Final Report on the Safety Assessment of Ethyl Hexanediol

Abstract

Ethyl Hexanediol is an aliphatic alcohol used as a solvent in a small number of cosmetic formulations applied to the skin and hair. Animal data indicate that Ethyl Hexanediol is absorbed through the skin and is metabolized and eliminated in the urine. Reported oral LD50 values in rats are generally above 5 g/kg. In subchronic oral studies, slight toxicity was manifested as reduced growth and increased liver weight. Oral delivery of Ethyl Hexanediol in female rats did show evidence of teratogenicity, but only at levels at which significant maternal toxicity was seen. Dermal exposure also resulted in developmental changes, again at levels that also caused maternal effects. Chromosome damage was reported in vitro, but several other genotoxicity assays were negative. Dermal exposure resulted in no dose-related increases in tumor incidence in rabbits and mice. In clinical studies, undiluted Ethyl Hexanediol was a weak irritant and a weak sensitizer. The concentration at which this ingredient is expected to be used is no greater than 5%. On the basis of the animal, clinical, and use data presented in this report, it is concluded that Ethyl Hexanediol is safe as a cosmetic ingredient.