GREEN. Dimethicone Crosspolymers

Transcription

1 GREEN Dimethicone s CIR EXPERT PANEL MEETING JUNE 11-12, 2012

2 June 11, 2012 MEMORANDUM To: From: Subject: CIR Expert Panel and Liaisons Lillian C. Becker, M.S. Scientific Analyst and Writer Draft Report for dimethicone s as used in cosmetics The Cosmetic Ingredient Review (CIR) announced the Scientific Literature Review (SLR) for dimethicone s in November, Comments and unpublished data have been received from industry and incorporated into the report. Much of this data were on undisclosed related ingredients. The Panel should review the Draft Report and decide whether r any additional data are needed in order to reach a safety conclusion. If additional data are needed, the Panel should issue an insufficient data announcement and identify the data needs. If no additional data are required,, then the Panel should develop a tentativee conclusion, with a rational to be included in the discussion, and issue a Tentative Report.

3 c;c SAFETY ASSESSMENT FLOW CHART Th rn L-Q-rcsç \( Distributed for Comment - Do Not Cite or Quote CIR Panel Book Page 1 Option for Re-review 1 Document for Panel Review **jf Draft Amended Report (DAR) is available, the Panel may choose to review; If not, CIR staff prepares DAR for Panel Review. Panel review, the statement is issued to the Public. Expert Panel Decision *The CIR Staff notifies of the public of the decision not to re-open the report and prepares a draft statement for review by the Panel. After Final Report At A1 Olfft. Concl. Report Draft Amended Final Tentative Report Report Tentative Amended Tentative Report 60 day public comment period Draft Amended time. Pink Cover 2nd time; Report Green Cowr 1 60 day public comment

4 History of Dimethicone s February, 2012 The SLR was announced. June, 2012 The Panel will examine the draft report for the first time. CIR Panel Book Page 2

5 Dimethicone Data Profile for June, Writer Lillian Becker Repeated dose ADME Acute toxicity Irritation Sensitization toxicity Phototoxicity Carcinogenicity Genotoxicity Repro/Devel toxicity Sensitization Human Sensitization Animal Dermal Irr Human Dermal Irr. Animal Ocular Irritation Inhale Dermal Oral Inhale Dermal Oral Use Log Kow Dermal Penetration Acrylates/Bis Hydroxypropyl Dimethicone Behenyl Dimethicone/Bis Vinyldimethicone Bis Phenylisopropyl Phenylisopropyl Dimethicone/ Vinyl Dimethicone Bis Vinyldimethicone /Bis Isobutyl PPG 20 Bis Vinyldimethicone Bis Vinyldimethicone /PEG 10 Dimethicone Bisvinyldimethicone /PPG 20 Butyldimethicon e Methacrylate/ Methyl Methacrylate C30 45 Alkyl Cetearyl Dimethicone C4 24 Alkyl Dimethicone/ Divinyldimethico ne C30 45 Alkyl Dimethicone/ Polycyclohexene Oxide Cetearyl Dimethicone Cetearyl Dimethicone/Vin yl Dimethicone Cetyl Dimethicone/Bis Vinyldimethicone Cetyl Hexacosyl X X X X CIR Panel Book Page 3

6 Dimethicone Data Profile for June, Writer Lillian Becker Repeated dose ADME Acute toxicity Irritation Sensitization toxicity Phototoxicity Carcinogenicity Genotoxicity Repro/Devel toxicity Sensitization Human Sensitization Animal Dermal Irr Human Dermal Irr. Animal Ocular Irritation Inhale Dermal Oral Inhale Dermal Oral Use Log Kow Dermal Penetration Dimethicone/ Bis Vinyldimethicone Crotonic Acid/Vinyl C8 12 Isoalkyl Esters/VA/Bis Vinyldimethicone Dimethicone/Bis Isobutyl PPG 20 Dimethicone/Bis Vinyldimethicone /Silsesquioxane Dimethicone Dimethicone 3 Dimethicone/ Divinyldimethico ne/ Silsesquioxane Dimethicone/ Lauryl Dimethicone/Bis Vinyldimethicone Dimethicone/ PEG 10 Dimethicone/ PEG 10/15 Dimethicone/ PEG 15 Dimethicone/ Phenyl Vinyl Dimethicone Dimethicone/ Polyglycerin 3 Dimethicone/ PPG 20 Dimethicone/ Titanate Dimethicone/ Vinyl Dimethicone Dimethicone/ Vinyltrimethylsiloxysilicate Diphenyl X X X X X X X X X X X X X X X X X X X X X X CIR Panel Book Page 4

7 Dimethicone Data Profile for June, Writer Lillian Becker Repeated dose ADME Acute toxicity Irritation Sensitization toxicity Phototoxicity Carcinogenicity Genotoxicity Repro/Devel toxicity Sensitization Human Sensitization Animal Dermal Irr Human Dermal Irr. Animal Ocular Irritation Inhale Dermal Oral Inhale Dermal Oral Use Log Kow Dermal Penetration Dimethicone Diphenyl Dimethicone/ Vinyl Diphenyl Dimethicone/ Silsesquioxane Divinyldimethicone/ Dimethicone Hydroxypropyl Dimethicone/ Polysorbate 20 Isopropyl Titanium Triisostearate/ Triethoxysilylethyl Polydimethylsilox yethyl Dimethicone Lauryl Dimethicone PEG 15 Lauryl Dimethicone/ Polyglycerin 3 Lauryl Polydimethylsiloxyethyl Dimethicone/Bis Vinyldimethicone PEG 10 Dimethicone PEG 12 Dimethicone PEG 8 Dimethicone/ Polysorbate 20 PEG 12 Dimethicone/Bis Isobutyl PPG 20 PEG 12 Dimethicone/ PPG 20 PEG 10 Dimethicone/ Vinyl Dimethicone X X X X X X X X CIR Panel Book Page 5

8 Dimethicone Data Profile for June, Writer Lillian Becker Repeated dose ADME Acute toxicity Irritation Sensitization toxicity Phototoxicity Carcinogenicity Genotoxicity Repro/Devel toxicity Sensitization Human Sensitization Animal Dermal Irr Human Dermal Irr. Animal Ocular Irritation Inhale Dermal Oral Inhale Dermal Oral Use Log Kow Dermal Penetration PEG 10/Lauryl Dimethicone PEG 15/Lauryl Dimethicone PEG 15/Lauryl Polydimethylsiloxyethyl Dimethicone Perfluorononyl Dimethicone/ Methicone/ Amodimethicone Polydimethylsiloxyethyl Dimethicone/Bis Vinyldimethicone Polyglyceryl 3/Lauryl Polydimethylsiloxyethyl Dimethicone Silicone Quaternium 16/ Glycidoxy Dimethicone Styrene/ Acrylates/ Dimethicone Acrylate Trifluoropropyl Dimethicone/ PEG 10 Trifluoropropyl Dimethicone/ Trifluoropropyl Divinyldimethicone Trifluoropropyl Dimethicone/ Vinyl Trifluoropropyl Dimethicone/ Silsesquioxane Trimethylsiloxysilicate/ Dimethicone Vinyl Dimethicone/ Lauryl/Behenyl Dimethicone X X X X X CIR Panel Book Page 6

9 Dimethicone Data Profile for June, Writer Lillian Becker Repeated dose ADME Acute toxicity Irritation Sensitization toxicity Phototoxicity Carcinogenicity Genotoxicity Repro/Devel toxicity Sensitization Human Sensitization Animal Dermal Irr Human Dermal Irr. Animal Ocular Irritation Inhale Dermal Oral Inhale Dermal Oral Use Log Kow Dermal Penetration Vinyl Dimethicone/ Lauryl Dimethicone Vinyl Dimethicone/ Methicone Silsesquioxane Vinyldimethyl/ Trimethylsiloxysilicate/ Dimethicone Vinyldimethyl/ Trimethylsiloxysilicate Stearyl Dimethicone X X X CIR Panel Book Page 7

10 Search Strategy Dimethicone s Date Search Terms Results Jan, 2012 Acrylates/Bis-Hydroxypropyl 40 possible Dimethicone Research Topic "Acrylates/Bis- Hydroxypropyl Dimethicone polymer" > references (656) > refine "Biography Book Clinical Trial Commentary Conference Dissertation Editorial Historical Journal Letter Preprint Report Review" (40) Feb, 2012 Opened saved answer set "Dimethicone s Starting Point" (3077) > remove 0 references (3077) > keep analysis "Index Term" (360) > refine "Biography Book Clinical Trial Commentary Conference Dissertation Editorial Historical Journal Letter Preprint Report Review" (29) 29 possible, ordered 6 CIR Panel Book Page 8

11 Report

12 Draft Report on the Safety Assessment of Dimethicone Ingredients as Used in Cosmetics June 11, 2012 The 2012 Cosmetic Ingredient Review Expert Panel members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is F. Alan Andersen, Ph.D. This report was prepared by Lillian C. Becker, Scientific Analyst/Writer. Cosmetic Ingredient Review th Street, NW, Suite 412 " Washington, DC " ph " fax " cirinfo@cirsafety.org i CIR Panel Book Page 9

13 TABLE OF CONTENTS TABLE OF CONTENTS... ii INTRODUCTION... 1 CHEMISTRY... 2 Overview... 2 Physical and Chemical Properties... 2 Particle Size... 2 Impurities... 2 USE... 3 Cosmetic... 3 TOXICOKINETICS... 5 Absorption, Distribution, Metabolism, and Excretion... 5 Dermal/Percutaneous... 5 Oral and Inhalation... 5 TOXICOLOGICAL STUDIES... 5 Acute Toxicity... 5 Dermal Non-Human... 5 Oral Non-Human... 5 Inhalation Non-Human... 6 In Vitro... 6 Repeated Dose Toxicity... 6 Dermal... 6 Oral Non-Human... 6 Inhalation Non-Human... 6 REPRODUCTIVE AND DEVELOPMENTAL TOXICITY... 6 GENOTOXICITY... 6 In Vitro... 6 CARCINOGENICITY... 6 IRRITATION AND SENSITIZATION... 7 Irritation... 7 Dermal Non-Human... 7 Dermal Human... 7 Mucosal... 7 Ocular... 7 Sensitization... 7 Dermal Non-Human... 7 Dermal Human... 7 Phototoxicity... 8 SUMMARY... 8 DISCUSSION... 9 CONCLUSION... 9 TABLES AND FIGURES REFERENCES ii CIR Panel Book Page 10

14 INTRODUCTION This is a draft report of the available published and unpublished data relevant to assessing the safety of 62 dimethicone s as used in cosmetics. As given in the International Cosmetic Ingredient Dictionary and Handbook, 1 these ingredients mostly function as absorbents, bulking agents, film formers, hair-conditioning agents, emollient skin-conditioning agents, slip modifiers, surface modifiers, and nonaqueous viscosity increasing agents (Table 1). The ingredients included in this report are: acrylates/bis-hydroxypropyl dimethicone behenyl dimethicone/bis-vinyldimethicone bis-phenylisopropyl phenylisopropyl dimethicone/vinyl dimethicone bis-vinyldimethicone/bis-isobutyl PPG-20 bis-vinyldimethicone bis-vinyldimethicone/ PEG-10 dimethicone bis-vinyldimethicone/ppg-20 butyldimethicone methacrylate/methyl methacrylate C30-45 alkyl cetearyl dimethicone C4-24 alkyl dimethicone/divinyldimethicone C30-45 alkyl dimethicone/polycyclohexene oxide cetearyl dimethicone cetearyl dimethicone/vinyl dimethicone cetyl dimethicone/bis-vinyldimethicone cetyl hexacosyl dimethicone/bisvinyldimethicone crotonic acid/vinyl C8-12 isoalkyl esters/va/bisvinyldimethicone dimethicone/bis-isobutyl PPG-20 dimethicone/bis-vinyldimethicone/ silsesquioxane dimethicone dimethicone -3 dimethicone/divinyldimethicone/silsesquioxane dimethicone/lauryl dimethicone/bisvinyldimethicone dimethicone/peg-10 dimethicone/peg-10/15 dimethicone/peg-15 dimethicone/phenyl vinyl dimethicone dimethicone/polyglycerin-3 dimethicone/ppg-20 dimethicone/titanate dimethicone/vinyl dimethicone dimethicone/vinyltrimethylsiloxysilicate diphenyl dimethicone diphenyl dimethicone/vinyl diphenyl 1 dimethicone/silsesquioxane divinyldimethicone/dimethicone hydroxypropyl dimethicone/polysorbate 20 isopropyl titanium triisostearate/ triethoxysilylethyl polydimethylsiloxyethyl dimethicone lauryl dimethicone PEG-15 lauryl dimethicone/polyglycerin-3 lauryl polydimethylsiloxyethyl dimethicone/bisvinyldimethicone PEG-10 dimethicone PEG-12 dimethicone PEG-8 dimethicone/polysorbate 20 PEG-12 dimethicone/bis-isobutyl PPG-20 PEG-12 dimethicone/ppg-20 PEG-10 dimethicone/vinyl dimethicone PEG-10/lauryl dimethicone PEG-15/lauryl dimethicone PEG-15/lauryl polydimethylsiloxyethyl dimethicone perfluorononyl dimethicone/methicone/ amodimethicone polydimethylsiloxyethyl dimethicone/bisvinyldimethicone polyglyceryl-3/lauryl polydimethylsiloxyethyl dimethicone silicone quaternium-16/glycidoxy dimethicone styrene/acrylates/dimethicone acrylate trifluoropropyl dimethicone/peg-10 trifluoropropyl dimethicone/trifluoropropyl divinyldimethicone trifluoropropyl dimethicone/vinyl trifluoropropyl dimethicone/silsesquioxane trimethylsiloxysilicate/dimethicone vinyl dimethicone/lauryl/behenyl dimethicone vinyl dimethicone/lauryl dimethicone vinyl dimethicone/methicone silsesquioxane vinyldimethyl/trimethylsiloxysilicate/ dimethicone vinyldimethyl/trimethylsiloxysilicate stearyl dimethicone CIR Panel Book Page 11

