1: Final Report on the Safety Assessment of Amyl Acetate and Isoamyl Acetate

Abstract

Amyl Acetate, as used in cosmetic products, is the ester of mixed isomers of amyl alcohol and acetic acid. In cosmetic products, it is used as a solvent in fingernail formulations at concentrations of up to 10%. Amyl Acetate can stimulate acetylcholine release in the nerve endings and act as a competitive inhibitor of acetylcholine in isolated nerves. Amyl Acetate was not cytotoxic to diploid ascites tumors and was not a mitotic arrestant in cytogenetic studies. Amyl Acetate and Isoamyl Acetate were nonmutagenic in a series of mutagenic assays. The acute oral toxicity of Amyl Acetate exceeds 5 g/kg. Only a low order of hepatotoxicity was reported following the intraperitoneal injection of 1.5 g/kg of Amyl Acetate in mature guinea pigs. No subchronic studies were available for Amyl Acetate; however, the results of subchronic studies of amyl alcohol in rats at concentrations up to 1 g/kg per day were unremarkable. Ocular studies of 100% Amyl Acetate in rabbits produced a conjunctival score of 6 (maximum 110) on day 1 that cleared by day 2. No evidence of delayed contact hypersensitivity, phototoxicity, or photoallergy due to Amyl Acetate or Isoamyl Acetate was observed in human repeat insult patch test studies. It is concluded that Amyl Acetate and Isoamyl Acetate are safe as presently used in cosmetic products.