80 yellow liquid Polyglyceryl-0 Isostearate pale yellow, extremely viscous liquid Polyglyceryl-3 Laurate 8 viscous liquid 4 (average) max Polyglyceryl-0 leate waxy solid5 Polyglyceryl-0 Palmate 86 liquid ; 8 74 viscous liquid87 molecular wt solubility meltig poit ( C) desity (g/ml) specific gravity (g/ml) p refractive idex (0ºC) sapoificatio value acid value (mg K/g) hydroxyl value (mg K/g) peroxide value (meq of active oxyge/kg) iodie value (gi/00g) polarity LB Polyglyceryl- Isostearate 79 slightly soluble to soluble i water Polyglyceryl-4 Laurate physical characteristics Polyglyceryl- Isopalmitate/Sebacate 78 liquid meltig poit ( C) desity (g/ml) specific gravity (g/ml) p refractive idex (0ºC) sapoificatio value acid value (mg K/g) hydroxyl value (mg K/g) peroxide value (meq of active oxyge/kg) iodie value (gi/00g) polarity LB Polyglyceryl-0 Distearate 77 yellow waxy solid ~ Polyglyceryl-0 Laurate light yellow viscous liquid ~5 Polyglyceryl-0 Myristate 85 pale yellow viscous liquid88 Polyglyceryl-0 Noaisostearate pale yellow viscous liquid89 Polyglyceryl-3 leate yellow liquid slightly soluble to soluble i water 63-83;6; o-ioic 87 ~ 60-70; ;88 5 max lipophilic90 ~

89 Distributed for Commet ly -- Do Not Cite or Quote Table 6. Physical ad Chemical Properties Polyglyceryl-6 Petacaprylate 94 physical characteristics liquid molecular wt solubility molecular wt solubility meltig poit ( C) desity (g/ml) specific gravity (g/ml) p refractive idex (0ºC) sapoificatio value acid value (mg K/g) hydroxyl value (mg K/g) peroxide value (meq of active oxyge/kg) iodie value (gi/00g) polarity LB Polyglyceryl-0 Petaisostearate pale yellow liquid 0 Polyglyceryl-3 Petaoleate 96 amber viscous liquid Polyglyceryl-0 Petaoleate 97,98 pale yellow to red-yellow viscous liquid Polyglyceryl-4 Petastearate 99 white to pale yellow pellet slightly soluble i water meltig poit ( C) desity (g/ml) specific gravity (g/ml) p refractive idex (0ºC) sapoificatio value acid value (mg K/g) hydroxyl value (mg K/g) peroxide value (meq of active oxyge/kg) iodie value (gi/00g) polarity LB physical characteristics Polyglyceryl-3 Petacaprylate/Caprate 95 liquid Polyglyceryl-6 Petastearate 00,0 pale yellow waxy solid easy to soluble i oil ad orgaic solvet, ad disperse ito hot water max o-ioic Polyglyceryl-0 Petastearate 03,04 Polyglyceryl-3 ice Braate 05 white to pale yellow solid 3.5 Polyglyceryl-3 icioleate 06 Polyglyceyl- Sesquicaprylate Polyglyceryl- Sesquioleate 07 light ivory (waxy solid (flakes) yellow, trasparet liquid 09 highly viscous liquid dispersible i water; miscible i oils isoluble i water, soluble i castor oil, ethaol, mieral oil09 ~7.0 Polyglyceryl-3 Soyate/Shea Butterate 08 liquid Polyglyceryl-3 Stearate 74 graules 09.5 slightly soluble to soluble i water > g/ml (5ºC) (5ºC) hydrophobic; o-ioic09 o-ioic ~4

90 Distributed for Commet ly -- Do Not Cite or Quote Table 6. Physical ad Chemical Properties Polyglyceryl-4 Stearate physical characteristics molecular wt solubility meltig poit ( C) desity (g/ml) specific gravity (g/ml) p refractive idex (0ºC) sapoificatio value acid value (mg K/g) hydroxyl value (mg K/g) peroxide value (meq of active oxyge/kg) iodie value (gi/00g) polarity LB Polyglyceryl-0 Stearate 76,0 pale yellow to light yellow liquid or solid Polyglyceryl- Tetraisostearate 09 yellow liquid Polyglyceryl-0 Tetraoleate viscous amber to brow liquid soluble i low ad high polar esters ad i vegetable oil, castor oil, ad mieral oil; isoluble i water ad ethaol isoluble i water Polyglyceryl- Tetrastearate Polyglyceryl-0 Tricocoate 3 pale yellow viscous liquid Polyglyceryl-0 Tridecaoate 4 liquid isoluble i water slightly soluble i water Schiziophyto autaeii Kerel il Polyglyceryl-6 Esters48 brow liquid Sclerocarya Birrea Seed il Polyglyceryl-6 Esters hydrophilic.0 Polyglyceryl-0 Triisostearate 5,6 Polyglyceryl-0 Trioleate 7 Polyglyceryl-0 Tristearate 8 ice Brai il Polyglyceryl-3 Esters Safflower Seed il Polyglyceryl-6 Esters47 physical characteristics pale yellow liquid light yellow to redyellow viscous liquid white to pale yellow waxy substace oily limpid liquid 9 clear, oily, amber-colored liquid0 amber (physical state ot specified) molecular wt solubility isoluble i water dispersible i water; miscible i oils 9 water dispersible water dispersible water dispersible > < < < approx..47 <5 approx <5 approx <5 <0 <0 < o-ioic, amphiphilic o-ioic, amphiphilic meltig poit ( C) desity (g/ml) specific gravity (g/ml) p refractive idex (0ºC) sapoificatio value acid value (mg K/g) hydroxyl value (mg K/g) peroxide value (meq of active oxyge/kg) iodie value (gi/00g) polarity LB o-ioic amber liquid

91 Distributed for Commet ly -- Do Not Cite or Quote Table 6. Physical ad Chemical Properties Sesame il Polyglyceryl-6 Esters50 physical characteristics amber liquid molecular wt solubility water dispersible meltig poit ( C) desity (g/ml) < specific gravity (g/ml) p refractive idex (0ºC) approx...47 sapoificatio value acid value (mg K/g) <5 hydroxyl value (mg K/g) peroxide value (meq of <0 active oxyge/kg) iodie value (gi/00g) polarity o-ioic, amphiphilic LB physical characteristics molecular wt solubility meltig poit ( C) desity (g/ml) specific gravity (g/ml) p refractive idex (0ºC) sapoificatio value acid value (mg K/g) hydroxyl value (mg K/g) peroxide value (meq of active oxyge/kg) iodie value (gi/00g) polarity LB imeia Americaa Seed il Polyglyceryl6 Esters3 oil hydrodispersible - water soluble Shea Butter Polyglyceryl-6 Esters5 beige solid Soybea il Polyglyceryl-6 Esters5 Suflower Seed il Polyglyceryl-0 Esters54 amber viscous liquid Sweet Almod il Polyglyceryl-6 Esters55 amber liquid Trichilia Emetica Seed il Polyglyceryl-6 Esters56 dark brow soft paste dark orage liquid water dispersible < water dispersible water dispersible water dispersible water dispersible < > < < approx <5 approx approx <5 approx <5 approx <5 <0 <0 < o-ioic, amphiphilic o-ioic, amphiphilic o-ioic, amphiphilic < o-ioic, amphiphilic o-ioic, amphiphilic Triisostearoyl Polyglyceryl-3 Dimer Dilioleate 56,, hazy, viscous liquid >

92 Distributed for Commet ly -- Do Not Cite or Quote Table 7. Specificatios, Impurities, ad/or Costituets Igrediet Specificatios/Impurities/Costituets Diisostearoyl Polyglyceryl-3 Dimer Dilioleate Polyglyceryl-4 Caprate Polyglyceryl-6 Distearate Polyglyceryl-0 Distearate Polyglyceryl-4 Laurate Polyglyceryl-4 leate Polyglyceryl-0 Myristate Abbreviatios: PEG polyethylee glycol eferece 59 PEG-free PEG-free 00% vegetable-derived ; PEG-free arseic = 0.00; heavy meals = PEG-free 00 ppm D,L-tocopherol; <% volatiles ppm arseic; 0 ppm heavy metals Table 8. Frequecy ad cocetratio of use accordig to duratio ad type of exposure # of Uses9 Max Coc of Use (%)0-4 # of Uses9 Max Coc of Use (%)0-4 Babassu il Polyglyceryl-4 Esters Cadelilla/Jojoba/ice Bra Polyglyceryl-3 Esters Totals* Duratio of Use Leave ise-ff 8.3 Diluted for (Bath) Use Exposure Type Eye Area 8 Icidetal Igestio Icidetal Ihalatio-Spray 5a; 3b b Icidetal Ihalatio-Powder 3 Dermal Cotact Deodorat (uderarm) aerosol: 0.5 air - No-Colorig 7 air-colorig Nail Mucous Membrae Baby Products.5 Cocout il Polyglyceryl-6 Esters Diisostearoyl Polyglyceryl-3 Dimer Dilioleate Totals* 4-4 Duratio of Use Leave- 4-4 ise ff Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio Icidetal Ihalatio-Spray 3a Icidetal Ihalatio-Powder Dermal Cotact 4-4 Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae Baby Products 64 84, # of Uses9 Max Coc of Use (%)0-4 Caprylic/Capric Glycerides Polyglyceryl-0 Esters a; 3b b 3 6 Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters 0 0 b 8 c

93 Distributed for Commet ly -- Do Not Cite or Quote Table 8. Frequecy ad cocetratio of use accordig to duratio ad type of exposure # of Uses9 Max Coc of Use (%)0-4 # of Uses9 Max Coc of Use (%)0-4 Macadamia Seed il Polyglyceryl-6 Esters Palm il Polyglyceryl-4 Esters Beheate 5-5 Duratio of Use Leave- 5-5 ise-ff Diluted for (Bath) Use Exposure Type Eye Area 3-3 Icidetal Igestio 5 Icidetal Ihalatio-Spray a b Icidetal Ihalatio-Powder b Dermal Cotact 4 Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae 5 Baby Products Polyglyceryl- Diisostearate Polyglyceryl- Isopalmitate Totals Duratio of Use Leave ise ff Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio Icidetal Ihalatio-Spray 7a; 4b ; 5a Icidetal Ihalatio-Powder 4b 0.; 0.4-c Dermal Cotact Deodorat (uderarm) 0. (ot spray) air - No-Colorig air-colorig Nail Mucous Membrae Baby Products Polyglyceryl- Laurate Polyglyceryl- leate Totals* Duratio of Use Leave ise-ff Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio.4 Icidetal Ihalatio-Spray 3a; b b a; b b b Icidetal Ihalatio-Powder 0.09c Dermal Cotact Deodorat (uderarm) air - No-Colorig -4.6 air-colorig Nail Mucous Membrae.4 Baby Products # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl- Caprate 6 6 ; a; 4b 4b 6 Polyglyceryl- Isostearate c Polyglyceryl- Sesquiisostearate a; b b c

94 Distributed for Commet ly -- Do Not Cite or Quote Table 8. Frequecy ad cocetratio of use accordig to duratio ad type of exposure # of Uses9 Max Coc of Use (%)0-4 # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl- Sesquistearate Polyglyceryl- Stearate Totals* Duratio of Use Leave ise-ff Diluted for (Bath) Use Exposure Type Eye Area 0.- Icidetal Igestio 0. Icidetal Ihalatio-Spray Icidetal Ihalatio-Powder.c Dermal Cotact Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae 0. Baby Products Polyglyceryl- Triisostearate Polyglyceryl-3 Beeswax Totals Duratio of Use Leave ise ff Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio Icidetal Ihalatio-Spray 6a; 3b ; 3a; 5c Icidetal Ihalatio-Powder ; 3b 0.49-; -5c 5c 3.4; 4c Dermal Cotact Deodorat (uderarm) air - No-Colorig air-colorig 3 Nail Mucous Membrae Baby Products Polyglyceryl-3 Caprylate Polyglyceryl-3 Dicitrate/Stearate Totals* Duratio of Use Leave ise-ff Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio Icidetal Ihalatio-Spray b a; 7b Icidetal Ihalatio-Powder 0.05c 7b -4c Dermal Cotact Deodorat (uderarm) 3a ot spray: 0.5-; aerosol: 0.6 air - No-Colorig 3. air-colorig Nail Mucous Membrae 0.6 Baby Products # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl- Tetraisostearate Polyglyceryl-3 Caprate a Polyglyceryl-3 Diisostearate a; 5b 5b ; 0.03-c (ot spray)

95 Distributed for Commet ly -- Do Not Cite or Quote Table 8. Frequecy ad cocetratio of use accordig to duratio ad type of exposure # of Uses9 Max Coc of Use (%)0-4 # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl-3 Distearate Polyglyceryl-3 Isostearate Totals* Duratio of Use Leave ise-ff 3 Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio a a a b Icidetal Ihalatio-Spray ; 6 3; 3;4 Icidetal Ihalatio-Powder 0.9c 4b Dermal Cotact Deodorat (uderarm) air - No-Colorig 6 air-colorig Nail Mucous Membrae Baby Products Polyglyceryl-3 leate Polyglyceryl-3 Palmitate Totals Duratio of Use Leave-.-.5 ise ff 3 Diluted for (Bath) Use Exposure Type Eye Area.5 Icidetal Igestio Icidetal Ihalatio-Spray 6a; b Icidetal Ihalatio-Powder b Dermal Cotact 4.5 Deodorat (uderarm) air - No-Colorig. air-colorig Nail Mucous Membrae Baby Products Polyglyceryl-3 icioleate Polyglyceryl-3 Stearate Totals* Duratio of Use Leave ise-ff Diluted for (Bath) Use Exposure Type Eye Area 5 Icidetal Igestio 0.5 Icidetal Ihalatio-Spray 36a; 3b 4a; 8b Icidetal Ihalatio-Powder 3b 0.5b 8b Dermal Cotact Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae 0.5 Baby Products # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl-3 Laurate b b Polyglyceryl-3 Petaricioleate Polyglyceryl-4 Caprate a; b b 8 a 5 0.5a 0.7c (ot spray)

96 Distributed for Commet ly -- Do Not Cite or Quote Table 8. Frequecy ad cocetratio of use accordig to duratio ad type of exposure # of Uses9 Max Coc of Use (%)0-4 # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl-4 Cocoate Polyglyceryl-4 Isostearate Totals* Duratio of Use Leave ise-ff Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio a b Icidetal Ihalatio-Spray 0 ; 7 0.6;.a b Icidetal Ihalatio-Powder ; c Dermal Cotact Deodorat (uderarm) air - No-Colorig. air-colorig Nail Mucous Membrae Baby Products Polyglyceryl-4 leate Polyglyceryl-5 Dioleate Totals 7.8 Duratio of Use Leave- 7.8 ise ff Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio Icidetal Ihalatio-Spray 3a.8 Icidetal Ihalatio-Powder Dermal Cotact 7.8 Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae Baby Products Polyglyceryl-5 Laurate Polyglyceryl-5 leate Totals* Duratio of Use Leave ise-ff 0.6 Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio Icidetal Ihalatio-Spray 7a 0.35c Icidetal Ihalatio-Powder 0.6c Dermal Cotact Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae Baby Products # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl-4 Laurate a Polyglyceryl-5 Isostearate b b Polyglyceryl-5 Stearate b b c

97 Distributed for Commet ly -- Do Not Cite or Quote Table 8. Frequecy ad cocetratio of use accordig to duratio ad type of exposure # of Uses9 Max Coc of Use (%)0-4 # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl-5 Triisostearate Polyglyceryl-5 Trioleate Totals* Duratio of Use Leave ise-ff.8 Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio 5 a b Icidetal Ihalatio-Spray ;5 Icidetal Ihalatio-Powder 5b Dermal Cotact 7 Deodorat (uderarm) air - No-Colorig.8 air-colorig Nail Mucous Membrae 5 Baby Products Polyglyceryl-6 Dioleate Polyglyceryl-6 Distearate Totals Duratio of Use Leave ise ff Diluted for (Bath) Use Exposure Type Eye Area 7 4 Icidetal Igestio.4 Icidetal Ihalatio-Spray b 6a; 6b Icidetal Ihalatio-Powder b.4c ; 6b Dermal Cotact Deodorat (uderarm) air - No-Colorig 6.8 air-colorig Nail 5 Mucous Membrae.4 Baby Products Polyglyceryl-6 ctastearate Polyglyceryl-6 leate Totals* Duratio of Use Leave- ise-ff Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio Icidetal Ihalatio-Spray a b Icidetal Ihalatio-Powder b Dermal Cotact Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae Baby Products # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl-6 Caprylate/Caprate Polyglyceryl-6 Isostearate 4 4 4a; 8b 8b 3 Polyglyceryl-6 Petastearate

98 Distributed for Commet ly -- Do Not Cite or Quote Table 8. Frequecy ad cocetratio of use accordig to duratio ad type of exposure # of Uses9 Max Coc of Use (%)0-4 # of Uses9 Max Coc of Use (%)0-4 # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl-6 icioleate Polyglyceryl-6 Tricaprylate Polyglyceryl-8 Decabeheate/Caprate Totals* Duratio of Use Leave ise-ff Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio 9 Icidetal Ihalatio-Spray Icidetal Ihalatio-Powder Dermal Cotact 3.6 Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae 9 Baby Products ] Polyglyceryl-8 Decaerucate/ Polyglyceryl-0 Beheate/Eicosadioate Polyglyceryl-0 Caprylate/Caprate Decaisostearate/Decaricioleate Totals -5 Duratio of Use Leave- ise ff 5 Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio Icidetal Ihalatio-Spray b Icidetal Ihalatio-Powder b Dermal Cotact 5 Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae Baby Products Polglyceryl-0 Decaisostearate Polyglyceryl-0 Decaoleate Polyglyceryl-0 Diisostearate Totals* Duratio of Use Leave ise-ff Diluted for (Bath) Use Exposure Type Eye Area 3.7 Icidetal Igestio Icidetal Ihalatio-Spray 5a 4a; 4b a b Icidetal Ihalatio-Powder 4 0.8c Dermal Cotact Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae Baby Products

99 Distributed for Commet ly -- Do Not Cite or Quote Table 8. Frequecy ad cocetratio of use accordig to duratio ad type of exposure # of Uses9 Max Coc of Use (%)0-4 # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl-0 Dioleate Polyglyceryl-0 Dipalmitate Totals* Duratio of Use Leave- 3 0 ise-ff Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio b Icidetal Ihalatio-Spray Icidetal Ihalatio-Powder b 0c Dermal Cotact Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae Baby Products Polyglyceryl-0 eptahydroxystearate Polyglyceryl-0 ydroxystearate/ Stearate/Eicosadioate Totals Duratio of Use Leave ise ff.8 Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio Icidetal Ihalatio-Spray Icidetal Ihalatio-Powder Dermal Cotact.8 Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae Baby Products Polyglyceryl-0 Laurate Polyglyceryl-0 Myristate Totals* Duratio of Use Leave ise-ff Diluted for (Bath) Use Exposure Type Eye Area 5 Icidetal Igestio Icidetal Ihalatio-Spray a; b 0.5; 6.5a 5a; 4b b b Icidetal Ihalatio-Powder 4 0.8c Dermal Cotact Deodorat (uderarm) ot spray: aerosol: 0. air - No-Colorig air-colorig Nail Mucous Membrae Baby Products 7 # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl-0 Distearate 0 9 a 9 0 Polyglyceryl-0 Isostearate a; b 0.6 b Polyglyceryl-0 Noaisostearate

