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对农药人类健康风险评估中 1 年狗研究增值的回顾性分析。

A retrospective analysis of the added value of 1-year dog studies in pesticide human health risk assessments.

机构信息

a Health Evaluation Directorate , Health Canada's Pest Management Regulatory Agency , Ottawa , ON , Canada.

出版信息

Crit Rev Toxicol. 2017 Aug;47(7):581-591. doi: 10.1080/10408444.2017.1290044. Epub 2017 Mar 21.

Abstract

The 1-year dog toxicity study is no longer required by certain pesticide regulatory jurisdictions, including the United States and the European Union. Health Canada's Pest Management Regulatory Agency (PMRA) examined its current requirement for this study to determine if it could be refined or eliminated. A retrospective analysis was conducted to examine the impact of the 1-year dog study on human health risk assessment. The Acceptable Daily Intake (ADI), a measure of the amount of a pesticide in food that can be ingested on a daily basis over a lifetime without an appreciable health risk, was the metric for this analysis. For 143 pesticides evaluated by the PMRA between 2008 and 2015, the supporting toxicology databases were examined to determine if other toxicology studies were protective of the findings in the 1-year dog study. When this criterion was not met, further investigation was undertaken to determine the potential impact of not having the 1-year dog study. For most of the pesticides, effect levels in the 1-year dog study were not substantially different from those in other toxicology studies, when considering factors such as dose-spacing and known experimental variability. The results of this analysis suggest that absence of the 1-year dog study would have minimal impact on the assessment of human health risk. Therefore, Health Canada's PMRA has removed the routine requirement for the 1-year dog study from its pesticide data requirements.

摘要

某些农药监管机构,包括美国和欧盟,不再要求进行为期 1 年的犬毒性研究。加拿大卫生部害虫管理监管机构(PMRA)审查了其目前对这项研究的要求,以确定是否可以对其进行改进或取消。进行了一项回顾性分析,以检查为期 1 年的犬研究对人类健康风险评估的影响。可接受日摄入量(ADI)是衡量食品中农药摄入量的指标,即一个人在一生中每天摄入的量而不会造成明显的健康风险。对于 PMRA 在 2008 年至 2015 年期间评估的 143 种农药,检查了支持毒理学数据库,以确定其他毒理学研究是否对 1 年犬研究的结果具有保护作用。当未满足此标准时,进行了进一步的调查,以确定没有 1 年犬研究的潜在影响。对于大多数农药,当考虑剂量间隔和已知实验变异性等因素时,1 年犬研究中的效应水平与其他毒理学研究中的效应水平没有实质性差异。这项分析的结果表明,没有 1 年犬研究将对人类健康风险评估的影响最小。因此,加拿大卫生部的 PMRA 已从其农药数据要求中删除了为期 1 年的犬研究的常规要求。

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