15 Several of the components of these ingredients have been previously reviewed by the Cosmetic Ingredient Review Expert Panel (Panel) including dimethicone, which was found to be safe as a cosmetic ingredient (Table 2). 2 CHEMISTRY Overview Definitions, functions and CAS nos. are provided in Table 1. Idealized structures are shown in Figure 1. These cosmetic ingredients are silicone elastomers comprised of dimethicone copolymers crosslinked with a bifunctional agent. For use in cosmetics, these s are typically supplied to finishing houses as swollen gels (i.e., trade name mixtures) that contain various oils (e.g., silicone oils such as dimethicone). 3 The addition of hydrophilic components (e.g., addition of polyethylene glycol [PEG] chains to produce dimethicone/peg-10 ) or hydrophobic components (e.g., addition of long alkyl chains to produce behenyl dimethicone/bis-vinyldimethicone ) affects both the chemical and rheological properties of the resultant ingredient. Accordingly, dimethicone s represent a wide variety of materials ranging from liquids to elastomeric solids. The majority of the ingredients in this review are produced by crosslinking dimethicone polymeric chains via a hydrosilation reaction. 3 This reaction consists of the addition of silicon hydride bonds (SiH) within the dimethicone polymer backbones across vinyl bonds within the selected crosslinking agents (Figure 2). These reactions usually require a catalyst, such as platinum. The reactions are rapid and produce chemically stable products. Since these reactions are net additions across a double bond, the only expected by-products are the starting materials, particularly the catalysts. In some silicone polymers such as dimethicone, that has no silicone-hydrogen bonds, some amount of silicon hydride may exist. However, a silicone precursor polymer is made in order to add the silicon hydride groups that are utilized for the crosslinking process. 3 For example, a dimethicone precursor polymer is made by the copolymerization of dimethyl siloxane units with methylhydrogen siloxane units. Accordingly, even though we define dimethicone as a polymer of dimethicone crosslinked with a C3 to C20 alkyl group, it is more likely that dimethicone is a methicone/ dimethicone copolymer (methicone has one methyl and one hydrogen on each silicone in the polymer backbone, whereas dimethicone has two methyl groups on each silicone in the polymer backbone) that is crosslinked with an α,ω-diene (i.e., the double bonds are at the ends of the chain), that is three to twenty carbons long. Physical and Chemical Properties Available information on the physical and chemical properties is provided in Table 3. Other data are provided below. CROTONIC ACID/VINYL C8-12 ISOALKYL ESTERS/VA/BIS-VINYLDIMETHICONE CROSSPOLYMER Crotonic acid/vinyl C8-12 isoalkyl esters/va/bis-vinyldimethicone is stable at < 20 C in a sealed container protected from light for at least 12 months. 4 DIMETHICONE CROSSPOLYMER In a product containing 12% dimethicone mixed with cyclomethicone, the has a molecular weight of > 15,500 1,000,000 g/mol. 5 The product is a clear/slightly translucent paste. DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER Dimethicone/divinyldimethicone/silsesquioxane is stable at room temperature for 36 months. 6 DIMETHICONE/VINYLTRIMETHYLSILOXYSILICATE CROSSPOLYMER Dimethicone/vinyltrimethylsiloxysilicate is provided by a manufacturer as a mixture with cyclopentasiloxane creating a semitransparent gel with thixotropic properties. 7 PEG-12 DIMETHICONE CROSSPOLYMER PEG-12 Dimethicone is an amphiphilic molecule. 8 The PEG-12 moiety is hydrophilic and the dimethicone moiety is lipophilic. VINYLDIMETHYL/TRIMETHYLSILOXYSILICATE STEARYL DIMETHICONE CROSSPOLYMER Vinyldimethyl/trimethylsiloxysilicate stearyl dimethicone (20% in isododecane) is stable for at least 1 year with no special storage requirements. 9 This ingredient is provided by a manufacturer as a mixture with isododecane creating a semitransparent gel with thixotropic properties. Particle Size Dimethicone/divinyldimethicone/silsesquioxane was reported in a patent to have a spherical shape with particle diameters ranging from 2 10 μm. 10 However, the significance of this observation is questionable, because it is not likely that this range represents aerodynamic equivalent diameters of particulates that would be released in substantial quantities from aerosolized products containing this ingredient. Impurities CROTONIC ACID/VINYL C8-12 ISOALKYL ESTERS/VA/BIS-VINYLDIMETHICONE CROSSPOLYMER Crotonic acid/vinyl C8-12 isoalkyl esters/va/bis-vinyldimethicone is reported to not contain any heavy metals, polycyclic aromatic hydrocarbons organohalogens, or nitrosamines. 4 Residuals from manufacturing include 2 CIR Panel Book Page 12

16 tert-butanol (<100 ppm), iso-dodecane (< 1000 ppm), vinyl acetate ( 100 ppm), vinyl-tert, decanoate ( 2000 ppm), crotonic acid ( 200 ppm), and trace amounts of isopropanol and ethyl acetate. DIMETHICONE CROSSPOLYMER A manufacturer s product containing dimethicone was reported to have no hazardous impurities. 5 DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER Dimethicone/divinyldimethicone/silsesquioxane was reported to be 100% pure by a manufacturer. 6 The same manufacture reported the content of heavy metals to be <20 ppm, arsenic < 2 ppm. 11 DIMETHICONE/VINYLTRIMETHYLSILOXYSILICATE CROSSPOLYMER Dimethicone/vinyltrimethylsiloxysilicate dimethicone (20% in cyclopentasiloxane) is reported to not contain any heavy metals, polycyclic aromatic hydrocarbons, organohalogen compounds, or nitrosamines. 7 Residuals from manufacturing include platinum (catalyst, < 25 ppm) and cyclotetrasiloxane (maximum 0.1%). VINYLDIMETHYL/TRIMETHYLSILOXYSILICATE STEARYL DIMETHICONE CROSSPOLYMER Vinyldimethyl/trimethylsiloxysilicate stearyl dimethicone (20% in isododecane) is reported to not contain any heavy metals, polycyclic aromatic hydrocarbons, organohalogen compounds, or nitrosamines. 9 Residuals from manufacturing include platinum (catalyst, < 25 ppm) and cyclotetrasiloxane (maximum < 1%). USE Cosmetic Data on ingredients usage are provided by manufacturers to the Food and Drug Administration s (FDA) Voluntary Cosmetic Registration Program (VCRP) and a survey conducted by the Personal Care Products Council (Council) collected use concentrations for ingredients in this group (Table 3). 12,13 The VCRP and Council data wre available for: Behenyl dimethicone/bis-vinyldimethicone was used in 3 eyeliners at concentrations up to 10% (eye liners at 2-10%, lipstick %, foundation 0.001%). C30-45 alkyl cetearyl dimethicone was reported to be used in 23 leave-on (up to 10%; including 5 eye products) and 2 rinse-off products. Cetearyl dimethicone was reported to be used in 7 leave-on products (0.002%-23%) in rinse-off products (0.2%), and in products diluted for bath use (0.002%). Dimethicone/bis-isobutyl PPG-20 was reported to be used in 5 leave-on products (0.1%-2%; 1 lipstick). Dimethicone was reported to be used in 376 leave-on products (0.007%-15%; including 32 eye products, 9 lipsticks and 11 deodorants) and in 9 rinse-off products (0.02%-5%). Dimethicone -3 was reported to be used in 41 leave-on products (including 13 eye products) and in rinse-off products (0.2%). Dimethicone/divinyldimethicone/silsesquioxane was reported to be used in 12 leave-on products (0.5%-5%). Dimethicone/PEG-10/15 was reported to be used in 45 leave-on products (0.03%-3%) and in a hair conditioner (0.8%). Dimethicone/phenyl vinyl dimethicone was reported to be used in 9 leave-on products (0.8%-2%). Dimethicone/vinyl dimethicone was reported to be used in 413 leave-on products (0.003%-46%; including 1 baby product, 65 eye products, 9 lipsticks, and 55 products that may be inhaled) and 12 rinse-off products (0.06%-37%). Dimethicone/vinyltrimethylsiloxysilicate was reported to be used in 20 leave-on products (0.04%-6%; including eye products). Diphenyl dimethicone/vinyl diphenyl dimethicone/silsesquioxane was reported to be used in 13 leaveon products (0.1%-7%; up to 7% in face powders). Divinyldimethicone/dimethicone was reported to be used in 4 leave-on products (0.007%-0.7%). Lauryl dimethicone/ polyglycerin-3 was reported to be used in 3 rinse-off products (2%). PEG-10 dimethicone was reported to be used in 16 leave-on products (0.6%-2%). PEG-12 dimethicone was reported to be used in 22 leave-on products (0.3%-2%; 17 deodorants) and 3 rinse-off products (0.3%). PEG-10/lauryl dimethicone was reported to be used in leave-on products (0.5%-0.7%) and rinse-off products (0.6%). Perfluorononyl dimethicone/methicone/amodimethicone was reported to be used in lipstick (0.7%). Distributed for Comment - Do Not Cite or Quote Silicone quaternium-16/glycidoxy dimethicone was reported to be used in 2 leave-on products (0.003%) and 4 rinse-off products. Vinyl dimethicone/lauryl dimethicone was reported to be used in 1 makeup base but was reported to be used in multiple cosmetic products (0.09%-2%) by the Council (up to 0.3% in hair products and 2% in lipstick). 3 CIR Panel Book Page 13

