Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.
Member Expert Panel for Fragrance Safety, Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY, 10032, USA.
Food Chem Toxicol. 2022 Dec;169 Suppl 1:113408. doi: 10.1016/j.fct.2022.113408. Epub 2022 Sep 7.
The existing information supports the use of this material as described in this safety assessment. 2-Tridecanone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 2-heptanone (CAS # 110-43-0) show that 2-tridecanone is not expected to be genotoxic and provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity and reproductive toxicity endpoints. Data from read-across analog 2-heptanone (CAS # 110-43-0) show that there are no safety concerns for 2-tridecanone for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 2-tridecanone 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 II material, and the exposure to 2-tridecanone is below the TTC (0.47 mg/day). The environmental endpoints were evaluated; 2-Tridecanone 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用于本安全评估中所述用途。2-十三酮已进行了遗传毒性、重复剂量毒性、生殖毒性、局部呼吸道毒性、光刺激性/光过敏、皮肤致敏和环境安全性评估。来自结构类似物 2-庚酮（CAS#110-43-0）的现有数据表明，2-十三酮预计不会具有遗传毒性，并且在重复剂量毒性和生殖毒性终点方面，计算得出的暴露量倍数（MOE）>100。来自结构类似物 2-庚酮（CAS#110-43-0）的现有数据表明，在当前申报的使用水平下，2-十三酮不会引起皮肤致敏。光刺激性/光过敏终点是根据紫外线/可见光（UV/Vis）光谱进行评估的；2-十三酮预计不会具有光刺激性/光过敏。局部呼吸道毒性终点是使用毒性关注阈值（TTC）来评估的，对于 Cramer 类 II 物质，2-十三酮的暴露量低于 TTC（0.47mg/天）。已对环境终点进行了评估；根据国际香料协会（IFRA）环境标准，2-十三酮被认为不是持久性、生物累积性和毒性（PBT）物质，并且基于其在欧洲和北美的当前用量，其风险商数（即预测环境浓度/无效应预测浓度 [PEC/PNEC]）<1。
