Update to RIFM fragrance ingredient safety assessment, 3,5-dimethylcyclohex-3-ene-1-methyl acetate, CAS Registry...

3,5-Dimethylcyclohex-3-ene-1-methyl acetate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data show that 3,5-dimethylcyclohex-3-ene-1-methyl acetate is not genotoxic. Data on read-across analog (1R)-nopyl acetate (CAS # 35836-72-7) 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 3,5-dimethylcyclohex-3-ene-1-methyl acetate for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 3,5-dimethylcyclohex-3-ene-1-methyl 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 3,5-dimethylcyclohex-3-ene-1-methyl acetate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 3,5-dimethylcyclohex-3-ene-1-methyl 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 (EU), North America (NA), Asia-Pacific (AP), Japan (JP), and South America (SA) (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.