Research Institute for Fragrance Materials, Inc, 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.
Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY, 10032, USA.
Food Chem Toxicol. 2020 Oct 15;144 Suppl 1:111474. doi: 10.1016/j.fct.2020.111474. Epub 2020 Jul 5.
The existing information supports the use of this material as described in this safety assessment. Ethyl (E)hex-3-enoate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog methyl 3-hexenoate (CAS # 2396-78-3) show that ethyl (E)hex-3-enoate is not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to ethyl (E)hex-3-enoate is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The skin sensitization endpoint was completed using 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; ethyl (E)hex-3-enoate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; ethyl (E)hex-3-enoate 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.
现有信息支持在本安全评估中按所述用途使用这种物质。已对乙基(E)己-3-烯酸酯进行了遗传毒性、重复剂量毒性、生殖毒性、局部呼吸毒性、光毒性/光变应性、皮肤致敏性和环境安全性评估。来自结构类似物甲基 3-己烯酸酯(CAS#2396-78-3)的研究数据表明,乙基(E)己-3-烯酸酯预计不会具有遗传毒性。使用毒性关注阈值(TTC)对重复剂量、生殖和局部呼吸毒性终点进行了评估,该物质属于 Cramer 分类 I 类物质,乙基(E)己-3-烯酸酯的暴露量低于 TTC(分别为 0.03mg/kg/天、0.03mg/kg/天和 1.4mg/天)。皮肤致敏性终点使用非反应性物质的皮肤致敏阈值(DST)完成(900μg/cm);暴露量低于 DST。光毒性/光变应性终点基于紫外线(UV)光谱进行评估;乙基(E)己-3-烯酸酯预计不会具有光毒性/光变应性。对环境终点进行了评估;根据国际香料协会(IFRA)环境标准,乙基(E)己-3-烯酸酯不具有持久性、生物累积性和毒性(PBT),并且根据其目前在欧洲和北美的用量(即预测环境浓度/无效应预测浓度 [PEC/PNEC]),其风险商数<1。