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Hazard identification and consumer safety characterization for trans-1-chloro-3,3,3-trifluoropropene [trans-1233zd(E)]
Toxicology Letters ( IF 2.9 ) Pub Date : 2020-10-01 , DOI: 10.1016/j.toxlet.2020.05.034
Madhuri Singal 1 , David Nuber 1 , George M Rusch 2 , Jeffery A Engelhardt 3 , Sandeep Mukhi 1
Affiliation  

Trans-1233zd(E) was developed as a refrigerant and propellant in consumer products; its toxicity has been studied extensively. The scope of this assessment is to apply the confirmed NOAEC to conduct Benchmark Dose Modeling (BMD) and determine the Point of Departure (POD). In a previously published 13-week inhalation study, a NOAEC was identified at 4000 ppm. Due to uncertainty concerning the cardiac lesion, an external pathology peer review of heart tissues was undertaken using published best practices and consistent nomenclature and diagnostic criteria. The cardiac lesion observed at 4000 ppm was considered to be spontaneous based on lesion location and microscopic features. BMD was applied to derive the BMDL05 and BMDL10; the more conservative BMDL05 was used as the POD for risk assessment to calculate the Reference Exposure Levels (RELs). The 2-Box Air Dispersion Model was used to calculate the exposure to consumer products. Both the acute and chronic exposure concentrations calculated were compared to the acute and chronic RELs. The acute and chronic exposure to trans-1233zd(E) in the assessed consumer products are below the RELs and safe for their intended use.

中文翻译:

trans-1-chloro-3,3,3-trifluoropropene [trans-1233zd(E)] 的危害识别和消费者安全表征

Trans-1233zd(E) 被开发为消费品中的制冷剂和推进剂;其毒性已被广泛研究。此评估的范围是应用已确认的 NOAEC 进行基准剂量建模 (BMD) 并确定出发点 (POD)。在之前发表的一项为期 13 周的吸入研究中,发现 NOAEC 为 4000 ppm。由于心脏病变的不确定性,使用已发表的最佳实践和一致的命名法和诊断标准对心脏组织进行了外部病理学同行审查。根据病变位置和微观特征,在 4000 ppm 观察到的心脏病变被认为是自发的。应用 BMD 推导出 BMDL05 和 BMDL10;更保守的 BMDL05 被用作风险评估的 POD,以计算参考暴露水平 (REL)。2-Box 空气扩散模型用于计算消费品的暴露量。计算出的急性和慢性暴露浓度都与急性和慢性 REL 进行了比较。评估消费品中反式 1233zd(E) 的急性和慢性暴露低于 REL,并且对于其预期用途是安全的。
更新日期:2020-10-01
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