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. 2021 Mar;149 Suppl 1:111993. doi: 10.1016/j.fct.2021.111993. Epub 2021 Jan 16.
The existing information supports the use of this material as described in this safety assessment. 7,9-Dimethylspiro[5.5]undecan-3-one was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that 7,9-dimethylspiro[5.5]undecan-3-one is not genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class II material, and the exposure to 7,9-dimethylspiro[5.5]undecan-3-one is below the TTC (0.009 mg/kg/day, 0.009 mg/kg/day, and 0.47 mg/day, respectively). Based on the existing data and readacross material spiro[5.5]undec-8-en-1-one, 2,2,7,9-tetramethyl- (CAS # 502847-01-0), 7,9-dimethylspiro[5.5]undecan-3-one presents no concern for skin sensitization under the current, declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet (UV) spectra; 7,9-dimethylspiro[5.5]undecan-3-one is not phototoxic/photoallergenic. The environmental endpoints were evaluated; 7,9-dimethylspiro[5.5]undecan-3-one 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按本安全评估中的说明使用。7,9-二甲基螺[5.5]十一烷-3-酮已进行了遗传毒性、重复剂量毒性、生殖毒性、局部呼吸毒性、光毒性/光过敏、皮肤致敏和环境安全性评估。数据表明，7,9-二甲基螺[5.5]十一烷-3-酮没有遗传毒性。重复剂量、生殖和局部呼吸毒性终点采用毒性关注阈值（TTC）评估 Cramer 分类 II 物质，并且 7,9-二甲基螺[5.5]十一烷-3-酮的暴露量低于 TTC（分别为 0.009 毫克/千克/天、0.009 毫克/千克/天和 0.47 毫克/天）。基于现有数据和阅读材料螺[5.5]十一烯-8-烯-1-酮，2,2,7,9-四甲基-（CAS # 502847-01-0），7,9-二甲基螺[5.5]十一烷-3-酮在当前申报的使用水平下，不会引起皮肤致敏。光毒性/光过敏终点基于数据和紫外线（UV）光谱进行评估；7,9-二甲基螺[5.5]十一烷-3-酮没有光毒性/光过敏。环境终点进行了评估；7,9-二甲基螺[5.5]十一烷-3-酮根据国际香料协会（IFRA）环境标准，发现其不属于持久性、生物蓄积性和毒性（PBT），并且根据其在欧洲和北美的当前使用量，其风险商数（基于预测环境浓度/无影响预测浓度 [PEC/PNEC]）<1。
