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 Jul;153 Suppl 1:112170. doi: 10.1016/j.fct.2021.112170. Epub 2021 Apr 7.
The existing information supports the use of this material as described in this safety assessment. Ethyl 2-methyl-4-pentenoate 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 undec-10-enoate (CAS # 111-81-9) show that ethyl 2-methyl-4-pentenoate 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 2-methyl-4-pentenoate 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 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/visible (UV/Vis) spectra; ethyl 2-methyl-4-pentenoate is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; ethyl 2-methyl-4-pentenoate 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该物质。已评估 2-甲基-4-戊烯酸乙酯的遗传毒性、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。来自结构类似物甲基十一碳-10-烯酸甲酯（CAS#111-81-9）的读项数据表明，2-甲基-4-戊烯酸乙酯预计没有遗传毒性。使用毒性关注阈值（TTC）评估了重复剂量、生殖和局部呼吸毒性终点，对于 Cramer 分类 I 物质，2-甲基-4-戊烯酸乙酯的暴露量低于 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/光过敏终点基于紫外线/可见光（UV/Vis）光谱进行评估；2-甲基-4-戊烯酸乙酯预计没有光毒性/光过敏。评估了环境终点；根据国际香料协会（IFRA）环境标准，2-甲基-4-戊烯酸乙酯不属于持久性、生物累积性和毒性（PBT）物质，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]）<1。
