Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.
Member RIFM Expert Panel, Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY, 10032, USA.
Food Chem Toxicol. 2020 Oct 15;144 Suppl 1:111468. doi: 10.1016/j.fct.2020.111468. Epub 2020 Jul 5.
The existing information supports the use of this material as described in this safety assessment. 2-Acetylthiazole was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 2-acetylthiazole is not genotoxic. 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 repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the threshold of toxicological concern (TTC) for a Cramer Class II material, and the exposure to 2-acetylthiazole is below the TTC (0.009 mg/kg/day, 0.009 mg/kg/day, and 0.47 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; 2-acetylthiazole is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated, 2-acetylthiazole 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材料。已对 2-乙酰噻唑进行遗传毒性、重复剂量毒性、生殖毒性、局部呼吸毒性、光毒性/光变应原性、皮肤致敏性和环境安全性评估。数据表明 2-乙酰噻唑没有遗传毒性。皮肤致敏性终点是使用非反应性材料的皮肤致敏阈值（DST）（900μg/cm）完成的；接触量低于 DST。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）评估的，对于 Cramer 二类物质，接触 2-乙酰噻唑的量低于 TTC（分别为 0.009mg/kg/天、0.009mg/kg/天和 0.47mg/天）。光毒性/光变应原性终点是根据紫外线光谱进行评估的；预计 2-乙酰噻唑没有光毒性/光变应原性。已对环境终点进行评估，根据国际香料协会（IFRA）环境标准，2-乙酰噻唑不属于持久性、生物累积性和毒性物质（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。