100 Distributed for Commet ly -- Do Not Cite or Quote Table 8. Frequecy ad cocetratio of use accordig to duratio ad type of exposure # of Uses9 Max Coc of Use (%)0-4 # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl-0 leate Polyglyceryl-0 Petahydroxystearate Totals* Duratio of Use Leave ise-ff Diluted for (Bath) Use Exposure Type Eye Area 0.63 Icidetal Igestio a b a Icidetal Ihalatio-Spray 9 ; 0 Icidetal Ihalatio-Powder 0b 0.-3c Dermal Cotact Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae Baby Products Polyglyceryl-0 Petaoleate Polyglyceryl-0 Petastearate Totals* Duratio of Use Leave ise-ff Diluted for (Bath) Use Exposure Type Eye Area Icidetal Igestio Icidetal Ihalatio-Spray 3; a a 5a; 5b Icidetal Ihalatio-Powder 5b -.c Dermal Cotact Deodorat (uderarm) air - No-Colorig 4 air-colorig Nail Mucous Membrae Baby Products Polyglyceryl-0 Tristearate Triisostearoyl Polyglyceryl-3 Dimer Dilioleate Totals* 0 -. Duratio of Use Leave ise-ff Diluted for (Bath) Use Exposure Type Eye Area -. Icidetal Igestio Icidetal Ihalatio-Spray Icidetal Ihalatio-Powder Dermal Cotact 3 -. Deodorat (uderarm) air - No-Colorig air-colorig Nail Mucous Membrae Baby Products # of Uses9 Max Coc of Use (%)0-4 Polyglyceryl-0 Petaisostearate c 4.8 Polyglyceryl-0 Stearate a; 34b 34b a 0.3-c *Because each igrediet may be used i cosmetics with multiple exposure types, the sum of all exposure types may ot equal the sum of total uses. a Icludes products that ca be sprays, but it is ot kow whether the reported uses are sprays b Not specified whether this product is a spray or a powder or either, but it is possible it may be a spray or a powder, so this iformatio is captured for both categories of icidetal ihalatio c Icludes products that ca be powders, but it is ot kow whether the reported uses are powders ot reported

101 Distributed for Commet ly -- Do Not Cite or Quote Table 9. Supplier ecommeded Use Levels Igrediet Diisostearoyl Polyglyceryl-3 Dimer Dilioleate Polyglyceyrl-4 Caprate Polyglyceryl-3 Caprylate Polyglyceryl-0 Caprylate/Caprate Polyglyceryl-4 Cocoate Polyglyceryl-6 Distearate Polyglyceryl-0 Eicosaedioate/Tetradecaedioate Polyglyceyrl-4 Isostearate Polyglyceryl-4 Laurate (i o/w lotio wipes) Polyglyceryl-0 Laurate (~60% pure, with ~40% polyglyceri-0 ad ~% sodium laurate) Polyglyceryl-3 leate Polyglyceryl-0 leate Polyglyceryl-3 icioleate Polyglyceryl- Sesquioleate Supplier-ecommeded Cocetratio 3.0% -0% 0.-% -7% -5% -3% %.5-4% % i cocetrates % i impregatig liquids 3%.5-4% -7% 3.5-4% (w/o emulsios); 5-5% (ahydrous products) -3% eferece

102 Distributed for Commet ly -- Do Not Cite or Quote Table 0. Igrediets Not eported to be Used 9-4 Adasoia Digitata Seed il Polyglyceryl-6 Esters Almod il/polyglyceryl-0 Esters Apricot Kerel il Polyglyceryl-3 Esters Apricot Kerel il Polyglyceryl-4 Esters Apricot Kerel il Polyglyceryl-5 Esters Apricot Kerel il Polyglyceryl-6 Esters Apricot Kerel il Polyglyceryl-0 Esters Arga il Polyglyceryl-6 Esters Astrocaryum Vulgare il Polyglyceryl-6 Esters Avocado il Polyglyceryl-6 Esters Babassu il Polyglyceryl-6 Esters Bertholletia Excelsa Seed il Polyglyceryl-6 Esters Borage Seed il Polyglyceryl-4 Esters Borage Seed il Polyglyceryl-6 Esters Carapa Guaiaesis il Polyglyceryl-6 Esters Castor il Polyglyceryl-6 Esters Cocoa Butter Polyglyceryl-6 Esters Coffee Seed il Polyglyceryl-6 Esters azelut Seed il Polyglyceryl-6 Esters Liseed il Polyglyceryl-4 Esters Macadamia Seed il Polyglyceryl-6 Esters Mauritia Flexuosa Seed il Polyglyceryl-6 Esters live il Polyglyceryl-3 Esters live il Polyglyceryl-4 Esters live il Polyglyceryl-6 Esters Palm Kerel il Polyglyceryl-4 Esters Palm il Polyglyceryl-3 Esters Palm il Polyglyceryl-5 Esters Palm il Polyglyceryl-6 Esters Pariari Curatellifolia il Polyglyceryl-6 Esters Pius Sibirica Seed il Polyglyceryl-6 Esters Polyglyceryl- Caprylate Polyglyceryl- Dioleate Polyglyceryl- Distearate Polyglyceryl- Isopalmitate/Sebacate Polyglyceryl- Myristate Polyglyceryl- Palmitate Polyglyceryl- Sesquicaprylate Polyglyceryl- Sesquioleate Polyglyceryl- Tetrabeheate/ Macadamiate/Sebacate Polyglyceryl- Tetraoleate Polyglyceryl- Tetrastearate Polyglyceryl-3 Beheate Polyglyceryl-3 Cocoate Polyglyceryl-3 Dicaprate Polyglyceryl-3 Dicocoate Polyglyceryl-3 Di-ydroxystearate Polyglyceryl-3 Dioleate Polyglyceryl-3 Myristate Polyglyceryl-3 Petacaprylate/Caprate Polyglyceryl-3 Petaolivate Polyglyceryl-3 ice Braate Polyglyceryl-3 Soyate/Shea Butterate Polyglyceryl-3 Stearate SE Polyglyceryl-3 Triisostearate Polyglyceryl-3 Triolivate Polyglyceryl-4 Almodate/Shea Butterate Polyglyceryl-4 Caprylate Polyglyceryl-4 Caprylate/Caprate Polyglyceryl-4 Dilaurate Polyglyceryl-4 Distearate Polyglyceryl-4 azelutseedate Polyglyceryl-4 Isostearate/Laurate Polyglyceryl-4 Laurate/Sebacate Polyglyceryl-4 Laurate/Succiate Polyglyceryl-4 Petaoleate Polyglyceryl-4 Petapalmitate/Stearate Polyglyceryl-4 Petastearate Polyglyceryl-4 Puicate Polyglyceryl-4 Stearate Polyglyceryl-4 Sweet Almodate Polyglyceryl-4 Tristearate Polyglyceryl-5 Caprate Polyglyceryl-5 Dicaprylate Polyglyceryl-5 Dilaurate Polyglyceryl-5 exastearate Polyglyceryl-5 Myristate Polyglyceryl-5 Petamyristate Polyglyceryl-5 icioleate Polyglyceryl-5 Tribeheate Polyglyceryl-5 Trimyristate Polyglyceryl-5 Tristearate Polyglyceryl-6 Adasoia Digitata Seedate Polyglyceryl-6 Apricot Kerelate Polyglyceryl-6 Arga Kerelate Polyglyceryl-6 Beheate Polyglyceryl-6 Caprate Polyglyceryl-6 Caprylate Polyglyceryl-6 Citrullus Laatus Seedate Polyglyceryl-6 Dicaprate Polyglyceryl-6 Diisostearate Polyglyceryl-6 Dipalmitate Polyglyceryl-6 eptacaprylate Polyglyceryl-6 exaoleate Polyglyceryl-6 exastearate Polyglyceryl-6 Laurate Polyglyceryl-6 Myristate Polyglyceryl-6 ctacaprylate Polyglyceryl-6 Palmitate Polyglyceryl-6 Palmitate/Succiate Polyglyceryl-6 Petacaprylate Polyglyceryl-6 Petaoleate Polyglyceryl-6 Petaricioleate Polyglyceryl-6 Schiziophyto autaeii Kerelate Polyglyceryl-6 Sclerocarya Birrea Seedate Polyglyceryl-6 Sesquicaprylate Polyglyceryl-6 Sesquiisostearate Polyglyceryl-6 Sesquistearate Polyglyceryl-6 Stearate Polyglyceryl-6 Tetrabeheate Polyglyceryl-6 Tetracaprylate Polyglyceryl-6 Tetraoleate Polyglyceryl-6 Trichilia Emetica Seedate Polyglyceryl-6 Tristearate Polyglyceryl-6 Udecyleate Polyglyceryl-6 imeia Americaa Seedate Polyglyceryl-8 C-0 Acid Ester Polyglyceryl-8 leate Polyglyceryl-8 Stearate Polyglyceryl-0 Apricot Kerelate Polyglyceryl-0 Caprate Polyglyceryl-0 Caprylate Polyglyceryl-0 Cocoate Polyglyceryl-0 Decaethylhexaoate Polyglyceryl-0 Decahydroxystearate Polyglyceryl-0 Decalioleate Polyglyceryl-0 Decamacadamiate Polyglyceryl-0 Decastearate Polyglyceryl-0 Dicocoate Polyglyceryl-0 Didecaoate Polyglyceryl-0 Dilaurate Polyglyceryl-0 Dimyristate Polyglyceryl-0 Dodecabeheate Polyglyceryl-0 Dodecacaprate Polyglyceryl-0 Dodecacaprylate Polyglyceryl-0 Dodeca-Caprylate/Caprate Polyglyceryl-0 Eicosaedioate/Tetradecaedioate Polyglyceryl-0 epta(beheate/stearate) Polyglyceryl-0 eptaoleate Polyglyceryl-0 eptastearate Polyglyceryl-0 exaerucate Polyglyceryl-0 exaisostearate Polyglyceryl-0 exaoleate Polyglyceryl-0 Lioleate Polyglyceryl-0 Moo/Dioleate Polyglyceryl-0 Noaerucate Polyglyceryl-0 Palmate Polyglyceryl-0 Palmitate Polyglyceryl-0 Petacaprylate Polyglyceryl-0 Petalaurate Polyglyceryl-0 Petalioleate Polyglyceryl-0 Petaricioleate Polyglyceryl-0 Sesquistearate Polyglyceryl-0 Tetradecaedioate Polyglyceryl-0 Tetralaurate Polyglyceryl-0 Tetraoleate Polyglyceryl-0 Tricocoate Polyglyceryl-0 Tridecaoate Polyglyceryl-0 Trierucate Polyglyceryl-0 Triisostearate Polyglyceryl-0 Trilaurate Polyglyceryl-0 Trioleate Polyglyceryl-0 Udecyleate Polyglyceryl-5 Diisostearate Polyglyceryl-0 Docosabeheate/Isostearate Polyglyceryl-0 Docosabeheate/Laurate Polyglyceryl-0 Docosabeheate/leate Polyglyceryl-0 eptacaprylate Polyglyceryl-0 eptadecabeheate/laurate Polyglyceryl-0 exacaprylate Polyglyceryl-0 ctadecabeheate/laurate Polyglyceryl-0 ctaisooaoate Pumpki Seed il Polyglyceryl-4 Esters Pumpki Seed il Polyglyceryl-4 Esters Succiate ice Bra il Polyglyceryl-3 Esters osa ubigiosa Seed il Polyglyceryl-6 Esters Safflower Seed il Polyglyceryl-6 Esters Schiziophyto autaeii Kerel il Polyglyceryl-6 Esters Sclerocarya Birrea Seed il Polyglyceryl-6 Esters Sclerocarya Birrea Seed il Polyglyceryl-0 Esters Sesame il Polyglyceryl-6 Esters Shea Butter Polyglyceryl-3 Esters Shea Butter Polyglyceryl-4 Esters Shea Butter Polyglyceryl-6 Esters Soybea il Polyglyceryl-6 Esters Suflower Seed il Polyglyceryl-3 Esters Suflower Seed il Polyglyceryl-4 Esters Suflower Seed il Polyglyceryl-5 Esters Suflower Seed il Polyglyceryl-6 Esters Suflower Seed il Polyglyceryl-0 Esters Sweet Almod il Polyglyceryl-4 Esters Sweet Almod il Polyglyceryl-6 Esters Theobroma Gradiflorum Seed Butter Polyglyceryl-6 Esters Trichilia Emetica Seed il Polyglyceryl-6 Esters Watermelo Seed il Polyglyceryl-6 Esters Watermelo Seed il Polyglyceryl-0 Esters imeia Americaa Seed il Polyglyceryl-6 Esters

103 Distributed for Commet ly -- Do Not Cite or Quote Table. Dispositio of radioactivity i rats after a sigle oral dose (5 h after feedig) Catabolism Study36 % radioactivity recovered C urie Feces Test Compoud - Igrediets [4C]Polyglyceryl-0 leate GI cotets carcass [ C]Polyglyceryl-0 Decaoleate polyglyceryl-3 [4C]oleate polyglyceryl-0 [4C]oleate polyglyceryl-0 [4C]decaoleate For Compariso glycerol-,3-4c [4C]polyglyceri [4C]polyglyceri triglycerol [4C]tetraoleate polyglyceri-0 [4C]mooeicosaoate Catabolism- Absorptio Study % radioactivity recovered C urie feces GI cotets carcass lymph [4C]Polyglyceryl-0 leate [4C]Polyglyceryl-0 Decaoleate polyglyceryl-3 [4C]oleate polyglyceryl-0 [4C]oleate polyglyceryl-0 [4C]decaoleate [ C]polyglyceri [4C]polyglyceri triglycerol [4C]tetraoleate polyglyceri-0 [4C]mooeicosaoate 8.9 Test Compoud - Igrediets For Compariso glycerol-,3-4c 4

104 Distributed for Commet ly -- Do Not Cite or Quote Table. Acute Toxicity Studies Igrediet Aimals No./Group Vehicle Cocetratio/Dose/Protocol LD50/esults,,3-propaetriol, homopolymer, diisooctadecaoate ( ot defied; most likely Polyglyceryl-3 Diisostearate) Wistar rats 5/sex DEMAL Polyglyceryl Multi-Esters udiluted 5 g/kg (5. ml/kg bw) was applied with >5 g/kg a semi-occlusive patch for 4 h o local effects were observed polyglyceryl ester (uspecified) polyglyceryl ester (uspecified) rats ot provided ot specified rabbits ot provided ot specified Polyglyceryl-3 Caprate rat ot provided Polyglyceryl-3 Caprylate rat ot provided Polyglyceryl-3 Isostearate Polyglyceryl-3 leate Polyglyceryl-4 Caprate rat rat rat ot provided ot provided ot provided Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters Sprague 3 females Dawley rats Polyglyceryl- Diisostearate female Wistar rats rats NMI mice Wistar rats 0 AL 7, 4 ad 9 g/kg bw by gavage 0-9 g/kg bw Polyglyceryl Mooesters ot specified ECD 40 (acute oral toxicity by gavage) ot specified ECD 43 (acute oral toxicity by gavage) ot specified FSA, 6 CF ot specified FSA, 6 CF ot specified ECD 40 (acute oral toxicity by gavage) arachis oil BP g/kg bw by gavage ( groups) water Polyglyceryl Multi-Esters ot provided eferece 39 o sigs of ay toxic effect 3 o sigs of ay toxic effect 3 LD50 > g/kg 40 LD50 > g/kg 4 LD50 > 5 g/kg LD50 > 5 g/kg LD50 > g/kg 4 LD50 >.5 g/kg bw (estimated) 45 >5 g/kg 38 Polyglyceryl- Diisostearate 5/sex ot specified ot provided >5 g/kg Polyglyceryl-3 Diisostearate 5 females ot specified g/kg > g/kg,,3-propaetriol, homo5/sex peaut oil sigle oral dose of 50% (w/v) by >5 g/kg polymer, diisooctadecaoate gavage ( ot defied; most likely Polyglyceryl-3 Diisostearate) Diisostearoyl Polyglyceryl-3 rat ot provided ot specified ECD 43 (acute oral toxicity by LD50 > g/kg bw Dimer Dilioleate gavage) tetraisostearoyl polyglyceryl- rats ot provided ot provided ot provided >5 g/kg 3 dimer dilioleate (as readacross for Diisostearoyl Polyglyceryl-3 Dimer Dilioleate ad Triisostearoyl Polyglyceryl-3 Dimer Dilioleate) Macadamia Seed il PolySprague3 females arachis oil dosed with g/kg by gavage ( groups) >.5 g/kg bw (estimated) glyceryl-6 Esters Beheate Dawley rats o mortality Polyglyceryl-8 Decabeheate/ Sprague female; arachis oil BP dosed with g/kg by gavage ( groups) >.0 g/kg bw (estimated) Caprate Dawley rats 4females o mortality Polyglyceryl-8 Decaerucate/ Sprague3 females oe dosed with g/kg, eat, by gavage ( >.5 g/kg bw (estimated) Decaisostearate/ DecariciDawley rats groups) o mortality oleate Polyglyceryl-0 Sprague3 females arachis oil 0.3 g/kg (30 mg/ml) i arachis oil or >.5 g/kg bw (estimated) Noaisostearate Dawley rats g/kg eat by gavage o mortality Abbreviatios: CF Code of Federal egulatios; FSA Federal azardous Substaces Act; ECD rgaisatio for Ecoomic Co-operatio ad Developmet , ,

105 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Geotoxicity studies Test Article Cocetratio/Vehicle Test System Procedure esults eferece IN VIT Polyglyceryl Mooesters ot mutageic cytotoxic at 5000 µg/plate i strai TA537 without activatio ad TA535 with activatio positive ad vehicle cotrols gave expected results ot geotoxic cytotoxic without activatio at 30 µg/ml ad with activatio at 50 µg/m positive ad vehicle cotrols gave expected results ot geotoxic positive ad vehicle cotrols gave expected results 46 Ames test; ECD 47 o evidece of mutageic activity 40 ot provided Ames test; ECD 47 o evidece of mutageic activity 4 ot provided Ames test; details ot provided egative 56 Polyglyceryl-3 Isostearate µg/plate (vehicle ot specified) ot provided ot provided Ames test; details ot provided o evidece of mutageic activity 4 Polyglyceryl-4 Caprate ot provided ot provided Ames test; ECD 47 o evidece of mutageic activity 44 Polyglyceryl-4 Isostearate ot provided ot provided Ames test; details ot provided egative 43 Polyglyceryl-4 Laurate/Succiate µg/plate i distilled water S. typhimurium TA535, TA537, TA98, TA00; E. coli WPuvrA Ames test, with ad without metabolic activatio 57 Glyceryl/Polyglyceryl-6 Isostearate/ Beheate Esters µg/plate i acetoe S. typhimurium TA535, TA537, TA98, TA00; E. coli WPuvrA µg/plate i distilled water S. typhimurium TA535, TA537, TA98, TA00; E. coli WPuvrA Ames test, assayed i triplicate, with ad without metabolic activatio; ( experimets performed) ot mutageic cytotoxicity was observed i S. typhimurium with several cocetratios positive ad vehicle cotrols gave expected results ot mutageic positive ad vehicle cotrols gave expected results ot mutageic cytotoxicity was observed with several cocetratios positive ad vehicle cotrols gave expected results Polyglyceryl- leate µg/plate i DMS S. typhimurium TA535, TA537, TA98 ad TA00; E. coli WPuvrA Ames test, with ad without metabolic activatio (ECD Guidelie 47) Polyglyceryl- leate mouse lymphoma L578Y cells mammalia cell gee mutatio assay, with ad without metabolic activatio (ECD test guidelie 476) huma peripheral blood lymphocytes chromosomal aberratio assay, with ad without metabolic activatio (ECD Guidelie 473) Polyglyceryl-3 Caprate 0-50 µg/ml, 4-h exposure with ad without activatio 5-75 µg/ml, 4-h exposure without activatio i DMS 5-50 ad µg/ml, 4-h exposure without ad with activatio, respectively; 5-00 µg/ml, -h exposure without activatio i DMS ot provided ot provided Polyglyceryl-3 Caprylate ot provided Polyglyceryl-3 Laurate Polyglyceryl- leate Polyglceryl-6 Caprylate/Caprate Ames test, with ad without metabolic activatio

