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CAAT Altex workshop paper entitled "Towards Good Read-Across Practice (GRAP) Guidance"
Citation:
Ball, N., M. Cronin, J. Shen, M. Adenuga, K. Blackburn, E. Booth, M. Bouhifd, B. Donley, L. Egnash, J. Freeman, C. Hastings, D. Juberg, A. Kleensang, N. Kleinstreuer, D. Kroese, T. Luechtefeld, A. Maertens, S. Marty, J. Naciff, J. Palmer, D. Pamies, M. Penman, A. Richarz, D. Russo, D. Steup, S. Stuard, G. Tier, B. van Ravenzwaay, S. Wu, H. Zhu, AND T. Hartung. CAAT Altex workshop paper entitled "Towards Good Read-Across Practice (GRAP) Guidance". ALTEX. Society ALTEX Edition, Kuesnacht, Switzerland, 33(2):149-166, (2016).
Impact/Purpose:
This is a paper that summarises different activities and research needs for read-across for regulatory purposes that has been compiled as a result of a CAAT initiative led by Thomas Hartung.
Description:
Grouping of substances and utilizing read-across 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 similarity. While read-across can play a key role in complying with legislations such as the European REACH legislation, the lack of consensus regarding the extent and type of evidence necessary to support it often hampers it’s 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, summarise insights learned from reviewing ECHA published decisions as far as the relative successes/pitfalls surrounding read-across under the REACH and compile the relevant activities and guidance documents. Special emphasis is given to the available existing tools and approaches, the consideration and expression of uncertainty, the use of biological support data and the potential impact of the ECHA Read-Across Assessment Framework (RAAF) which was published in 2015.
