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. 2020 Dec 15;146 Suppl 1:111759. doi: 10.1016/j.fct.2020.111759. Epub 2020 Sep 20.
Dodecane was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog nonane (CAS # 111-84-2) show that dodecane is not expected to be genotoxic. Data on read-across analog undecane (CAS # 1120-21-4) provide a calculated Margin of Exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints. 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/visible (UV/vis) spectra; dodecane is not expected to be phototoxic/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 dodecane is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; dodecane 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.
十二烷已进行遗传毒性、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评估。来自同系物非十二烷（CAS#111-84-2）的现有数据表明，十二烷预计不会具有遗传毒性。来自同系物十一烷（CAS#1120-21-4）的数据为重复剂量毒性和生殖毒性终点提供了 >100 的计算暴露量倍数（MOE）。皮肤致敏性终点使用非反应性物质的皮肤致敏阈值（DST）（900μg/cm2）完成；暴露量低于 DST。光毒性/光过敏终点基于紫外线/可见光（UV/vis）光谱进行评估；十二烷预计不会具有光毒性/光过敏。局部呼吸毒性终点使用毒理学关注阈值（TTC）对 Cramer 分类 I 物质进行评估，十二烷的暴露量低于 TTC（1.4mg/天）。对环境终点进行了评估；根据国际香料协会（IFRA）环境标准，十二烷未被发现具有持久性、生物蓄积性和毒性（PBT），其风险商数基于其在欧洲和北美的当前用量（即预测环境浓度/无效应预测浓度 [PEC/PNEC]）<1。