106 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Geotoxicity studies Test Article Test System Procedure esults Polyglyceryl-0 Laurate (~60% pure, 0-5 µg/ml without activatio with ~40% polyglyceri-0 ad ~% 0-50 µg/ml with activatio sodium laurate) Chiese hamster V79 cells chromosomal aberratio assay; 0 h harvest time 0 Polyglyceryl-0 Laurate (~60% pure, µg/ml, 4-h exposure withwith ~40% polyglyceri-0 ad ~% out ad with activatio sodium laurate) µg/ml, 0-h exposure without activatio huma peripheral lymphocytes equivocal without ad positive with activatio without activatio, a slight icrease of aberrat cells was see with 50 ad 70, but ot 65, µg/ml with activatio, the aberratio rates with 50 ad 500 µg/ml were sigificatly icreased, ad a dose relatioship was observed ot clastogeic; o sigificat icreases i chromosomal aberratios were observed i ay treatmet group at ay dose level ot mutageic 38 o evidece of a cocetratio-related positive respose 38 ot clastogeic 38 ot mutageic positive ad vehicle cotrols gave expected results ot geotoxic positive ad egative cotrols gave expected results 39 ot clastogeic 39 egative 48 ot mutageic positive ad vehicle cotrols gave expected results ot mutageic positive ad vehicle cotrols gave expected results ot mutageic positive ad vehicle cotrols gave expected results 60 Polyglyceryl- Diisostearate Polyglyceryl- Diisostearate Polyglyceryl- Diisostearate,,3-propaetriol, homopolymer, diisooctadecaoate ( ot defied; most likely Polyglyceryl-3 Diisostearate),,3-propaetriol, homopolymer, diisooctadecaoate ( ot defied; most likely Polyglyceryl-3 Diisostearate) Cocetratio/Vehicle chromosomal aberratio assay; 0 h harvest time metaphase aalysis was performed with cultures exposed to µg/ml for 4 h ad µg/ml for 0 h without metabolic activatio, ad to µg/ml with metabolic activatio Polyglyceryl Multi-esters µg/plate i acetoe S. typhimurium TA535, Ames test, with ad without metabolic activatio TA537, TA98, TA µg/ml, 4-h exposure Chiese hamster lug fibroblasts mammalia cell gee mutatio assay, with ad without ad with activatio V79 cells without metabolic activatio; 0 h harvest time µg/ml, 0-h exposure withchromosomal aberratios were evaluated i culout activatio tures exposed to µg/ml for 4 h ad µg/ml for 0 h without metabolic activatio, cell culture medium (MEM) served as the vehicle ad to µg/ml with metabolic activatio µg/ml i cell culture Chiese hamster lug fibroblasts chromosomal aberratio assay, with ad without medium (MEM) V79 cells metabolic activatio µg/plate i Twee S. typhimurium TA535, Ames test, with ad without metabolic activatio 80/bidistilled water TA537, TA538, TA98 ad TA µg/ml, 4-h exposure C cells mammalia cell gee mutatio assay, with ad without activatio without metabolic activatio; 4-h exposure µg/ml, 4-h exposure with activatio i DMS.5-800µg/ml without ad 3.3Chiese hamster lug fibroblasts chromosomal aberratio assay, with ad without 800µg/ml with activatio, i V79 cells metabolic activatio; 4 ad 8-h exposure DMS ot provided ot provided Ames test; ECD 47,,3-propaetriol, homopolymer, diisooctadecaoate ( ot defied; most likely Polyglyceryl-3 Diisostearate) Diisostearoyl Polyglyceryl-3 Dimer Dilioleate Macadamia See il Polyglyceryl µg/plate i acetoe Esters Beheate S. typhimurium TA535, TA537, TA98, TA00; E. coli WPuvrA Polyglyceryl-8 Decabeheate/Caprate µg/plate i tetrahydrofura S. typhimurium TA535, TA537, TA98, TA00; E. coli WPuvrA Polyglyceryl-8 Decaerucate/Decaiso µg/plate i tetrahydrofura S. typhimurium TA535, stearate/decaricioleate TA537, TA98, TA00; E. coli WPuvrA Ames test, assayed i triplicate, with ad without metabolic activatio; ( experimets performed) Ames test, assayed i triplicate, with ad without metabolic activatio; ( experimets performed) Ames test, assayed i triplicate, with ad without metabolic activatio; ( experimets performed) eferece

107 Distributed for Commet ly -- Do Not Cite or Quote Table 3. Geotoxicity studies Test Article Cocetratio/Vehicle Test System Procedure esults eferece 63 S. typhimurium TA535, Ames test, with ad without metabolic activatio ot mutageic TA537, TA98, TA00; E. coli positive ad vehicle cotrols gave WPuvrA expected results 64 Polyglyceryl-0 Petaisostearate S. typhimurium TA535, Ames test, with ad without metabolic activatio ot mutageic TA537, TA98, TA00; E. coli positive ad vehicle cotrols gave WPuvrA expected results 65 Polyglyceryl-0 Noaisostearate S. typhimurium TA535, Ames test, assayed i triplicate, with ad without ot mutageic TA537, TA98, TA00; E. coli metabolic activatio; ( experimets performed) positive ad vehicle cotrols gave WPuvrA expected results Abbreviatios: C Chiese hamster ovary; DMF N,N-dimethylformamide; DMS dimethyl sulfoxide; MEM miimum essetial medium; ECD rgaisatio for Ecoomic Co-operatio ad Developmet Polyglyceryl-0 Decaethylhexaoate rage-fidig test: µg/ plate; mai experimets: µg/plate; i DMF rage-fidig test: µg/ plate; mai experimets: µg/plate; i acetoe µg/plate i tetrahydrofura Table 4. Dermal irritatio ad sesitizatio Test Article Cocetratio/Dose test system/# per Group Procedure esults eferece ALTENATIVE STUDIES Polyglyceryl Mooesters Apricot Kerel il Polyglyceryl-4 6 ± 0.5 µl Esters Palm il Polyglyceryl-4 Esters 6 ± 0.5 µl Polyglyceryl-4 Laurate/Sebacate eat Polyglyceryl-4 Laurate/Succiate eat Polyglyceryl-6 Caprylate/Caprate eat Polyglyceryl-0 Decaethylhexaoate eat; 30 µl Polyglyceryl-0 Petaisostearate eat; 30 µl recostituted huma epidermis recostituted huma epidermis recostituted huma epidermis SkiEthicTM irritatio test; test material was applied for 4 mi; cell viability assessmet by MTT method after 4 h SkiEthicTM irritatio test; protocol as described previously classified as o-irritat 47 classified as o-irritat 47 cosidered to be o-irritat relative mea viability was 05.4% 66 recostituted huma epidermis recostituted huma epidermis recostituted huma epidermis (surface: 0.63 cm); 3 tissues recostituted huma epidermis (surface: 0.63 cm); 3 tissues EpiSkiTM model; 5 mi treatmet period with a 4 h post-exposure icubatio period; cell viability was measured by MTT reductio EpiSkiTM model; protocol as described previously cosidered to be o-irritat relative mea viability was 04.% EpiSkiTM model; protocol as described previously cosidered to be o-irritat relative mea viability was 05.7% EpiDermTM model performed accordig to Method B.46; 60 cosidered to be o-irritatig mi exposure time, followed by a 4-h icubatio period; avg. viability was 0.4% of egative cotrol avg. value cell viability was measured i a MTT assay EpiDermTM model; protocol as described previously cosidered to be o-irritatig avg. viability was 94.7% of egative cotrol avg. value ANIMAL Polyglyceryl- Isostearate udiluted; 0.5 ml 3 NZW rabbits Polyglyceryl Mooesters 4-h, x 3 cm semi-occlusive patch applied to clipped ski Polyglyceryl-3 Caprate Polyglyceryl-3 Caprate ot provided ot provided rabbit guiea pig ECD TG 404 (acute dermal irritatio/corrosio) ECD TG 406 (sesitizatio) PII of 0.8 (mildly irritatig); very slight erythema was observed i all 3 aimals ad resolved i -7 days ot irritatig o ski sesitizatio effect

108 Distributed for Commet ly -- Do Not Cite or Quote Table 4. Dermal irritatio ad sesitizatio Test Article Cocetratio/Dose Procedure esults ot provided test system/# per Group rabbit a polyglyceryl moo/diester of capric acid (C0) (provided as read-across for Polyglyceryl-3 Caprylate) Polyglyceryl-3 Caprylate Polyglyceryl-3 Isostearate Polyglyceryl-3 Isostearate Polyglyceryl-3 leate Polyglyceryl-4 Caprate Polyglyceryl-4 Caprate Polyglyceryl-4 Isostearate Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters ECD TG 404 (acute dermal irritatio/corrosio) ot irritatig 4 ot provided ot provided ot provided ot provided ot provided ot provided ot provided applied eat; 0.5 ml mouse rabbit guiea pig rabbit rabbit guiea pig guiea pig NZW rabbit ECD TG 49; LLNA FSA, 6 CF ECD TG 406 (sesitizatio) FSA, 6 CF ECD TG 404 (acute dermal irritatio/corrosio) ECD TG 406 (sesitizatio) ECD TG 406 (sesitizatio) sigle 3 mi, h, ad 4 h semi-occlusive applicatio usig a.5 cm patch ot sesitizig moderately irritatig o ski sesitizatio effect moderately irritatig ot irritatig o ski sesitizatio effect o sesitizig effect o irritatio observed after 3 mi or h (4 results icluded below) 4 NZW rabbits sigle 4-h semi-occluded patch to clipped ski o the dorsal/flak are prelimiary sightig tests for sesitizatio study; 4 h occlusive patch; determiatio of cocetratio for topical iductio ( aimals) ad topical challege (3 aimals) GPMT itradermal iductio: 3 pairs of ijectios o day :.) FCA + isotoic sodium chloride (:).) test article 3.) test article + FCA/ isotoic sodium chloride topical iductio: 48-h occlusive patch o day 7 challege: 4-h occlusive patches (study day ot specified) Polyglyceryl Multi-Esters 4-h,.5 cm semi-occlusive patch PII of 0.3 (mild irritat); very slight erythema i aimals at 4 h was resolved by 48-h o ski reactios were observed i either group Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters.5, 5, 50% i liquid paraffi; udiluted Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters itradermal iductio: female albio guiea 5% i olive oil pigs; 0 test ad 5 topical iductio: 00% cotrol aimals topical challege: 00%; 50% i liquid paraffi Polyglyceryl- Diisostearate udiluted; 0.5 ml Polyglyceryl- Diisostearate ad 0% i salie, ad Albio-imalayaudiluted; 0.5 ml Kaiche rabbits/gp 4-h,.5 cm occlusive patch o itact ad abraded ski Polyglyceryl- Diisostearate iductio: 00% challege: 0% i acetoe ot specified Buehler test usig occlusive patches; 0 cotrol aimals were exposed to a ethaol-water (80:0) mixture Polyglyceryl-3 Diisostearate Polyglyceryl-3 Diisostearate 5-50% i paraffi perliquid DAB 8 or 3 female albio guiea pigs 3 NZW rabbits 0 female PirbrightWhite guiea pigs/gp 3 NZW rabbits method was described as ECD Guidelie 404, but study details were ot provided; test sites were scored accordig to Draize 3 Pirbright-White guiea i a rage-fidig study for a sesitizatio test, the test pigs material was applied to the shaved flak for 6 h eferece ot sesitizig; o reactios were observed 73 o-irritatig; aimal had well-defied erythema 4 h after patch removal slightly irritatig; with udiluted test substace, distict erythema ad slight to distict edema was observed i both aimals; with 0%, marked erythema was observed i aimal for a short time; with %, slight erythema i aimal o-sesitizig 38 ot irritatig; slight erythema was see o ski of all 3 aimals tested startig hour followig applicatio, ad this effect was fully reversible withi by 7 h ot irritatig after 4 h ,47 46

109 Distributed for Commet ly -- Do Not Cite or Quote Table 4. Dermal irritatio ad sesitizatio Test Article Cocetratio/Dose,,3-propaetriol, homopolymer, udiluted; 0.5 ml diisooctadecaoate ( ot defied; most likely Polyglyceryl-3 Diisostearate) Polyglyceryl-3 Diisostearate iductio: 50% i paraffi perliquid DAB 8 (iductio ) or i petrolatum (iductios ad 3) challege: 50% paraffi perliquid DAB 8 rechallege: 5% Polyglyceryl-3 Diisostearate itradermal iductio: 0.% or 0.% topical iductio: 40% challege: 0 ad 5% rechallege: 8 ad 4% vehicle was paraffium perliquidum DAB 8 for all phases Polyglyceryl-4 Diisostearate/ Polyhydroxystearate/Sebacate (provided as read-across for Diisostearoyl Polyglyceryl-3 Dimer Dilioleate due to similar MW ad chemical characterizatio) ot provided test system/# per Group 4 male rabbits 0 (test) or 9 (cotrol) female Pirbright-White guiea pigs 0 (test) or 9 (cotrol) female Pirbright-White guiea pigs guiea pig Procedure 4-h occlusive patch to a shaved 6.5 cm² area esults ot irritatig; very slight to slight erythema i 3/4 aimals at 4 ad 48 h; slight ad moderate erythema i /4 aimals at 7 h; the effects were reversible i all aimals withi 7 d test sites were pre-treated with 0% SDS i petrolatum, 4 h o-sesitizig prior to each iductio applicatio very slight ski reactios (erythema ad edema) were see at 4-h followig the challege ad rechallege patches i epicutaeous iductio: 6-h occlusive patches (0. ml) applied x/wk for 3 wks; half of the cotrols were test ad cotrol aimals; these reactios were reversible i all aimals withi 48 h ad were attributed to irritatio pretreated with SDS 4 h prior to applicatio of patches cotaiig vehicle challege: 6-h occlusive patch (0. ml) applied o day 8 rechallege: 6-h occlusive patch (0. ml) applied o day 35 GPMT, o positive cotrol results were icoclusive itradermal iductio: 3 pairs of ijectios o day : itradermal iductio: 0. ml FCA (50% (v/v)), the test.) FCA + physiological salie i water (:) substace (0.% (v/v)) ad a : mixture of the test.) 0.% test article substace with FCA caused moderate to severe ski 3.) 0.% test article + FCA/ physiological salie i reactios; i the cotrol group, 0. ml of the vehicle water (:) resulted i moderate ski reactios topical iductio: 48-h occlusive patch o day 8 (0. ml) epicutaeous iductio: after treatmet with 40% of the challege: 4-h occlusive patches o day (0. ml) test substace, the ijectio sites of the itradermal iductio were bloody ad purulet ad at a later stage, rechallege: 4 h occlusive patches o day 9 (0. ml) this sites showed ecrotic ad scabby ski lesios challege with 5%: at 4 h, erythema () was observed i 9 test ad cotrol aimals; edema () i test aimal, ad edema () i test ad cotrol aimals; at 48 h, erythema () i test aimal (that was 0 at 4 h), erythema () i 7 test aimals, same edema scores as at 4 h for test aimals, o edema i cotrols challege with 0%: at 4 h, erythema (3) i ad erythema () i 5 test aimals, edema (3) i ad edema () i test aimal; at 48 h, erythema (3) ad edema (3) i aimal ad erythema () ad edema () i test aimal; o erythema or edema i cotrols at 4 or 48 h rechallege with 8%: at 4 h, erythema () i 6 test ad 4 cotrol aimals, o edema i test or cotrols; at 48-h, erythema () i 3 test ad cotrol aimals, o edema i test or cotrols rechallege with 4%: o erythema or edema ECD 406 (sesitizatio) ot sesitizig eferece

110 Distributed for Commet ly -- Do Not Cite or Quote Table 4. Dermal irritatio ad sesitizatio Test Article Cocetratio/Dose Macadamia Seed il Polyglyceryl-6 Esters Beheate applied eat; 0.5 ml test system/# per Group NZW rabbit Procedure NZW rabbits sigle 4-h semi-occluded patch to clipped ski o the dorsal/flak area prelimiary sightig tests for sesitizatio study; 4 h occlusive patch; determiatio of cocetratio for topical iductio ( aimals) ad topical challege (3 aimals) GPMT itradermal iductio: 3 pairs of ijectios o day :.) FCA + isotoic sodium chloride (:).) test article 3.) test article + FCA/ isotoic sodium chloride topical iductio: 48-h occlusive patch o day 7 challege: 4-h occlusive patches (study day ot specified) sigle 3 mi, h, ad 4 h semi-occlusive applicatio usig a.5 cm patch PII of 0.0 (o-irritat; very slight erythema was observed at two sites h after patch removal o ski reactios were observed i either group sigle 4-h semi-occluded patch to clipped ski o the dorsal/flak area prelimiary sightig tests for sesitizatio study; 4 h occlusive patch; determiatio of cocetratio for topical iductio ( aimals) ad topical challege (3 aimals) GPMT itradermal iductio: 3 pairs of ijectios o day :.) FCA + isotoic sodium chloride (:).) test article 3.) test article + FCA/ isotoic sodium chloride topical iductio: 0% SLS i vaselie was applied o day 6; 48-h occlusive patch o day 7 challege: 4-h occlusive patches (study day ot specified) sigle 4 h semi-occlusive applicatio to clipped ski o the dorsal/flak area usig a.5 cm patch PII of 0.0 (o-irritat; very slight erythema was observed at two sites h after patch removal o ski reactios were observed i either group Macadamia Seed il Polyglyceryl-6 Esters Beheate.5, 5, 50% i liquid paraffi; udiluted or 3 female albio guiea pigs Macadamia Seed il Polyglyceryl-6 Esters Beheate itradermal iductio: 5% i olive oil topical iductio: 00% topical challege: 00%; 50% i liquid paraffi female albio Duki artley guiea pigs; 0 test ad 5 cotrol aimals Polyglyceryl-8 Decabeheate/Caprate applied eat; 0.5 g moisteed with 0.5 ml distilled water NZW rabbit NZW rabbits esults sigle 3 mi, h, ad 4 h semi-occlusive applicatio usig a o irritatio observed after 3 mi or h (4 results icluded.5 cm patch below) Polyglyceryl-8 Decabeheate/Caprate 7.5, 5, 30, ad 60% i liquid paraffi or 3 female albio guiea pigs Polyglyceryl-8 Decabeheate/Caprate itradermal iductio: 5% i olive oil topical iductio: 60% i liquid paraffi topical challege: 30 ad 60% i liquid paraffi female albio Duki artley guiea pigs; 0 test ad 5 cotrol aimals Polyglyceryl-8 Decaerucate/ Decaisostearate/Decaricioleate applied eat; 0.5 ml 3 NZW rabbits Polyglyceryl-8 Decaerucate/ Decaisostearate/Decaricioleate udiluted ad 5, 50, ad 75% i arachis oil BP male albio guiea pigs prelimiary sightig tests for sesitizatio study; aimals were ijected with FCA, ad after 45 days, a 48 h occlusive patch was applied Polyglyceryl-8 Decaerucate/ Decaisostearate/Decaricioleate udiluted ad 5, 50, ad 75% i arachis oil BP male albio guiea pigs prelimiary sightig tests for dermal iductio i the sesitizatio study; 4 h occlusive patch; aimals were ot part of the mai study, but were treated idetically to cotrols up to day 4 eferece ot sesitizig; o reactios were observed 75 o irritatio observed after 3 mi or h (4 results icluded below) ot sesitizig; o reactios were observed 77 PII of 0.0 (o-irritat) 78 h after patch removal, both aimals had erythema scores of (moderate ad cofluet erythema) at cocetratios 50-00%, oe aimal had a erythema score of ad oe had a score of discrete or patchy erythema) with 5%; all reactios resolved by 4 h h after patch removal, aimal had a score of for erythema with 00% test article; all other erythema scores were at ; all reactios resolved by 4 h 79 79

