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针对欧盟化学品注册、评估、授权和限制法规(REACH)要求的综合测试策略。

Integrated testing strategies for use with respect to the requirements of the EU REACH legislation.

作者信息

Grindon Christina, Combes Robert, Cronin Mark T D, Roberts David W, Garrod John F

机构信息

FRAME, Nottingham, UK.

出版信息

Altern Lab Anim. 2008 Oct;36 Suppl 1:7-27. doi: 10.1177/026119290803601s03.

Abstract

Integrated testing strategies have been proposed to facilitate the process of chemicals risk assessment to fulfil the requirements of the proposed EU REACH system. Here, we present individual, decision-tree style, strategies for the eleven major toxicity endpoints of the REACH system, including human health effects and ecotoxicity. These strategies make maximum use of non-animal approaches to hazard identification, before resorting to traditional animal test methods. Each scheme: a) comprises a mixture of validated and non-validated assays (distinguished in the schemes); and b) decision points at key stages to allow the cessation of further testing, should it be possible to use the available information to classify and label and/or undertake risk assessment. The rationale and scientific justification for each of the schemes, with respect to the validation status of the tests involved and their individual advantages and limitations, will be discussed in detail in a series of future publications.

摘要

为满足欧盟拟议的化学品注册、评估、授权和限制(REACH)制度的要求,已提出综合测试策略以促进化学品风险评估过程。在此,我们针对REACH制度的十一个主要毒性终点(包括对人类健康的影响和生态毒性)提出了单独的、决策树形式的策略。这些策略在采用传统动物测试方法之前,最大限度地利用非动物方法进行危害识别。每个方案:a)包括经过验证和未经验证的分析方法的组合(在方案中加以区分);b)在关键阶段设置决策点,以便在能够利用现有信息进行分类和标签标注及/或进行风险评估时停止进一步测试。关于每个方案所涉及测试的验证状态及其各自的优缺点的原理和科学依据,将在一系列未来出版物中详细讨论。

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