Final Report on the Safety Assessment of PEG-7, -30, -40, -78, and -80 Glyceryl Cocoate1

Abstract

PEGs Glyceryl Cocoate polymers are the polyethylene glycol ethers of glyceryl cocoate. They function as skin conditioning agents, emollients, surfactants, nonionic emulsifying agents, and solubilizing agents in cosmetic formulations. Only limited data on the safety of PEG-7 Glyceryl Cocoate were found, and no data were available on the higher molecular weight polymers in this group. Data from previous safety assessments of Polyethylene Glycol (PEG), and several fatty acids (Stearic Acid, Oleic Acid, Lauric Acid, Palmitic Acid, and Myristic Acid) were considered relevant and added to the review. PEG has low oral and dermal toxicity. The fatty acids have slight oral toxicity, but little or no dermal toxicity. Dermal application of PEG-7 Glyceryl Cocoate at a concentration of SO% did not produce irritation in mice and guinea pigs, but did produce slight irritation in rabbits. Intracutaneous injection of PEG-7 Glyceryl Cocoate at a concentration of 10% did not produce sensitization. This same concentration was not an ocular irritant in animal tests. PEG-7 Glyceryl Cocoate was not phototoxic at a concentration of SO%. Although monoalkyl ethers of ethylene glycol are reproductive and developmental toxins, given the methods of manufacture of PEG-7 Glyceryl Cocoate, there is no likelihood of such compounds being present as impurities. The structure of the PEGs Glyceryl Cocoate polymers is such that it is unlikely that they would cause reproductive or developmental effects. PEG did not produce reproductive toxicity in oral toxicity studies. Oleic Acid in feed at a concentration of 15% did impair reproductive capacity in female rats, but growth and general health were not affected. No data were available on genotoxicity or carcinogenicity of PEGs Glyceryl Cocoate. PEG was not genotoxic. The fatty acids were generally not genotoxic, but positive results were seen for Oleic Acid in one assay. Neither PEG nor the fatty acids were carcinogenic in animals tests. Of concern was the possible presence of 1,4-dioxane and ethylene oxide impurities. The importance of using the necessary purification procedures to remove these impurities was stressed. In clinical studies PEG-7 Glyceryl Cocoate was neither a dermal irritant nor a photosensitizer. The principal clinical finding related to PEGs is based on data in burn patients—PEGs were mild irritant/sensitizers and there was evidence of nephrotoxicity. No such effects were seen in animal studies on intact skin. Cosmetic manufacturers should adjust product formulations containing Polyethylene Glycol to minimize any untoward effects when products are used on damaged skin. In recognition that PEG-7 Glyceryl Cocoate can enhance the skin penetration of other chemicals, care should also be exercised in using these ingredients in products where the penetration of other ingredients is aconcern. Based on the limited data on PEGs Glyceryl Cocoate and on safety assessments of other related ingredients, it was concluded that PEG-7, -30, -40, -70, and -80 Glyceryl Cocoate are safe as used in rinse-off products and safe at concentrations up to 10% in leave-on products.