US EPA

2144420 

Journal Article 

Final Report on the Safety Assessment of Lauramine and Stearamine 

Pang, S 

1995 

Yes 

Journal of the American College of Toxicology
ISSN: 0730-0913 

NIOSH/00228000 

14 

3 

196-203 

The results of safety assessment testing of lauramine (124221) and stearamine (124301) for use in cosmetic products were reported. Lauramine and stearamine have been formulated for use as antistatic agents, although no current uses have been reported. Alterations including weight loss, increased mortality, and intestinal and mesenteric lymph node histiocyte accumulation have been reported in a study following treatment of experimental animals with 3,000 parts per million (ppm) stearamine, but these effects were not seen after exposure to 500ppm. Chronic stearamine exposure has not been reported to induce tumor formation, although 0.01% stearamine in the presence of a high fat diet promoted the carcinogenic effects of 7,12-dimethylbenz(a)anthracene, while 0.1% inhibited tumor production. This compound was also reported to induce severe hyperplasia in the skin of albino-mice in concentrations as low as 3 milligrams. Lauramine has been reported to cause severe dermal irritation and necrosis in animals. It was concluded that these data are insufficient to support the use of these compounds in cosmetic products and additional testing including assessment of impurities, genotoxicity assays, dermal carcinogenesis assays, and human repeat insult patch tests was recommended.