Final Report on the Safety Assessment of Lauramine and Stearamine

Abstract

Lauramine and Stearamine are aliphatic amines intended for use in cosmetic formulations as antistatic agents, but no current uses have been reported. In a subchronic feeding study in rats, 3,000 ppm of Stearamine in the diet caused weight loss and increased mortality, with an accumulation of histiocytes in the mucosa of the small intestine and mesenteric lymph nodes. A diet of 500 ppm did not produce these effects. Dogs fed Stearamine at 15 mg/kg/day snowed the same histiocyte accumulation. In a 2-year chronic feeding study in rats, Stearamine at concentrations up to 500 ppm (maximum tested) showed no significant increase in the incidence of tumors. Stearamine at 0.01% in a high-fat diet promoted the carcinogenic effects of DMBA in female rats, whereas 0.1% significantly inhibited the production of tumors. Tests in animals showed Lauramine to cause severe dermal irritation and necrosis. Stearamine (in an ether vehicle) applied to the skin of albino mice caused severe hyperplasia at concentrations as low as 3 mg in a 0.2-ml application. These available data were insufficient to support the safety of Lauramine and Stearamine in cosmetic formulations. Additional data considered necessary to evaluate the safety of these ingredients include the following: impurities (especially data on nitrosamines); two different genotoxicity assays (one using a mammalian system and, if positive, a dermal carcinogenesis assay by National Toxicology Program standards may be required); and a human repeat-insult patch test. It cannot be concluded that these ingredients are safe for use in cosmetic products until the listed safety data have been obtained and evaluated.