An Approach to Setting Vertebrate Animal-use Benchmarks for Agrochemical and GM Crop Testing to Facilitate Future Animal Reduction Efforts.

IF 2.4 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Atla-Alternatives To Laboratory Animals Pub Date : 2025-03-01 Epub Date: 2025-02-26 DOI:10.1177/02611929251323270
Joseph Henriquez, Matthew Merrell, Carey Mathesius, Raja Settivari, Lynea Murphy, Susan Kisielewski, Jessica LaRocca, Kathleen Mikles, Sean Gehen
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引用次数: 0

Abstract

Agrochemical active ingredients are among the most toxicologically evaluated chemical substances, and genetically modified (GM) crops must be evaluated for safety and nutritional adequacy. Traditionally, these evaluations are conducted in vivo. There are concerted efforts in the agrochemical sector to reduce animal testing, but there is also an emphasis on updating test guidelines and fulfilling new data package requirements, which can both result in increased animal testing. The purpose of this project was to generate benchmarks for the numbers of vertebrate animals used in: a) evaluating agrochemical pesticidal active ingredients for human health hazards; and b) assessing GM crops for safety and nutritional adequacy, based on guideline studies for data package requirements. To achieve this, guideline studies employing vertebrates, as required by regulatory bodies for developing global data packages for new active ingredients and for GM crops, were listed. These listed guideline studies were reviewed, in terms of the study details and the required animal-use, which was determined based on best testing practices. For historical animal-use benchmarking, Corteva's six most recent agrochemical pesticidal active ingredients and four most recent GM crop events were evaluated. Across the six most recently developed active ingredients, an average of approximately 10,000 mammals were used for the testing of each (range: 5500-19,000); across the four most recently developed GM crops, the average number of vertebrates similarly used for each was approximately 1200 (range: 1000-1500). Though regulatory testing requirements are likely to change with time, as new technologies become available, this project has established a theoretical minimum requirement to help drive aspirational animal reduction goals, identified regulatory challenges associated with the reduction of animal-use, and helped to refine Corteva's vertebrate animal-use tracking approaches.

为农业化学品和转基因作物测试设定脊椎动物使用基准的方法,以促进未来减少动物使用的努力。
农用化学活性成分是毒性评价最高的化学物质之一,转基因作物必须进行安全性和营养充分性评价。传统上,这些评估是在体内进行的。农用化学品部门正在共同努力减少动物试验,但也强调更新试验准则和满足新的数据包要求,这两者都可能导致动物试验的增加。该项目的目的是为用于以下方面的脊椎动物数量制定基准:a)评估农药农药活性成分对人类健康的危害;b)基于对数据包要求的指导性研究,评估转基因作物的安全性和营养充分性。为了实现这一目标,根据管理机构为开发新的活性成分和转基因作物的全球数据包的要求,列出了使用脊椎动物的指导性研究。根据研究细节和根据最佳试验实践确定的所需动物使用情况,对列出的指南研究进行了审查。对于历史动物使用基准,Corteva的六种最新农用化学农药活性成分和四种最近的转基因作物事件进行了评估。在六种最新开发的活性成分中,平均约有10,000只哺乳动物被用于每种成分的测试(范围:5500-19,000);在最近开发的四种转基因作物中,每种作物使用的脊椎动物的平均数量约为1200只(范围:1000-1500只)。尽管随着新技术的出现,监管测试要求可能会随着时间的推移而改变,但该项目已经建立了一个理论上的最低要求,以帮助推动减少动物使用的理想目标,确定与减少动物使用相关的监管挑战,并帮助改进Corteva的脊椎动物使用跟踪方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
3.80
自引率
3.70%
发文量
60
审稿时长
>18 weeks
期刊介绍: Alternatives to Laboratory Animals (ATLA) is a peer-reviewed journal, intended to cover all aspects of the development, validation, implementation and use of alternatives to laboratory animals in biomedical research and toxicity testing. In addition to the replacement of animals, it also covers work that aims to reduce the number of animals used and refine the in vivo experiments that are still carried out.
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