111 Distributed for Commet ly -- Do Not Cite or Quote Table 4. Dermal irritatio ad sesitizatio Test Article Cocetratio/Dose Procedure esults ot sesitizig at 4 h after itradermal iductio, all test ad cotrol aimals had a erythema score of or, which was resolved i almost all cotrol aimals, but ot test aimals at 48 h; h after topical iductio, there was bleedig from the itradermal ijectio sites of 8/0 test aimals, ad at 4 h, aimals had a erythema score of 79 Polyglyceryl-0 Noaisostearate udiluted; 0.5 ml 3 rabbits GPMT; itradermal iductio: 3 pairs of ijectios o day :.) FCA + distilled water (:).) test article 3.) test article + FCA/distilled water topical iductio: 48-h occlusive patch (40 mm x 0 mm patch) o day 7 challege: 4-h occlusive patch (0 mm x 0 mm) o day 4-h closed patch to itact ad abraded ski 8 Polyglyceryl-0 Noaisostearate 00%; 50 µl Duki artley albio guiea pigs, 4/sex Polyglyceryl-0 Noaisostearate udiluted ad 0, 5, ad 4 CBA/Ca mice 50% v/v i acetoe/ olive oil (4:); 5 µl/ear very slightly irritatio; PII =.08 PII of utreated patch was 0.4) itact ski: very slight erythema was observed i all 3 aimals at 4 h ad i aimals at 7 h abraded ski: very slight to slight erythema was observed i all 3 aimals at 4 h, ad slight erythema was still observed at 7 h practically o-irritat; the wk ad maximum WII was 0.06; the week WII was 0 slight erythema was observed i 3 test aimals o day o-sesitizer; stimulatio idex of 0.68, 0.70, ad 0.87 with 5, 50, ad 00% Polyglyceryl-8 Decaerucate/ Decaisostearate/Decaricioleate test system/# per Group itradermal iductio: male albio Duki 5% i arachis oil BP artley guiea pigs; 0 topical iductio: 00% test ad 5 cotrol topical challege: aimals 00%; 75% arachis oil BP the test material was applied daily for 4 days to a cm x cm area of the right flak; paraffi oil was applied to the left flak ad served as the cotrol LLNA; the test material was applied to the dorsal surface of each ear for 3 cosecutive days; all mice were ijected with 3 Td o day 6 eferece 8 80 UMAN Polyglyceryl- Isostearate 7% i ESTL 5 (i.e., 30 subjects isopropyl myristate); 0.4 ml Polyglyceryl-3 Laurate 00%; 50 µl/patch Glyceryl/Polyglyceryl-6 Isostear- 00%; 0.0 g ate/beheate Esters 4 subjects 45 subjects Polyglyceryl-0 Laurate 35 subjects 5% i purified water; 0.03 g Polyglyceryl-0 Myristate 5% i purified water; 0.03 g Polyglyceryl-0 Myristate 0% Polyglyceryl-0 Isostearate 5% i purified water; 0.03 g Polyglyceryl-0 leate 5% i purified water; 0.03 g Polyglyceryl-0 Stearate 0% 60% Polyglyceryl-0 Eicosaedi- udiluted oate/ Tetradecaedioate/40% glyceri mixture 35 subjects 48 subjects 35 subjects 35 subjects 48 subjects 45 subjects Polyglyceryl Mooesters three 4-h occlusive patches, with 4 to 48-h betwee applicatios elicited slight irritatio; sigificatly less irritatig tha the positive cotrol (0.3% sodium lauryl sulfate) ad sigificatly more irritatig tha the egative cotrol (deioized water) (p=0.05) IPT ot a irritat or a sesitizer 4-h occlusive patch test usig Fi chambers applied to the o reactios or 4 h after patch removal upper arm; petrolatum ad 0.5% soap were used as cotrols 4-h occlusive patch applied to the upper arm ot irritatig; o resposes were observed or 4 h after patch removal 4-h occlusive patch applied to the upper arm ot irritatig; o resposes were observed or 4 h after patch removal 48-h occlusive patch test egative 4-h occlusive patch applied to the upper arm ot irritatig; o resposes were observed or 4 h after patch removal 4-h occlusive patch applied to the upper arm ot irritatig; o resposes were observed or 4 h after patch removal 48-h occlusive patch test o-irritatig closed patch test; details ot provided egative

112 Distributed for Commet ly -- Do Not Cite or Quote Table 4. Dermal irritatio ad sesitizatio Test Article Cocetratio/Dose test system/# per Group Polyglyceryl- Sesquiisostearate,,3-propaetriol, homopolymer, diisooctadecaoate ( ot defied; likely Polyglyceryl-3 Diisostearate) Diisostearoyl Polyglyceryl-3 Dimer Dilioleate Triisostearoyl Polyglyceryl-3 Dimer Dilioleate Macadamia Seed il Polyglyceryl-6 Esters Beheate udiluted 50 subjects 0% active substace 0 subjects i cosmetic alcohol ; 70 µl Procedure Polyglyceryl Multi-Esters 4-h semi-occlusive patches 4-h occlusive patches esults eferece ot irritatig ot irritatig slight erythema i 3 ad slight scalig i subjects ot provided o provided occlusive patch test; details ot provided o cocer 48 00%; 50 µl/patch 03 subjects IPT ot a irritat or a sesitizer 56 00%; 0.0 g 45 subjects o reactios or 4 h after patch removal 89 Polyglyceryl-8 Decabeheate/ Caprate 00%; 0.0 g 43 subjects o reactios or 4 h after patch removal 90 Polyglyceryl-0 Decaethylhexaoate 00% 43 subjects 4-h occlusive patch test usig Fi chambers applied to the upper arm; petrolatum ad 0.5% soap were used as cotrols 4-h occlusive patch test usig Fi chambers applied to the upper arm; petrolatum ad 0.5% soap were used as cotrols 4-h occlusive patch test usig Fi chambers applied to the upper arm; purified water served as the cotrol Polyglyceryl-0 Decaethylhexaoate 00%; 5 µl 50 subjects Polyglyceryl-0 Diisostearate 35 subjects Polyglyceryl-0 Petaisostearate Polyglyceryl-0 Petaisostearate 5% i purified water; 0.03 g 50% 00% Polyglyceryl-0 Petaisostearate 00%; 5 µl 5 subjects Polyglyceryl-0 Noaisostearate 0.0 g 35 subjects Polyglyceryl-0 Decaoleate eat 44 Japaese subjects 44 Japaese subjects 43 subjects at h after patch removal, erythema with swellig or with papule was observed at the test ad cotrol site of subject, ad the test site had well-defied erythema at 4 h after patch removal; well-defied erythema was observed i 3 subjects; 3 cotrols also had well-defied erythema iductio: 48-h occlusive patches applied usig 8 mm Fi o-irritatig ad o-sesitizig chambers 3x/wk for 3 wks challege: 48-h occlusive patch was applied followig a wk o-treatmet period 4-h occlusive patch applied to the upper arm ot irritatig; o resposes were observed or 4 h after patch removal 4-h occlusive patch egative 4-h occlusive patch test usig Fi chambers applied to the subject exhibited well-defied erythema at h after patch upper arm; purified water served as the cotrol removal (this subject had erythema with swellig at the cotrol site) iductio: 48-h occlusive patches applied usig 8 mm Fi o-irritatig ad o-sesitizig chambers 3x/wk for 3 wks challege: 48-h occlusive patch was applied followig a wk o-treatmet period 4-h occlusive applicatio to the upper arm usig a Fi egative; o resposes were observed or 4 h after patch chamber removal 4-h occlusive patch egative Abbreviatios: CF Code of Federal egulatios; CPSC Cosumer Product Safety Commissio; FCA Freud s Complete Adjuvat; FSA Federal azardous Substaces Act; GPMT guiea pig maximizatio test; ET-CAM he s egg test chorioallatoic membrae; IPT huma repeated isult patch test; 3Td 3-methyl thymidie; LLNA local lymph ode assay; ME microemulsio; MW molecular weight; ECD rgaisatio for Ecoomic Co-operatio ad Developmet; SDS sodium dodecyl sulfate; SLS sodium lauryl sulfate; TG test guidelie; WII weakly irritatio idices

113 Distributed for Commet ly -- Do Not Cite or Quote Table 5. cular irritatio studies Test Article Cocetratio/Dose #/Aimals/Grp Method esults eferece ALTENATIVE STUDIES Polyglyceryl-3 Laurate 0% i cor oil ME cotaiig 30% Polyglyceryl-4 Laurate 00 µl 6 replicates ME cotaiig 40% Polyglyceryl-4 Laurate 00 µl 6 replicates Apricot Kerel il Polyglyceryl- 0.3 g 4 Esters Palm il Polyglyceryl-4 Esters 0.3 g Polyglyceryl Mooesters EpicularTM tissue model classified as o-irritatig ET50 was >56 mi ET-CAM assay; the test article also cotaied or o-irritat % lioleic acid, 4 or 5% isopropyl palmitate, ad 65% water-,-petaediol (:9) or 63 or 65% water-,-petaediol (.5:8.5) ET-CAM; this test article also cotaied % o-irritat lioleic acid, 5% isopropyl palmitate, 53% water,-petaediol (:9) ET-CAM; CAM was rised with 5 ml practically o-irritatig physiological salie after 40 s of cotact ET-CAM; CAM was rised with 5 ml practically o-irritatig physiological salie after 40 s of cotact SkiEthicTM recostituted CE model; protocol as cosidered to be o-irritat described previously relative mea viability was 85.9% SkiEthicTM recostituted CE model; protocol as cosidered to be o-irritat described previously relative mea viability was 70.0% SkiEthicTM recostituted CE model; protocol as cosidered to be o-irritat described previously relative mea viability was 88.4% EET; test material was applied oto the corea cosidered ulikely to cause severe ocular irritatio i 0.9% salie was applied to cotrols vivo SIC- o-irritat Polyglyceryl-6 Caprylate/Caprate Polyglyceryl-0 Laurate 30 µl Polyglyceryl-0 Myristate 000 mg/l (max) Polyglceryl-0 Myristate 0. ml Polyglyceryl-0 Isostearate 0. ml Polyglyceryl-0 Stearate 000 mg/l (max) 60% Polyglyceryl-0 Eicosaedioate/ Tetradecaedioate/40% glyceri mixture udiluted # of replicates ot stated # of replicates ot stated huma coreal epithelial cells huma coreal epithelial cells huma coreal epithelial cells 3 rabbit eucleated eyes rabbit coreal epithelial cells 3 rabbit eucleated eyes 3 rabbit eucleated eyes rabbit coreal epithelial cells Polyglyceryl- Dioleate udiluted; 300 µl 6 eggs Polyglyceryl Multi-Esters ET-CAM assay Diisostearoyl Polyglyceryl-3 Dimer Dilioleate Triisostearoyl Polyglyceryl-3 Dimer Dilioleate Polyglyceryl-0 Decaethylhexaoate Polyglyceryl-0 Diisostearate ot stated ot stated ET-CAM assay 0% i cor oil -- EpicularTM tissue model udiluted; 00 µl huma-derived epidermal keratiocytes rabbit coreal epithelial cells huma-derived epidermal keratiocytes Polyglyceryl-4 Laurate/Sebacate 30 µl Polyglyceryl-4 Laurate/Succiate 30 µl 0. ml 000 mg/l (max) Polyglyceryl-0 Petaisostearate udiluted; 00 µl EET; test material was applied oto the corea 0.9% salie was applied to cotrols EET; test material was applied oto the corea 0.9% salie was applied to cotrols SIC- cosidered ulikely to cause severe ocular irritatio i vivo cosidered ulikely to cause severe ocular irritatio i vivo o-irritat 04 EpicularTM test o-irritat 88 classified as o-irritatig Q-score <. (up to 300 s) mior irritatio EpicularTM tissue model distilled water served as a egative cotrol SIC- classified as o-irritatig ET50 was >56 mi classified as o-irritatig ET50 was >56 mi o-irritat EpicularTM tissue model distilled water served as a egative cotrol classified as o-irritatig ET50 was >56 mi

114 Distributed for Commet ly -- Do Not Cite or Quote Table 5. cular irritatio studies Test Article Cocetratio/Dose #/Aimals/Grp Method esults eferece ANIMAL Polyglyceryl Mooesters ECD 405 (acute eye irritatio/corrosio) ECD 405 (acute eye irritatio/corrosio) Polyglyceryl-3 Caprate a polyglyceryl moo/diester of capric acid (C0) (provided as read-across for Polyglyceryl-3 Caprylate) Polyglyceryl-3 Isostearate Polyglyceryl-3 leate Polyglyceryl-4 Caprate Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters ot provided ot provided rabbits; # ot stated rabbits; # ot stated ot provided ot provided ot provided udiluted; 0. ml rabbits;# ot stated rabbits;# ot stated rabbits; # ot stated 3 NZW rabbits FSA/CPSC 6 CF FSA/CPSC 6 CF ECD 405 (acute eye irritatio/corrosio) sigle istillatio ito the cojuctival sac of the right eye, ad the eyes were ot rised; the cotralateral eye served as a cotrol Polyglyceryl-0 Laurate udiluted; 0.ml 3 NZW rabbits i accordace with ECD 405 test guidelie eyes were ot rised Polyglyceryl-0 Myristate udiluted; 0.ml 3 NZW rabbits i accordace with ECD 405 test guidelie eyes were ot rised Polyglyceryl-0 Isostearate udiluted; 0.ml 3 NZW rabbits ECD 405 test guidelie eyes were ot rised Polyglyceryl- Diisostearate udiluted, 0. ml 3 NZW rabbits Polyglyceryl- Diisostearate udiluted, 0. ml 6 NZW rabbits Polyglyceryl- Diisostearate 0. ad 0% i salie ad udiluted; 0. ml eyes were rised after 4 h Polyglyceryl- Dioleate Polyglyceryl-3 Diisostearate udiluted ot stated; assumed to be udiluted AlbioimalayaKaiche rabbits/gp 3 rabbits 3 New Zealad albio rabbits 4 male Kleirusse rabbits eyes were ot rised 3 NZW rabbits sigle istillatio ito the cojuctival sac of the right eye, ad the eyes were ot rised; the cotralateral eye served as a cotrol,,3-propaetriol, homopolyudiluted; 0. ml mer, diisooctadecaoate ( ot defied most likely Polyglyceryl3 Diisostearate) Macadamia Seed il udiluted; 0. ml Polyglyceryl-6 Esters Beheate Polyglyceryl Multi-Esters i accordace with ECD test guidelie 405 eyes were rised after 4 h ad at all exams risig ot specified risig ot specified i accordace with ECD test guidelie 405 ot irritatig ot irritatig 40 mildly irritatig mildly irritatig ot irritatig miimal irritat; maximum group mea score of.7 miimal cojuctival irritatio was observed i all treated eyes h after istillatio; eyes were ormal after 4 h, ad all 3 were ormal at 48 h miimal irritat; maximum group mea score of 0.7/0 (at h); moderate cojuctival irritatio observed after h ad miimal cojuctival irritatio at 4 h was completely reversible by 48 h miimal irritat; maximum group mea score of 0.0/0 (at h); moderate cojuctival irritatio observed after h ad miimal cojuctival irritatio at 4 h was completely reversible by 48 h miimal irritat; maximum group mea score of 8.0/0 (at h); moderate cojuctival irritatio observed after h was completely reversible by 48 h ot irritatig; some observatios were made at 4 h, but were fully reversible at 48 h ot a primary eye irritat; at 4 h, 4 aimals had ijected vessels ad had swellig; at 48 h, aimals had erythema ad had swellig; o effects were see at 7 h some ocular effects, icludig reddeig were observed at all cocetratios tested, but the results were ot quatified 38 ot irritatig; o sigs of irritatio were observed o-irritatig; at h i aimals, chemosis (score of ) ad redess (score of ) were reported; at 7 h, chemosis was completely resolved ad the redess score was ot irritatig; at 4 h, very slight redess of the cojuctivae was observed i aimal, ad the effect was reversible withi 48 h 46 miimal irritat; maximum group mea score of 3.3 miimal cojuctival irritatio was observed i all treated eyes h after istillatio; all eyes were ormal after 4 h

115 Distributed for Commet ly -- Do Not Cite or Quote Table 5. cular irritatio studies Test Article Cocetratio/Dose Polyglyceryl-8 Decabeheate/ udiluted; 0. ml Caprate #/Aimals/Grp 3 NZW rabbits Method sigle istillatio ito the cojuctival sac of the right eye, ad the eyes were ot rised; the cotralateral eye served as a cotrol Polyglyceryl-8 Decaerucate/ udiluted; 0. ml Decaisostearate/Decaricioleate 3 NZW rabbits sigle istillatio ito the cojuctival sac of the right eye, ad the eyes were ot rised; the cotralateral eye served as a cotrol Polyglyceryl-0 Noaisostearate udiluted; 0. ml 3 NZW rabbits i accordace with ECD 405 test guidelie eyes were ot rised Polyglyceryl-0 Laurate (~60% ot provided pure, with ~40% polyglyceri-0 ad ~% sodium laurate) ot provided UMAN Polyglyceryl Mooesters ot provided esults miimal irritat; maximum group mea score of 3.0 moderate cojuctival irritatio was observed i all treated eyes at h ad miimal cojuctival irritatio i all treated eyes at 4 h after istillatio; all eyes were ormal after 48 h mild irritat; maximum group mea score of 0.0 moderate cojuctival irritatio was observed i all treated eyes h after istillatio; miimal cojuctival irritatio was observed i all treated eyes at 4 h ad i eye at 48 h after istillatio mild irritat; maximum group mea score of 6.7/0 (at h); miimal to moderate cojuctival irritatio was completely reversible by 48 h ( aimals) to 7 h possibly slightly irritatig to the eyes eferece 0 0 Abbreviatios: CE huma coreal epithelium; ET-CAM - e's Egg Test Chorioallatoic Membrae; ME microemulsio; eutral red; NZW New Zealad White; ECD rgaisatio for Ecoomic Co-operatio ad Developmet; EET rabbit eucleated eye test; SIC States Serumistitut rabbit corea cells

116 Distributed for Commet ly -- Do Not Cite or Quote EFEENCES. Nikitakis J ad Breslawec P. Iteratioal Cosmetic Igrediet Dictioary ad adbook. 5 ed. Washigto, DC: Persoal Care Products Coucil, 04.. Johso Jr W, eldreth B, Bergfeld WF, Belsito DV, Klaasse CD, ill A, Liebler DC, Marks Jr JG, Shak C, Slaga TJ, Syder PW, ad Aderse FA. Fial eport of the Cosmetic Igrediet eview Expert Pael o the Safety Assessmet of Pelargoic Acid (Noaoic Acid) ad Noaoate Esters. It J Toxicol. 0;30(Suppl 3):8S-69S Fiume MM, eldreth BA, Bergfeld WF, Belsito DV, ill A, Klaasse CD, Liebler DC, Marks Jr JG, Shak C, Slaga TJ, Syder PW, ad Gill LJ. 05. Fial Ameded eport of the Safety Assessmet of Mooglyceryl Mooesters as Used i Cosmetics. Available o the Cosmetic Igrediet eview website. 4. Europea Chemical Agecy (ECA). Iformatio o Chemicals. Last Updated 05. Date Accessed Nor V. Polyglycerol esters. Emulsifiers Food Techol CAPLUS AN 004:07707(Coferece; Geeral eview). 6. Dürr-Auster N. Doctor of Scieces. Formatio ad stability of a liquid foam prepared from a lamellar surfactat dispersio Switzerlad: Swiss Federal Istitute of Techology Zurich. ET Dissertatio Number Accessed asehuettl GL. Sythesis ad Commercial Preparatio of Food Emulsifiers. Chapter:. asehuettl GL ad artel W. I: Food Emulsifiers ad Their Applicatios. New York: Spriger; 008: Food ad Agriculture rgaizatio (FA) of the Uited Natios. Polyglycerol Esters of Fatty Acids. Last Updated 006. Date Accessed Food ad Drug Admiistratio (FDA). Frequecy of use of cosmetic igrediets. FDA Database Persoal Care Products Coucil Cocetratio of Use by FDA Product Category: Glyceryl Mooesters. Upublished data submitted by Persoal Care Products Coucil.. Persoal Care Products Coucil Cocetratio of Use by FDA Product Category: Polyglyceryl Esters. Upublished data submitted by Persoal Care Products Coucil. pages.. Persoal Care Products Coucil Cocetratio of Use by FDA Product Category: Polyglyceryl Compouds icluded i the February 05 Survey. Upublished data submitted by Persoal Care Products Coucil. 3. Persoal Care Products Coucil. 05. Cocetratio of use iformatio: polyglyceryl-0 hydroxystearate/stearate/eicosodioate. Upublished data submitted by the Persoal Care Products Coucil. 4. Persoal Care Products Coucil Cocetratio of Use by FDA Product Category: Caprylic/Capric Glycerides Polyglyceryl-0 Esters ad Pumpki Seed il Polyglyceryl-4 Esters Succiate. Upublished data submitted by Persoal Care Products Coucil. 5. Johse MA. The ifluece of particle size. Spray Techology ad Marketig. 004;4(): othe. Special Aspects of Cosmetic Spray Evalulatio Upublished data preseted at the 6 September CI Expert Pael meetig. Washigto, D.C. 7. Bremmer J, Prud'homme de Lodder LC, ad Egele JGM. Cosmetics Fact Sheet: To assess the risks for the cosumer; Updated versio for CosExpo eport No. IVM /006. pp othe, Fautz, Gerber E, Neuma L, ettiger K, Schuh W, ad Groewold C. Special aspects of cosmetic spray safety evaluatios: Priciples o ihalatio risk assessmet. Toxicol Lett. 0;05():97-04.

