G WHEAT MILK Version: 21-28/03/2012

Size: px

Start display at page:

Download "G WHEAT MILK Version: 21-28/03/2012"

Rosemary Fisher
5 years ago
Views:

1 1. PRODUCT IDENTIFICATION Trade Name: WHEAT MILK Manufacturer: PROVITAL,S.A. Responsible for the Safety Assessment: Lourdes Mayordomo Tlf./Fax: / Kind of Raw Material: Active Ingredient Function of the Ingredient (CTFA Handbook): Skin-Conditioning Agents - Occlusive; Skin Bleaching Agents, Skin-Conditioning - Miscellaneous Function of the Ingredient (UE Inventory): Skin Conditioning, Emollient; Skin Protecting Maximum Suggested Concentration: 100 % INCI approved in: Registered in EU, USA, Japan Japanese Name: JCLS: Wheat Germ Oil, Wheat Germ Extract Japanese translation from PCPC:, 2. PRODUCT COMPOSITION Components Breakdown (INCI). Including actives, solvents, s, preservatives, antioxidants and other additive dditives: [EU] CAS EINECS Aqua % Triticum Vulgare Germ Oil 3-6 % Triticum Vulgare Germ Extract 3-6 % Glyceryl Stearate 2-5 % PEG-60 Hydrogenated Castor Oil 2-5 % Propylene Glycol 1-5 % Antioxidants BHT % Preservatives Phenoxyethanol % Methylparaben % Butylparaben % Ethylparaben % Isobutylparaben % Propylparaben %

2 PCPC [CTFA] CAS EINECS Water % Triticum Vulgare (Wheat) Germ Oil 3-6 % Triticum Vulgare (Wheat) Germ Extract 3-6 % Glyceryl Stearate 2-5 % PEG-60 Hydrogenated Castor Oil 2-5 % Propylene Glycol 1-5 % Antioxidants BHT % Preservatives Phenoxyethanol % Methylparaben % Butylparaben % Ethylparaben % Isobutylparaben % Propylparaben % Impurities: Heavy Metals (as Pb) Pesticides Less than 20 ppm. No data available. Not expected to be found. 3. TOXICOLOGICAL INFORMATION Data obtained in our own toxicological tests and/or bibliographical research Animal testing: This product has not been the subject of animal testing or retesting for cosmetic purposes by or on behalf of this company. General information: The CIR Final Report on Safety Assessment of Wheat Germ Oil exists, which includes all toxicological data and concludes that the Wheat Germ Oil is safe: JEPT 4 (4), 33-35, Confirmed later in: IJT 22(S1), 1-35, The CIR Final Report on Safety Assessment declares safe for their use in cosmetic products, and includes all the toxicological data of: Palmitic Acid; Oleic Acid; Stearic Acid (CIR Final Safety Assessment: JACT-6 (3) 1987; confirmed 06/05, IJT25 (S2), 2006), Tocopherol (CIR Final Report: IJT 21 (3) 2002). The CIR Final Report on Safety Assessment of Wheat Germ Oil, Wheat Germ Glycerides, Wheat Flour, Wheat Gluten and Wheat Starch includes all the toxicological data (JEPT, 4 (4) 1980). The following substances are permitted for human consumption as Food Additives by FDA: Palmitic Acid; Oleic Acid; Stearic Acid (21CFR ). The following substances have the GRAS status ('Generally Recognized As Safe'): Linoleic Acid (21CFR ), Tocopherol (21CFR ), (21 CFR ), (21CFR ). alfa-tocopherol: Clinical experience indicates that the safety margin is substantial even with the prolonged daily administration (Fed. Reg. 1979; Briggs 1978). The CIR Final Report declares safe and includes all toxicological data of the following substances: Glyceryl Stearate (JACT, 1 (4), 1982); Propylene Glycol (JACT, 13 (6), 1994, reopened 12/09, and Tentative Amended Report from 04/10, available in CIR), BHT (IJT-21 (Suppl. 2), 2002). 2

