DuPont Haskell Global Centers for Health and Environmental Sciences, 1090 Elkton Road, Newark, DE 19711, USA.
Regul Toxicol Pharmacol. 2013 Oct;67(1):1-12. doi: 10.1016/j.yrtph.2013.06.002. Epub 2013 Jun 11.
Read-across has generated much attention since it may be used as an alternative approach for addressing the information requirements under regulatory programmes, notably the EU's REACH regulation. Read-across approaches are conceptually accepted by ECHA and Member State Authorities (MS) but difficulties remain in applying them consistently in practice. Technical guidance is available and there are a plethora of models and tools that can assist in the development of categories and read-across, but guidance on how to practically apply categorisation approaches is still missing. This paper was prepared following an ECETOC (European Centre for Ecotoxicology and Toxicology) Task Force that had the objective of summarising guidance and tools available, reviewing their practical utility and considering what technical recommendations and learnings could be shared more widely to refine and inform on the current use of read-across. The full insights are recorded in ECETOC Technical Report TR No. 116. The focus of this present paper is to describe some of the technical and practical considerations when applying read-across under REACH. Since many of the deliberations helped identify the issues for discussion at a recent ECHA/Cefic LRI workshop on "read-across", summary outcomes from this workshop are captured where appropriate for completeness.
由于读通（read-across）方法可作为满足法规方案（尤其是欧盟 REACH 法规）信息要求的替代方法而备受关注。概念上，ECHA 和成员国主管当局（MS）均认可读通方法，但在实践中一致应用这些方法仍存在困难。目前已有技术指南，并且有大量模型和工具可协助开展类别和读通，但是在如何实际应用分类方法方面仍然缺乏指导。本文是在 ECETOC（欧洲生态毒理学和毒物学中心）专门工作组之后编写的，该工作组的目的是总结现有的指导和工具，审查其实际效用，并考虑可以更广泛分享哪些技术建议和经验教训，以完善和告知当前读通的使用。全部见解记录在 ECETOC 技术报告 TR No. 116 中。本文件的重点是描述在 REACH 下应用读通时的一些技术和实际考虑因素。由于许多审议有助于确定最近在 ECHA/Cefic LRI 研讨会上关于“read-across”的讨论问题，因此在适当的情况下会捕获该研讨会的总结结果以保持完整性。
