Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.
Member Expert Panel, Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY, 10032, USA.
Food Chem Toxicol. 2021 Mar;149 Suppl 1:111885. doi: 10.1016/j.fct.2020.111885. Epub 2020 Nov 26.
The existing information supports the use of this material as described in this safety assessment. 3,4,4a,5,8,8a (Or 3,4,4a,7,8,8a)-Hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran 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 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran 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/cm); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 3,4,4a, 5,8,8a (Or 3,4,4a,7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 3,4,4a, 5,8,8a (Or 3,4,4a, 7,8,8a)-hexahydro-3,3,6,7-tetramethyl-1H-2-benzopyran 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.
现有信息支持将这种材料按本安全评估中的说明使用。3,4,4a,5,8,8a(或 3,4,4a,7,8,8a)-六氢-3,3,6,7-四甲基-1H-2-苯并吡喃已针对遗传毒性、重复剂量毒性、生殖毒性、局部呼吸毒性、光毒性/光过敏、皮肤致敏和环境安全性进行了评估。数据表明，3,4,4a,5,8,8a(或 3,4,4a,7,8,8a)-六氢-3,3,6,7-四甲基-1H-2-苯并吡喃没有遗传毒性。重复剂量、生殖和局部呼吸毒性终点是使用毒理学关注阈值（TTC）来评估的，对于 Cramer 类 III 物质，3,4,4a,5,8,8a(或 3,4,4a,7,8,8a)-六氢-3,3,6,7-四甲基-1H-2-苯并吡喃的暴露量低于 TTC（分别为 0.0015mg/kg/天、0.0015mg/kg/天和 0.47mg/天）。皮肤致敏终点是使用非反应性物质的皮肤致敏阈值（DST）完成的（900μg/cm）；暴露量低于 DST。光毒性/光过敏终点是基于紫外线（UV）光谱进行评估的；3,4,4a,5,8,8a(或 3,4,4a,7,8,8a)-六氢-3,3,6,7-四甲基-1H-2-苯并吡喃预计不会具有光毒性/光过敏。环境终点进行了评估；根据国际香料协会（IFRA）环境标准，3,4,4a,5,8,8a(或 3,4,4a,7,8,8a)-六氢-3,3,6,7-四甲基-1H-2-苯并吡喃不属于持久性、生物蓄积性和毒性物质（PBT），并且根据其在欧洲和北美的当前用量，其风险商数（基于预测环境浓度/无效应预测浓度 [PEC/PNEC]）均<1。
