Api A M, Belsito D, Biserta S, Botelho D, Bruze M, Burton G A, Buschmann J, Cancellieri M A, Dagli M L, Date M, Dekant W, Deodhar C, Fryer A D, Gadhia S, Jones L, Joshi K, Lapczynski A, Lavelle M, Liebler D C, Na M, O'Brien D, Patel A, Penning T M, Ritacco G, Rodriguez-Ropero F, Romine J, Sadekar N, Salvito D, Schultz T W, Siddiqi F, Sipes I G, Sullivan G, Thakkar Y, Tokura Y, Tsang S
Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.
Member 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 1:111696. doi: 10.1016/j.fct.2020.111696. Epub 2020 Aug 25.
The existing information supports the use of this material as described in this safety assessment. 3,7-Dimethyl-3,6-octadienal was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog citral (CAS # 5392-40-5) show that 3,7-dimethyl-3,6-octadienal is not expected to be genotoxic and provided a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and developmental and reproductive endpoints. Data from the read-across analog citronellal (CAS # 106-23-0) provided 3,7-dimethyl-3,6-octadienal a No Expected Sensitization Induction Level (NESIL) of 7000 μg/cm for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 3,7-dimethyl-3,6-octadienal is not expected to be phototoxic/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 3,7-dimethyl-3,6-octadienal is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 3,7-dimethyl-3,6-octadienal 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.
现有信息支持按本安全评估所述使用该物质。对3,7 - 二甲基 - 3,6 - 辛二烯醛进行了遗传毒性、重复剂量毒性、发育和生殖毒性、局部呼吸道毒性、光毒性/光致敏性、皮肤致敏性及环境安全性评估。来自交叉参照类似物柠檬醛（CAS编号5392 - 40 - 5）的数据表明，预计3,7 - 二甲基 - 3,6 - 辛二烯醛无遗传毒性，且重复剂量毒性以及发育和生殖终点的计算暴露限值（MOE）>100。来自交叉参照类似物香茅醛（CAS编号106 - 23 - 0）的数据表明，3,7 - 二甲基 - 3,6 - 辛二烯醛皮肤致敏终点的无预期致敏诱导水平（NESIL）为7000μg/cm²。基于紫外（UV）光谱对光毒性/光致敏性终点进行了评估；预计3,7 - 二甲基 - 3,6 - 辛二烯醛无光毒性/光致敏性。使用Cramer I类物质的毒理学关注阈值（TTC）对局部呼吸道毒性终点进行了评估，3,7 - 二甲基 - 3,6 - 辛二烯醛的暴露低于TTC（1.4mg/天）。对环境终点进行了评估；根据国际香精协会（IFRA）环境标准，发现3,7 - 二甲基 - 3,6 - 辛二烯醛不具有持久性、生物累积性和毒性（PBT），并且基于其在欧洲和北美的当前使用量计算的风险商（即预测环境浓度/预测无效应浓度[PEC/PNEC]）<1。
