Evaluation of Subchronic (13 Week), Reproductive, and in Vitro Genetic Toxicity Potential of 2-Ethylhexyl-2-cyano-3,3-diphenyl Acrylate (Octocrylene)

Use of 2-ethylhexyl-2-cyano-3,3-diphenyl acrylate (Octocrylene)in commercial sunscreen products has increased considerablyin recent years. To support larger scale human exposure to thiscompound, additional toxicological information was needed inseveral key areas. The present studies evaluated subchronictoxicity, developmental toxicity, and in vitro genotoxic potentialof Octocrylene. In the subchronic study, male and female NewZealand white (NZW) rabbits treated topically with concentrationsof octocrylene up to 534 mg/kg/day for 13 weeks showed slightto moderate dose-dependent skin irritation that correlated positivelywith a mild depression in body weight gain. Lack of associatedhistopathologic or clinical hematology abnormalities suggestedthat the body weight effect probably reflected a nonspecificresponse to topical irritation. In percutaneous developmentaltoxicity studies, NZW does were treated topically with Octocryleneat levels up to 267 mg/kg/day on Days 6 through 18 of gestation.Body weight gain, food consumption, and all maternal, reproductive,and offspring parameters evaluated were comparable between Octocrylene-treatedand control animals. In the oral developmental toxicity assay,female CD-1 mice received oral doses of Octocrylene up to 1000mg/kg/day on Days 8–12 of gestation. No evidence of maternalor developmental toxicity was seen at any dose tested. Genotoxicitywas evaluated in vitro using the Chinese hamster ovary cellassay to assess clastogenicity and the mouse lymphoma cell assayto assess forward gene mutations. Octocrylene did not induceany significant increase in genotoxicity. This evaluation oftoxicological potential supports the use of Octocrylene as ahuman photoprotectant.