期刊
REGULATORY TOXICOLOGY AND PHARMACOLOGY
卷 67, 期 1, 页码 1-12出版社
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2013.06.002
关键词
Category approach; Analogue approach; Read-across; Data gap filling; (Q)SAR; REACH
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. (C) 2013 Elsevier Inc. All rights reserved.
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