7 Final Report on the Safety Assessment of Cocamide DEA, Lauramide DEA, Linoleamide DEA, and Oleamide DEA

Abstract

Cocamide DEA, Lauramide DEA, Linoleamide DEA, and Oleamide DEA are fatty acid diethanolamides that may contain 4–33% diethanolamine. These ingredients are used in cosmetics at concentrations of <0.1–50%, with most products containing 1–25% diethanolamide. Cocamide DEA and Lauramide DEA are inactive ingredients in prescription drugs. These four fatty acid alkanolamides were slightly toxic to nontoxic to rats in formulations and inert vehicles via acute oral administration. Lauramide DEA was not a significant subchronic oral toxin in rats or dogs. Cocamide DEA, Lauramide DEA, and Linoleamide DEA were not dermal toxins in acute and subchronic animal studies. Cocamide DEA was a minimal eye irritant and a moderate skin irritant in rabbits. Lauramide DEA and Linoleamide DEA were mild to moderate eye irritants and mild to severe skin irritants. Undiluted Oleamide DEA was not an eye irritant and was a moderate skin irritant in single and cumulative applications. Lauramide DEA did not demonstrate mutagenic activity in three different Ames-type assays. No data were available on the mutagenic or carcinogenic activity of Cocamide DEA, Linoleamide DEA, and Oleamide DEA. The clinical information on these ingredients was confined to Cocamide DEA, Lauramide DEA, and Linoleamide DEA. Generally, these products were mild skin irritants but not sensitizers or photosensitizers.