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. 2022 Jan 15;159 Suppl 1:112734. doi: 10.1016/j.fct.2021.112734. Epub 2021 Dec 3.
The existing information supports the use of this material as described in this safety assessment. Tetrahydro-6-(3-pentenyl)-2H-pyran-2-one was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that tetrahydro-6-(3-pentenyl)-2H-pyran-2-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 tetrahydro-6-(3-pentenyl)-2H-pyran-2-one is below the TTC (0.009 mg/kg/day, 0.009 mg/kg/day, and 0.47 mg/day, respectively). Data and read-across to 5-hydroxy-7-decenoic acid δ-lactone (CAS # 25,524-95-2) show that there are no safety concerns for tetrahydro-6-(3-pentenyl)-2H-pyran-2-one for skin sensitization under the current declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on data and ultraviolet/visible (UV/Vis) spectra; tetrahydro-6-(3-pentenyl)-2H-pyran-2-one is not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; tetrahydro-6-(3-pentenyl)-2H-pyran-2-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.
现有信息支持在本安全评估中按所述用途使用该物质。四氢-6-(3-戊烯基)-2H-吡喃-2-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,四氢-6-(3-戊烯基)-2H-吡喃-2-酮没有遗传毒性。重复剂量、生殖和局部呼吸毒性终点是使用毒性关注阈值(TTC)评估的,对于 Cramer 类 II 物质,四氢-6-(3-戊烯基)-2H-吡喃-2-酮的暴露量低于 TTC(分别为 0.009mg/kg/天、0.009mg/kg/天和 0.47mg/天)。数据和 5-羟基-7-癸烯酸 δ-内酯(CAS#25,524-95-2)的类推表明,在当前申报的使用水平下,四氢-6-(3-戊烯基)-2H-吡喃-2-酮不会引起皮肤致敏。光毒性/光过敏终点是基于数据和紫外线/可见光(UV/Vis)光谱评估的;预计四氢-6-(3-戊烯基)-2H-吡喃-2-酮不会具有光毒性/光过敏。已对环境终点进行了评估;根据国际香料协会(IFRA)环境标准,四氢-6-(3-戊烯基)-2H-吡喃-2-酮不属于持久性、生物累积性和毒性(PBT),而且根据其在欧洲和北美的当前用量,其风险商数(基于预测环境浓度/无影响预测浓度[PEC/PNEC])<1。