下一代生态风险评估决策能否在今天做出?--美国监管风险评估案例研究。

IF 3 4区 医学 Q1 MEDICINE, LEGAL
Paul C. DeLeo
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引用次数: 0

摘要

我们研究了对三种常见工业化学品(1,2 二氯丙烷、1,1,2-三氯乙烷和磷酸三苯酯)进行新的体内禽类毒性测试的必要性,所依据的是在当前使用条件下使用逸散和多媒体归宿模型估算的禽类暴露量,并与危害信息(包括化学品和类似物的现有体内测试数据、物种间相关性估算以及数百项急性禽类膳食毒性研究的结果)进行了比较。数据表明,除具有特定毒性作用模式的化学品外,任何化学品在膳食中低于 10 ppm 的浓度都不会对鸟类产生急性毒性。建模表明,陆生鸟类接触这三种化学品中任何一种的可能性都很低,估计膳食浓度低于 0.001 ppm。尽管基础数据来源存在不确定性,但潜在暴露量与最低危害阈值之间存在四个数量级的差距,这表明额外的鸟类体内测试不会产生有价值的数据。然而,如果某项体内研究的数据预计不会改善风险决策,而现有的数据缺口仍未填补,则有必要采用证据权重法来整合数据,以增强政府决策者的信心。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Can next generation ecological risk assessment decisions be made today?―A case study of regulatory risk assessment in the United States

We examined the need for new in vivo avian toxicity testing for three common industrial chemicals (1,2 dichloropropane, 1,1,2-trichloroethane and triphenyl phosphate) based on estimated avian exposures using fugacity and multimedia fate models for current conditions of use compared to hazard information including existing in vivo test data for the chemicals and analogs, interspecies correlation estimates and results from hundreds of acute avian dietary toxicity studies. The data indicated that acute avian toxicity is not likely to be observed below 10 ppm in the diet for any chemical with the exception of those with a specific mode of toxic action. Modeling indicated low exposure potential for terrestrial birds to any of the three chemicals, with estimated dietary concentration of less than 0.001 ppm. Despite uncertainty associated with the underlying data sources, the four order of magnitude gap between potential exposure and a minimum hazard threshold suggests that additional avian in vivo testing would not generate valuable data. However, a weight of evidence approach for integrating data is necessary to engender greater confidence among government decision-makers in cases where data from a particular in vivo study is not expected to improve risk decision-making and an existing data gap can remain unfilled.

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来源期刊
CiteScore
6.70
自引率
8.80%
发文量
147
审稿时长
58 days
期刊介绍: Regulatory Toxicology and Pharmacology publishes peer reviewed articles that involve the generation, evaluation, and interpretation of experimental animal and human data that are of direct importance and relevance for regulatory authorities with respect to toxicological and pharmacological regulations in society. All peer-reviewed articles that are published should be devoted to improve the protection of human health and environment. Reviews and discussions are welcomed that address legal and/or regulatory decisions with respect to risk assessment and management of toxicological and pharmacological compounds on a scientific basis. It addresses an international readership of scientists, risk assessors and managers, and other professionals active in the field of human and environmental health. Types of peer-reviewed articles published: -Original research articles of relevance for regulatory aspects covering aspects including, but not limited to: 1.Factors influencing human sensitivity 2.Exposure science related to risk assessment 3.Alternative toxicological test methods 4.Frameworks for evaluation and integration of data in regulatory evaluations 5.Harmonization across regulatory agencies 6.Read-across methods and evaluations -Contemporary Reviews on policy related Research issues -Letters to the Editor -Guest Editorials (by Invitation)
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