17 Vinyl dimethicone/methicone silsesquioxane was reported to be used in 78 leave-on products (0.1%- 20%; mostly in make-up products) and 1 rinse off product (0.5%-0.6%). VCRP 12 only data were available for: C4-24 alkyl dimethicone/divinyldimethicone was reported to be used in 1 leave-on product (a moisturizer). Isopropyl titanium triisostearate/ triethoxysilylethyl polydimethylsiloxyethyl dimethicone was reported to be used in 5 leave-on products. PEG-12 dimethicone/ppg-20 was reported to be used in 3 leave-on and 3 rinse-off products. PEG-10 dimethicone/vinyl dimethicone was reported to be used in 7 leave-on products. PEG-15/lauryl dimethicone was reported to be used in 3 leave-on and 3 rinse-off products. Styrene/acrylates/ dimethicone acrylate was reported to be used in 1 nail polish product. Coucil 13 data were available for: Distributed for Comment - Do Not Cite or Quote Dimethicone/PEG-10 was reported to be used in leave-on products (0.5%; foundations). Dimethicone/PPG-20 was reported to be used in skin fresheners (0.2%). There were no reported uses in either the VCRP or in the Council survey for: acrylates/bis-hydroxypropyl dimethicone bis-phenylisopropyl phenylisopropyl dimethicone/vinyl dimethicone bis-vinyldimethicone/bis-isobutyl PPG-20 bis-vinyldimethicone bis-vinyldimethicone/ PEG-10 dimethicone bis-vinyldimethicone/ppg-20 butyldimethicone methacrylate/methyl methacrylate C30-45 alkyl dimethicone/polycyclohexene oxide cetearyl dimethicone/vinyl dimethicone cetyl dimethicone/bis-vinyldimethicone cetyl hexacosyl dimethicone/bisvinyldimethicone crotonic acid/vinyl C8-12 isoalkyl esters/va/bis-vinyldimethicone dimethicone/bis-vinyldimethicone/ silsesquioxane dimethicone/lauryl dimethicone/bisvinyldimethicone dimethicone/peg-15 dimethicone/polyglycerin-3 dimethicone/titanate diphenyl dimethicone hydroxypropyl dimethicone/polysorbate 20 lauryl dimethicone PEG-15 lauryl polydimethylsiloxyethyl dimethicone/bis-vinyldimethicone PEG-8 dimethicone/polysorbate 20 PEG-12 dimethicone/bis-isobutyl PPG-20 PEG-12 dimethicone/ppg-20 polydimethylsiloxyethyl dimethicone/bisvinyldimethicone polyglyceryl-3/lauryl polydimethylsiloxyethyl dimethicone trifluoropropyl dimethicone/peg-10 trifluoropropyl dimethicone/trifluoropropyl divinyldimethicone trifluoropropyl dimethicone/vinyl trifluoropropyl dimethicone/silsesquioxane trimethylsiloxysilicate/dimethicone vinyl dimethicone/lauryl/behenyl dimethicone vinyldimethyl/trimethylsiloxysilicate/ dimethicone vinyldimethyl/trimethylsiloxysilicate stearyl dimethicone Dimethicone, dimethicone/vinyl dimethicone, and PEG-12 dimethicone are used in cosmetic sprays, including hair and deodorant products, and could possibly be inhaled. In practice, 95% - 99% of the droplets/particles released from cosmetic sprays have aerodynamic equivalent diameters > 10 μm, with propellant sprays yielding a greater fraction of droplets/particles below 10 μm compared with pump sprays. 14,15 Therefore, most droplets/particles incidentally inhaled from cosmetic sprays would be deposited in the nasopharyngeal region and would not 4 CIR Panel Book Page 14

18 be respirable (i.e., they would not enter the lungs) to any appreciable amount. 16,17 However, the potential for inhalation toxicity is not limited to respirable droplets/ particles deposited in the lungs. Inhaled droplets/particles deposited in the nasopharyngeal and thoracic regions of the respiratory tract may cause toxic effects depending on their chemical and other properties. There is some evidence indicating that deodorant spray products can release substantially larger fractions of particulates having aerodynamic equivalent diameters in the range considered to be respirable. 18 However, the information is not sufficient to determine whether significantly greater lung exposures result from the use of deodorant sprays compared to other cosmetic sprays. TOXICOKINETICS Absorption, Distribution, Metabolism, and Excretion Dermal/Percutaneous No data were discovered on the dermal or percutaneous toxicokinetics of these ingredients. However, data were submitted on related ingredients. CROTONIC ACID/VINYL C8-12 ISOALKYL ESTERS/VA/BIS-VINYLDIMETHICONE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymers, crotonic acid/vinyl C8-12 isoalkyl esters/va/bis-vinyldimethicone is unlikely to have any skin absorption due to the polymeric nature of the chemical. 19 No further data on the similar polymers were provided. DIMETHICONE/VINYLTRIMETHYLSILOXYSILICATE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymers, dimethicone/vinyltrimethylsiloxysilicate is unlikely to penetrate the skin. 7 No further data on the similar polymers were provided. VINYLDIMETHYL/TRIMETHYLSILOXYSILICATE STEARYL DIMETHICONE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymer, vinyldimethyl/trimethylsiloxysilicate stearyl dimethicone is unlikely to penetrate the skin. 9 No further data on the similar polymers were provided. Oral and Inhalation No data were discovered on the oral or inhalation toxicokinetics of these ingredients. TOXICOLOGICAL STUDIES Acute Toxicity Dermal Non-Human CROTONIC ACID/VINYL C8-12 ISOALKYL ESTERS/VA/BIS-VINYLDIMETHICONE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymers, the acute dermal LD 50 for crotonic acid/vinyl C8-12 isoalkyl esters/va/bis-vinyldimethicone for rats was estimated to be > 2000 mg/kg. 4 No further data on the similar polymers were provided. DIMETHICONE CROSSPOLYMER Dimethicone is reported to have a dermal LD 50 of > 2000 mg/kg in rabbits (n = 5/sex). 5 There were no deaths or clinical signs. DIMETHICONE/VINYLTRIMETHYLSILOXYSILICATE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymers, the acute dermal LD 50 for dimethicone/vinyltrimethylsiloxysilicate for rats was estimated to be > 2000 mg/kg. 9 No further data on the similar polymers were provided. VINYLDIMETHYL/TRIMETHYLSILOXYSILICATE STEARYL DIMETHICONE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymers, the acute dermal LD 50 of vinyldimethyl/ trimethylsiloxysilicate stearyl dimethicone for rats was expected to be > 2000 mg/kg. 9 No further data on the similar polymers were provided. Oral Non-Human CROTONIC ACID/VINYL C8-12 ISOALKYL ESTERS/VA/BIS-VINYLDIMETHICONE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymers, the acute oral LD 50 of crotonic acid/vinyl C8-12 isoalkyl esters/va/bis-vinyldimethicone for rats is estimated to be > 2000 mg/kg. 4 No further data on the similar polymers were provided. DIMETHICONE CROSSPOLYMER The oral LD 50 of dimethicone was reported to be > 2000 mg/kg for rats (n = 5/sex). 5 There were no deaths or clinical signs of toxicity. DIMETHICONE/VINYLTRIMETHYLSILOXYSILICATE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymers, the acute oral LD 50 for dimethicone/ vinyltrimethylsiloxysilicate for rats is estimated to be > CIR Panel Book Page 15

19 mg/kg. 7 No further data on the similar polymers were provided. VINYLDIMETHYL/TRIMETHYLSILOXYSILICATE STEARYL DIMETHICONE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymers, the acute oral LD 50 of vinyldimethyl/trimethylsiloxysilicate stearyl dimethicone for rats is expected to be > 2000 mg/kg. 9 No further data on the similar polymers were provided. Inhalation Non-Human CROTONIC ACID/VINYL C8-12 ISOALKYL ESTERS/VA/BIS-VINYLDIMETHICONE CROSSPOLYMER The acute inhalation LC 50 of crotonic acid/vinyl C8-12 isoalkyl esters/va/bis-vinyldimethicone (10% in ethanol/water, 4 h) for rats was > 5.29 mg/l. 4 In Vitro DIMETHICONE/BIS-VINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER In an agar diffusion cytotoxicity test, dimethicone/bis-vinyldimethicone/silsesquioxane (concentration not provided, 100% assumed) was not cytotoxic to mammal cell cultures (type of cell not provided). 20 Dermal Repeated Dose Toxicity No repeated dose dermal toxicity studies were discovered for these ingredients. Oral Non-Human No repeated dose oral toxicity studies were discovered for these ingredients. Inhalation Non-Human No repeated dose inhalation studies were discovered for these ingredients. REPRODUCTIVE AND DEVELOPMENTAL TOXICITY No primary reproductive or developmental toxicity studies were discovered. DIMETHICONE/VINYLTRIMETHYLSILOXYSILICATE CROSSPOLYMER According to a supplier of a trade name mixture, based on the chemical structure of a similar polymer, dimethicone/vinyltrimethylsiloxysilicate is not expected to be a reproductive toxicant. 7 No further data on the similar polymers were provided. GENOTOXICITY DIMETHICONE CROSSPOLYMER Dimethicone ( μg/plate) was not mutagenic to Salmonella typhimurium (strains TA98, TA100, TA1535 and TA1537) and Escherichia coli (WP2uvrA (pkm101) and WP2 (pkm101) with or without metabolic activation. 5 In Vitro CROTONIC ACID/VINYL C8-12 ISOALKYL ESTERS/VA/BIS-VINYLDIMETHICONE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymers, crotonic acid/vinyl C8-12 isoalkyl esters/va/bis-vinyldimethicone is not expected to be mutagenic. 4 No further data on the similar polymers were provided. DIMETHICONE/VINYLTRIMETHYLSILOXYSILICATE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymers, dimethicone/vinyltrimethylsiloxysilicate is not expected to be mutagenic. 7 No further data on the similar polymers were provided. VINYLDIMETHYL/TRIMETHYLSILOXYSILICATE STEARYL DIMETHICONE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymers, vinyldimethyl/trimethylsiloxysilicate stearyl dimethicone is not expected to be mutagenic. 9 No further data on the similar polymers were provided. CARCINOGENICITY No carcinogenicity studies were discovered on these ingredients. DIMETHICONE/VINYLTRIMETHYLSILOXYSILICATE CROSSPOLYMER According to a supplier of a trade name mixture, based on the chemical structure of similar polymers, dimethicone/ vinyltrimethylsiloxysilicate is not expected to be carcinogenic. 7 No further data on the similar polymers 6 CIR Panel Book Page 16

20 were provided. IRRITATION AND SENSITIZATION Irritation Dermal Non-Human CROTONIC ACID/VINYL C8-12 ISOALKYL ESTERS/VA/BIS-VINYLDIMETHICONE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymers, crotonic acid/vinyl C8-12 isoalkyl esters/va/bis-vinyldimethicone is not expected to be dermally irritating. 4 No further data on the similar polymers were provided. DIMETHICONE CROSSPOLYMER Dimethicone (100%; 0.5 ml) was not dermally irritating when administered to female New Zealand White rabbits (n = 3) under semi-occlusion for 4 h. 5 DIMETHICONE/VINYLTRIMETHYLSILOXYSILICATE CROSSPOLYMER Dimethicone/vinyltrimethylsiloxysilicate was not dermally irritating to rabbits. 7 No further information was provided. Dermal Human No human dermal irritation tests were discovered for these ingredients. Mucosal No mucosal irritation data were discovered for these ingredients. Ocular DIMETHICONE CROSSPOLYMER Dimethicone (100%; 0.1 ml) was not an ocular irritant to male New Zealand White rabbits (n = 3). 5 There were no iris or corneal effects observed. DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER In a Skin ZK-1200 (tissue equivalent) ocular assay, dimethicone/phenyl vinyl dimethicone (25 μl) was not predicted to by an ocular irritant after 30 min of exposure. 21 DIMETHICONE/VINYLTRIMETHYLSILOXYSILICATE CROSSPOLYMER Dimethicone/vinyltrimethylsiloxysilicate was not an ocular irritant to rabbits. 7 No further information was provided. Sensitization Dermal Non-Human CROTONIC ACID/VINYL C8-12 ISOALKYL ESTERS/VA/BIS-VINYLDIMETHICONE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics of data on similar polymers, crotonic acid/vinyl C8-12 isoalkyl esters/va/bis-vinyldimethicone is not expected to be sensitizing. 4 No further data on the similar polymers were provided. DIMETHICONE CROSSPOLYMER Dimethicone (100%) was not sensitizing to the clipped backs of Hartley guinea pigs (n = 10/sex). 5 There was no difference between the treatment and control groups. DIMETHICONE/VINYLTRIMETHYLSILOXYSILICATE CROSSPOLYMER According to a supplier of a trade name mixture, based on physico-chemical characteristics and data on similar polymers, dimethicone/vinyltrimethylsiloxysilicate is not expected to be sensitizing. 7 No further data on the similar polymers were provided. VINYLDIMETHYL/TRIMETHYLSILOXYSILICATE STEARYL DIMETHICONE CROSSPOLYMER Vinyldimethyl/trimethylsiloxysilicate stearyl dimethicone (20% in isododecane) was not sensitizing to guinea pigs. 9 Dermal Human DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER In a human repeated insult patch test (HRIPT; n = 55) of dimethicone/divinyldimethicone/silsesquioxane (30% in corn oil), there were no adverse reactions of any kind during the course of this study. 23 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER In two modified human repeated insult patch tests (n = 107), a facial lotion containing dimethicone/vinyl dimethicone (1%) was not sensitizing CIR Panel Book Page 17

