RIFM fragrance ingredient safety assessment, 2-methyl-4-(camphenyl-8)-cyclohexanone, CAS Registry Number 68901-22-4

Summary: The existing information supports the use of this material as described in this safety assessment. 2-Methyl-4-(camphenyl-8)-cyclohexanone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 2-methyl-4-(camphenyl-8)-cyclohexanone is not genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class III material, and the exposure to 2-methyl-4-(camphenyl-8)-cyclohexanone is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). The skin sensitization endpoint was completed using the Dermal Sensitization Threshold (DST) for reactive materials (64 μg/cm2); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 2-methyl-4-(camphenyl-8)-cyclohexanone is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 2-methyl-4-(camphenyl-8)-cyclohexanone was found not to be persistent, bioaccumulative, and toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are