对发育和生殖毒性研究剂量水平选择的考虑：行业观点

IF 2.9 3区医学 Q2 TOXICOLOGY

Toxicology letters Pub Date : 2025-09-01 DOI:10.1016/j.toxlet.2025.07.063

M. Beekhuijzen

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引用次数: 0

摘要

在2020年期间，ECHA开始对OECD测试指南443：延长一代生殖毒性研究（EOGRTS）进行评估，目的是分析与该研究在设计、实施和毒理学发现方面的表现有关的具体方面。ECHA评估的一个重要结果集中在适当的剂量水平选择上，随后，在2022年，ECHA发布了他们关于发育和生殖毒性（DART）研究的建议。然而，遵循这些建议对进行这些研究的工业和实验室提出了一些挑战。本报告将涵盖对不同化学品和行业的研究结果的影响和解释，强调在平衡动物使用和福利与监管要求方面的挑战，以及就这一主题继续对话的必要性。

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S06-03 Considerations for dose level selection for developmental and reproductive toxicity studies: Industry perspectives

During 2020, ECHA started an evaluation of the OECD Test Guideline 443: Extended One Generation Reproductive Toxicity Study (EOGRTS) with the aim to analyse specific aspects relating to the performance of the study with respect to design, conduct and toxicological findings. A significant outcome of this ECHA evaluation focused on adequate dose level selection and subsequently, in 2022, ECHA published their recommendations for developmental and reproductive toxicity (DART) studies. However, following these recommendations poses several challenges for industry and the laboratories conducting these studies. This presentation will cover the implications for, and impact on, study outcomes and interpretation for different chemicals and sectors, highlighting the challenges in balancing animal use and welfare with regulatory requirements and the need for continued dialogue on this topic.

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