21 Phototoxicity No phototoxicity studies were discovered for these ingredients. SUMMARY This is a safety assessment of 62 dimethicone s as used in cosmetics. These ingredients function as absorbents, bulking agents, film formers, hair conditioning agents, skin-conditioning agents-emollient, slip modifiers, surface modifiers, and viscosity increasing agents-nonaqueous. The dimethicone ingredients in this report are silicone elastomers comprised of dimethicone copolymers that are crosslinked with a bi-functional agent. Dimethicone/divinyldimethicone/silsesquioxane has a spherical shape with a particle diameter ranging from 2 10 μm. Dimethicone s are reported to not contain any heavy metals, polycyclic aromatic hydrocarbons, organohalogen compounds, or nitrosamines. Residuals from manufacturing include platinum and cyclotetrasiloxane. The VCRP reported that behenyl dimethicone/bis-vinyldimethicone was used in 3 eyeliners; the Council reports that it is used up to 10%. C30-45 alkyl cetearyl dimethicone was reported to be used in 23 leave-on (up to 10%) and 2 rinse-off products. Cetearyl dimethicone was reported to be used in 7 leave-on products (up to 23%) in rinse-off products (0.2%), and in products diluted for bath use (0.002%). Dimethicone/bis-isobutyl PPG-20 was reported to be used in 5 leave-on products (up to 2%). Dimethicone was reported to be used in 376 leave-on products (up to 15%) and in 9 rinse-off products (up to 5%). Dimethicone -3 was reported to be used in 41 leave-on products and in rinse-off products (up to 0.2%). Dimethicone/divinyldimethicone/silsesquioxane was reported to be used in 12 leave-on products (up to 5%). Dimethicone/PEG-10/15 was reported to be used in 45 leave-on products (up to 3%) and is reported in a hair conditioner (0.8%). Dimethicone/phenyl vinyl dimethicone was reported to be used in 9 leave-on products (up to 2%). Dimethicone/vinyl dimethicone was reported to be used in 413 leave-on products (up to 46%) and 12 rinse-off products (up to 37%). Dimethicone/vinyltrimethylsiloxysilicate is used in 20 leave-on products (up to 6%). Diphenyl dimethicone/vinyl diphenyl dimethicone/silsesquioxane is used in 13 leave-on products (up to 7%). Divinyldimethicone/dimethicone was reported to be used in 4 leave-on products (up to 0.7%). Lauryl dimethicone/ polyglycerin-3 was reported to be used in 3 rinse-off products (2%). PEG-10 dimethicone was reported to be used in 16 leave-on products (up to 2%). PEG-12 dimethicone was reported to be used in 22 leave-on products (up to 2%) and 3 rinse-off products (0.3%). PEG-12 dimethicone was reported to be used in 22 leave-on products (up to 2%) and 3 rinse-off products (0.3%). PEG-10/lauryl dimethicone was reported to be used in leave-on products (up to 0.7%) and rinse-off products (0.6%). Perfluorononyl dimethicone/methicone/ amodimethicone was reported to be used in lipstick (0.7%). Silicone quaternium- 16/glycidoxy dimethicone was reported to be used in 2 leave-on products (0.003%) and 4 rinse-off products. Vinyl dimethicone/lauryl dimethicone was reported to be used in 1 makeup base but is reported to be used in multiple cosmetic products (up to 2%). Vinyl dimethicone/methicone silsesquioxane is used in 78 leave-on products (up to 20%) and 1 rinse off product (up to 0.6%). The VCRP reported that C4-24 alkyl dimethicone/divinyldimethicone was used in 1 leave-on product. Isopropyl titanium triisostearate/ triethoxysilylethyl polydimethylsiloxyethyl dimethicone was reported to be used in 5 leave-on products. PEG-12 dimethicone/ppg-2 is used in 3 leave-on and 3 rinse-off products. PEG- 10 dimethicone/vinyl dimethicone was reported to be used in 7 leave-on products. PEG-15/lauryl dimethicone was reported to be used in 3 leave-on and 3 rinse-off products. Styrene/acrylates/ dimethicone acrylate is reported to be used in 1 nail polish product. The Council reported that dimethicone/peg-10 was used in leave-on products (0.5%). Dimethicone/PPG-20 was reported to be used in skin fresheners (0.2%). Dimethicone had a dermal LD 50 of > 2000 mg/kg in rabbits. The oral LD 50 of dimethicone was > 2000 mg/kg for rats. The acute inhalation LC 50 of crotonic acid/vinyl C8-12 isoalkyl esters/va/bisvinyldimethicone at 10% over 4 h for rats was > 5.29 mg/l. In an agar diffusion cytotoxicity test, dimethicone/bis-vinyldimethicone/silsesquioxane was not cytotoxic to mammal cell cultures. The acute inhalation LC 50 of crotonic acid/vinyl C8-12 isoalkyl esters/va/bis-vinyldimethicone (10% in ethanol/water, 4 h) for rats was > 5.29 mg/l. Dimethicone was not mutagenic to S. typhimurium and E. coli with or without metabolic activation up to 1000 μg/plate. Dimethicone was not dermally irritating when administered to rabbits at 100%. Dimethicone/vinyltrimethylsiloxysilicate was not dermally irritating to rabbits. Dimethicone was not an ocular irritant to rabbits at 100%. In a Skin ZK-1200 ocular assay, dimethicone/phenyl vinyl dimethicone was not predicted to be an ocular irritant. Dimethicone/vinyltrimethylsiloxysilicate was not an ocular irritant to rabbits. Dimethicone was not sensitizing to guinea pigs at 100%. Vinyldimethyl/trimethylsiloxysilicate stearyl dimethicone was not sensitizing to guinea pigs. 8 CIR Panel Book Page 18

22 A product containing dimethicone/vinyl dimethicone at 1% was not sensitizing in an HRIPT. In an HRIPT of dimethicone/divinyldimethicone/silsesquioxane at 30%, there were no adverse reactions of any kind during the course of this study. DISCUSSION [The Panel will develop the discussion at the June, 2012 meeting] CONCLUSION [The Panel will develop the conclusion at the June, 2012 meeting] 9 CIR Panel Book Page 19

23 TABLES AND FIGURES Table 1. Definitions and functions of the ingredients in this safety assessment. 1 (The italicized text below represents additions made by CIR staff.) Ingredient CAS No. Definition Function Acrylates/Bis-Hydroxypropyl Dimethicone Behenyl Dimethicone/Bis- Vinyldimethicone Bis-Phenylisopropyl Phenylisopropyl Dimethicone/ Vinyl Dimethicone Bis-Vinyldimethicone/Bis- Isobutyl PPG-20 Bis-Vinyldimethicone Bis-Vinyldimethicone/PEG-10 Dimethicone Bis-vinyldimethicone/PPG-20 Butyldimethicone Methacrylate/Methyl Methacrylate C30-45 Alkyl Cetearyl Dimethicone C4-24 Alkyl Dimethicone/ Divinyldimethicone C30-45 Alkyl Dimethicone/ Polycyclohexene Oxide Cetearyl Dimethicone Cetearyl Dimethicone/Vinyl Dimethicone Cetyl Dimethicone/Bis- Vinyldimethicone Cetyl Hexacosyl Dimethicone/ Bis-Vinyldimethicone Crotonic Acid/Vinyl C8-12 Isoalkyl Esters/VA/Bis- Vinyldimethicone Dimethicone/Bis-Isobutyl PPG- 20 Distributed for Comment - Do Not Cite or Quote Acrylates/Bis-Hydroxypropyl Dimethicone is a crosslinked polymer of bis-hydroxypropyl dimethicone, and one or more monomers consisting of acrylic acid, methacrylic acid, or one of their simple esters. Herein, simple esters means methyl, ethyl, propyl, or butyl esters. Behenyl Dimethicone/Bis-Vinyldimethicone is structurally defined. It is a copolymer of behenyl dimethicone crosslinked with divinyl dimethicone. Bis-Phenylisopropyl Phenylisopropyl Dimethicone/Vinyl Dimethicone is a copolymer of phenylisopropyl dimethicone crosslinked with vinyl dimethicone. Bis-Vinyldimethicone/Bis-Isobutyl PPG-20 is a crosslinked polymer of Bis-Vinyldimethicone partially crosslinked with methylhydrogen cyclic siloxanes and then further crosslinked with bis-methallyl PPG-20. Bis-Vinyldimethicone is structurally defined. It is a copolymer of Dimethicone crosslinked with divinyl dimethicone. Bis-Vinyldimethicone/PEG-10 Dimethicone is a copolymer of PEG-10 Dimethicone crosslinked with Vinyl Dimethicone. Bis-vinyldimethicone/PPG-20 is a crosslinked polymer of bis-vinyldimethicone partially crosslinked with methylhydrogen cyclic siloxanes and the further crosslinked with bis-ally PPG-20. Butyldimethicone Methacrylate/Methyl Methacrylate is a copolymer of butyl dimethicone methacrylate and methyl methacrylate monomers crosslinked with ethylene glycol dimethacrylate. C30-45 Alkyl Cetearyl Dimethicone is a copolymer of C30-45 alkyl cetearyl dimethicone crosslinked with vinyl cyclohexene oxide. C4-24 Alkyl Dimethicone/Divinyldimethicone is a copolymer of C4-24 alkyl dimethicone crosslinked with divinyldimethicone. C30-45 Alkyl Dimethicone/Polycyclohexene Oxide is C30-45 Alkyl Dimethicone cross-linked with a polyether made from vinyl cyclohexene oxide. Cetearyl Dimethicone is a copolymer of cetearyl dimethicone crosslinked with vinyl cyclohexene oxide. Cetearyl Dimethicone/Vinyl Dimethicone is a copolymer of cetearyl dimethicone crosslinked with vinyl dimethylpolysiloxane. Cetyl Dimethicone/Bis-Vinyldimethicone is structurally defined. It is a copolymer of cetyl dimethicone crosslinked with divinyl dimethicone. Cetyl Hexacosyl Dimethicone/Bis-Vinyldimethicone is a crosslinked polymer of cetyl hexacosyl dimethicone and bis-vinyldimethicone. Crotonic Acid/Vinyl C8-12 Isoalkyl Esters/VA/Bis- Vinyldimethicone is a copolymer of crotonic acid, vinyl C8-12 isoalkyl esters and vinyl acetate crosslinked with bis-vinyldimethicone. Dimethicone/Bis-Isobutyl PPG-20 is a crosslinked polymer of Hydrogen Dimethicone crosslinked with bis-methallyl PPG CIR Panel Book Page 20 Absorbent, film former, skin protectant, viscosity increasing agent-nonaqueous Skin-conditioning agent-emollient Humectant None listed Emulsion stabilizer, film former, skin-conditioning agentmiscellaneous, slip modifier, viscosity increasing agentnonaqueous Skin-conditioning agentemollient; viscosity increasing agent-nonaqueous Film former, hair conditioning agent, skin-conditioning agentemollient Dispersing agent-nonsurfactant, film former, skin-conditioning agent-occlusive, slip modifier, viscosity increasing agentnonaqueous Dispersing agent-nonsurfactant, film former, skin-conditioning agent-occlusive, slip modifier, viscosity increasing agentnonaqueous Dispersing agent-nonsurfactant, film former, skin-conditioning agent-occlusive, slip modifier, viscosity increasing agentnonaqueous Film former; hair fixative Film former; hair fixative Skin-conditioning agent-emollient Skin-conditioning agent-emollient Film former; hair conditioning agent; hair fixative Skin-conditioning agentsemollient; viscosity increasing agent-nonaqueous

