Final Report on the Safety Assessment of Cocamide MEA
AbstractCocamide MEA is a mixture of ethanolamines of fatty acids derived from coconut oil. This cosmetic ingredient functions as a surfactant—foam booster and an aqueous viscosity-increasing agent. To supplement the available data on Cocamide MEA, data from previous safety assessments of Coconut Oil and its derivatives, Monoethanolamine (MEA), and Cocamide DEA (Diethanolamine) were included in this safety assessment. These data suggest little acute, short-term, or chronic toxicity associated with dermal application. MEA vapor, however, is highly toxic. Although DEA is readily nitrosated to form N-nitrosodiethanolamine, a known animal carcinogen, MEA has not been found to form a stable nitrosamine. Dermal application of Cocamide MEA at concentrations of 50% was nonirritating to mildly irritating in animal tests. For comparison, Cocamide DEA at a concentration of 30% was a moderate irritant; Coconut Oil was nonsensitizing; and MEA was irritating and corrosive. Cocamide MEA was negative in the Ames Test. Cocamide DEA was positive in some mutagenesis assays, but negative in others. In clinical tests, Cocamide MEA at a concentration of 50% was not irritating in a single-insult patch test. Cocamide DEA at 2% in formulation caused irritation, but not sensitization. Predictive patch tests with a surfactant containing Cocamide DEA at 10% produced no adverse effects. Inhalation of MEA by humans is toxic. Based on the limited data available data on Cocamide MEA, and on the data on those ingredients previously reviewed, particularly Cocamide DEA, it was concluded that Cocamide MEA is safe as used in rinse-off products and safe at concentrations up to 10% in leave-on products. It was further concluded, however, that Cocamide MEA should not be used as an ingredient in cosmetic products in which N-nitroso compounds are formed or in formulations that will be aerosolized.