Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.
Expert Panel for Fragrance Safety, Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY, 10032, USA.
Food Chem Toxicol. 2024 Oct;192 Suppl 1:114938. doi: 10.1016/j.fct.2024.114938. Epub 2024 Aug 14.
The existing information supports the use of this material as described in this safety assessment. 2-Methyl-4-phenylbutyraldehyde was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog β-methyl-benzenepentanal (CAS # 55,066-49-4) show that 2-methyl-4-phenylbutyraldehyde is not expected to be genotoxic and provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity endpoint. Data on read-across analog phenylacetaldehyde (CAS # 122-78-1) provide a calculated MOE >100 for the reproductive toxicity endpoint. Data show that there are no safety concerns for 2-methyl-4-phenylbutyraldehyde for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 2-methyl-4-phenylbutyraldehyde is not expected to be photoirritating/photoallergenic. The local respiratory toxicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to 2-methyl-4-phenylbutyraldehyde is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 2-methyl-4-phenylbutyraldehyde 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 (VoU) 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使用这种材料。已对 2-甲基-4-苯基丁醛进行遗传毒性、重复剂量毒性、生殖毒性、局部呼吸毒性、光致过敏/光致变应性、皮肤致敏和环境安全性评估。来自读-跨类似物β-甲基-苯戊醛（CAS#55,066-49-4）的数据表明，2-甲基-4-苯基丁醛预计不会具有遗传毒性，并为重复剂量毒性终点提供了计算的暴露量倍数（MOE）>100。来自读-跨类似物苯乙醛（CAS#122-78-1）的数据为生殖毒性终点提供了计算的 MOE>100。数据表明，在当前申报的使用水平下，2-甲基-4-苯基丁醛不会引起皮肤致敏。光致过敏/光致变应性终点是根据紫外线/可见光（UV/Vis）光谱进行评估的；2-甲基-4-苯基丁醛预计不会具有光致过敏/光致变应性。局部呼吸毒性终点是使用毒性关注阈值（TTC）评估的，对于 Cramer 类 I 物质，2-甲基-4-苯基丁醛的暴露量低于 TTC（1.4mg/天）。对环境终点进行了评估；根据国际香料协会（IFRA）环境标准，2-甲基-4-苯基丁醛被发现不是持久性、生物蓄积性和毒性（PBT），并且基于其在欧洲和北美的当前用量（VoU），其风险商数（基于其当前的用量和暴露量）<1。
