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寻找 3Rs 的协同作用——重复剂量毒性试验:来自 EPAA 合作伙伴论坛的报告。

Finding synergies for the 3Rs - Repeated Dose Toxicity testing: Report from an EPAA Partners' Forum.

机构信息

The International Fragrance Association (IFRA) Europe, Geneva, Switzerland; European Partnership for Alternative Approaches to Animal Testing (EPAA), Industry Secretariat, Belgium.

The European Chemical Industry Council (Cefic), Belgium.

出版信息

Regul Toxicol Pharmacol. 2019 Nov;108:104470. doi: 10.1016/j.yrtph.2019.104470. Epub 2019 Aug 31.

DOI:10.1016/j.yrtph.2019.104470
PMID:
31479718
Abstract

The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a Partners' Forum on repeated dose toxicity (RDT) testing to identify synergies between industrial sectors and stakeholders along with opportunities to progress these in existing research frameworks. Although RTD testing is not performed across all industrial sectors, the OECD accepted tests can provide a rich source of information and play a pivotal role for safety decisions relating to the use of chemicals. Currently there are no validated alternatives to repeated dose testing and a direct one-to-one replacement is not appropriate. However, there are many projects and initiatives at the international level which aim to implement various aspects of replacement, reduction and refinement (the 3Rs) in RDT testing. Improved definition of use, through better problem formulation, aligned to harmonisation of regulations is a key area, as is the more rapid implementation of alternatives into the legislative framework. Existing test designs can be optimised to reduce animal use and increase information content. Greater use of exposure-led decisions and improvements in dose selection will be beneficial. In addition, EPAA facilitates sharing of case studies demonstrating the use of Next Generation Risk Assessment applying various New Approach Methodologies to assess RDT.

摘要

欧洲替代动物试验方法合作组织(EPAA)召开了一次关于重复剂量毒性(RDT)测试的合作伙伴论坛,旨在确定工业部门和利益相关者之间的协同作用,以及在现有研究框架中推进这些协同作用的机会。尽管并非所有工业部门都进行 RTD 测试,但经 OECD 认可的测试可以为与化学品使用相关的安全性决策提供丰富的信息,并发挥关键作用。目前,还没有经过验证的重复剂量测试替代品,直接一对一替换并不合适。然而,国际上有许多项目和倡议旨在实施 RDT 测试中的替代、减少和优化(3Rs)的各个方面。通过更好的问题表述来改善用途的定义,并与法规的协调一致,这是一个关键领域,同时也是将替代品更快速地纳入立法框架的关键领域。现有的测试设计可以进行优化,以减少动物使用并增加信息量。更多地利用基于暴露的决策和改进剂量选择将是有益的。此外,EPAA 还促进了案例研究的共享,这些案例研究展示了如何应用各种新方法来评估 RDT,以进行下一代风险评估。

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