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 1:111697. doi: 10.1016/j.fct.2020.111697. Epub 2020 Aug 25.
The existing information supports the use of this material as described in this safety assessment. 2-Phenylpropionaldehyde was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data on read-across analogs 3-phenylbutanal (CAS # 16251-77-7) and isopropylphenylbutanal (CAS # 125109-85-5) show that this material is not expected to be genotoxic. Data from the target material provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity endpoint and a No Expected Sensitization Induction Level (NESIL) of 380 μg/cm for the skin sensitization endpoint. The developmental and reproductive toxicity and the local respiratory toxicity endpoints were completed using the threshold of toxicological concern (TTC) for a Cramer Class I material (0.03 mg/kg/day and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 2-phenylpropionaldehyde is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 2-phenylpropionaldehyde 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.
现有信息支持将该材料按本安全评估中的说明使用。2-苯丙醛已进行了遗传毒性、重复剂量毒性、发育和生殖毒性、局部呼吸毒性、光毒性/光过敏、皮肤致敏和环境安全性评估。关于类似物 3-苯基丁醛（CAS#16251-77-7）和异丙基苯基丁醛（CAS#125109-85-5）的已有数据表明，该材料预计不会具有遗传毒性。来自目标物质的数据为重复剂量毒性终点提供了计算暴露量倍数（MOE）>100，皮肤致敏终点的无预期致敏诱导水平（NESIL）为 380μg/cm。发育和生殖毒性以及局部呼吸毒性终点均采用毒理学关注阈值（TTC）完成，适用于 Cramer 类 I 物质（分别为 0.03mg/kg/天和 1.4mg/天）。光毒性/光过敏终点根据紫外线（UV）光谱进行评估；2-苯丙醛预计不会具有光毒性/光过敏。对环境终点进行了评估；根据国际香料协会（IFRA）环境标准，2-苯丙醛被发现不具有持久性、生物蓄积性和毒性（PBT），且其风险商数（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。