24 Table 1. Definitions and functions of the ingredients in this safety assessment. 1 (The italicized text below represents additions made by CIR staff.) Ingredient CAS No. Definition Function Dimethicone/Bis- Vinyldimethicone/ Silsesquioxane Dimethicone/Bis-Vinyldimethicone/Silsesquioxane is a copolymer of dimethicone, bis-vinyldimethicone and silsesquioxane monomers. Skin-conditioning agentmiscellaneous Dimethicone [CAS No. is specific to C5] Dimethicone -3 Dimethicone/ Divinyldimethicone/ Silsesquioxane Dimethicone/Lauryl Dimethicone/Bis- Vinyldimethicone Dimethicone/ PEG-10 Dimethicone/ PEG-10/15 Dimethicone/ PEG-15 Dimethicone/ Phenyl Vinyl Dimethicone Dimethicone/Polyglycerin-3 Dimethicone/PPG-20 Dimethicone/Titanate Dimethicone/Vinyl Dimethicone Dimethicone/ Vinyltrimethylsiloxysilicate Diphenyl Dimethicone Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/ Silsesquioxane Divinyldimethicone/ Dimethicone Hydroxypropyl Dimethicone/ Polysorbate 20 Isopropyl Titanium Triisostearate/ Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone Distributed for Comment - Do Not Cite or Quote Dimethicone is a polymer of dimethicone crosslinked with a C3 to C20 alkyl group. Dimethicone -3 is structurally defined. It is a polymer of dimethicone, crosslinked with ethylene linkages to form cyclized-like repeat units. Dimethicone/Divinyldimethicone/Silsesquioxane is a crosslinked copolymer of dimethicone, divinyldimethicone, and silsesquioxane monomers. Dimethicone/Lauryl Dimethicone/Bis-Vinyldimethicone is a copolymer of dimethicone and lauryl dimethicone crosslinked with bis-vinyl dimethicone. Dimethicone/PEG-10 is a copolymer of dimethylpolysiloxane crosslinked with diallyl PEG-10. Dimethicone/PEG-10/15 is a copolymer of dimethicone crosslinked with a mixture of PEG-10 and PEG-15 diallyl ethers. Dimethicone/PEG-15 is a polymer of dimethicone crosslinked with PEG-15 diallyl ether. Dimethicone/Phenyl Vinyl Dimethicone is a copolymer of dimethylpolysiloxane crosslinked with phenyl vinyl dimethylpolysiloxane. Dimethicone/Polyglycerin-3 is the polymer of dimethicone crosslinked with diallyl polyglycerin-3. Dimethicone/PPG-20 is a crosslinked polymer of hydrogen dimethicone crosslinked with bisallyl PPG-20. Dimethicone/Titanate is the crosslinked polymer formed by the reaction of titanium tetraisopropoxide and methoxy dimethicone. Dimethicone/Vinyl Dimethicone is a copolymer of dimethylpolysiloxane crosslinked with vinyl dimethylpolysiloxane. Dimethicone/Vinyltrimethylsiloxysilicate is a copolymer of dimethylpolysiloxane crosslinked with vinyltrimethylsiloxysilicate. Diphenyl Dimethicone is crosslinked Diphenyl Dimethicone. Wherein the crosslinking agent is not disclosed. Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane is a crosslinked copolymer of diphenyl dimethicone, vinyl diphenyl dimethicone and silsesquioxane monomers. Divinyldimethicone/Dimethicone is dimethicone crosslinked with divinyldimethicone. Hydroxypropyl Dimethicone/Polysorbate 20 is a copolymer of hydroxypropyldimethicone and polysorbate 20 crosslinked with succinic acid. Isopropyl Titanium Triisostearate/Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone is a complex polymer formed by the hydrolysis and condensation of isopropyl titanium triisostearate with triethoxysilylethyl polydimethylsiloxyethyl dimethicone. 11 CIR Panel Book Page 21 Dispersing agent-nonsurfactant; emulsion stabilizer; hair fixative; viscosity increasing agentnonaqueous Skin-conditioning agentmiscellaneous; slip modifier Anticaking agent; humectant; skin protectant; viscosity increasing agent-nonaqueous Emulsion stabilizer; skinconditioning agent-miscellaneous; viscosity increasing agentnonaqueous Skin-conditioning agentemollient; surfactant-dispersing agent; surfactant-emulsifying agent; viscosity increasing agentaqueous None reported Deodorant agent; emulsion stabilizer; skin-conditioning agent-miscellaneous; sunscreen agent; surfactant-dispersing agent; surfactant-emulsifying agent; viscosity increasing agentaqueous Viscosity increasing agentnonaqueous Skin-conditioning agentmiscellaneous; surfactantcleansing agent; surfactantemulsifying agent; surfactantsolubilizing agent; viscosity increasing agent-nonaqueous Skin-conditioning agentemollient; viscosity increasing agent-nonaqueous Bulking agent Viscosity increasing agentnonaqueous Film former; viscosity increasing agent-nonaqueous Skin-conditioning agentmiscellaneous; slip modifier Viscosity increasing agentnonaqueous Film former; skin-conditioning agent-miscellaneous; viscosity increasing agent-nonaqueous Hair fixatives Surface modifier

25 Table 1. Definitions and functions of the ingredients in this safety assessment. 1 (The italicized text below represents additions made by CIR staff.) Ingredient CAS No. Definition Function Lauryl Dimethicone PEG-15 Lauryl Dimethicone/ Polyglycerin-3 Lauryl Polydimethylsiloxyethyl Dimethicone/Bis- Vinyldimethicone PEG-10 Dimethicone PEG-12 Dimethicone PEG-8 Dimethicone/ Polysorbate 20 PEG-12 Dimethicone/Bis- Isobutyl PPG-20 PEG-12 Dimethicone/ PPG-20 PEG-10 Dimethicone/ Vinyl Dimethicone PEG-10/Lauryl Dimethicone PEG-15/Lauryl Dimethicone PEG-15/Lauryl Polydimethylsiloxyethyl Dimethicone Perfluorononyl Dimethicone/ Methicone/Amodimethicone Polydimethylsiloxyethyl Dimethicone/Bis- Vinyldimethicone Polyglyceryl-3/Lauryl Polydimethylsiloxyethyl Dimethicone Silicone Quaternium-16/ Glycidoxy Dimethicone Styrene/Acrylates/ Dimethicone Acrylate Trifluoropropyl Dimethicone/ PEG-10 Distributed for Comment - Do Not Cite or Quote Lauryl Dimethicone PEG-15 is a crosslinked copolymer formed from diallyl PEG-15 and lauryl dimethicone. Lauryl Dimethicone/Polyglycerin-3 is a polymer of lauryl dimethicone crosslinked with diallyl polyglycerin-3. Lauryl Polydimethylsiloxyethyl Dimethicone/Bis- Vinyldimethicone is a copolymer of lauryl polydimethylsiloxyethyl dimethicone crosslinked by bisvinyldimethicone PEG-10 Dimethicone is a crosslinked copolymer formed from diallyl PEG-10 and dimethicone PEG-12 Dimethicone is a copolymer of PEG-12 dimethicone crosslinked with a C3-20 diene. PEG-8 Dimethicone/Polysorbate 20 is a copolymer of a complex mixture of esters formed from the reaction of PEG-8 dimethicone and polysorbate 20 crosslinked with succinic acid. PEG-12 Dimethicone/Bis-Isobutyl PPG-20 is a polymer of PEG-12 dimethicone crosslinked with bismethallyl PPG-20. PEG-12 Dimethicone/PPG-20 is a crosslinked polymer of hydrogen dimethicone crosslinked with bis-allyl PPG-20. PEG-10 Dimethicone/Vinyl Dimethicone is PEG-10 dimethicone crosslinked with vinyl dimethicone PEG-10/Lauryl Dimethicone is a copolymer of Lauryl Dimethicone crosslinked with diallyl PEG-10. PEG-15/Lauryl Dimethicone is a copolymer of lauryl dimethicone crosslinked with diallyl PEG-15. PEG-15/Lauryl Polydimethylsiloxyethyl Dimethicone is a copolymer of lauryl polydimethylsiloxyethyl dimethicone crosslinked with diallyl PEG-15. Perfluorononyl Dimethicone/Methicone/Amodimethicone is a crosslinked silicone polymer that is formed by reacting a copolymer of perfluorononyl dimethicone and methicone with methicone and amodimethicone Polydimethylsiloxyethyl Dimethicone/Bis- Vinyldimethicone is a copolymer of polydimethylsiloxyethyl dimethicone crosslinked with bisvinyldimethicone Polyglyceryl-3/Lauryl Polydimethylsiloxyethyl Dimethicone is a copolymer of lauryl polydimethylsiloxyethyl dimethicone crosslinked with an diallyl polyglyceryl-3. Silicone Quaternium-16/Glycidoxy Dimethicone is silicone quaternium-16 that has been crosslinked with glycidoxy dimethicone. Styrene/Acrylates/Dimethicone Acrylate is a copolymer of styrene, dimethicone acrylate and one or more monomers of acrylic acid, methacrylic acid or one of their simple esters crosslinked with divinylbenzene. Herein, simple esters means methyl, ethyl, propyl, or butyl esters Trifluoropropyl Dimethicone/PEG-10 is a polymer of trifluoropropyl dimethicone crosslinked with PEG-10 diallyl ether. Surfactant-dispersing agent; surfactant-emulsifying agent; viscosity increasing agentaqueous Skin-conditioning agentmiscellaneous; surfactantcleansing agent; surfactantemulsifying agent; surfactantsolubilizing agent; viscosity increasing agent-nonaqueous Viscosity increasing agentnonaqueous Viscosity increasing agentnonaqueous Dispersing agent-nonsurfactant; emulsion stabilizer; surfactantemulsifying agent; viscosity increasing agent-nonaqueous Emulsion stabilizer None reported Skin-conditioning agent-emollient Skin protectants; viscosity increasing agents-nonaqueous Surfactant-dispersing agent; viscosity increasing agentaqueous Viscosity increasing agentaqueous Viscosity increasing agentnonaqueous Slip modifier; surface modifier Viscosity increasing agentnonaqueous Viscosity increasing agentnonaqueous Hair conditioning agent; hair fixative Skin-conditioning agentmiscellaneous Skin-conditioning agentmiscellaneous; surfactantdispersing agent; surfactantemulsifying agent; viscosity increasing agent-nonaqueous 12 CIR Panel Book Page 22

26 Table 1. Definitions and functions of the ingredients in this safety assessment. 1 (The italicized text below represents additions made by CIR staff.) Ingredient CAS No. Definition Function Trifluoropropyl Dimethicone/ Trifluoropropyl Divinyldimethicone Trifluoropropyl Dimethicone/Trifluoropropyl Divinyldimethicone is a copolymer of trifluoropropyl dimethicone crosslinked with trifluoropropyl divinyldimethicone. Skin-conditioning agentmiscellaneous; surfactantdispersing agent; viscosity increasing agent-nonaqueous Trifluoropropyl Dimethicone/Vinyl Trifluoropropyl Dimethicone/ Silsesquioxane Trimethylsiloxysilicate/ Dimethicone Vinyl Dimethicone/Lauryl/ Behenyl Dimethicone Vinyl Dimethicone/ Lauryl Dimethicone Vinyl Dimethicone/ Methicone Silsesquioxane Vinyldimethyl/ Trimethylsiloxysilicate/ Dimethicone Vinyldimethyl/ Trimethylsiloxysilicate Stearyl Dimethicone Distributed for Comment - Do Not Cite or Quote Trifluoropropyl Dimethicone/Vinyl Trifluoropropyl Dimethicone/Silsesquioxane is a crosslinked copolymer of trifluoropropyl dimethicone, vinyl trifluoropropyl dimethicone and silsesquioxane monomers. Trimethylsiloxysilicate/Dimethicone is the product of the reaction between dimethicone and trimethylsiloxysilicate under conditions that produce rearrangement, condensation, and crosslinking of the dimethicone polymer onto the trimethylsiloxysilicate resin. Vinyl Dimethicone/Lauryl/Behenyl Dimethicone is lauryl/behenyl dimethicone crosslinked with divinyl dimethicone. Vinyl Dimethicone/Lauryl Dimethicone is lauryl dimethicone crosslinked with divinyl dimethicone. Vinyl Dimethicone/Methicone Silsesquioxane is a copolymer of methicone silsesquioxane crosslinked with bis-vinyl dimethylpolysiloxane. Monograph in development Vinyldimethyl/Trimethylsiloxysilicate Stearyl Dimethicone is stearyl methicone crosslinked with bis-vinyldimethyl/trimethylsiloxysilicate. Viscosity increasing agentnonaqueous Antifoaming agent Skin-conditioning agentmiscellaneous Surfactant-dispersing agent; viscosity increasing agentnonaqueous Viscosity increasing agentnonaqueous None reported Absorbent; bulking agent; film former; viscosity increasing agent-nonaqueous Table 2. Component ingredients previously reviewed by CIR. Component ingredient Conclusion Reference Acrylates copolymer Safe for use in cosmetic ingredients when formulated to avoid skin irritation 24 Dimethicone, methicone, vinyl Safe as a cosmetic ingredient 2 dimethicone PEG-8, -10, -15, -12, Safe in the present practices of use and concentration 25 Polysorbate 20 Safe as a cosmetic ingredient in the concentration of present use 26 PPG-20 Safe for use in cosmetic products at concentrations up to 50% 27,28 Trimethylsiloxysilicate Safe as used when formulated and delivered in the final product to be not irritating or sensitizing to the respiratory tract 29 Table 3. Chemical and physical properties of dimethicone s Property Value Reference No data were discovered. No data were discovered. Acrylates/bis-hydroxypropyl dimethicone Behenyl dimethicone/bis-vinyldimethicone Bis-phenylisopropyl phenylisopropyl dimethicone/vinyl dimethicone No data were discovered. No data were discovered. Bis-vinyldimethicone/bis-isobutyl ppg-20 Bis-vinyldimethicone 13 CIR Panel Book Page 23

27 Table 3. Chemical and physical properties of dimethicone s Property Value Reference No data were discovered. No data were discovered. No data were discovered. Bis-vinyldimethicone/peg-10 dimethicone Bis-vinyldimethicone/ppg-20 Butyldimethicone methacrylate/methyl methacrylate No data were discovered. No data were discovered. C30-45 alkyl cetearyl dimethicone C4-24 alkyl dimethicone/divinyldimethicone No data were discovered. C30-45 alkyl dimethicone/polycyclohexene oxide No data were discovered. No data were discovered. Cetearyl dimethicone Cetearyl dimethicone/vinyl dimethicone No data were discovered. Physical form Water solubility 1% & 10% Other solubility isopropyl alcohol 1% & 10% mineral spirits 1% & 10% mineral Oil 1% & 10% aromatic Solvents 1% & 10% cyclo methicone 1% & 10% Cetyl dimethicone/bis-vinyldimethicone Liquid Insoluble Insoluble Soluble Soluble Soluble Soluble Cetyl hexacosyl dimethicone/bis-vinyldimethicone No data were discovered. Crotonic acid/vinyl C8-12 isoalkyl esters/va/bis-vinyldimethicone Physical form Granules Density g/cm Water solubility Other solubility cyclopentasiloxane dimethicone isopropanol ethanol acetone isopropyl myristate ethyl acetate butyl acetate Dispersible Insoluble Insoluble 1-10% soluble Soluble Soluble Insoluble Soluble 1%-10% soluble No data were discovered. Dimethicone/bis-isobutyl ppg-20 Dimethicone/bis-vinyldimethicone/silsesquioxane No data were discovered. No data were discovered. Dimethicone Dimethicone CIR Panel Book Page 24

28 Table 3. Chemical and physical properties of dimethicone s Property Value Reference No data were discovered. Dimethicone/divinyldimethicone/silsesquioxane Physical Form Powder Color Off white Odor Typical Vapor pressure mmhg@ 25 o C <0.1 Boiling Point o C >300 (decomposes) Water Solubility o C & ph Insoluble Dimethicone/lauryl dimethicone/bis-vinyldimethicone No data were discovered. No data were discovered. No data were discovered. No data were discovered. Dimethicone/peg-10 Dimethicone/peg-10/15 Dimethicone/peg-15 No data were discovered. No data were discovered. No data were discovered. No data were discovered. No data were discovered. Dimethicone/phenyl vinyl dimethicone Dimethicone/polyglycerin-3 Dimethicone/ppg-20 Dimethicone/titanate Dimethicone/vinyl dimethicone Dimethicone/vinyltrimethylsiloxysilicate No data were discovered No data were discovered. Diphenyl dimethicone Diphenyl dimethicone/vinyl diphenyl dimethicone/silsesquioxane No data were discovered. No data were discovered. Divinyldimethicone/dimethicone Hydroxypropyl dimethicone/polysorbate 20 No data were discovered. Isopropyl titanium triisostearate/triethoxysilylethyl polydimethylsiloxyethyl dimethicone No data were discovered. No data were discovered. No data were discovered. Lauryl dimethicone peg-15 Lauryl dimethicone/polyglycerin-3 15 CIR Panel Book Page 25

29 Table 3. Chemical and physical properties of dimethicone s Property Value Reference Lauryl polydimethylsiloxyethyl dimethicone/bis-vinyldimethicone No data were discovered. No data were discovered. No data were discovered. No data were discovered. No data were discovered. No data were discovered. No data were discovered. No data were discovered. PEG-10 dimethicone PEG-12 dimethicone PEG-8 dimethicone/polysorbate 20 PEG-12 dimethicone/ppg-20 PEG-12 dimethicone/ppg-20 PEG-10/lauryl dimethicone PEG-15/lauryl dimethicone PEG-15/lauryl polydimethylsiloxyethyl dimethicone No data were discovered. Perfluorononyl dimethicone/methicone/amodimethicone No data were discovered. Polydimethylsiloxyethyl dimethicone/bis-vinyldimethicone No data were discovered. Polyglyceryl-3/lauryl polydimethylsiloxyethyl dimethicone No data were discovered. Silicone quaternium-16/glycidoxy dimethicone No data were discovered. No data were discovered. No data were discovered. Styrene/acrylates/dimethicone acrylate Trifluoropropyl dimethicone/peg-10 Trifluoropropyl dimethicone/trifluoropropyl divinyldimethicone No data were discovered. Trifluoropropyl dimethicone/vinyl trifluoropropyl dimethicone/silsesquioxane No data were discovered. No data were discovered. Trimethylsiloxysilicate/dimethicone Vinyl dimethicone/lauryl/behenyl dimethicone No data were discovered. No data were discovered. Vinyl dimethicone/lauryl dimethicone Vinyl dimethicone/methicone silsesquioxane 16 CIR Panel Book Page 26

30 Table 3. Chemical and physical properties of dimethicone s Property Value Reference No data were discovered. Distributed for Comment - Do Not Cite or Quote Vinyldimethyl/trimethylsiloxysilicate/dimethicone No data were discovered. Vinyldimethyl/trimethylsiloxysilicate stearyl dimethicone No data were discovered. Use type Table 4. Frequency of use of dimethicone s according to duration and exposure. 12,13 Uses Maximum Concentration (%) Uses C30-45 alkyl cetearyl dimethicone 17 Maximum Concentration (%) Uses C4-24 alkyl dimethicone/divinyldime thicone Maximum Concentration (%) Cetearyl dimethicone Total/range Duration of use Leave-on Rinse-off NR NR 2 NR NR NR NR 0.2 Diluted for (bath) NR NR NR NR NR NR NR use Exposure type Eye area NR NR NR NR Incidental ingestion NR 2 NR NR NR NR NR NR Incidental Inhalation-sprays NR NR NR NR NR NR NR Incidental inhalation-powders NR NR NR NR NR NR NR 0.6 Dermal contact Deodorant (underarm) NR NR NR NR NR NR NR Hair-noncoloring NR NR NR NR NR NR NR NR Hair-coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR NR Baby NR NR NR NR NR NR NR NR Maximum Concentrat Uses ion (%) Behenyl dimethicone/bisvinyldimethicone Dimethicone/bisisobutyl PPG-20 Dimethicone Dimethicone -3 Dimethicone/ divinyldimethicone/ silsesquioxane Total/range Duration of use Leave-on Rinse-off NR NR NR 0.2 NR NR Diluted for (bath) NR NR NR NR NR NR NR NR use Exposure type Eye area NR NR NR NR Incidental ingestion NR NR NR NR NR NR Incidental Inhalation-sprays NR NR NR NR Incidental inhalation-powders NR NR NR 0.03 NR NR NR NR Dermal contact Deodorant (underarm) NR NR NR NR NR NR Hair-noncoloring NR NR NR NR NR NR Hair-coloring NR NR NR NR NR NR Nail NR NR 1 4 NR NR NR NR Mucous Membrane NR NR NR NR Baby NR NR NR NR NR NR NR NR CIR Panel Book Page 27

31 Use type Table 4. Frequency of use of dimethicone s according to duration and exposure. 12,13 Uses Maximum Concentrat ion (%) Dimethicone/PEG-10 Uses Maximum Concentration (%) Uses Dimethicone/PEG-10/15 Maximum Concentration (%) Uses Dimethicone/phenyl vinyl dimethicone Maximum Concentration (%) Dimethicone/PPG-20 Total/range NR NR 0.2 Duration of use Leave-on NR NR 0.2 Rinse-off NR NR NR 0.8 NR NR NR NR Diluted for (bath) NR NR NR NR NR NR NR NR use Exposure type Eye area NR NR NR NR NR NR NR Incidental ingestion NR NR NR NR NR NR NR NR Incidental Inhalation-sprays NR NR NR NR NR NR Incidental inhalation-powders NR NR NR NR NR NR NR NR Dermal contact NR NR 0.2 Deodorant (underarm) NR NR NR NR NR NR NR Hair-noncoloring NR NR NR NR NR NR NR Hair-coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR NR Baby NR NR NR NR NR NR NR NR Dimethicone/vinyl dimethicone Distributed for Comment - Do Not Cite or Quote Dimethicone/ vinyltrimethylsiloxysilicate Diphenyl dimethicone/vinyl diphenyl dimethicone/ silsesquioxane Divinyldimethicone/ dimethicone Total/range Duration of use Leave-on Rinse-off NR NR NR NR NR Diluted for (bath) NR NR NR NR NR NR NR NR use Exposure type Eye area NR NR Incidental ingestion NR NR NR 0.1 NR NR Incidental Inhalation-sprays NR NR NR 0.1 NR NR Incidental inhalation-powders NR NR NR NR Dermal contact Deodorant (underarm) NR NR NR NR NR NR NR NR Hair-noncoloring NR NR NR 0.2 NR Hair-coloring NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR Mucous Membrane NR NR NR 0.1 NR NR Baby 1 NR NR NR NR NR NR NR 18 CIR Panel Book Page 28

32 Use type Table 4. Frequency of use of dimethicone s according to duration and exposure. 12,13 Maximum Concentrat Uses ion (%) Isopropyl titanium triisostearate/ triethoxysilylethyl polydimethylsiloxyethyl dimethicone Uses Maximum Concentration (%) Uses Lauryl dimethicone/ polyglycerin-3 Maximum Concentration (%) Uses PEG-10 dimethicone Maximum Concentration (%) PEG-12 dimethicone Total/range 5 NR Duration of use Leave-on 5 NR NR NR Rinse-off NR NR 3 2 NR NR Diluted for (bath) NR NR NR NR NR NR NR NR use Exposure type Eye area 4 NR NR NR 1 NR 1 NR Incidental ingestion NR NR NR NR NR NR NR NR Incidental Inhalation-sprays NR NR NR NR NR NR Incidental inhalation-powders 5 NR NR NR NR NR NR NR Dermal contact NR NR Deodorant (underarm) NR NR NR NR NR NR Hair-noncoloring NR NR NR NR NR NR Hair-coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR NR 0.3 Baby NR NR NR NR NR NR PEG-10/lauryl dimethicone Distributed for Comment - Do Not Cite or Quote PEG-15/lauryl dimethicone Silicone quaternium-16/ glycidoxy dimethicone Styrene/acrylates/ dimethicone acrylate Total/range NR NR Duration of use Leave-on NR NR Rinse-off NR NR 4 NR NR NR Diluted for (bath) use NR NR NR NR NR NR NR NR Exposure type NR Eye area NR NR NR NR NR NR NR NR Incidental ingestion NR NR NR NR NR NR NR NR Incidental Inhalation-sprays NR NR NR NR NR NR NR NR Incidental inhalation-powders NR NR NR NR NR NR NR NR Dermal contact NR NR NR NR NR Deodorant (underarm) NR NR NR NR NR NR NR NR Hair-noncoloring NR NR NR NR NR NR Hair-coloring NR NR NR NR NR NR NR NR Nail NR NR NR NR NR NR 1 NR Mucous Membrane NR NR NR NR NR 0.7 NR NR Baby NR NR NR NR NR NR NR NR 19 CIR Panel Book Page 29

33 Use type Table 4. Frequency of use of dimethicone s according to duration and exposure. 12,13 Uses Maximum Concentrat ion (%) Vinyl dimethicone/ lauryl dimethicone Maximum Concentration (%) Uses Uses Vinyl dimethicone/methicone silsesquioxane Total/range Duration of use Leave-on Rinse-off NR Diluted for (bath) NR NR NR NR use Exposure type Eye area NR NR Incidental ingestion NR Incidental Inhalation-sprays NR NR Incidental inhalation-powders NR NR Dermal contact Deodorant (underarm) NR NR NR NR Hair-noncoloring NR Hair-coloring NR NR NR Nail NR NR NR 0.5 Mucous NR Distributed for Comment - Do Not Cite or Quote Maximum Concentration (%) Uses Maximum Concentration (%) Membrane Baby NR NR NR NR NR = Not Reported; Totals = Rinse-off + Leave-on Product Uses. Note: Because each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure type uses may not equal the sum total uses. 20 CIR Panel Book Page 30

