Api A M, Bartlett A, Belsito D, Botelho D, Bruze M, Bryant-Friedrich A, Burton G A, Cancellieri M A, Chon H, Cronin M, Crotty S, Dagli M L, Dekant W, Deodhar C, Farrell K, Fryer A D, Jones L, Joshi K, Lapczynski A, Laskin D L, Lavelle M, Lee I, Moustakas H, Muldoon J, Penning T M, Piersma A H, Ritacco G, Sadekar N, Schember I, Schultz T W, Siddiqi F, Sipes I G, Sullivan G, Thakkar Y
Research Institute for Fragrance Materials, Inc., 1200 MacArthur Boulevard, Suite 306, Mahwah, NJ, 07430, 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. 2025 Jul;201 Suppl 1:115470. doi: 10.1016/j.fct.2025.115470. Epub 2025 Apr 23.
1,1-Diethoxyheptane was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog octanal dimethyl acetal (CAS # 10022-28-3) show that 1,1-diethoxyheptane is not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to 1,1-diethoxyheptane is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). The skin sensitization endpoint was completed using the Dermal Sensitization Threshold (DST) for non-reactive materials (900 μg/cm); exposure is below the DST. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 1,1-diethoxyheptane is not expected to be photoirritating/photoallergenic. The environmental endpoints were evaluated; 1,1-diethoxyheptane 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.
对1,1 - 二乙氧基庚烷进行了遗传毒性、重复剂量毒性、生殖毒性、局部呼吸道毒性、光刺激性/光致敏性、皮肤致敏性和环境安全性评估。来自交叉参照类似物辛醛二甲基缩醛(CAS编号10022 - 28 - 3)的数据表明,预计1,1 - 二乙氧基庚烷无遗传毒性。使用针对克莱默I类物质的毒理学关注阈值(TTC)对重复剂量、生殖和局部呼吸道毒性终点进行了评估,1,1 - 二乙氧基庚烷的暴露量低于TTC(分别为0.03毫克/千克/天、0.03毫克/千克/天和1.4毫克/天)。使用非反应性物质的皮肤致敏阈值(DST)(900微克/平方厘米)完成了皮肤致敏终点评估;暴露量低于DST。基于紫外/可见(UV/Vis)光谱对光刺激性/光致敏性终点进行了评估;预计1,1 - 二乙氧基庚烷无光刺激性/光致敏性。对环境终点进行了评估;根据国际香料协会(IFRA)环境标准,发现1,1 - 二乙氧基庚烷不具有持久性、生物累积性和毒性(PBT),并且根据其在欧洲和北美的当前使用量(VoU)计算的风险商数(即预测环境浓度/预测无效应浓度[PEC/PNEC])<1。