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. 2021 Mar;149 Suppl 1:111982. doi: 10.1016/j.fct.2021.111982. Epub 2021 Jan 14.
The existing information supports the use of this material as described in this safety assessment. p-Tolualdehyde was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity, skin sensitization potential, and environmental safety. Data from read-across analog benzaldehyde (CAS # 100-52-7) show that p-tolualdehyde is not expected to be genotoxic. Data from read-across analog cuminaldehyde (CAS # 122-03-2) provided p-tolualdehyde a No Expected Sensitization Induction Level (NESIL) of 1100 μg/cm for the skin sensitization endpoint. The repeated dose toxicity, developmental and reproductive toxicity, and local respiratory toxicity endpoints were completed using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to p-tolualdehyde is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on data from read-across analog 4-ethylbenzaldehyde (CAS # 4748-78-1); p-tolualdehyde is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; p-tolualdehyde 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。对对甲苯醛进行了遗传毒性、重复剂量毒性、发育和生殖毒性、局部呼吸道毒性、光毒性、皮肤致敏性潜力和环境安全性评估。来自结构类似物苯甲醛(CAS#100-52-7)的现有数据表明,对甲苯醛预计不会具有遗传毒性。来自结构类似物洋茉莉醛(CAS#122-03-2)的数据为皮肤致敏终点提供了对甲苯醛的 1100μg/cm 的无预期致敏诱导水平(NESIL)。重复剂量毒性、发育和生殖毒性以及局部呼吸道毒性终点均采用毒理学关注阈值(TTC)完成,对甲苯醛的暴露低于 TTC(分别为 0.03mg/kg/天、0.03mg/kg/天和 1.4mg/天)。光毒性/光致敏性终点基于结构类似物 4-乙基苯甲醛(CAS#4748-78-1)的数据进行评估;对甲苯醛预计不会具有光毒性/光致敏性。对环境终点进行了评估;根据国际香料协会(IFRA)环境标准,对甲苯醛不属于持久性、生物累积性和毒性(PBT)物质,且其风险商数(基于其在欧洲和北美的当前用量)<1,即预测环境浓度/无效应预测浓度(PEC/PNEC)。