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 1:111863. doi: 10.1016/j.fct.2020.111863. Epub 2020 Nov 18.
The existing information supports the use of this material as described in this safety assessment. 2-Thiophenecarboxylic acid, ethyl ester was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 2-thiophenecarboxylic acid, ethyl ester 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 2-thiophenecarboxylic acid, ethyl ester 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 UV spectra; 2-thiophenecarboxylic acid, ethyl ester is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 2-thiophenecarboxylic acid, ethyl ester was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.
现有信息支持将该材料按本安全评估中的描述使用。已对 2-噻吩羧酸乙酯进行遗传毒性、重复剂量毒性、生殖毒性、局部呼吸毒性、光毒性/光过敏、皮肤致敏和环境安全评估。数据表明 2-噻吩羧酸乙酯没有遗传毒性。重复剂量、生殖和局部呼吸毒性终点使用毒性关注阈值 (TTC) 评估 Cramer 分类 III 物质,2-噻吩羧酸乙酯的暴露量低于 TTC(分别为 0.0015 mg/kg/天、0.0015 mg/kg/天和 0.47 mg/天)。皮肤致敏终点使用非反应性物质的皮肤致敏阈值 (DST) 完成(900 μg/cm);暴露量低于 DST。光毒性/光过敏终点基于 UV 光谱进行评估;预计 2-噻吩羧酸乙酯没有光毒性/光过敏。对环境终点进行了评估;根据 IFRA 环境标准,2-噻吩羧酸乙酯不属于 PBT,并且根据其在欧洲和北美的当前用量(即 PEC/PNEC),其风险商数<1。