3 Methylparaben, Butylparaben, Ethylparaben and Propylparaben are safe for their use in cosmetic products (CIR Final Report: JACT, 3 (5), 1984; confirmed 06/06). Isobutylparaben (CIR Final Report: JACT, 14 (5), 1995; confirmed 06/06) and Phenoxyethanol (CIR Final Report: JACT, 9(2): , 1990) are safe for their use in cosmetic products. Classification according to Council of Europe (*): Non-classified. *(1) - Non-recommended ingredients. (2) - Ingredients which could not be assessed. (3) Recommended ingredients Cytotoxicity: No data available. Skin Irritation: Test done with other Provital products: Wheat Germ Oil (Cod. 1230) at 100%: Patch Test on 10 volunteers, Index of Primary Cutaneous Irritation = 0, Very Well Tolerated. Palmitic Acid (RTECS no. RT ): Standard Draize Test, skin, human = 75 mg/3d-i, mild irritation. Stearic Acid (RTECS no. WI ): Standard Draize Test, skin, human = 75 mg/3d-i, mild irritation; Standard Draize Test, skin, rabbit = 500 mg/24h, moderate irritation. Oleic Acid (RTECS no. RG ): Standard Draize Test, skin, human = 15 g/3d-i, moderate irritation; Open Irritation Test = 500 mg, mild irritation. Linoleic Acid (RTECS no. RF ): Standard Draize Test, skin, human = 75 mg/3d-i, moderate irritation. Test on guinea pig, occlusive patch for 24 h, slight skin irritation (HSDB no. 5200). Skin Sensitization: Test done with other Provital products: Wheat Germ Oil (Cod. 1230) at 100%: RIPT test on 54 volunteers, no pathological irritation, nor sensitisation reaction indicative of cutaneous intolerance was observed. Eye Irritation: A study on rabbit eye with undiluted Wheat Germ Oil showed no eye irritation (CIR Final Report, November 11, 1979). Oleic Acid (RTECS no. RG ): Standard Draize Test, eye, rabbit = 100 mg, mild irritation. Linoleic Acid (HSDB no. 5200): Irritation Test on rabbit eye, mild conjunctive erythema. Mutagenicity: Palmitic Acid (RTECS no. RT ): DNA damage: rat = 50 µmol/l/16h; human fibroblast = 1 mmol/l/16h. Stearic Acid (RTECS no. WI ): DNA damage, human liver = 10 mg/l/20h. EPA GENETOX PROGRAM 1988, Negative: E. coli pola without S9. Oleic Acid (RTECS no. RG ): Cytogenetic analysis Saccharomyces cerevisae = 100 mg/l; Unscheduled DNA synthesis rectal mouse = 35 mg/kg; Cytogenetic analysis hamster fibroblast = 2500 µg/l. Ames Test on Salmonella with and without S9, Results: negative, the substance did not show mutagenic activity (HSDB no. 1240). Linolenic Acid: Negative in Ames Test in Salmonella typhimurium at doses of µg/plate, and negative in L5178 mouse lymphona cell mutation assay at doses of µl/ml and µl/ml (Chemical Carcinogenesis Research Information System - CCRIS, record number: 656). Linoleic Acid: Negative in Ames Test in Salmonella typhimurium at doses of µg/plate, and negative in L5178 mouse lymphona cell mutation assay at doses of µl/ml and µl/ml (Chemical Carcinogenesis Research Information System - CCRIS, record number: 650). dl-alpha-tocopherol: Antimutagenic effect on 5 strains of Salmonella and on leucocyte cultures at a concentration of 10 µm (WHO Food Additives Series 21). alfa-tocopherol acetate: DNA damage i.p. rat = 2500 µg/kg (CALEDQ 25, 163, 1984). alpha-tocopherol: DNA (rat) i.v. 26 nmol/kg (EXPEAM 31, 1023, 75). 3