34 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Idealized structure Ingredient Acrylates/bis-hydroxypropyl dimethicone 21 CIR Panel Book Page 31

35 Ingredient Behenyl dimethicone/bis- vinyldimethicone Figure 1. Idealized structures of the dimethicone s ingredients in thiss safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, thesee structures aree meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Idealized structure Distributed for Comment - Do Not Cite or Quote 22 CIR Panel Book Page 32

36 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Bis-phenylisopropyl phenylisopropyl dimethicone/vinyl dimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure 23 CIR Panel Book Page 33

37 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Bis-vinyldimethicone/bisisobutyl PPG-20 Distributed for Comment - Do Not Cite or Quote Idealized structure Bis-vinyldimethicone (H 3 C) 3 Si O Si O y Si O Si( ) 3 z (H 2 C) 2 H 3 C Si O x H 3 C Si (CH 2 ) 2 (H 3 C) 3 Si O Si O Si O Si( ) 3 y z Bis-Vinyldimethicone/ PPG-20 Bis-Vinyldimethicone/PPG-20 is a crosslinked polymer of Bis-Vinyldimethicone partially crosslinked with methylhydrogen cyclic siloxanes and then further crosslinked with bis-allyl PPG-20. The immense connectivity variability added by methylhydrogen cyclic siloxanes makes a structural representation of this ingredient quite challenging. 24 CIR Panel Book Page 34

38 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Bis-vinyldimethicone/ PEG-10 dimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure 25 CIR Panel Book Page 35

39 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Butyldimethicone methacrylate/methyl methacrylate Distributed for Comment - Do Not Cite or Quote Idealized structure 26 CIR Panel Book Page 36

40 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient C30-45 alkyl cetearyl dimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure 27 CIR Panel Book Page 37

41 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient C4-24 alkyl dimethicone/ divinyldimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure C30-45 alkyl dimethicone/ polycyclohexene oxide CIR Panel Book Page 38

42 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Cetearyl dimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure Cetearyl dimethicone/ vinyl dimethicone 29 CIR Panel Book Page 39

43 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Cetyl dimethicone/bisvinyldimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure Cetyl hexacosyl dimethicone/ bis-vinyldimethicone 30 CIR Panel Book Page 40

44 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Crotonic acid/vinyl C8-12 isoalkyl esters/ VA/bisvinyldimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure Dimethicone/bis-isobutyl PPG CIR Panel Book Page 41

45 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Dimethicone/bisvinyldimethicone/ silsesquioxane Distributed for Comment - Do Not Cite or Quote Idealized structure Dimethicone Dimethicone CIR Panel Book Page 42

46 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Dimethicone/divinyldimethic one/silsesquioxane Distributed for Comment - Do Not Cite or Quote Idealized structure Dimethicone/lauryl dimethicone/bisvinyldimethicone (H 3 C) 3 Si O Si O x Si O Si O Si( ) 3 (CH 2 ) 11 z (CH 2 ) 2 y H 3 C Si O w H 3 C Si (CH 2 ) 2 (H 3 C) 3 Si O Si O Si O Si O Si( ) 3 x (CH 2 ) 11 z y 33 CIR Panel Book Page 43

47 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Dimethicone/ PEG-10 Distributed for Comment - Do Not Cite or Quote Idealized structure Dimethicone/ PEG-10/15 34 CIR Panel Book Page 44

48 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Dimethicone/ PEG-15 Distributed for Comment - Do Not Cite or Quote Idealized structure Dimethicone/ phenyl vinyl dimethicone 35 CIR Panel Book Page 45

49 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Dimethicone/polyglycerin-3 Distributed for Comment - Do Not Cite or Quote Idealized structure (H 3 C) 3 Si O Si O y Si O Si( ) 3 z O OH O w OH O x (H 3 C) 3 Si O Si O Si O Si( ) 3 y z 36 CIR Panel Book Page 46

50 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Dimethicone/PPG-20 Distributed for Comment - Do Not Cite or Quote Idealized structure (H 3 C) 3 Si O Si O y Si O Si( ) 3 z O H 3 C O 20 (H 3 C) 3 Si O Si O y Si O Si( ) 3 Dimethicone/titanate z (H 3 C) 3 Si O Si O y Si O Si( ) 3 RO Ti O z RO O (H 3 C) 3 Si O Si O Si O Si( ) 3 CH y 3 z wherein R is isopropyl or an additional dimethicone crosslink 37 CIR Panel Book Page 47

51 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Dimethicone/vinyl dimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure (H 3 C) 3 Si O Si O Si y O Si( ) 3 z H 3 C Si O H 3 C Si H 3 C O Si x (H 3 C) 3 Si O Si O Si O Si( ) 3 Dimethicone/ vinyltrimethylsiloxysilicate y z. (H 3 C) 3 Si O Si O Si y O Si( ) 3 z R Si R O x R Si R (H 3 C) 3 Si O Si O Si O Si( ) 3 y wherein R represents a variable network of polysilicic acid units, which are endblocked with trimethylsilyl groups z 38 CIR Panel Book Page 48

52 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Diphenyl dimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure (H 3 C) 3 Si O Si O Si O Si x O Si( ) 3 z? y (H 3 C) 3 Si O Si O Si O Si O Si( ) 3 x z Diphenyl dimethicone/vinyl diphenyl dimethicone/ silsesquioxane Divinyldimethicone/ dimethicone y Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane is a crosslinked copolymer of diphenyl dimethicone, vinyl diphenyl dimethicone and silsesquioxane monomers. The crosslinking connectivity here is unclear. (H 3 C) 3 Si O Si O Si y O Si( ) 3 z H 3 C Si O H 3 C Si H 3 C O Si x (H 3 C) 3 Si O Si O Si O Si( ) 3 y z 39 CIR Panel Book Page 49

53 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Hydroxypropyl dimethicone/ polysorbate 20 Isopropyl titanium triisostearate/triethoxysilylethyl polydimethylsiloxyethyl dimethicone Lauryl dimethicone PEG-15 Distributed for Comment - Do Not Cite or Quote Idealized structure Hydroxypropyl Dimethicone/Polysorbate 20 is a copolymer of Hydroxypropyldimethicone and Polysorbate 20 crosslinked with Succinic Acid. The immense connectivity variability added by Polysorbate 20 makes a structural representation of this ingredient quite challenging. Isopropyl Titanium Triisostearate/Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone is a complex polymer formed by the hydrolysis and condensation of Isopropyl Titanium Triisostearate with Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone. The immense connectivity variability in this polymer makes a structural representation of this ingredient quite challenging. (H 3 C) 3 Si O Si O x Si O Si O Si( ) 3 (CH 2 ) 11 z y CH O (H 3 C) 3 Si O Si O Si O 31x (CH 2 ) 11 y Si O Si( ) 3 z 40 CIR Panel Book Page 50

54 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Lauryl dimethicone/ polyglycerin-3 Distributed for Comment - Do Not Cite or Quote Idealized structure (H 3 C) 3 Si O Si O x Si O Si O Si( ) 3 (CH 2 ) 11 z y O OH O v OH O w (H 3 C) 3 Si O Si O Si O Si O Si( ) 3 Lauryl polydimethylsiloxyethyl dimethicone/bisvinyldimethicone x (CH 2 ) 11 z y Wherein v + w = 3 Lauryl polydimethylsiloxyethyl dimethicone/bis-vinyldimethicone is a copolymer of lauryl polydimethylsiloxyethyl dimethicone crosslinked by bis-vinyldimethicone. The immense connectivity variability in this polymer makes a structural representation of this ingredient quite challenging. 41 CIR Panel Book Page 51

55 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient PEG-10 dimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure (H 3 C) 3 Si O Si O y Si O Si( ) 3 z10o O (H 3 C) 3 Si O Si O Si O Si( ) 3 PEG-12 dimethicone y z (H 3 C) 3 Si O Si O x Si O y Si O Si( ) 3 z (CH 2 ) 3-20 O OH 12 (H 3 C) 3 Si O Si Si O Si O Si( ) 3 y x z O 12 PEG-8 dimethicone/ polysorbate 20 OH PEG-8 dimethicone/polysorbate 20 is a copolymer of a complex mixture of esters formed from the reaction of PEG-8 dimethicone and polysorbate 20 crosslinked with Succinic Acid. The immense connectivity variability added by Polysorbate 20 makes a structural representation of this ingredient quite challenging. 42 CIR Panel Book Page 52

56 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient PEG-12 dimethicone/bisisobutyl PPG-20 (H 3 C) 3 Si O Si O H 3 C Distributed for Comment - Do Not Cite or Quote x Idealized structure Si O y Si O Si( ) 3 z O O H 3 C O OH (H 3 C) 3 Si O Si O x Si O y Si O Si( ) 3 z O OH CIR Panel Book Page 53

57 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient PEG-12 dimethicone/ppg-20 Distributed for Comment - Do Not Cite or Quote Idealized structure (H 3 C) 3 Si O Si O x Si O y Si O Si( ) 3 z O O H 3 C O OH (H 3 C) 3 Si O Si O x Si O y Si O Si( ) 3 z O OH CIR Panel Book Page 54

58 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient PEG-10 dimethicone/vinyl dimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure (H 3 C) 3 Si O Si O x Si O y Si O Si( ) 3 z (CH 2 ) 2 H 3 C Si O O w H 3 C Si (CH 2 ) 2 10 OH (H 3 C) 3 Si O Si O Si O Si O Si( ) 3 x y z O 10 OH 45 CIR Panel Book Page 55

59 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient PEG-10/lauryl dimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure (H 3 C) 3 Si O Si O Si O Si x (CH 2 ) 11 y O Si( ) 3 z O 10 O (CH 2 ) 11 (H 3 C) 3 Si O Si O Si O Si O Si( ) 3 PEG-15/lauryl dimethicone x y z (H 3 C) 3 Si O Si O Si O Si x (CH 2 ) 11 y O Si( ) 3 z O 15 O (CH 2 ) 11 (H 3 C) 3 Si O Si O Si O Si O Si( ) 3 PEG-15/lauryl polydimethylsiloxyethyl dimethicone Perfluorononyl dimethicone/ methicone/amodimethicone Polydimethylsiloxyethyl CH x y 3 z PEG-15/lauryl polydimethylsiloxyethyl dimethicone is a copolymer of lauryl polydimethylsiloxyethyl dimethicone crosslinked with diallyl PEG-15. The immense connectivity variability in this polymer makes a structural representation of this ingredient quite challenging. Perfluorononyl dimethicone/methicone/amodimethicone is a crosslinked silicone polymer that is formed by reacting a copolymer of perfluorononyl dimethicone and methicone with methicone and amodimethicone. Polydimethylsiloxyethyl dimethicone/bis-vinyldimethicone is a copolymer of 46 CIR Panel Book Page 56

60 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient dimethicone/bisvinyldimethicone Polyglyceryl-3/lauryl polydimethylsiloxyethyl dimethicone Silicone quaternium-16/ glycidoxy dimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure polydimethylsiloxyethyl dimethicone crosslinked with bis-vinyldimethicone. The immense connectivity variability in this polymer makes a structural representation of this ingredient quite challenging. Polyglyceryl-3/lauryl polydimethylsiloxyethyl dimethicone is a copolymer of lauryl polydimethylsiloxyethyl dimethicone crosslinked with an allyl polyglyceryl-3. The immense connectivity variability in this polymer makes a structural representation of this ingredient quite challenging. (H 3 C) 3 Si O Si O Si O Si x y H 3 C H 3 C O Si( ) 3 z R N N R' R' OH N O OH O (H 3 C) 3 Si O Si O Si O Si x y wherein R represents CH 2 CH 2 NR' O Si( ) 3 z Styrene/acrylates/ dimethicone acrylate R' repesents CH 2 CH(OH)CH 2 N((CH 2 ) 0-17 ) 3 Cl (H 3 C) 3 Si O Si O Si O Si( ) 3 y (CH 2 ) 3 z R O O O O H CH 2 C H x CH 2 CH CH 2 C CH 2 u v CH H R' wherein R is hydrogen, methyl, ethyl, propyl, or butyl and R' is hydrogen or methyl R' H CH 2 H C CH 2 CH CH 2 C CH 2 CH w H O O O O (CH 2 ) 3 R u v (H 3 C) 3 Si O Si O Si O Si( ) 3 y z x 47 CIR Panel Book Page 57

