RIFM fragrance ingredient safety assessment, 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole, CAS Registry Number...

The existing information supports the use of this material as described in this safety assessment. 4,5,6,7,8,9,10,11,12,13-Decahydrocyclododecaoxazole was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole 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 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole 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 non-reactive materials (900 μg/cm²); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 4,5,6,7,8,9,10,11,12,13-decahydrocyclododecaoxazole 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 <1.