4 Triticum vulgare Extract (RTECS no. YM ): Unscheduled DNA synthesis, mouse lymphocyte = 30 mg/l; mouse fibroblast = 30 mg/l. Acute toxicity: Wheat Germ Oil (CIR Final Report, November 11, 1979): LD50 p.o. rat > 64 g/kg. Palmitic Acid (RTECS no. RT ): LD50 p.o. rat > 10 mg/kg; LD50 i.v.mouse = 57 mg/kg. Stearic Acid (RTECS no. WI ): LDLo p.o. rat = 4640 mg/kg; LD50 i.v. rat = µg/kg; LD50 i.v. mouse = 23 mg/kg; LD50 rabbit skin > 5 g/kg; LD50 p.o. rat = 4600 mg/kg; LD50 p.o. human = mg/kg. Oleic Acid (RTECS no. RG ): LD50 i.v. rat = 2400 µg/kg; LD50 i.p. mouse = 282 mg/kg; LD50 i.v. mouse = 230 mg/kg; LD i.v. monkey > 40 µl/kg; LD i.v. mouse > 55 mg/kg; TDLo i.v. monkey = 0.08 mg/kg; LD50 p.o. rat = mg/kg; LD50 p.o. mouse = mg/kg; TDLo rabit skin = 100 pph; TDLo i.d. guinea pig = 400 µg/kg; TCLo inhalation rat = 30 mg/m3/4h; TDLo i.v. rat = 0.15 ml/kg; TDLo i.v. rat = 100 mg/kg; TDLo i.v. guinea pig = 15 µl/kg; TDLo skin rabbit = 100 pph/2h. LD50 p.o. rat = 74 g/kg; LD50 i.v. rat = 2.4 mg/kg; LD50 i.v. mouse = 230 mg/kg; LD50 guinea pig > 3000 mg/kg (HSDB no. 1240). Linoleic Acid (RTECS no. RF ): LD50 i.p. rat > 50 g/kg; LD50 p.o. mouse > 50 g/kg; LD50 i.p. mouse = 280 mg/kg. Practically non-toxic. Probable oral lethal dose (human) above 15 g/kg (Hazardous Substances Databank - HSDB, number: 5200). alpha-tocopherol: In humans, at therapeutic daily doses of 20 to 600 mg no toxic effects are observed (WHO Food Additives Series 21). Subchronic and chronic toxicity: During a 12 weeks study using Wheat Germ Oil on rats at doses up to 25%, no evidence of adverse effects induced by the material under investigation was shown (CIR Final Report, November 11, 1979). Stearic Acid (RTECS no. WI ): TDLo p.o. rat = 313 g/kg/30w-c; TDLo i.m. rat = mg/kg/30w-c; TDLo p.o. rat = 31.5 mg/kg/30w-i; TDLo p.o. mouse = 252 mg/kg/3w-i. Oleic Acid (RTECS no. RG ): TDLo i.p. mouse = 2712 mg/kg/6w-i; TDLo mouse skin = 1500 mg/kg/3d-i. Linolenic Acid (RTECS no. RG ): TDLo mouse skin = 1500 mg/kg/3d-i. Linoleic Acid (RTECS no. RF ): TDLo, skin, mouse = 1500 mg/kg/3d-i; i.p. rat = 40 or 200 mg/kg/day-4weeks. Decreased liver microsomal activity (HSDB no. 5200). alpha-tocopherol: Study on rats, 10 mg/rat/day for 19 weeks, no toxic effects observed (WHO Food Additives Series 21). Grain dust (RTECS no. MD ): TCLo inhalation, rabbit = 20 mg/m3/7h/26w-i. Propylene Glycol: Rat, 102 wk (daily, 5 days/week), oral NOAEL = 1700 mg/kg/day (supplier data). Rat, 15 wk, oral NOAEL = ppm in diet (= 2.5 g/kg/day); dog, 104 wk, oral, NOAEL = 2000 mg/kg (OECD SIDS Assessment Report, 2001). Reproductive effects: Linoleic Acid: Pregnant rats fed with conjugated Linoleic Acid at concentrations of 0.25 and 0.5% of the diet during gestation and lactation produced normal offspring with no evidence of embryotoxicity, fetotoxicity or malformations (Hazardous Substances Databank - HSDB, number: 5200). Linoleic Acid (14 ml/kg/day) was administered by oral intubation to pregnant ICR/SIM mice on days 8 to 12 of gestation. Linoleic Acid did not affect adversely any of the perinatal parameters examined: weight, mortality and external abnormalities (Hazardous Substances Databank - HSDB, number: 5200). Wheat extract (RTECS no. ZC ): TDLo p.o. mammal = 1400 mg/kg in female 7 day pre-mating. Other data: Palmitic Acid (RTECS no. RT ): Tumorigenic data, TDLo implant mouse = 1 g/kg. Stearic Acid (RTECS no. WI ): Tumorigenic data, TDLo implant ratón = 400 mg/kg. Oleic Acid (HSDB no. 1240): Practically not toxic. Lethal dose in human > 15 g/kg. 4

5 Linoleic Acid and Linolenic Acid inhibit both, initiation and promotion stages of skin carcinogenesis. Results of study performed in mice show that free fatty acids inhibit the formation of papilloma induced by benzo-a-pyrene (Chemical Carcinogenesis Research Information System - CCRIS, record number: 650 and 656; Cancer Letters, 1996, vol. 100 (1-2): ). 4. ECOLOGICAL DATA Biodegradability: Propylene Glycol: Assay Method: OCDE 302B/ISO 9888/EEC 88/302, C. Analysis Method: Diminution COD. Elimination grade: > 70%. Evaluation: Good elimination. Aquatic Toxicity: Stearic Acid (HSDB no. 2000): LC50 Red killfish = 125 mg/l. Propylene Glycol: Acute toxicity (fish): CL50/oncorhynchus mykiss: > 1000 mg/l/96h. Acute toxicity (daphnia): Daphnia magna: CE/CL50 (48 h): mg/l. Other data: No data available. 5. CONCLUSION The components of this product have registered adverse effects neither in its traditional uses nor in the historical marketing of this company. These data and the available toxicological information lead to the conclusion that the use of this product, under the normal conditions of cosmetic use and at the maximum recommended concentration, involves no risk for consumers. 5

SWEET ALMOND MILK - NAT

4254100G SWEET ALMOND MILK - NAT Version: 25-08/FEB/2018 1. PRODUCT IDENTIFICATION Trade Name: SWEET ALMOND MILK - NAT Manufacturer: PROVITAL Responsible for the Safety Assessment: Lourdes Mayordomo Tf./Fax: