香料成分互认组织香料成分安全性评估，5,8-亚甲基-2H-1-苯并吡喃，6（或7）-亚乙基八氢-，[4aR,5S,8S,8aS（或4aR,5R,8S,8aR）]-相对构型-，化学物质登记号943723-15-7
RIFM fragrance ingredient safety assessment, 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel-, CAS Registry Number 943723-15-7.
作者信息
Api A M, Belsito D, Botelho D, Bruze M, Burton G A, Buschmann J, Cancellieri M A, Dagli M L, Date M, Dekant W, Deodhar C, Fryer A D, Jones L, Joshi K, Kumar M, Lapczynski A, Lavelle M, Lee I, Liebler D C, Moustakas H, Na M, Penning T M, Ritacco G, Romine J, Sadekar N, Schultz T W, Selechnik D, Siddiqi F, Sipes I G, Sullivan G, Thakkar Y, Tokura Y
机构信息
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.
出版信息
Food Chem Toxicol. 2022 Jan 15;159 Suppl 1:112647. doi: 10.1016/j.fct.2021.112647. Epub 2021 Oct 29.
The existing information supports the use of this material as described in this safety assessment. 5,8-Methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 5,8-methano-2H-1-benzopyran-2-one, 6- ethylideneoctahydro- (CAS # 69486-14-2) show that 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- is not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class III material, and the exposure to 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). Data provided 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- a NESIL of 8200 μg/cm for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on human study data and UV/Vis spectra; 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; 5,8-methano-2H-1-benzopyran, 6(or 7)-ethylideneoctahydro-, [4aR,5S,8S,8aS(or 4aR,5R,8S,8aR)]-rel- was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.
现有信息支持按照本安全评估中所述使用该物质。对5,8-亚甲基-2H-1-苯并吡喃，6(或7)-亚乙基八氢-，[4aR,5S,8S,8aS(或4aR,5R,8S,8aR)]-rel-进行了遗传毒性、重复剂量毒性、生殖毒性、局部呼吸道毒性、光毒性/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5,8-亚甲基-2H-1-苯并吡喃-2-酮，6-亚乙基八氢-（CAS编号69486-14-2）的数据表明，5,8-亚甲基-2H-1-苯并吡喃，6(或7)-亚乙基八氢-，[4aR,5S,8S,8aS(或4aR,5R,8S,8aR)]-rel-预计无遗传毒性。使用适用于克莱默III类物质的阈限值（TTC）对重复剂量、生殖和局部呼吸道毒性终点进行了评估，5,8-亚甲基-2H-1-苯并吡喃，6(或7)-亚乙基八氢-，[4aR,5S,8S,8aS(或4aR,5R,8S,8aR)]-rel-的暴露量低于TTC（分别为0.0015毫克/千克/天、0.0015毫克/千克/天和0.47毫克/天）。所提供的数据表明，5,8-亚甲基-2H-1-苯并吡喃，6(或7)-亚乙基八氢-，[4aR,5S,8S,8aS(或4aR,5R,8S,8aR)]-rel-的皮肤致敏终点的无预期致敏剂量（NESIL）为8200微克/平方厘米。基于人体研究数据和紫外/可见光谱对光毒性/光致敏性终点进行了评估；5,8-亚甲基-2H-1-苯并吡喃，6(或7)-亚乙基八氢-，[4aR,5S,8S,8aS(或4aR,5R,8S,8aR)]-rel-预计无光毒性/光致敏性。对环境终点进行了评估；根据国际日用香料协会（IFRA）环境标准，发现5,8-亚甲基-2H-1-苯并吡喃，6(或7)-亚乙基八氢-，[4aR,5S,8S,8aS(或4aR,5R,8S,8aR)]-rel-不是持久性、生物累积性和毒性物质（PBT），并且根据其目前在欧洲和北美的使用量计算的风险商数（即预测环境浓度/预测无效应浓度，PEC/PNEC）<1。
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