117 Distributed for Commet ly -- Do Not Cite or Quote 9. Europea Commissio. CosIg database; followig Cosmetic egulatio No. 3/ Last Updated 05. Date Accessed Natioal INdustrial Chemicals Notificatio ad Assessmet Scheme (NICNAS). File No. STD/453. Public report:,,3propaetriol, homopolymer, dodecaoate (CAS No ) data/assets/word_doc/0003/6096/std453-f-final.docx. Date Accessed eport No. File No: STD/453.. World ealth rgaizatio (W). Evaluatio of certai food additives ad cotamiats. Thirty-fifth report of the Joit FA/W Expert Committe o Food Additives. W Techical eport Series (TS) Last Updated 990. Date Accessed Food ad Agriculture rgaizatio (FA) of the Uited Natios. Polyglycerol esters of iteresterified ricioleic acid. Last Updated 000. Date Accessed Europea Food Safety Authority (EFSA) Pael o Food Cotact Materials, Ezymes, Flavourigs ad Processig Aids (CEF Pael). Scietific piio o the safety assessmet of the substace, polyglycerol, CAS No , for use i food cotact materials. EFSA Joural. 05;(0): Loza. Product data sheet: Polyaldo 0- CC KFG (Polyglyceryl-0 Caprylate/Caprate). Last Updated 00. Date Accessed ChemicalBook. Polyglyceryl-0 leate. Last Updated 00. Date Accessed Food ad Drug Admiistratio (FDA). Iactive Igrediet Search for Approved Drug Products. Last Updated Date Accessed Corwell PA, Tubek J, va Gompel AP, Little CJ, ad Wiechers JW. Glyceryl moocaprylate/caprate as a moderate ski peetratio ehacer. Iteratioal Joural of Pharmaceutics. 998;7(): Gattefossé. Plurol leique CC 497 (Polyglyceryl-3 Dioleate). Last Updated 00. Date Accessed Sahle FF, Metz, Wohlrab J, ad Neubert. Polyglycerol fatty acid ester surfactat-based microemulsios for targeted delivery of ceramide AP ito the stratum coreum: formulatio, characterisatio, i vitro release ad peetratio ivestigatio. Eur J Pharm Biopharm. 0;8(): Sahle FF, Wohlrab J, ad Neubert. Cotrolled peetratio of ceramides ito ad across the stratum coreum usig various types of microemulsios ad formulatio associated toxicity studies. Eur J Pharm Biopharm. 04;86(): Edo M, Yamamoto T, ad IjuiT. Effect of oioic surfactats o the percutaeous absorptio teoxicam. Chem Pharm Bull (Tokyo). 996;44(4): World ealth rgaizatio (W). Toxicological evaluatio of some atimicrobials, atioxidats, emulsifiers, stablizers, flourtreamet agets, acids ad bases. Polyglycerol esters of fatty acids Date Accessed eport No. eport Series No. 40A, B, C; W/Food Add./ Bodasky M, errma CL, ad Campbell K. CCLI. Utliizatio of polyglycerol esters. Biochem J. 938;3(): Babaya VK, Kauitz, ad Slaetz CA. Nutritioal studies of polyglycerol esters. Joural of the America il Chemists' Society. 964;4(6): World ealth rgaizatio (W). Toxicological evaluatio of some food additives icludig aticakig agets, atimicrobials, atioxidats, emulsifiers ad thickeig agets. Polyglycerol esters of fatty acids Date Accessed eport No. W Food Additives Series No Michael W ad Coots. Metabolism of polyglycerol ad polyglycerol esters. Toxicol Appl Pharmacol. 97;0(3):

118 Distributed for Commet ly -- Do Not Cite or Quote 37. Kig W, Michael W, ad Coots. Subacute oral toxicity of polyglycerol ester. Toxicol Appl Pharmacol. 97;0(3): Europea Chemicals Agecy (ECA). Di(isooctadecaoic) acid, diester with oxydi(propaediol) (CAS No ). Last Updated Date Accessed Europea Chemicals Agecy (ECA).,,3-Propaetriol, homopolymer, diisooctadecaoate (CAS No ). Last Updated 04. Date Accessed Aoymous. 06. Polyglyceryl-3 Caprate: Summary of product data with referece to toxicology. Upublished data submitted by Persoal Care Products Coucil. 4. Aoymous. 06. Polyglyceryl-3 Caprylate: Summary of product data with referece to toxicology. Upublished data submitted by Persoal Care Products Coucil. 4. Aoymous. 06. Polyglyceryl-3 Isostearate: Summary of product data with referece to toxicology. Upublished data submitted by Persoal Care Products Coucil. 43. Aoymous. 06. Polyglyceryl-3 leate: Summary of product data with referece to toxicology. Upublished data submitted by Persoal Care Products Coucil. 44. Aoymous. 06. Polyglyceryl-4 Caprate: Summary of product data with referece to toxicology. Upublished data submitted by Persoal Care Products Coucil. 45. SafePharm Laboratories Acute oral toxicity i the rat - acute toxic class method (Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters). Upublished data submitted by Persoal Care Products Coucil. 46. Europea Chemicals Agecy (ECA). leic acid, mooester with oxybis(propaediol (CAS No ). Last Updated 03. Date Accessed Aoymous. 06. Summary iformatio Palm il Polyglyceryl-4 Esters, Apricot Kerel il Polyglyceryl-4 Esters ad Polyglyceryl-3 Diisostearate. Upublished data submitted by Persoal Care Products Coucil. 48. Aoymous. 06. Diisostearoyl Polyglyceryl-3 Dimer Dilioleate: Summary of product data with referece to toxicology. Upublished data submitted by Persoal Care Products Coucil. 49. Lubrizol. Toxicology & Microbiology Studies (T-04): Schercemol PTID Ester( Triisostearoyl Polyglyceryl-3 Dimer Dilioleate). Last Updated 007. Date Accessed Lubrizol Advaced Materials Schercemol PDD Ester (Diisostearoyl Polyglyceryl-3 Dimer Dilioleate) toxicology studies. Upublished data submitted by Persoal Care Products Coucil. 5. SafePharm Laboratories Acute oral toxicity i the rat - acute toxic class method Macadamia Seed il Polyglyceryl-6 Esters Beheate. Upublished data submitted by Persoal Care Products Coucil. 5. SafePharm Laboratories Acute oral toxicity i the rat- acute toxic class method (Polyglyceryl-8 Decabeheate/Caprate). Upublished data submitted by Persoal Care Products Coucil. 53. SafePharm Laboratories Acute oral toxicity i the rat- acute toxic class method (Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate). Upublished data submitted by Persoal Care Products Coucil. 54. SafePharm Laboratories Acute oral toxicity i the rat - acute toxic class method (Polyglyceryl-0 Noaisostearate ). Upublished data submitted by Persoal Care Products Coucil. 55. Baichwal M ad Lalla JK. Polyglycerol esters. III. Stability, toxicity, ad compatibility of polyglycerol stearate with pharmaceutical adjuvats. Idia Joural of Pharmacy. 973;35(5): Lubrizol Advaced Materials. 06. Summary iformatio polyglyceryl fatty acid esters. Upublished data submitted by Persoal Care Products Coucil.

119 Distributed for Commet ly -- Do Not Cite or Quote 57. arla Laboratories, Ltd. 00. Summary: everse mutatio assay "Ames test" usig Salmoella typhimurium ad Escherichia coli (Polyglyceryl-4 Laurate/Succiate). Project No. 400/367. Upublished data submitted by Persoal Care Products Coucil. 58. SafePharm Laboratories everse mutatio assay "Ames test" usig Salmoella typhimurium ad Escherichia coli (Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters). Upublished data submitted by Persoal Care Products Coucil. 59. arla Laboratories, Ltd. 00. Summary: everse mutatio assay "Ames test" usig Salmoella typhimurium ad Escherichia coli (Polyglyceryl-6 Caprylate/Caprate). Project No Upublished data submitted by Persoal Care Products Coucil. 60. SafePharm Laboratories everse mutatio assay "Ames test" usig Salmoella typhimurium ad Escherichia coli (Macadamia Seed il Polyglyceryl-6 Esters Beheate). Upublished data submitted by Persoal Care Products Coucil. 6. SafePharm Laboratories everse mutatio assy "Ames test" usig Salmoella typhimurium ad Escherichia coli (Polyglyceryl-8 Decabeheate/Caprate). Upublished data submitted by Persoal Care Products Coucil. 6. SafePharm Laboratories everse mutatio assay "Ames test" usig Salmoella typhimurium ad Escherichia coli (Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate). Upublished data submitted by Persoal Care Products Coucil. 63. CiTox LAB ugary Ltd. 0. The testig of Polyglyceryl-0 Decaethylhexaoate with bacterial reverse mutatio assay. Upublished data submitted by Persoal Care Products Coucil. 64. CiTox LAB ugary Ltd. 0. The testig of Polyglyceryl-0 Petaisostearate with bacterial reverse mutatio assay. Upublished data submitted by Persoal Care Products Coucil. 65. SafePharm Laboratories everse mutatio assay "Ames test" usig Salmoella typhimurium ad Escherichia coli (Polyglyceryl-0 Noaisostearate ). Upublished data submitted by Persoal Care Products Coucil. 66. arla Laboratories, Ltd. Summary: Determiatio of ski irritatio potetial usig the Episki recostituted huma epidermis model (Polyglyceryl-4 Laurate/Sebacate). Project No. 74/ Upublished data submitted by Persoal Care Products Coucil. 67. arla Laboratories, Ltd. 00. Summary: Determiatio of ski irritatio potetial usig the Episki recostituted huma epidermis model (Polyglyceryl-4 Laurate/Succiate). Project No. 74/0055. Upublished data submitted by Persoal Care Products Coucil. 68. arla Laboratories, Ltd. 00. Summary: Determiatio of ski irritatio potetial usig the Episki recostituted huma epidermis model (Polyglyceryl-6 Caprylate/Caprate). Project No. 74/0057. Upublished data submitted by Persoal Care Products Coucil. 69. esearch Istitute for rgaic Sytheses Ic. 0. I vitro ski irritatio test (EpiDerm Model) (Polyglyceryl-0 Decaethylhexaoate ). Upublished data submitted by Persoal Care Products Coucil. 70. esearch Istitute for rgaic Sytheses Ic. 0. I vitro ski irritatio test (EpiDerm Model) (Polyglyceryl-0 Petaisostearate ). Upublished data submitted by Persoal Care Products Coucil. 7. Notox BV. Primary ski irritatio/corrosio study with Polyglyeryl- Isostearate i the rabbit eport No. NT Project Upublished data submitted by Persoal Care Products Coucil. 7. SafePharm Laboratories Acute dermal irritatio i the rabbit (Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters). Upublished data submitted by Persoal Care Products Coucil. 73. Phycher Ski sesitizatio i the guiea pig- Magusso ad Kligma maximisatio method (Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters). Upublished data submitted by Persoal Care Products Coucil. 74. SafePharm Laboratories Acute dermal irritatio i the rabbit (Macadamia Seed il Polyglyceryl-6 Esters Beheate ). Upublished data submitted by Persoal Care Products Coucil. 75. Phycher Ski sesitizatio i the guiea pig- Magusso ad Kligma maximisatio method (Macadamia Seed il Polyglyceryl-6 Esters Beheate ). Upublished data submitted by Persoal Care Products Coucil.

120 Distributed for Commet ly -- Do Not Cite or Quote 76. SafePharm Laboratories Acute dermal irritatio i the rabbit (Polyglyceryl-8 Decabeheate/Caprate). Upublished data submitted by Persoal Care Products Coucil. 77. Phycher Ski seistizatio i the guiea pig - Magusso ad Kligma maximisatio method (Polyglyceryl-8 Decabeheate/Caprate ). Upublished data submitted by Persoal Care Products Coucil. 78. SafePharm Laboratories Acute dermal irritatio i the rabbit (Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate). Upublished data submitted by Persoal Care Products Coucil. 79. SafePharm Laboratories Ski seistizatio i the guiea pig - Magusso ad Kligma maximisatio method (Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate). Upublished data submitted by Persoal Care Products Coucil. 80. SafePharm Laboratories Local lymph ode assay i the mouse (Polyglyceryl-0 Noaisostearate). Upublished data submitted by Persoal Care Products Coucil. 8. Life Sciece Laboratories Ltd Primary ski irritatio study of S-Face IS-I009P (Polyglyceryl-0 Noaisostearate) i rabbits. Upublished data submitted by Persoal Care Products Coucil. 8. Phycher Assessmet of cotact phototoxicity o the albio guiea pig (Polyglyceryl-0 Noaisostearate). Upublished data submitted by Persoal Care Products Coucil. 83. Globecrow Services Ltd. A three-applicatio patch trial i healthy voluteers to ivestigate the ski irritatio potetial of Polyglyceryl- Isostearate followig cutaeous patch applicatios. Globecrow eport No. 97/UNCPAT Upublished data submitted by Persoal Care Products Coucil. 84. Japa air Sciece Associatio Patch test o the cosmetic igrediet Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters. Upublished data submitted by Persoal Care Products Coucil. 85. Japa air Sciece Associatio. 00. Test for irritatio effects of the cosmetic igrediet o huma ski: Polyglycery-0 Isostearate, Polyglyceryl-0 Diisostearate, Polyglycery-0 Laurate, Polyglycery-0 Myristate ad Polyglyceryl-0 leate. Upublished data submitted by Persoal Care Products Coucil. 86. Nikko Chemicals Co. Ltd. 06. Safety iformatio NIKKL Decagly -M (Polyglyceryl-0 Myristate). Upublished data submitted by Persoal Care Products Coucil. 87. Nikko Chemicals Co. Ltd. 06. Safety iformatio NIKKL Decagly -SV (Polyglyceryl-0 Stearate). Upublished data submitted by Persoal Care Products Coucil. 88. Aoymous Material safety data sheet o a trade ame mixture cotaiig 60% Polyglyceryl-0 Eicosaedioate/Tetradecaedioate. Upublished data submitted by Persoal Care Products Coucil. 89. Japa air Sciece Associatio. 00. Patch test o the cosmetic igrediet (Macadamia Seed il Polyglyceryl-6 Esters Beheate). Upublished data submitted by Persoal Care Products Coucil. 90. Japa air Sciece Associatio Test for irritatio effects of cosmetic igrediet o huma ski (Polyglyceryl-8 Decabeheate/Caprate). Upublished data submitted by Persoal Care Products Coucil. 9. Japa air Sciece Associatio. 0. Patch test o the cosmetic igrediet (Polyglyceryl-0 Decaethylhexaoate). Upublished data submitted by Persoal Care Products Coucil. 9. Dermsca Asia. 0. Assessmet of the sesitizig potetial of a cosmetic product: fial cliical safety test uder dermatological cotrol (Polyglyceryl-0 Decaethylhexaoate). Upublished data submitted by Persoal Care Products Coucil. 93. Japa air Sciece Associatio. 0. Patch test o the cosmetic igrediet (Polyglyceryl-0 Petaisostearate). Upublished data submitted by Persoal Care Products Coucil. 94. Dermsca Asia. 0. Assessmet of the sesitizig potetial of a cosmetic product: fial cliical safety test uder dermatological cotrol (Polyglyceryl-0 Petaisostearate ). Upublished data submitted by Persoal Care Products Coucil.

121 Distributed for Commet ly -- Do Not Cite or Quote 95. Japa air Sciece Associatio A study report "Patch test o a cosmetic igrediet" (Polyglyceryl-0 Noaisostearate). Upublished data submitted by Persoal Care Products Coucil. 96. Nikko Chemicals Co. Ltd. 06. Safety iformatio NIKKL Decagly 5-IS (Polyglyceryl-0 Petaisostearate). Upublished data submitted by Persoal Care Products Coucil. 97. Nikko Chemicals Co. Ltd. 06. Safety iformatio NIKKL Decagly 0- (Polyglyceryl-0 Decaoleate). Upublished data submitted by Persoal Care Products Coucil. 98. Phycher Assessmet of photosesitizatio o the albio guiea pig (Polyglyceryl-0 Noaisostearate). Fial report: PAC-P-06/0083; SPL project 043/009. Upublished data submitted by Persoal Care Products Coucil. 99. Lubrizol. Toxicology studies (T-094): ydramol TGL Ester (Polyglyceryl-3 Laurate). Last Updated 007. Date Accessed arla Laboratories, Ltd. 00. Summary: Assessmet of ocular irritatio potetial usig the Skiethic recocsituted huma coreal epithelium model (Polyglyceryl-4 Laurate/Sebacate). Project No. 74/0059. Upublished data submitted by Persoal Care Products Coucil. 0. arla Laboratories, Ltd. 00. Summary: Assessmet of ocular irritatio potetial usig the Skiethic recostituted huma coreal epithelium model (Polyglyceryl-4 Laurate/Succiate). Project No. 74/0058. Upublished data submitted by Persoal Care Products Coucil. 0. arla Laboratories, Ltd. 00. Summary: Assessmet of ocular irritatio potetial usig the Skiethic recosituted huma coreal epithelium model (Polyglyceryl-6 Caprylate/Caprate). Project o. 74/0060. Upublished data submitted by Persoal Care Products Coucil. 03. SafePharm Laboratories Acute eye irritatio i the rabbit: Polyglyceryl-0 Laurate. Upublished data submitted by Persoal Care Products Coucil. 04. SafePharm Laboratories Acute eye irritatio i the rabbit: Polyglyceryl-0 Myristate. Upublished data submitted by Persoal Care Products Coucil. 05. Cosumer Product Testig Co. 0. The MatTek Corporatio Epiocular tissue model i vitro toxicity testig system (Polyglyceryl-0 Decaethylhexaoate). Upublished data submitted by Persoal Care Products Coucil. 06. Nikko Chemicals Co. Ltd. 06. Safety iformatio NIKKL Decagly -ISV (Polyglyceryl-0 Diisostearate). Upublished data submitted by Persoal Care Products Coucil. 07. Cosumer Product Testig Co. 0. The MatTek Corporatio Epicular tissue model i vitro toxicity testig system (Polyglyceryl-0 Petaisostearate). Upublished data submitted by Persoal Care Products Coucil. 08. SafePharm Laboratories Acute eye irritatio i the rabbit Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters). Upublished data submitted by Persoal Care Products Coucil. 09. SafePharm Laboratories Acute eye irritatio i the rabbit (Macadamia Seed il Polyglyceryl-6 Esters Beheate ). Upublished data submitted by Persoal Care Products Coucil. 0. SafePharm Laboratories Acute eye irritatio i the rabbit (Polyglyceryl-8 Decabeheate/Caprate). Upublished data submitted by Persoal Care Products Coucil.. SafePharm Laboratories Acute eye irritatio i the rabbit (Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate). Upublished data submitted by Persoal Care Products Coucil.. SafePharm Laboratories Acute eye irritatio i the rabbit (Polyglyceryl-0 Noaisostearate). Upublished data submitted by Persoal Care Products Coucil. 3. Washizaki K, Kato, Yazaki S, ad Ito M. A case of allergic cotact dermatitis to polyglyceryl laurate. Cotact Dermatitis. 008;58(3): SafePharm Laboratories Acute eye irritatio i the rabbit: Polyglyceryl-0 lsostearate. Upublished data submitted by Persoal Care Products Coucil.

