GUIDANCE DOCUMENT FOR NEUROTOXICITY TESTING

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GUIDANCE DOCUMENT FOR NEUROTOXICITY TESTING

机译：神经毒性测试指导文件

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5. This document is intended to provide guidance on strategies and methods for testing of chemicals for potential neurotoxicity. The primary objective of this guidance is to ensure that necessary and sufficient data are obtained to enable adequate evaluation of the risk of neurotoxicity arising from exposure to a chemical. This document does not specifically address developmental neurotoxicity testing as this area will be covered by another Guidance Document (Draft OECD Guidance Document on Reproductive Toxicity Testing and Assesment) and a Test Guideline (Draft OECD 426). 6. An iterative assessment/testing strategy is recommended. To minimise animal usage and optimise allocation of resources, data should be assessed before each iteration of testing to decide if they are adequate to evaluate the risk arising from the intended use of the chemical, or if further testing is needed. Because assessment of data is an essential part of the overall strategy, this document provides a definition of neurotoxicity, and discusses different types of neurotoxic effects. Guidance is provided on test methods, because familiarity with these methods is required to assess data or to select methods to identify and/or characterise neurotoxic effects.

机译：5.本文件旨在就化学物质潜在的神经毒性测试的策略和方法提供指导。该指南的主要目的是确保获得必要和足够的数据，以便能够充分评估由于接触化学品而引起的神经毒性风险。本文档未专门针对发育性神经毒性测试，因为该领域将被另一份指导文件（OECD生殖毒性测试和评估指南文件）和测试指南（OECD 426版）所涵盖。 6.建议采用迭代评估/测试策略。为了最大程度地减少动物的使用并优化资源分配，应该在每次测试迭代之前评估数据，以确定它们是否足以评估化学药品预期用途所引起的风险，或者是否需要进一步测试。由于数据评估是整体策略的重要组成部分，因此本文档提供了神经毒性的定义，并讨论了不同类型的神经毒性作用。提供了有关测试方法的指南，因为需要熟悉这些方法才能评估数据或选择识别和/或表征神经毒性作用的方法。

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《OECD Papers》 |2004年第11期|p.372.1-372.67|共67页
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GUIDANCE DOCUMENT FOR NEUROTOXICITY TESTING

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