Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.
Member RIFM Expert Panel, Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY, 10032, USA.
Food Chem Toxicol. 2019 May 15;127 Suppl 1:S90-S99. doi: 10.1016/j.fct.2019.01.031. Epub 2019 Feb 1.
4H-4a,9-Methanoazuleno[5,6-d]-1,3-dioxole, octahydro-2,2,5,8,8,9a-hexamethyl-, (4aR,5R,7aS,9R) (CAS # 211299-54-6) was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from 4H-4a,9-methanoazuleno[5,6-d]-1,3-dioxole, octahydro-2,2,5,8,8,9a-hexamethyl-, (4aR,5R,7aS,9R) show that it is not genotoxic, and that there are no safety concerns for skin sensitization under the current, declared levels of use. Data from 4H-4a,9-methanoazuleno[5,6-d]-1,3-dioxole, octahydro-2,2,5,8,8,9a-hexamethyl-, (4aR,5R,7aS,9R) provide a calculated MOE >100 for the repeated dose toxicity endpoint. The reproductive and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class III material, and the exposure to 4H-4a,9-methanoazuleno[5,6-d]-1,3-dioxole, octahydro-2,2,5,8,8,9a-hexamethyl-, (4aR,5R,7aS,9R) is below the TTC (0.0015 mg/kg/day and 0.47 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; 4H-4a,9-methanoazuleno[5,6-d]-1,3-dioxole, octahydro-2,2,5,8,8,9a-hexamethyl-, (4aR,5R,7aS,9R) is not expected to be phototoxic/photoallergenic. For the environmental endpoints, 4H-4a,9-methanoazuleno[5,6-d]-1,3-dioxole, octahydro-2,2,5,8,8,9a-hexamethyl-, (4aR,5R,7aS,9R) is not PBT as per the IFRA Environmental Standards, and its risk quotients (i.e., PEC/PNEC) for the aquatic environment based on its current volume of use in Europe and North America are <1.
4H-4a,9-甲烷并[5,6-d]-1,3-二氧杂环戊烯,八氢-2,2,5,8,8,9a-六甲基-,(4aR,5R,7aS,9R)(CAS#211299-54-6)被评估了遗传毒性、重复剂量毒性、生殖毒性、局部呼吸毒性、光毒性/光过敏、皮肤致敏性和环境安全性。4H-4a,9-甲烷并[5,6-d]-1,3-二氧杂环戊烯,八氢-2,2,5,8,8,9a-六甲基-,(4aR,5R,7aS,9R)的数据表明它没有遗传毒性,并且在当前申报的使用水平下,皮肤致敏性没有安全问题。4H-4a,9-甲烷并[5,6-d]-1,3-二氧杂环戊烯,八氢-2,2,5,8,8,9a-六甲基-,(4aR,5R,7aS,9R)的数据为重复剂量毒性终点提供了计算 MOE>100。生殖毒性和局部呼吸毒性终点使用 Cramer 类 III 物质的 TTC 进行评估,并且暴露于 4H-4a,9-甲烷并[5,6-d]-1,3-二氧杂环戊烯,八氢-2,2,5,8,8,9a-六甲基-,(4aR,5R,7aS,9R)的量低于 TTC(分别为 0.0015mg/kg/天和 0.47mg/天)。光毒性/光过敏终点基于 UV 光谱进行评估;4H-4a,9-甲烷并[5,6-d]-1,3-二氧杂环戊烯,八氢-2,2,5,8,8,9a-六甲基-,(4aR,5R,7aS,9R)预计不会具有光毒性/光过敏。对于环境终点,根据 IFRA 环境标准,4H-4a,9-甲烷并[5,6-d]-1,3-二氧杂环戊烯,八氢-2,2,5,8,8,9a-六甲基-,(4aR,5R,7aS,9R)不是 PBT,并且根据其在欧洲和北美的当前使用量,其水生环境的风险商数(即 PEC/PNEC)<1。