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. 2021 Mar;149 Suppl 1:111989. doi: 10.1016/j.fct.2021.111989. Epub 2021 Jan 16.
The existing information supports the use of this material as described in this safety assessment. 3,7-Dimethyl-1,3,6-octatriene was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from 3,7-dimethyl-1,3,6-octatriene and read-across analog myrcene (β-myrcene; CAS # 123-35-3) show that 3,7-dimethyl-1,3,6-octatriene is not expected to be genotoxic and provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and developmental and reproductive toxicity endpoints. The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for non-reactive materials (900 μg/cm 2 ); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 3,7-dimethyl-1,3,6- octatriene 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-1,3,6-octatriene is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 3,7-dimethyl-1,3,6- octatriene 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 oncentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.
现有信息支持在本安全评估中使用该物质。3,7-二甲基-1,3,6-辛三烯已进行遗传毒性、重复剂量毒性、发育和生殖毒性、局部呼吸道毒性、光毒性/光过敏、皮肤致敏和环境安全评估。3,7-二甲基-1,3,6-辛三烯和可类推的类似物β-月桂烯（β- 月桂烯；CAS#123-35-3）的数据表明，3,7-二甲基-1,3,6-辛三烯预计不会具有遗传毒性，且对重复剂量毒性和发育与生殖毒性终点的暴露计算得出的安全系数（MOE）＞100。皮肤致敏终点采用非反应性物质的皮肤致敏阈值（DST）（900μg/cm 2）完成；暴露量低于 DST。光毒性/光过敏终点是根据紫外线（UV）光谱进行评估的；3,7-二甲基-1,3,6-辛三烯预计不会具有光毒性/光过敏。局部呼吸道毒性终点采用毒理学关注阈值（TTC）评估 Cramer 分类 I 物质，3,7-二甲基-1,3,6-辛三烯的暴露量低于 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，3,7-二甲基-1,3,6-辛三烯被发现不具有持久性、生物累积性和毒性（PBT），且其风险商数（基于其在欧洲和北美的当前用量）基于其在欧洲和北美的当前用量，低于 1。
