RIFM fragrance ingredient safety assessment, 2-tert-butylcyclohexyl acetate, CAS Registry Number 88-41-5

Abstract

The existing information supports the use of this material as described in this safety assessment. 2-tert-Butylcyclohexyl acetate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Target data show that 2-tert-butylcyclohexyl acetate is not genotoxic. Data on 2-tert-butylcyclohexyl acetate provide a calculated Margin of Exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints. Data show that there are no safety concerns for 2-tert-butylcyclohexyl acetate for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 2-tert-butylcyclohexyl acetate is not expected to be photoirritating/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to 2-tert-butylcyclohexyl acetate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 2-tert-butylcyclohexyl acetate was found not to be Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients (RQs), based on its current volume of use (VoU) in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.