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Toward Good Read-Across Practice (GRAP) guidance.

Ball, N and Cronin, MTD and Shen, J and Blackburn, K and Booth, ED and Bouhifd, M and Donley, E and Egnash, L and Hastings, C and Juberg, DR and Kleensang, A and Kleinstreuer, N and Kroese, ED and Lee, AC and Luechtefeld, T and Maertens, A and Marty, S and Naciff, JM and Palmer, J and Pamies, D and Penman, M and Richarz, AN and Russo, DP and Stuard, SB and Patlewicz, G and van Ravenzwaay, B and Wu, S and Zhu, H and Hartung, T (2016) Toward Good Read-Across Practice (GRAP) guidance. ALTEX. ISSN 1868-8551

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Abstract

Grouping of substances and utilizing read-across of data within those groups represents an important data gap filling technique for chemical safety assessments. Categories/analogue groups are typically developed based on structural similarity and, increasingly often, also on mechanistic (biological) similarity. While read-across can play a key role in complying with legislations such as the European REACH regulation, the lack of consensus regarding the extent and type of evidence necessary to support it often hampers its successful application and acceptance by regulatory authorities. Despite a potentially broad user community, expertise is still concentrated across a handful of organizations and individuals. In order to facilitate the effective use of read-across, this document aims to summarize the state-of-the-art, summarizes insights learned from reviewing ECHA published decisions as far as the relative successes/pitfalls surrounding read-across under REACH and compile the relevant activities and guidance documents. Special emphasis is given to the available existing tools and approaches, an analysis of ECHA's published final decisions associated with all levels of compliance checks and testing proposals, the consideration and expression of uncertainty, the use of biological support data and the impact of the ECHA Read-Across Assessment Framework (RAAF) published in 2015.

Item Type: Article
Uncontrolled Keywords: read-across; chemical similarity; computational toxicology; hazard assessment; uncertainty
Subjects: R Medicine > RM Therapeutics. Pharmacology
R Medicine > RS Pharmacy and materia medica
Divisions: Pharmacy & Biomolecular Sciences
Publisher: ALTEX edition
Related URLs:
Date Deposited: 21 Mar 2016 11:42
Last Modified: 21 Mar 2016 11:42
DOI or Identification number: 10.14573/altex.1601251
URI: http://researchonline.ljmu.ac.uk/id/eprint/3303

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