61 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Trifluoropropyl dimethicone/ PEG-10 Distributed for Comment - Do Not Cite or Quote Idealized structure (H 3 C) 3 Si O Si O x Si O y Si O Si( ) 3 z F O F F O 10 F F F (H 3 C) 3 Si O Si O Si O Si O Si( ) 3 Trifluoropropyl dimethicone/ trifluoropropyl divinyldimethicone (H 3 C) 3 Si O Si O x x Si O y z Si O Si( ) 3 (CH 2 ) 2 z Si CF 3 y F 3 C O w Si F 3 C (CH 2 ) 2 CF 3 (H 3 C) 3 Si O Si O Si O Si O Si( ) 3 x y z 48 CIR Panel Book Page 58

62 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Trifluoropropyl dimethicone/ vinyl trifluoropropyl dimethicone/silsesquioxane (H 3 C) 3 Si O Si O Si w Distributed for Comment - Do Not Cite or Quote (CH 2 ) 2 Idealized structure O R Si OR' O y Si O Si( ) 3 z Si CF 3 x F 3 C O v Si F 3 C (CH 2 ) 2 CF 3 R (H 3 C) 3 Si O Si O Si O Si O Si O Si( ) 3 Trimethylsiloxysilicate/ dimethicone Vinyl dimethicone/ lauryl/ behenyl dimethicone CH CH w 3 x OR' y 3 wherein z R represents a hydrogen, alkyl, or aryl group R' represents crosslinks to other dimethicone backbones Trimethylsiloxysilicate/dimethicone is the product of the reaction between dimethicone and trimethylsiloxysilicate under conditions that produce rearrangement, condensation, and crosslinking of the dimethicone polymer onto the trimethylsiloxysilicate resin. The immense connectivity variability in this polymer makes a structural representation of this ingredient quite challenging. (H 3 C) 3 Si O Si O w Si O Si O Si O Si( ) 3 (CH) 11 (CH) 21 z (CH 2 ) 2 x y H 3 C Si O v H 3 C Si (CH 2 ) 2 (H 3 C) 3 Si O Si O Si O Si O Si O Si( ) 3 w (CH) 11 (CH) 21 z x y 49 CIR Panel Book Page 59

63 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Vinyl dimethicone/lauryl dimethicone Distributed for Comment - Do Not Cite or Quote Idealized structure (H 3 C) 3 Si O Si O x Si O Si O Si( ) 3 (CH 2 ) 11 z (CH 2 ) 2 y H 3 C Si O w H 3 C Si (CH 2 ) 2 (H 3 C) 3 Si O Si O Si O Si O Si( ) 3 x (CH 2 ) 11 z Vinyl dimethicone/methicone silsesquioxane R y (H 3 C) 3 Si O Si O x Si OR' O y Si H O Si( ) 3 z (CH 2 ) 2 H 3 C Si O w H 3 C Si (CH 2 ) 2 R H (H 3 C) 3 Si O Si O Si O Si O Si( ) 3 Vinyldimethyl/ trimethylsiloxysilicate/ dimethicone CH x OR' y 3 wherein R represents a hydrogen, alkyl, or aryl group R' represents crosslinks to other dimethicone backbones Monograph in development z 50 CIR Panel Book Page 60

64 Figure 1. Idealized structures of the dimethicone s ingredients in this safety assessment. These idealized structures are merely generalized, two-dimensional estimations of the true three-dimensional frameworks that comprise theses polymers. Though monomer units are drawn sequentially, by necessity, this by no means implies that these are block-type polymers. Instead, these structures are meant to represent only one example of the multitude of potentially produced connectivities found within these macromolecules. Ingredient Vinyldimethyl/ trimethylsiloxysilicate stearyl dimethicone Distributed for Comment - Do Not Cite or Quote (H 3 C) 3 Si O Si O Si y (CH 2 ) 17 Idealized structure O Si( ) 3 z R Si R O x R Si R (CH 2 ) 17 (H 3 C) 3 Si O Si O Si O Si( ) 3 y wherein R represents methyl or a variable network of polysilicic acid units, which are endblocked with trimethylsilyl groups z 51 CIR Panel Book Page 61

65 Figure 2. Example of the hydrosilation-crosslinking of a dimethicone precursor polymer. 52 CIR Panel Book Page 62

66 REFERENCES 1. Gottschalck TE and Breslawec HP. International Cosmetic Ingredient Dictionary and Handbook. 14 ed. Washington, DC: Personal Care Products Council, Nair B, Elmore AR, Berfeld WF, Belsito DV, Klaassen CD, Marks, Jr JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final Report on the Safety Assessment of Stearoxy Dimethicone, Dimethicone, Methicone, Amino Bispropyl Dimethicone, Aminopropyl Dimethicone, Amodimethicone, Amodimethicone Hydroxystearate, Behenoxy Dimethicone, C24-28 Alkyl Methicone, C30-45 Alkyl Methicone, C30-45 Alkyl Dimethicone, Cetearyl Methicone, Cetyl Dimethicone, Dimethoxysilyl Ethylenediaminopropyl Dimethicone, Hexyl Methicone, Hydroxypropyldimethicone, Stearamidopropyl Dimethicone, Stearyl Dimethicone, Stearyl Methicone, and Vinyldimethicone. International Journal of Toxicology. 2003;22:(Suppl. 2): Starch MS, Fiori JE, and Lin Z. Beyond rheology modification: Hydrophilically modified silcone elastomers provide new benefits. Journal of Cosmetic Science. 2003;54: Wacker Chemie AG. Product dossier Belsil P101 (Crotonic Acid/ Vinyl 8-12 Isoalkyl Esters/VA/Bis-Vinyldimethicone [pamphlet] Burghausen Germany: Wacker Chemie AG; National Industrial Chemicals Notification and Assessment Scheme. Full public report: Polymer in DOW CORNING 9040 Silicone Elastomer Blend. Sidney, Australia, National Occupational Health and Safety Commission pp Grant Industries Product information: Dimethicone/divinyldimethicone/Silsesquioxane. 12 pages. 7. Wacker Chemie AG. Product dossier Wacker-Belsil RG100 (Cylcopentasiloxane (and) Dimethicone/Vinyltrimethylsiloxysilicate ) [pamphlet] Burghausen Germany: Wacker Chemie AG; CosmetoScope. PEG-12 Dimethicone Date Accessed Wacker Chemie AG. Product dossier Wacker-Belsil RG90 (Isodecane (and) Vinyldimethyl/Trimethylsiloxysilicate Stearyl Dimethicone [pamphlet] Burghausen Germany: Wacker Chemie AG; Wang J, Hung JL, Hrubec TJ, and et al. United States Patent Application Publication: Topical cosmetic composition containing hybrid silicone composite powder (US2005/ A1):Date Accessed Grant Industries Product information: Gransil EPSQ Dimethicone/divinyldimethicone/Silsesquioxane. 12 pages. 12. U.S.Food and Drug Administration. FDA database. Cosmetic production fomulation and frequency of use data submitted to the Voluntary Cosmetic Registration Program (VCRP) Washington, DC: FDA. 13. Personal Care Products Council Concentration of use by FDA product category: Dimethicone Ingredients. 11 pages. 14. Johnsen MA. The Influence of Particle Size. Spray Technology and Marketing. 2004; Rothe H. Special aspects of cosmetic spray safety evaluation Bremmer HJ, Prud'homme de Lodder LCH, and van Engelen JGM. General Fact Sheet: Limiting conditions and reliability, ventilation, room size, body surface area; Updated version for ConsExpo Date Accessed Report No. RIVM /2006. pp Rothe H, Fautz R, Gerber E, Neumann L, Rettinger K, Schuh W, and Gronewold C. Special aspects of cosmetic spray safety evaluations: Principles on inhalation risk assessment. Toxicol Lett ;205:(2): Bremmer HJ, Prud'homme de Lodder LCH, and van Engelen JGM. Cosmetics Fact Sheet: To assess the risks for the consumer; Updated version for ConsExpo Date Accessed Report No. RIVM /2006. pp Wacker Chemie AG. Liquid chromotography Belsil P101 (Crotonic Acid/ Vinyl 8-12 Isoalkyl Esters/VA/Bis-Vinyldimethicone [pamphlet] Burghausen Germany: Wacker Chemie AG; AMA Laboratories Inc. Agar diffusion cytotoxiciity test of Gransil EPSQ (Dimethicone/divinyldimethicone/Silsesquioxane ). AMA Ref. No. MS06.CYTOTOX.K9528.GII Cassidy SL and Stanton E. In vitro eye irritation studies on organosilicon compounds. Cutaneous & Ocular Toxicology. 1997;16:(1): Clinical Research Laboratories Inc Repeated insult patch test of a makeup preparation containing 0.65% Lysine. 20 pages. 53 CIR Panel Book Page 63

67 23. AMA Laboratories Inc. 50 Human subject repeat insult patch test skin irritation/sensitization evaluation (occlusive patch) of Gransil EPSQ (Dimethicone/divinyldimethicone/Silsesquioxane ). AMA Ref. No. MS04.RIPT.K Fiume MZ, Berfeld WF, Belsito DV, Klaassen CD, Marks, Jr JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report on the safety assessment of acrylates copolymer and 33 related cosmetic ingredients. International Journal of Toxicology. 2002;21:(Suppl 3): Berfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks, Jr JG, Shank RC, Slaga TJ, and Snyder PW. Final Report of the Cosmetic Ingredient Review Expert Panel: Amended Safety Assessment of Triethylene Glycol and Polyethylene Glycols (PEGs)-4, -6, -7, -8, -9, - 10, -12, -14, -16, -18, -20, -32, -33, -40, -45, -55, -60, -75, -80, -90, -100, -135, -150, -180, -200, -220, -240, -350, -400, -450, -500, -800, -2M, -5M, -7M, -9M, -14M, -20M, -23M, -25M, -45M, -65M, -90M, -115M, -160M and -180M and any PEGs >= 4 as used in Cosmetics. Washington, DC, Cosmetic Ingredient Review pp Elder RW. Final report on the safety assessment of polysorbates 20, 21, 40, 60, 65, 80, 81, and 85. Journal of the American College of Toxicology. 1984;3:(5): Berfeld WF, Belsito DV, Klaassen CD, Marks, Jr JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report on the safety assessment of propylene glycol and polypropylene glycols. Journal of the American College of Toxicology. 1994;13:(6): Fiume MZ, Berfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks, Jr JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final amended report of the Cosmetic Ingredient Review Expert Panel: Safety assessment of Propylene glycol, tripropylene glycol, and PPGs as used in cosmetics. Washington, DC, Cosmetic Ingredient Review pp Becker LC, Bergfeld WF, Belsito DV, Klaassen CD, Marks, Jr JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final safety assessment: Silylates and surface modifiedsiloxysilicates as used in cosmetics. Washington, DC, Cosmetic Ingredient Review pp Siltech Corporation. Siltech: Innovative silicone specialties [pamphlet]. Toronto, Ontario: Siltech Corporation; CIR Panel Book Page 64

68 Data

69 June 11, 2011 MEMORANDUM To: From: Subject: CIR Expert Panel and Liaisons Lillian C. Becker, M.S. Scientific Analyst and Writer Unpublished data and comments submitted for dimethicone s as used in cosmetics The Cosmetic Ingredient Review (CIR) received unpublished data and comments from industry. These data include: 1) A request to remove acrylates/bis-hydroxypropyl dimethicone from the report due to lack of use and no known supplier 2) Chemical and physical dataa on dimethicone/divinyldimethicone/silsesquioxane r as well as a cytotoxicity and a human patch test. There is also a patent for a hybrid silicone composite powder containing Dimethicone/divinyldimethicone/silsesquioxane containing chemical and physical data 3) Product information on crotonic acid/vinyl C8-12 isoalkyl esters/va/bis-vinyldimethicone, dimethicone/ /vinyltrimethylsiloxysilicate stearyl dimethicone, and vinyldimethyl/trimethylsiloxysilicate stearyl dimethicone 4) An HRIPT of a facial lotion containing dimethicone/vinyl dimethicone 5) Product information of crotonic acid/vinyl C8-12 isoalkyl esters/va/ /bis-vinyldimethicone ; cyclopentasiloxane and dimethicone/vinyltrimethylsiloxysilicate ; and isododecane and vinyldimethyl/trimethylsiloxysiliate stearyl dimethicone 6) Concentration of use survey. 7) VCRP Data. CIR Panel Book Page 65

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