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首页> 外文期刊>Journal of applied toxicology >Development of an oral reference dose for the perfluorinated compound GenX
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Development of an oral reference dose for the perfluorinated compound GenX

机译：用于全氟化复合剂的口参考剂量的研制

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Abstract Ammonium 2,3,3,3‐tetrafluoro‐2‐(heptafluoropropoxy)‐propanoate, also known as GenX, is a processing aid used in the manufacture of fluoropolymers. GenX is one of several chemistries developed as an alternative to long‐chain poly‐fluoroalkyl substances, which tend to have long clearance half‐lives and are environmentally persistent. Unlike poly‐fluoroalkyl substances, GenX has more rapid clearance, but has been detected in US and international water sources. There are currently no federal drinking water standards for GenX in the USA; therefore, we developed a non‐cancer oral reference dose (RfD) for GenX based on available repeated dose studies. The review of the available data indicate that GenX is unlikely to be genotoxic. A combination of traditional frequentist benchmark dose models and Bayesian benchmark dose models were used derive relevant points of departure from mammalian toxicity studies. In addition, deterministic and probabilistic RfD values were developed using available tools and regulatory guidance. The two approaches resulted in a narrow range of RfD values for liver lesions observed in a 2‐year bioassay in rats (0.01–0.02?mg/kg/day). The probabilistic approach resulted in the lower, i.e., more conservative RfD. The probabilistic RfD of 0.01?mg/kg/day results in a maximum contaminant level goal of 70?ppb. It is anticipated that these values, along with the hazard identification and dose‐response modeling described herein, should be informative for risk assessors and regulators interested in setting health‐protective drinking water guideline values for GenX.
机译：摘要铵2,3,3,3-四氟氟-2-（庚二丙氧基） - 丙二醇酸盐，也称为Genx，是用于制造含氟聚合物的加工助剂。 Genx是作为长链多氟烷基物质的替代品开发的几种化学物质之一，这往往具有长距离的半衰期，并且是环保的。与聚氟烷基物质不同，Genx具有更快的清除，但已在美国和国际水源中检测到。目前美国目前没有联邦饮用水标准。因此，我们基于可用的重复剂量研究开发了Genx的非癌症口参考剂量（RFD）。对可用数据的审查表明Genx不太可能是遗传毒性的。使用传统的频率基准剂量模型和贝叶斯基准剂量模型的组合使用了哺乳动物毒性研究的相关偏离点。此外，使用可用的工具和监管指导开发了确定性和概率的RFD值。两种方法导致肝脏病变的窄范围的RFD值，在大鼠的2年生物测定中观察到（0.01-0.02？mg / kg /天）。概率方法导致较低，即更保守的RFD。概率RFD为0.01？mg / kg /天导致最大污染物水平目标为70？ppb。预计这些值以及本文所述的危害鉴定和剂量 - 响应建模以及感兴趣的风险评估员和监管机构的危险鉴定和剂量响应建模以及对Genx的制定健康保护饮水准则值的风险评估员和监管机构。

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