Final Report on the Safety Assessment of PEG-2, -3, -5, -10, -15, and -20 Cocamine1

Abstract

The PEGs Cocamine are the polyethylene glycol ethers of the primary aliphatic amine derived from coconut oil. These ingredients are used in cosmetic formulations as surfactants which function as emulsifying and solubilizing agents. Very little data were available on metabolism and toxicity, and no clinical data were found or provided. Toxicity data, including reproductive and developmental toxicity, carcinogenesis data, and clinical testing data available from previous safety assessments on Polyethylene Glycol and Coconut Oil were summarized. The principal finding related to PEGs was based on clinical 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. Various PEGs Cocamine were found to be mild to moderate skin irritants and were ocular irritants. PEG-15 Cocamine was negative in bacterial mutagenicity studies. Although metabolites of ethylene glycol monoalkyl ethers are reproductive and developmental toxins, it was considered unlikely that the relevant metabolites would be found in or produced from the use of PEGs Cocamine in cosmetic formulations. 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. The limited data on PEGs Cocamine and the related data on other ingredients, however, were not sufficient to support the safety of PEGs Cocamine for use in cosmetic formulations. Additional data needs include: (1) physical and chemical properties, including impurities, and especially nitrosamines; (2) genotoxicity in a mammalian system; if the results are positive, then a dermal carcinogenesis study using National Toxicology Program (NTP) methods may be needed; (3) 28-day dermal toxicity using PEG-2 Cocamine; and (4) dermal sensitization data on PEG-2 Cocamine.