122 Distributed for Commet ly -- Do Not Cite or Quote 5. Becker LC, Bergfeld WF, Belsito DV, ill A, Klaasse CD, Liebler DC, Marks JG Jr, Shak C, Slaga TJ, Syder PW, ad Gill LJ. Safety assessmet of glyceri as used i cosmetics Date Accessed Available o the CI website. 6. Elder L (ed). Fial eprt o the Safety Assessmet of Butylee Glycol, exylee Glycol, Ethoxydiglycol, ad Dipropylee Glycol. J Am Coll Toxicol. 985;4(5): Aderse FA (ed). Aual eview of Cosmetic Igrediet Safety Assessmets - 004/005. It J Toxicol. 006;5(Suppl ): Fiume MM, eldreth BA, Bergfeld WF, Belsito DV, ill A, Klaasse CD, Liebler DC, Marks JG Jr, Shak C, Slaga TJ, Syder PW, ad Aderse FA. Safety Assessmet of Propylee Glycol, Tripropylee Glycol, ad PPGs as Used i Cosmetics. It J Toxicol. 0;3(Suppl ):45S-60S. 9. Johso WJ Jr, eldreth BA, Bergfeld WF, Belsito DV, ill A, Klaasse CD, Liebler DC, Marks JG Jr, Shak C, Slaga TJ, Syder PW, ad Gill LJ. 05. Fial eport o the Safety Assessmet of Polysaccharide Gums as Used i Cosmetics. Available o the CI website. 0. Becker LC, Bergfeld WF, Belsito DV, ill A, Klaasse CD, Marks JG Jr, Shak C, Slaga TJ, Syder PW, ad Aderse FA. Fial eport o the Ameded Safety Assessmet of Myrisitic Acid ad Its Salts ad Esters as Used i Cosmetics. It J Toxicol. 00;9(Suppl 3):6S-86S.. Fiume MM, eldreth BA, Bergfeld WF, Belsito DV, ill A, Klaasse CD, Liebler DC, Marks JG Jr, Shak C, Slaga TJ, Syder PW, ad Aderse FA. Safety assessmet of citric acid, iorgaic citrate salts, ad alkyl citrate esters as used i cosmetics. It J Toxicol. 04;33(Suppl ):6S-46S. Burett CL, Bergfeld WF, Belsito DV, Klaasse CD, Marks JG Jr, Shak C, Slaga TJ, Syder PW, ad Aderse FA. Fial report o the safety assessmet of Cocos ucifera (cocout) oil ad related igrediets. It J Toxicol. 0;30(Suppl ):5S-6S Aderse FA (ed). Ameded fial report o the safety assessmet of hydroxystearic acid. It J Toxicol. 999;8(Suppl ): Elder L (ed). Fial report o the safety assessmet of isostearic acid. J Am Coll Toxicol. 983;(7): Elder L (ed). Fial report o the safety assessmet of oleic acid, lauric acid, palmitic acid. myristic acid, ad stearic acid. J Am Coll Toxicol. 987;6(3): Burett CL, Fiume MM, Bergfeld WF, Belsito DV, ill A, Klaasse CD, Liebler DC, Marks JG Jr, Shak C, Slaga TJ, Syder PW, ad Aderse FA. 0. Fial report o the safety assessemet of plat-derived fatty acid oils as used i cosmetics. Available o the CI website. 7. Aderse FA (ed). Fial eport o the Safety Assessmet of icius Commuis (Castor) Seed il, ydrogeated Castor il, Glyceryl icioleate, Glyceryl icioleate SE, icioleic Acid, Potassium icioleate, Sodium icioleate, Zic icioleate, Cetyl icioleate, Ethyl icioleate, Glycol icioleate, Isopropyl icioleate, Methyl icioleate, ad ctyldodecyl icioleate. It J Toxicol. 007;6(Suppl 3): Fiume MM, eldreth BA, Bergfeld WF, Belsito DV, ill A, Klaasse CD, Liebler DC, Marks JG Jr, Shak C, Slaga TJ, Syder PW, ad Aderse FA. Fial report of the Cosmetic Igrediet eview Expert Pael o the safety assessmet of dicarboxylic acids, salts, ad esters. It J Toxicol. 0;3(Suppl ):5S-76S Elder L (ed). Fial eport of the Safety Assessmet of Lithium Stearate, Alumium Distearate, Alumium Stearate, Alumium Tristearate, Ammoium Stearate, Calcium Stearate, Magesium Stearate, Potassium Stearate, Sodium Stearate, ad Zic Stearate. J Am Coll Toxicol. 06;(): Aderse FA (ed). Aual eview of Cosmetic Igrediet Safety Assessmets - 00/00. It J Toxicol. 003;(Suppl ): Elder L (ed). Fial eport o the safety assessmet of Cadelilla Wax, Carauba Wax, Japa Wax, ad Beeswax. J Am Coll Toxicol. 984;3(3):-4.

123 Distributed for Commet ly -- Do Not Cite or Quote 3. Aderse FA (ed). Aual eview of Cosmetic Igrediet Safety Assessmets - 00/003. It J Toxicol. 005;4(Suppl ): Aderse FA (ed). Ameded Fial eport o the Safety Assessmet of ryza Sativa (ice) Bra il, ryza Sativa (ice) Germ il, ice Bra Acid, ryza Sativa (ice) Bra Wax, ydrogeated ice Bra Wax, ryza Sativa (ice) Bra Extract, ryza Sativa (ice) Extract, ryza Sativa (ice) Germ Powder, ryza Sativa (ice) Starch, ryza Sativa (ice) Bra, ydrolyzed ice Bra Extract, ydrolyzed ice Bra Protei, ydrolyzed ice Extract, ad ydrolyzed ice Protei. It J Toxicol. 006;5(Suppl ): Becker LC, Bergfeld WF, Belsito DV, Klaasse CD, Marks JG Jr, Shak C, Slaga TJ, Syder PW, ad Aderse FA Safety Assessmet of Simmodsia Chiesis (Jojoba) Seed il, Simmodsia Chiesis (Jojoba) Seed Wax, ydrogeated Jojoba il, ydrolyzed Jojoba Esters, Isomerized Jojoba il, Jojoba Esters, Simmodsia Chiesis (Jojoba) Butter, Jojoba Alcohol, ad Sythetic Jojoba il. Available o the Cosmetic Igrediet eview website. 35. Aldivia. Techical Data Sheet: VIATENZA Baobab P6 (Adasoia Digitata Seed il Polyglyceryl-6 Esters). Last Updated 008. Date Accessed Aldivia. Data sheet: VIATENZA Apricot P6 (Apricot Kerel il Polyglyceryl-6 Esters ). Last Updated 03. Date Accessed Aldivia. Data Sheet: VIATENZA Apricot P0 (Apricot Kerel il Polyglyceryl-0 Esters). Last Updated 008. Date Accessed Aldivia. Techical Data Sheet: VIATENZA Arga P6 (Arga il Polyglyceryl-6 Esters). Last Updated 03. Date Accessed Aldivia. Techical Data Sheet: VIATENZA Babassu P6 (Babassu il Polyglyceryl-6 Esters). Last Updated 03. Date Accessed Aldivia. Techical data sheet: VIATENZA Brazil Nut P6 (Bertholletia Excelsa Seed il Polyglyceryl-6 Esters). Last Updated 0. Date Accessed Aldivia. Data Sheet: VIATENZA Caprylic/Capric P0 (Caprylic/Capric Glycerides Polyglyceri-0 Esters). Last Updated 008. Date Accessed Abitec. Techical Data Sheet: VIATENZA Cocoa P6 (Cocoa butter Polyglyceryl-6 Esters). Last Updated 03. Date Accessed Aldivia. Techical Data Sheet: VIATENZA Coco P6 (Cocout il Polyglyceryl-6 Esters). Last Updated 03. Date Accessed Aldivia. Techical data sheet: VIATENZA azel P6 (azel Seed il Polyglyceryl-6 Esters). Last Updated 008. Date Accessed Aldivia. Techical data sheet: VIATENZA Macadamia P6 (Macadamia Seed il Polyglyceryl-6 Esters). Last Updated 00. Date Accessed Aldivia. Techical data sheet: VIATENZA live P6 (live il Polyglyceryl-6 Esters). Last Updated 03. Date Accessed

124 Distributed for Commet ly -- Do Not Cite or Quote 47. Aldivia. Techical data sheet: VIATENZA Safflower P6 (Safflower il Polyglyceryl-6 Esters). Last Updated 008. Date Accessed Aldivia. Techical data sheet: VIATENZA Mogogo P6 (Schiziophyto autaeii Kerel il Polyglyceryl-6 Esters). Last Updated 008. Date Accessed Aldivia. Techical data sheet: VIATENZA Marula P6 (Sclerocarya Birrea Seed il Polyglyceryl-6 Esters). Last Updated 008. Date Accessed Aldivia. Techical data sheet: VIATENZA Sesame P6 (Sesame il Polyglyceryl-6 Esters). Last Updated 008. Date Accessed Aldivia. Techical data sheet: VIATENZA Shea P6 (Shea Butter Polyglyceryl-6 Esters). Last Updated 03. Date Accessed Aldivia. Techical data sheet: VIATENZA Soybea P06 (Soybea il Polyglyceryl-6 Esters). Last Updated 008. Date Accessed Aldivia. Techical data sheet: VIATENZA leic Suflower P6 (Suflower Seed il Polyglyceryl-6 Esters). Last Updated 0. Date Accessed Aldivia. Techical data sheet: VIATENZA leic Suflower P0 (Suflower Seed il Polyglyceryl-0 Esters ). Last Updated 008. Date Accessed Aldivia. Techical data sheet: VIATENZA Almod P6 (Sweet Almod il Polyglyceryl-6 Esters ). Last Updated 03. Date Accessed Aldivia. Techical data sheet: VIATENZA Mafura P6 (Trichilia Emetica Seed il Polyglyceryl-6 Esters). Last Updated 008. Date Accessed AVG Pharma. P6 Viateza Borage (Borage Seed il Polyglyceryl-6 Esters). Last Updated 05. Date Accessed Lubrizol. Techical data sheet (TDS-399): Schercemol PDD Ester (Diisostearoyl Polyglyceryl-3 Dimer Dilioleate). Last Updated Evoik Idustries. Techical Data Sheet: Isola PDI (Diisotearoyl Polyglyceryl-3 Dimer Dilioleate). Last Updated 03. Date Accessed Stepheso Persoal Care. Durosoft. Last Updated 05. Date Accessed Koster Keue. Techical data sheet: Cera Bellia (Polyglyceryl-3 Beeswax). f. Last Updated 05. Date Accessed ChemNet ; Polyglyceryl- Caprate. Last Updated 05. Date Accessed

125 Distributed for Commet ly -- Do Not Cite or Quote 63. Evoik Idustries. TEG Cosmo P 83 (Polyglyceryl-3 Caprylate). Last Updated 008. Date Accessed AIC. Specificatio Sheet: Polyglyceryl-4 Caprate (SLDC PG 40 ). Last Updated 04. Date Accessed Evoik Idustries. TEGSFT PC 4 (Polyglyceryl-4 Caprate). Last Updated 03. Date Accessed Loza. Product iformatio: Polyaldo 0--CC KFG (Polyglyceryl-0 Caprylate/Caprate) [pamphlet] Nikko Chemicals co., Ltd. Material Safety Data Sheet: NIKKL Decagly 0-ISV (Polyglyceryl-0 Decaisostearate). Last Updated 004. Date Accessed Sakamoto Yakuhi Kogyo Co., Ltd Certificate of Aalysis: S-Face BC-80 (Polyglyceryl-8 Decabeheate/Caprate). Upublished data submitted by Persoal Care Products Coucil. 69. Sakamoto Yakuhi Kogyo Co., Ltd Certificate of Aalysis: S-Face M-0 (Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricioleate). Upublished data submitted by Persoal Care Products Coucil. 70. Sakamoto Yakuhi Kogyo Co., Ltd Certificate of Aalysis: Polyglyceryl-0 Decaethylhexaoate. Upublished data submitted by Persoal Care Products Coucil. 7. Nihoh Emulsio Co., Ltd. Product iformatio: Emalex DISG-6 (Polyglyceryl-6 Diisostearate). Last Updated 05. Date Accessed Uited States Pharmacopeial Covetio. Material Safety Data Sheet: Polyglyceryl-3 Dioleate. Last Updated 00. Date Accessed Sigma-Aldrich. Polyglyceryl-6 Dioleate. Last Updated 05. Date Accessed Loza. Iformatio brochure: Aldo ad Polyaldo Specific Emulsifier Solutio for All Types of Formulatios [pamphlet] BASF. Techical Iformatio: Cremophor GS 3 (Polyglyceryl-3 Distearate). Last Updated 006. Date Accessed U.S. Natioal Library of Medicie (NLM). ChemID Plus. Last Updated 05. Date Accessed Parchem. Data sheet. Polyglyceryl-0 Distearate. Last Updated 993. Date Accessed FTA Global. Polyglyceryl isopalmitate/sebacate. Last Updated 03. Date Accessed ChemNet ; Isooctadecaoic acid, ester with oxybis[propaediol] (polyglyceryl- isostearate). Last Updated 05. Date Accessed Goldschmidt AG. ISLAN GI 34 (Polyglyceryl-4 Isostearate). Last Updated 007. Date Accessed Lubrizol. Techical data sheet (TDS-37): ydramol TGL Ester (Polyglyceryl-3 Laurate). Last Updated 04. Date Accessed Sakamoto Yakuhi Kogyo Co., Ltd Certificate of Aalysis: S-Face IS-00P (Polyglyceryl-0 Isostearate). Upublished data submitted by Persoal Care Products Coucil.

126 Distributed for Commet ly -- Do Not Cite or Quote 83. The Good Scets Compay. Polyglyceryl-6 Distearate. Last Updated 05. Date Accessed Loza. Iformatio pamphlet: Polyaldo GDS KFG (6--S) (Polyglyceryl-6 Distearate) [pamphlet] Baret Products Corporatio. Product sepecificatios: Decagly -M (polyglyceyrl-0 myristate; CAS No ). Last Updated 00. Date Accessed SAAPedia. Polyglyceryl palmate. Last Updated 03. Date Accessed Evoik Idustries. TEG Care PL 4 (Polyglyceryl-4 Laurate). Last Updated 009. Date Accessed Sakamoto Yakuhi Kogyo Co., Ltd Certificate of Aalysis: S-Face M-00 (Polyglyceryl-0 Myristate). Upublished data submitted by Persoal Care Products Coucil. 89. Sakamoto Yakuhi Kogyo Co., Ltd Certificate of Aalysis: S-Face IS-009 P (Polyglyceryl-0 Noaisostearate). Upublished data submitted by Persoal Care Products Coucil. 90. Evoik Idustries. ISLAN G 33 (Polyglyceryl-3 leate). Last Updated 999. Date Accessed The Good Scets Compay. Polyglyceryl-0 leate. Last Updated 05. Date Accessed Sakamoto Yakuhi Kogyo Co., Ltd Certificate of Aalysis: S-Face L-00 (Polyglyceryl-0 Laurate). Upublished data submitted by Persoal Care Products Coucil. 93. Loza. Iformatio brochure: Polyaldo 0-- KFG (NN GM) (Polyglyceryl-0 leate) [pamphlet] SAAPedia. Polyglyceryl petacaprylate. Last Updated 03. Date Accessed Stepa. NEBEE Medium Chai Triglycerides, WECBEE Triglycerides, DEWPL Polyglycerol Esters, ad DEWMULSE Moo ad Diglcyerides. px%3fid%3d459+&cd=6&hl=e&ct=clk&gl=us. Last Updated 008. Date Accessed Medolla. Techical datasheet: livatis (Polyglyceryl-3 Petaolivate). Last Updated 04. Date Accessed Nikko Chemicals Co. Ltd. Safety Data Sheet: NIKKL Decagly 5-V (Polyglyceryl-0 Petaoleate). Last Updated 04. Date Accessed Nikko Chemicals Co. Ltd. Product Details: NIKKL Decagly 5-V (Polyglyceryl-0 Petaoleate). Last Updated 00. Date Accessed Nikko Chemicals Co. Ltd. Product Details: NIKKL Tetragly 5-S (Polyglyceryl-4 Petastearate). Last Updated 00. Date Accessed Parchem. Specificatios: Polyglyceryl-6 Petastearate. Last Updated 99. Date Accessed Dowi Chemical. Polyglyceryl-6 Petastearate ( ). Last Updated 05. Date Accessed Sakamoto Yakuhi Kogyo Co., Ltd Certificate of Aalysis: S Face IS-005P (Polyglyceryl-0 Petaisostearate). Upublished data submitted by Persoal Care Products Coucil. 03. Nikko Chemicals Co. Ltd. Product Details: NIKKL Decagly 5-SV (Polyglyceryl-0 Petastearate). Last Updated 00. Date Accessed --05.

127 Distributed for Commet ly -- Do Not Cite or Quote 04. The Good Scets Compay. Polyglyceryl-0 Petastearate. Last Updated 05. Date Accessed Progressus s.r.l. 05. Material safety data sheet PLI B (Polyglyceryl-3 ice Braate). Upublished data submitted by Persoal Care Products Coucil. 06. AAK. Product iformatio: Akolie PGP (Polyglyceryl-3 icioleate). Last Updated 008. Date Accessed Dr. Straetmas Chemische Produkte Gmb. Product iformatio: dermofeel G (Polyglyceryl- Sesquioleate). Last Updated 0. Date Accessed SAAPedia. Polyglyceryl soyate/shea butterate. Last Updated 03. Date Accessed Nisshi illi Group Ltd. aw materials for the cosmetics idustry. Last Updated 03. Date Accessed Nikko Chemicals Co. Ltd. Product Details: Nikkol Decagly -SV (Polyglyceryl-0 Stearate). Last Updated 00. Date Accessed Abitec. Material Safety Data Sheet: Caprol 0G40 (Polyglyceryl-0 Tetraoleate; CAS No ). Last Updated 005. Date Accessed U.S. Evirometal Protectio Agecy (EPA). Substace Details - ctadecaoic acid, tetraester with oxybis[propaediol]. N&p_value= Last Updated 05. Date Accessed Nihoh Emulsio Co., Ltd. Material Safety Data Sheet: Emalex TCCG-0 (Polyglyceryl-0 Tricocoate). Last Updated 03. Date Accessed SAAPedia. Polyglyceryl tridecaoate. Last Updated 03. Date Accessed Nihoh Emulsio Co., Ltd. Material Safety Data Sheet: Emalex TISG-0 (Polyglyceryl-0 Triisostearate). Last Updated 04. Date Accessed Nihoh Emulsio Co., Ltd. Product ifo: Emalex TISG-0 (Polyglyceryl-0 Triisostearate). Last Updated 05. Date Accessed Nikko Chemicals Co. Ltd. Product Details: NIKKL Decagly 3-V (Polyglyceryl-0 Trioleate). Last Updated 00. Date Accessed Nikko Chemicals Co. Ltd. Product Details: NIKKL Decagly 3-SV (Polyglyceryl-0 Tristearate). Last Updated 00. Date Accessed Progressus s.r.l. 05. Material safety data sheet PLI (ice Brai il Polyglyceryl-3 Esters). Upublished data submitted by Persoal Care Products Coucil. 0. Progressus. Prolix (ice Bra il Polyglyceryl-3 Ester). Last Updated 05. Date Accessed Lubrizol. Product Specificatios: Schercemol PTID Ester (Triisostearoyl Polyglycerol-3 Dimer Dilioleate). Last Updated 008. Date Accessed

128 Distributed for Commet ly -- Do Not Cite or Quote. Lubrizol. Techical data sheet (TDS-403): Schercemol PTID Ester (Triisostearoyl Polyglyceryl-3 Dimer Dilioleate). Last Updated 009. Date Accessed AVG Persoal Care. Viateza imeia P6 (imeia Americaa Seed il Polyglyceryl-6 Esters). YTYNjUyZDUtZDgwMS00NzhlLWJiTYtZTM3NTAxGZiZDlmb58x4ypbPeWwG0Ktbz4s8jaQ%9S%8 gxx5te45akx045cte4xtb%9%9/attivo.aspx%3factiveid%3d7%6fuctioid%3d3%6productid%3d0 %6CategoryID%3D0&prev=search. Last Updated 04. Date Accessed Gattefossé. Plurol Stearique WL 009 (Polyglyceryl-6 Distearate). Last Updated 05. Date Accessed Aoymous. 06. Compositio ad physical ad chemical properties Polyglyceryl-4 leate. Upublished data submitted by Persoal Care Products Coucil. 6. CEME LE Gmb & Co. KG. CremerC PG4 Cocoate (Polyglyceryl-4 Cocoate). Last Updated 05. Date Accessed Vatage Specialty Igrediets. Neosolue -Aqua (Polyglyceryl-0 Eicosaedioate/Tetradecaedioate). Last Updated 05. Date Accessed Phycher Assessmet of local cutaeous tolerace after repeated applicatios for two weeks i guiea pigs (Polyglyceryl0 Noaisostearate). Upublished data submitted by Persoal Care Products Coucil. 9. arla Laboratories, Ltd. 00. Summary: Assessmet of ocular irritatio potetial usig the Skiethic recosituted huma coreal epithelium modole. Project o. 74/0060.

129 Distributed for Commet ly -- Do Not Cite or Quote ACACIA DECUENS/JJBA/SUNFLWE SEED WA/PLYGLYCEYL-3 EST03B - Eyelier ACACIA DECUENS/JJBA/SUNFLWE SEED WA/PLYGLYCEYL-3 EST03F - Mascara ACACIA DECUENS/JJBA/SUNFLWE SEED WA/PLYGLYCEYL-3 EST04E - ther Fragrace Preparatio ACACIA DECUENS/JJBA/SUNFLWE SEED WA/PLYGLYCEYL-3 EST07A - Blushers (all types) ACACIA DECUENS/JJBA/SUNFLWE SEED WA/PLYGLYCEYL-3 EST07E - Lipstick ACACIA DECUENS/JJBA/SUNFLWE SEED WA/PLYGLYCEYL-3 EST07I - ther Makeup Preparatios ACACIA DECUENS/JJBA/SUNFLWE SEED WA/PLYGLYCEYL-3 EST0E - ther Persoal Clealiess ACACIA DECUENS/JJBA/SUNFLWE SEED WA/PLYGLYCEYL-3 ESTC - Face ad Neck (exc shave) 3 ACACIA DECUENS/JJBA/SUNFLWE SEED WA/PLYGLYCEYL-3 ESTD - Body ad ad (exc shave) ACACIA DECUENS/JJBA/SUNFLWE SEED WA/PLYGLYCEYL-3 ESTF - Moisturizig BABASSU IL PLYGLYCEYL-4 ESTES 05F - Shampoos (o-colorig) BABASSU IL PLYGLYCEYL-4 ESTES A - Cleasig 7 BABASSU IL PLYGLYCEYL-6 ESTES A - Cleasig CANDELILLA/JJBA/ICE BAN PLYGLYCEYL-3 ESTES 0B - Baby Lotios, ils, Powders CANDELILLA/JJBA/ICE BAN PLYGLYCEYL-3 ESTES 03D - Eye Lotio 4 CANDELILLA/JJBA/ICE BAN PLYGLYCEYL-3 ESTES 03G - ther Eye Makeup Preparat 4 CANDELILLA/JJBA/ICE BAN PLYGLYCEYL-3 ESTES 07C - Foudatios CANDELILLA/JJBA/ICE BAN PLYGLYCEYL-3 ESTES 07E - Lipstick CANDELILLA/JJBA/ICE BAN PLYGLYCEYL-3 ESTES A - Cleasig CANDELILLA/JJBA/ICE BAN PLYGLYCEYL-3 ESTES C - Face ad Neck (exc shave) CANDELILLA/JJBA/ICE BAN PLYGLYCEYL-3 ESTES D - Body ad ad (exc shave) CANDELILLA/JJBA/ICE BAN PLYGLYCEYL-3 ESTES F - Moisturizig CANDELILLA/JJBA/ICE BAN PLYGLYCEYL-3 ESTES G - Night 3 CAPYLIC/CAPIC GLYCEIDES PLYGLYCEIN-0 ESTES A - Cleasig CAPYLIC/CAPIC GLYCEIDES PLYGLYCEIN-0 ESTES C - Face ad Neck (exc shave) CAPYLIC/CAPIC GLYCEIDES PLYGLYCEIN-0 ESTES D - Body ad ad (exc shave) CAPYLIC/CAPIC GLYCEIDES PLYGLYCEIN-0 ESTES F - Moisturizig CCNUT IL PLYGLYCEYL-6 ESTES 0E - ther Persoal Clealiess CCNUT IL PLYGLYCEYL-6 ESTES A - Cleasig DIISSTEAYL PLYGLYCEYL-3 DIME DILINLEATE 03C - Eye Shadow DIISSTEAYL PLYGLYCEYL-3 DIME DILINLEATE G - Night 3 GLYCEYL/PLYGLYCEYL-6 ISSTEAATE/BEENATE ESTES 03B - Eyelier GLYCEYL/PLYGLYCEYL-6 ISSTEAATE/BEENATE ESTES 03C - Eye Shadow GLYCEYL/PLYGLYCEYL-6 ISSTEAATE/BEENATE ESTES 07A - Blushers (all types) GLYCEYL/PLYGLYCEYL-6 ISSTEAATE/BEENATE ESTES 07C - Foudatios GLYCEYL/PLYGLYCEYL-6 ISSTEAATE/BEENATE ESTES 07E - Lipstick GLYCEYL/PLYGLYCEYL-6 ISSTEAATE/BEENATE ESTES D - Body ad ad (exc shave) GLYCEYL/PLYGLYCEYL-6 ISSTEAATE/BEENATE ESTES J - ther Ski Care Preps MACADAMIA SEED IL PLYGLYCEYL-6 ESTES BEENATE 03C - Eye Shadow MACADAMIA SEED IL PLYGLYCEYL-6 ESTES BEENATE 03F - Mascara MACADAMIA SEED IL PLYGLYCEYL-6 ESTES BEENATE 03G - ther Eye Makeup Preparat MACADAMIA SEED IL PLYGLYCEYL-6 ESTES BEENATE 07G - ouges MACADAMIA SEED IL PLYGLYCEYL-6 ESTES BEENATE 3A - Suta Gels, Creams, ad L PALM IL PLYGLYCEYL-4 ESTES D - Body ad ad (exc shave)

130 Distributed for Commet ly -- Do Not Cite or Quote PLYGLYCEYL- CAPATE 04E - ther Fragrace Preparatio PLYGLYCEYL- CAPATE D - Body ad ad (exc shave) 4 PLYGLYCEYL- CAPATE F - Moisturizig PLYGLYCEYL- DIISSTEAATE 03C - Eye Shadow PLYGLYCEYL- DIISSTEAATE 03D - Eye Lotio 3 PLYGLYCEYL- DIISSTEAATE 03F - Mascara PLYGLYCEYL- DIISSTEAATE 07A - Blushers (all types) PLYGLYCEYL- DIISSTEAATE 07C - Foudatios PLYGLYCEYL- DIISSTEAATE 07E - Lipstick PLYGLYCEYL- DIISSTEAATE 07F - Makeup Bases PLYGLYCEYL- DIISSTEAATE 07G - ouges 7 PLYGLYCEYL- DIISSTEAATE 07 - Makeup Fixatives 3 PLYGLYCEYL- DIISSTEAATE 07I - ther Makeup Preparatios 4 PLYGLYCEYL- DIISSTEAATE A - Cleasig PLYGLYCEYL- DIISSTEAATE C - Face ad Neck (exc shave) PLYGLYCEYL- DIISSTEAATE D - Body ad ad (exc shave) 3 PLYGLYCEYL- DIISSTEAATE F - Moisturizig 5 PLYGLYCEYL- DIISSTEAATE - Paste Masks (mud packs) PLYGLYCEYL- DIISSTEAATE 3A - Suta Gels, Creams, ad L PLYGLYCEYL- ISPALMITATE 07E - Lipstick 9 PLYGLYCEYL- ISSTEAATE 07B - Face Powders PLYGLYCEYL- ISSTEAATE 07C - Foudatios PLYGLYCEYL- ISSTEAATE 07E - Lipstick PLYGLYCEYL- ISSTEAATE 07I - ther Makeup Preparatios PLYGLYCEYL- ISSTEAATE PLYGLYCEYL- ISSTEAATE 0E - ther Persoal Clealiess J - ther Ski Care Preps PLYGLYCEYL- LAUATE 03D - Eye Lotio PLYGLYCEYL- LAUATE 05F - Shampoos (o-colorig) PLYGLYCEYL- LAUATE A - Cleasig PLYGLYCEYL- LAUATE C - Face ad Neck (exc shave) PLYGLYCEYL- LAUATE F - Moisturizig PLYGLYCEYL- LAUATE G - Night PLYGLYCEYL- LAUATE I - Ski Fresheers PLYGLYCEYL- LAUATE J - ther Ski Care Preps PLYGLYCEYL- LEATE 07C - Foudatios PLYGLYCEYL- LEATE C - Face ad Neck (exc shave) PLYGLYCEYL- LEATE F - Moisturizig PLYGLYCEYL- SESQUIISSTEAATE 07C - Foudatios PLYGLYCEYL- SESQUIISSTEAATE 07E - Lipstick 39 PLYGLYCEYL- SESQUIISSTEAATE 07I - ther Makeup Preparatios PLYGLYCEYL- SESQUIISSTEAATE 08G - ther Maicurig Preparatio

131 Distributed for Commet ly -- Do Not Cite or Quote PLYGLYCEYL- SESQUIISSTEAATE A - Cleasig PLYGLYCEYL- SESQUIISSTEAATE C - Face ad Neck (exc shave) PLYGLYCEYL- SESQUIISSTEAATE F - Moisturizig Polyglyceryl- Stearate o VCP, but coc of use PLYGLYCEYL- TETAISSTEAATE 07C - Foudatios PLYGLYCEYL- TETAISSTEAATE 07E - Lipstick PLYGLYCEYL- TETAISSTEAATE 07I - ther Makeup Preparatios PLYGLYCEYL- TIISSTEAATE 03A - Eyebrow Pecil 6 PLYGLYCEYL- TIISSTEAATE 03B - Eyelier PLYGLYCEYL- TIISSTEAATE 03C - Eye Shadow PLYGLYCEYL- TIISSTEAATE 03E - Eye Makeup emover PLYGLYCEYL- TIISSTEAATE 03F - Mascara PLYGLYCEYL- TIISSTEAATE 07A - Blushers (all types) 7 PLYGLYCEYL- TIISSTEAATE 07B - Face Powders PLYGLYCEYL- TIISSTEAATE 07C - Foudatios PLYGLYCEYL- TIISSTEAATE 07E - Lipstick PLYGLYCEYL- TIISSTEAATE 07F - Makeup Bases PLYGLYCEYL- TIISSTEAATE 07G - ouges 9 PLYGLYCEYL- TIISSTEAATE 07I - ther Makeup Preparatios PLYGLYCEYL- TIISSTEAATE 0E - ther Persoal Clealiess PLYGLYCEYL- TIISSTEAATE C - Face ad Neck (exc shave) PLYGLYCEYL- TIISSTEAATE D - Body ad ad (exc shave) PLYGLYCEYL- TIISSTEAATE F - Moisturizig 4 PLYGLYCEYL- TIISSTEAATE G - Night PLYGLYCEYL- TIISSTEAATE J - ther Ski Care Preps PLYGLYCEYL-3 BEESWA 0D - ther Bath Preparatios PLYGLYCEYL-3 BEESWA 03C - Eye Shadow PLYGLYCEYL-3 BEESWA 03D - Eye Lotio 6 PLYGLYCEYL-3 BEESWA 03F - Mascara 3 PLYGLYCEYL-3 BEESWA 03G - ther Eye Makeup Preparat PLYGLYCEYL-3 BEESWA 04E - ther Fragrace Preparatio PLYGLYCEYL-3 BEESWA 07C - Foudatios PLYGLYCEYL-3 BEESWA 07E - Lipstick 9 PLYGLYCEYL-3 BEESWA 07F - Makeup Bases PLYGLYCEYL-3 BEESWA 07I - ther Makeup Preparatios PLYGLYCEYL-3 BEESWA 0A - Bath Soaps ad Detergets 8 PLYGLYCEYL-3 BEESWA E - Shavig Cream 3 PLYGLYCEYL-3 BEESWA A - Cleasig 9 PLYGLYCEYL-3 BEESWA C - Face ad Neck (exc shave) 6 PLYGLYCEYL-3 BEESWA D - Body ad ad (exc shave) 9 PLYGLYCEYL-3 BEESWA F - Moisturizig PLYGLYCEYL-3 BEESWA G - Night 3 PLYGLYCEYL-3 BEESWA - Paste Masks (mud packs) 5 9

132 Distributed for Commet ly -- Do Not Cite or Quote PLYGLYCEYL-3 BEESWA J - ther Ski Care Preps 3 PLYGLYCEYL-3 CAPATE 0A - Bath Soaps ad Detergets PLYGLYCEYL-3 CAPATE 0B - Deodorats (uderarm) PLYGLYCEYL-3 CAPYLATE 0A - Bath Soaps ad Detergets PLYGLYCEYL-3 CAPYLATE 0B - Deodorats (uderarm) 3 PLYGLYCEYL-3 CAPYLATE A - Cleasig PLYGLYCEYL-3 CAPYLATE C - Face ad Neck (exc shave) PLYGLYCEYL-3 CAPYLATE J - ther Ski Care Preps PLYGLYCEYL-3 DICITATE/STEAATE 05G - Toics, Dressigs, ad the 3 PLYGLYCEYL-3 DICITATE/STEAATE C - Face ad Neck (exc shave) PLYGLYCEYL-3 DICITATE/STEAATE D - Body ad ad (exc shave) 5 PLYGLYCEYL-3 DICITATE/STEAATE F - Moisturizig 3 PLYGLYCEYL-3 DIISSTEAATE 0A - Bath ils, Tablets, ad Salts PLYGLYCEYL-3 DIISSTEAATE 03B - Eyelier PLYGLYCEYL-3 DIISSTEAATE 03C - Eye Shadow PLYGLYCEYL-3 DIISSTEAATE 03D - Eye Lotio PLYGLYCEYL-3 DIISSTEAATE 03F - Mascara 5 PLYGLYCEYL-3 DIISSTEAATE 03G - ther Eye Makeup Preparat 5 PLYGLYCEYL-3 DIISSTEAATE 07A - Blushers (all types) 5 PLYGLYCEYL-3 DIISSTEAATE 07B - Face Powders 5 PLYGLYCEYL-3 DIISSTEAATE 07C - Foudatios PLYGLYCEYL-3 DIISSTEAATE 07E - Lipstick PLYGLYCEYL-3 DIISSTEAATE 07F - Makeup Bases PLYGLYCEYL-3 DIISSTEAATE 07I - ther Makeup Preparatios 0 PLYGLYCEYL-3 DIISSTEAATE 0A - Bath Soaps ad Detergets PLYGLYCEYL-3 DIISSTEAATE 0E - ther Persoal Clealiess 3 PLYGLYCEYL-3 DIISSTEAATE E - Shavig Cream PLYGLYCEYL-3 DIISSTEAATE A - Cleasig PLYGLYCEYL-3 DIISSTEAATE C - Face ad Neck (exc shave) 4 PLYGLYCEYL-3 DIISSTEAATE D - Body ad ad (exc shave) PLYGLYCEYL-3 DIISSTEAATE F - Moisturizig 3 PLYGLYCEYL-3 DIISSTEAATE G - Night PLYGLYCEYL-3 DIISSTEAATE J - ther Ski Care Preps 4 PLYGLYCEYL-3 DIISSTEAATE 3A - Suta Gels, Creams, ad L 5 PLYGLYCEYL-3 DIISSTEAATE 3B - Idoor Taig Preparatios PLYGLYCEYL-3 DIISSTEAATE 3C - ther Suta Preparatios PLYGLYCEYL-3 DISTEAATE 05A - air Coditioer PLYGLYCEYL-3 DISTEAATE 05B - air Spray (aerosol fixatives PLYGLYCEYL-3 DISTEAATE 05F - Shampoos (o-colorig) PLYGLYCEYL-3 DISTEAATE 05G - Toics, Dressigs, ad the PLYGLYCEYL-3 DISTEAATE F - Moisturizig 4

133 Distributed for Commet ly -- Do Not Cite or Quote PLYGLYCEYL-3 ISSTEAATE 03D - Eye Lotio PLYGLYCEYL-3 ISSTEAATE 07F - Makeup Bases PLYGLYCEYL-3 ISSTEAATE A - Cleasig PLYGLYCEYL-3 ISSTEAATE C - Face ad Neck (exc shave) PLYGLYCEYL-3 ISSTEAATE D - Body ad ad (exc shave) PLYGLYCEYL-3 ISSTEAATE F - Moisturizig 3 PLYGLYCEYL-3 LAUATE 05F - Shampoos (o-colorig) 3 PLYGLYCEYL-3 LAUATE 0A - Bath Soaps ad Detergets 85 PLYGLYCEYL-3 LAUATE 0E - ther Persoal Clealiess PLYGLYCEYL-3 LAUATE A - Cleasig PLYGLYCEYL-3 LAUATE D - Body ad ad (exc shave) PLYGLYCEYL-3 LAUATE - Paste Masks (mud packs) PLYGLYCEYL-3 LEATE 03G - ther Eye Makeup Preparat PLYGLYCEYL-3 LEATE A - Cleasig PLYGLYCEYL-3 LEATE C - Face ad Neck (exc shave) PLYGLYCEYL-3 LEATE D - Body ad ad (exc shave) PLYGLYCEYL-3 LEATE F - Moisturizig 3 PLYGLYCEYL-3 LEATE - Paste Masks (mud packs) PLYGLYCEYL-3 LEATE I - Ski Fresheers PLYGLYCEYL-3 LEATE J - ther Ski Care Preps PLYGLYCEYL-3 LEATE 3A - Suta Gels, Creams, ad L PLYGLYCEYL-3 PALMITATE 0E - ther Persoal Clealiess PLYGLYCEYL-3 ICINLEATE 03F - Mascara PLYGLYCEYL-3 ICINLEATE 03G - ther Eye Makeup Preparat 3 PLYGLYCEYL-3 ICINLEATE 07C - Foudatios 3 PLYGLYCEYL-3 ICINLEATE 07I - ther Makeup Preparatios PLYGLYCEYL-3 ICINLEATE D - Body ad ad (exc shave) PLYGLYCEYL-3 ICINLEATE F - Moisturizig PLYGLYCEYL-3 ICINLEATE 3B - Idoor Taig Preparatios PLYGLYCEYL-3 STEAATE 07A - Blushers (all types) PLYGLYCEYL-3 STEAATE 07E - Lipstick PLYGLYCEYL-3 STEAATE A - Cleasig 3 PLYGLYCEYL-3 STEAATE C - Face ad Neck (exc shave) 3 PLYGLYCEYL-3 STEAATE D - Body ad ad (exc shave) 5 PLYGLYCEYL-3 STEAATE F - Moisturizig PLYGLYCEYL-3 STEAATE G - Night PLYGLYCEYL-4 CAPATE 0A - Bath ils, Tablets, ad Salts PLYGLYCEYL-4 CAPATE 03E - Eye Makeup emover 3 35 PLYGLYCEYL-4 CAPATE 05G - Toics, Dressigs, ad the PLYGLYCEYL-4 CAPATE 07I - ther Makeup Preparatios PLYGLYCEYL-4 CAPATE 0A - Bath Soaps ad Detergets 3

134 Distributed for Commet ly -- Do Not Cite or Quote PLYGLYCEYL-4 CAPATE 0B - Deodorats (uderarm) PLYGLYCEYL-4 CAPATE 0E - ther Persoal Clealiess PLYGLYCEYL-4 CAPATE A - Cleasig 5 PLYGLYCEYL-4 CAPATE C - Face ad Neck (exc shave) PLYGLYCEYL-4 CAPATE - Paste Masks (mud packs) PLYGLYCEYL-4 CCATE 0E - ther Persoal Clealiess PLYGLYCEYL-4 ISSTEAATE 0B - Baby Lotios, ils, Powders PLYGLYCEYL-4 ISSTEAATE 03A - Eyebrow Pecil PLYGLYCEYL-4 ISSTEAATE 03B - Eyelier 3 PLYGLYCEYL-4 ISSTEAATE 03C - Eye Shadow PLYGLYCEYL-4 ISSTEAATE 03D - Eye Lotio PLYGLYCEYL-4 ISSTEAATE 03F - Mascara 4 3 PLYGLYCEYL-4 ISSTEAATE 03G - ther Eye Makeup Preparat 8 PLYGLYCEYL-4 ISSTEAATE 05G - Toics, Dressigs, ad the PLYGLYCEYL-4 ISSTEAATE 07A - Blushers (all types) 3 PLYGLYCEYL-4 ISSTEAATE 07B - Face Powders PLYGLYCEYL-4 ISSTEAATE 07C - Foudatios PLYGLYCEYL-4 ISSTEAATE 07D - Leg ad Body Paits PLYGLYCEYL-4 ISSTEAATE 07E - Lipstick 44 PLYGLYCEYL-4 ISSTEAATE 07F - Makeup Bases 7 PLYGLYCEYL-4 ISSTEAATE 07G - ouges PLYGLYCEYL-4 ISSTEAATE 07 - Makeup Fixatives PLYGLYCEYL-4 ISSTEAATE 07I - ther Makeup Preparatios PLYGLYCEYL-4 ISSTEAATE 08G - ther Maicurig Preparatio PLYGLYCEYL-4 ISSTEAATE C - Face ad Neck (exc shave) 7 PLYGLYCEYL-4 ISSTEAATE F - Moisturizig PLYGLYCEYL-4 ISSTEAATE G - Night PLYGLYCEYL-4 ISSTEAATE - Paste Masks (mud packs) PLYGLYCEYL-4 ISSTEAATE J - ther Ski Care Preps PLYGLYCEYL-4 ISSTEAATE 3B - Idoor Taig Preparatios 0 5 PLYGLYCEYL-4 LAUATE 03D - Eye Lotio PLYGLYCEYL-4 LAUATE 07C - Foudatios PLYGLYCEYL-4 LAUATE 07I - ther Makeup Preparatios PLYGLYCEYL-4 LAUATE A - Cleasig 4 PLYGLYCEYL-4 LAUATE F - Moisturizig 3 PLYGLYCEYL-4 LAUATE 3B - Idoor Taig Preparatios PLYGLYCEYL-4 LEATE 03D - Eye Lotio PLYGLYCEYL-4 LEATE 07C - Foudatios PLYGLYCEYL-4 LEATE 07D - Leg ad Body Paits PLYGLYCEYL-4 LEATE F - Moisturizig 3 PLYGLYCEYL-5 DILEATE 0E - ther Persoal Clealiess

135 Distributed for Commet ly -- Do Not Cite or Quote PLYGLYCEYL-5 ISSTEAATE 03G - ther Eye Makeup Preparat PLYGLYCEYL-5 ISSTEAATE D - Body ad ad (exc shave) PLYGLYCEYL-5 LAUATE 0B - Bubble Baths PLYGLYCEYL-5 LAUATE 0A - Bath Soaps ad Detergets PLYGLYCEYL-5 LEATE 0E - ther Persoal Clealiess PLYGLYCEYL-5 LEATE A - Cleasig PLYGLYCEYL-5 LEATE F - Moisturizig PLYGLYCEYL-5 LEATE I - Ski Fresheers 5 PLYGLYCEYL-5 LEATE J - ther Ski Care Preps PLYGLYCEL-5 STEAATE C - Face ad Neck (exc shave) PLYGLYCEYL-5 TILEATE C - Face ad Neck (exc shave) 5 PLYGLYCEYL-5 TILEATE F - Moisturizig Polyglyceryl-6 Caprylate/Caprate o VCP, but coc of use PLYGLYCEYL-6 DILEATE 05A - air Coditioer 6 PLYGLYCEYL-6 DILEATE 07E - Lipstick PLYGLYCEYL-6 DILEATE 07I - ther Makeup Preparatios 7 PLYGLYCEYL-6 DILEATE A - Cleasig PLYGLYCEYL-6 DILEATE C - Face ad Neck (exc shave) PLYGLYCEYL-6 DILEATE D - Body ad ad (exc shave) 9 PLYGLYCEYL-6 DILEATE F - Moisturizig PLYGLYCEYL-6 DILEATE J - ther Ski Care Preps PLYGLYCEYL-6 DISTEAATE 0B - Baby Lotios, ils, Powders PLYGLYCEYL-6 DISTEAATE 0D - ther Bath Preparatios PLYGLYCEYL-6 DISTEAATE 03B - Eyelier PLYGLYCEYL-6 DISTEAATE 03C - Eye Shadow PLYGLYCEYL-6 DISTEAATE 03D - Eye Lotio PLYGLYCEYL-6 DISTEAATE 03F - Mascara 3 PLYGLYCEYL-6 DISTEAATE 07C - Foudatios PLYGLYCEYL-6 DISTEAATE 07E - Lipstick PLYGLYCEYL-6 DISTEAATE 0A - Bath Soaps ad Detergets 8 PLYGLYCEYL-6 DISTEAATE 0E - ther Persoal Clealiess PLYGLYCEYL-6 DISTEAATE A - Cleasig 9 PLYGLYCEYL-6 DISTEAATE C - Face ad Neck (exc shave) 8 PLYGLYCEYL-6 DISTEAATE D - Body ad ad (exc shave) 8 PLYGLYCEYL-6 DISTEAATE F - Moisturizig 3 PLYGLYCEYL-6 DISTEAATE G - Night PLYGLYCEYL-6 DISTEAATE 3B - Idoor Taig Preparatios PLYGLYCEYL-6 ISSTEAATE 07E - Lipstick PLYGLYCEYL-6 ISSTEAATE C - Face ad Neck (exc shave) 7

136 Distributed for Commet ly -- Do Not Cite or Quote PLYGLYCEYL-6 ISSTEAATE D - Body ad ad (exc shave) PLYGLYCEYL-6 ISSTEAATE F - Moisturizig 3 PLYGLYCEYL-6 ISSTEAATE J - ther Ski Care Preps PLYGLYCEYL-6 ISSTEAATE 3A - Suta Gels, Creams, ad L PLYGLYCEYL-6 CTASTEAATE F - Moisturizig PLYGLYCEYL-6 LEATE C - Face ad Neck (exc shave) PLYGLYCEYL-6 ICINLEATE 07E - Lipstick PLYGLYCEYL-6 ICINLEATE 0E - ther Persoal Clealiess PLYGLYCEYL-8 DECAEUCATE/DECAISSTEAATE/DECAICINLEATE C - Face ad Neck (exc shave) PLYGLYCEYL-0 BEENATE/EICSADIATE A - Cleasig PLYGLYCEYL-0 BEENATE/EICSADIATE J - ther Ski Care Preps PLYGLYCEYL-0 CAPYLATE/CAPATE A - Cleasig PLYGLYCEYL-0 DECAISSTEAATE 03C - Eye Shadow 3 PLYGLYCEYL-0 DECALEATE 07C - Foudatios PLYGLYCEYL-0 DECALEATE 07E - Lipstick 3 PLYGLYCEYL-0 DECALEATE 07F - Makeup Bases PLYGLYCEYL-0 DECALEATE F - Moisturizig 5 PLYGLYCEYL-0 DECALEATE J - ther Ski Care Preps PLYGLYCEYL-0 DIISSTEAATE 07F - Makeup Bases PLYGLYCEYL-0 DIISSTEAATE A - Cleasig PLYGLYCEYL-0 DIISSTEAATE C - Face ad Neck (exc shave) 4 PLYGLYCEYL-0 DIISSTEAATE F - Moisturizig 4 PLYGLYCEYL-0 DIPALMITATE 0A - Bath ils, Tablets, ad Salts PLYGLYCEYL-0 DIPALMITATE 07E - Lipstick PLYGLYCEYL-0 DIPALMITATE 0E - ther Persoal Clealiess 9 PLYGLYCEYL-0 DIPALMITATE A - Cleasig PLYGLYCEYL-0 DIPALMITATE C - Face ad Neck (exc shave) PLYGLYCEYL-0 DIPALMITATE - Paste Masks (mud packs) PLYGLYCEYL-0 DIPALMITATE J - ther Ski Care Preps PLYGLYCEYL-0 DISTEAATE 0E - ther Persoal Clealiess PLYGLYCEYL-0 DISTEAATE F - Moisturizig 9 PLYGLYCEYL-0 EPTAYDYSTEAATE 07C - Foudatios PLYGLYCEYL-0 YDYSTEAATE/STEAATE/EICSADIATE 07I - ther Makeup Preparatios PLYGLYCEYL-0 YDYSTEAATE/STEAATE/EICSADIATE A - Cleasig PLYGLYCEYL-0 ISSTEAATE C - Face ad Neck (exc shave) PLYGLYCEYL-0 ISSTEAATE F - Moisturizig 4 PLYGLYCEYL-0 ISSTEAATE G - Night PLYGLYCEYL-0 LAUATE 0A - Baby Shampoos

137 Distributed for Commet ly -- Do Not Cite or Quote PLYGLYCEYL-0 LAUATE 0C - ther Baby Products 5 PLYGLYCEYL-0 LAUATE 03B - Eyelier PLYGLYCEYL-0 LAUATE 03D - Eye Lotio PLYGLYCEYL-0 LAUATE 03G - ther Eye Makeup Preparat PLYGLYCEYL-0 LAUATE 04A - Cologe ad Toilet waters PLYGLYCEYL-0 LAUATE 04B - Perfumes PLYGLYCEYL-0 LAUATE 05A - air Coditioer PLYGLYCEYL-0 LAUATE 05I - ther air Preparatios PLYGLYCEYL-0 LAUATE 07I - ther Makeup Preparatios PLYGLYCEYL-0 LAUATE A - Cleasig PLYGLYCEYL-0 LAUATE C - Face ad Neck (exc shave) 0 PLYGLYCEYL-0 LAUATE D - Body ad ad (exc shave) PLYGLYCEYL-0 LAUATE F - Moisturizig 8 PLYGLYCEYL-0 LAUATE G - Night PLYGLYCEYL-0 LAUATE I - Ski Fresheers PLYGLYCEYL-0 LAUATE J - ther Ski Care Preps 4 PLYGLYCEYL-0 MYISTATE 0A - Baby Shampoos PLYGLYCEYL-0 MYISTATE 03C - Eye Shadow PLYGLYCEYL-0 MYISTATE 03D - Eye Lotio PLYGLYCEYL-0 MYISTATE 07I - ther Makeup Preparatios PLYGLYCEYL-0 MYISTATE A - Cleasig 6 PLYGLYCEYL-0 MYISTATE C - Face ad Neck (exc shave) 4 PLYGLYCEYL-0 MYISTATE F - Moisturizig PLYGLYCEYL-0 MYISTATE 3A - Suta Gels, Creams, ad L 3 PLYGLYCEYL-0 MYISTATE 3B - Idoor Taig Preparatios 5 PLYGLYCEYL-0 NNAISSTEAATE 03C - Eye Shadow PLYGLYCEYL-0 NNAISSTEAATE 03G - ther Eye Makeup Preparat 5 PLYGLYCEYL-0 NNAISSTEAATE 07C - Foudatios PLYGLYCEYL-0 NNAISSTEAATE PLYGLYCEYL-0 NNAISSTEAATE 07E - Lipstick 07I - ther Makeup Preparatios PLYGLYCEYL-0 LEATE 0A - Baby Shampoos PLYGLYCEYL-0 LEATE 05A - air Coditioer PLYGLYCEYL-0 LEATE 05F - Shampoos (o-colorig) PLYGLYCEYL-0 LEATE 05G - Toics, Dressigs, ad the PLYGLYCEYL-0 LEATE G - ther Shavig Preparatio P PLYGLYCEYL-0 LEATE C - Face ad Neck (exc shave) 8 PLYGLYCEYL-0 LEATE D - Body ad ad (exc shave) PLYGLYCEYL-0 LEATE F - Moisturizig 5 PLYGLYCEYL-0 LEATE - Paste Masks (mud packs) PLYGLYCEYL-0 LEATE J - ther Ski Care Preps PLYGLYCEYL-0 LEATE 3A - Suta Gels, Creams, ad L 3 PLYGLYCEYL-0 PENTAYDYSTEAATE 03F - Mascara PLYGLYCEYL-0 PENTAYDYSTEAATE G - Night PLYGLYCEYL-0 PENTAYDYSTEAATE - Paste Masks (mud packs) PLYGLYCEYL-0 PENTALEATE 05B - air Spray (aerosol fixatives 3 PLYGLYCEYL-0 PENTALEATE 05G - Toics, Dressigs, ad the PLYGLYCEYL-0 PENTALEATE 07E - Lipstick PLYGLYCEYL-0 PENTALEATE G - Night PLYGLYCEYL-0 PENTASTEAATE 03D - Eye Lotio

138 Distributed for Commet ly -- Do Not Cite or Quote PLYGLYCEYL-0 PENTASTEAATE 05A - air Coditioer PLYGLYCEYL-0 PENTASTEAATE 07C - Foudatios PLYGLYCEYL-0 PENTASTEAATE A - Cleasig PLYGLYCEYL-0 PENTASTEAATE C - Face ad Neck (exc shave) 5 PLYGLYCEYL-0 PENTASTEAATE F - Moisturizig 3 PLYGLYCEYL-0 PENTASTEAATE G - Night PLYGLYCEYL-0 STEAATE 03C - Eye Shadow 3 PLYGLYCEYL-0 STEAATE 03D - Eye Lotio PLYGLYCEYL-0 STEAATE 03G - ther Eye Makeup Preparat 8 PLYGLYCEYL-0 STEAATE 05G - Toics, Dressigs, ad the PLYGLYCEYL-0 STEAATE 07C - Foudatios PLYGLYCEYL-0 STEAATE 07F - Makeup Bases PLYGLYCEYL-0 STEAATE A - Cleasig PLYGLYCEYL-0 STEAATE C - Face ad Neck (exc shave) 9 PLYGLYCEYL-0 STEAATE D - Body ad ad (exc shave) 4 PLYGLYCEYL-0 STEAATE E - Foot Powders ad Sprays PLYGLYCEYL-0 STEAATE F - Moisturizig PLYGLYCEYL-0 STEAATE G - Night 5 PLYGLYCEYL-0 STEAATE - Paste Masks (mud packs) PLYGLYCEYL-0 STEAATE I - Ski Fresheers PLYGLYCEYL-0 STEAATE J - ther Ski Care Preps 9 PLYGLYCEYL-0 STEAATE 3A - Suta Gels, Creams, ad L 3 PLYGLYCEYL-0 TISTEAATE 03D - Eye Lotio TIISSTEAYL PLYGLYCEYL-3 DIME DILINLEATE 03C - Eye Shadow TIISSTEAYL PLYGLYCEYL-3 DIME DILINLEATE 07E - Lipstick TIISSTEAYL PLYGLYCEYL-3 DIME DILINLEATE 07I - ther Makeup Preparatios 5 3 7

139 Distributed for Commet ly -- Do Not Cite or Quote Persoal Care Products Coucil Committed to Safety, Quality & Iovatio Memoradum T: Lillia Gill, D.P.A. Director- CSMETIC INGEDIENT EVIEW (CI) FM: Beth A. Lage, Ph.D. Idustry Liaiso to the CI Expert Pael DATE: March 5,06 SUBJECT: Iformatio o Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters (SL posted Jauary 8, 06) SafePharm Laboratories Acute dermal irritatio i the rabbit (Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters). Japa air Sciece Associatio Patch test o the cosmetic igrediet Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters. SafePharm Laboratories Acute eye irritatio i the rabbit Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters ). Phycher Ski sesitizatio i the guiea pig- Magusso ad Kligma maximisatio method (Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters). SafePharm Laboratories Acute oral toxicity i the rat - acute toxic class method ( Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters). SafePharm Laboratories everse mutatio assay "Ames test" usig Salmoella typhimurium ad Escherichia coli (Glyceryl/Polyglyceryl-6 Isostearate/Beheate Esters ). I I 60 L Street, N.W., Suite 00 Washigto, D.C. 0036, (fax) I

140 Distributed for Commet ly -- Do Not Cite or Quote Persoal Care Products Coucil Committed to Safety, Quality & Iovatio Memoradum T: FM: Lillia Gill, D.P.A. Director - CSMETIC INGEDIENT EVIEW (CI) Beth A. Lage, Ph.D. Idustry Liaiso to the CI Expert Pael DATE: March 4, 06 SUBJECT: Commets o the Draft eport: Safety Assessmet of Polyglyceryl Fatty Acid Esters as Used i Cosmetics (prepared for the March 3-April,06 CI Expert Patwl meetig) Cosmetic Use, Summary - Please state the product category i which the highest use cocetratios of Polyglycery l- Triisostearate ad Polyglycery l-3 Diisostearate were reported. No-Cosmetic Use - The FDA iactive igrediet data base ( u/idex.c Cm) is also a useful source for drug use of igrediets. For example, this database idicates that Polyglyceryl-3 leate is used i vagial drug products at a cocetratio up to.7%. Toxicokietics - It is ot clear how GLC aalysis showig a dose-related icrease i oleic acid idicated hat the absorptio of dietary Polyglvce l-l Decaoleate was ot complete (referece3) I what, e.g., urie, feces, did they measure the oleic acid? cular Irritatio. Summary. Table 5- SIC is a type of cell - States Semmistitut abbil Corea Cells. stads for eutral red. The followig referece provides details about the method. Tai N, Koshita S. kamoto Y Iterlaboratory validatio of the i vitro eye irritatio tests for cosmetic igrediets (8) Evaluatio of cytotoxicity tests o SIC cells. Toxicoll Vitro 3(): Table 3 - For the sectios of Table 3 that show the same structure multiple times, e.g., Polyglyceryl-3 mixed esters (ad other Polyglyceryl- mixed esters), perhaps the structure could be show oce i the row with the group headig. For example, i the headig for Polyglycervl-3 mixed esters, the mooester structure ca be show with replaced by 3 ad there could be a statemet i the headig that the structures vary by igrediet ad are stated i the defiitios. Table 3, live il Polyglyceryl-3 Esters - There is a 4 with this structure that does ot belog. Table 7 - BT ca be deleted from the bottom of the Table as it is ot i the table. 60 L Street, N.W., Suite 00 Washigto, D.C I I (fax)

141 3/306 lerlaboratciyelidatio &the I *o ee irritatio tests for casmtic igreiels. (8) Eeluatla, of c,4otodcitytesft al SIC cells. - PubM&J - Distributed for Commet ly -- Do Not Cite or Quote NCBI rpubmed Abstract Toxicol I Vitro. 999 Feb;3(): Full text liks : L. L I Iterlaboratory validatio of the i vitro eye irritatio tests for cosmetic igrediets. (8) Evaluatio of cytotoxicity tests o SIC cells. Tai N, Kioshita S, kamoto Y, Kotai M, Itagaki, Murakami N, Suiura S, Usami M, Kato K, Kojima, ho T, SaUo K, Kato M, avashi M, ho Y. Author iformatio Abstract Two commo assays, the eutral red uptake assay (SIC-U) ad the crystal violet staiig assay (SIC-CVS), were evaluated as alteratives to the Draize eye irritatio test (Draize test).the cytotoxicity of thirty-eight cosmetic igrediets as well as a physiological salie solutio was determied o SIC cells at five to seve laboratories. SIC-U ad SIC-CVS were performed accordig to the commo stadard operatig procedure (SP). The 50% effective cocetratio (EC(50)) was determied for each igrediet. The EC(50) of SIC-CVS was similar to that of SIC U, showig a strog correlatio (r=0.995). The coefficiet of variatio (CV) of EC(5) which represets the iterlaboratory reproducibility of SIC-U was 3.%, whereas that of S IC-CVS was 3.8%. The logarithmically trasformed EC(50) values showed a strog correlatio with the maximal average Draize total score (MAS) (SIC-U: r=-.86 (=30), SIC-CVS: r-.805 (=9)). Both methods could be applied to water-isoluble substaces ad dyes. owever, strog acids, alkaolamies ad alcohols had a tedecy to deviate from the liear regressio lies which were obtaied from the i vivo ad i vitro data for both methods i the preset study. These results suggest that cytotoxicological testig o SIC cells may provide a alterative method to the Draize test for cosmetic igrediets. PMID: [PubMed] Likut - more resources PubMed Commos PubMed Commos home 0 commets ow to joi PubMed Commos olpubme&