Toward Good Read-Across Practice (GRAP) guidance

Main Article Content

Nicholas Ball
Mark T. D. Cronin
Jie Shen
Karen Blackburn
Ewan D. Booth
Mounir Bouhifd
Elizabeth Donley
Laura Egnash
Charles Hastings
Daland R. Juberg
Andre Kleensang
Nicole Kleinstreuer
E. Dinant Kroese
Adam C. Lee
Thomas Luechtefeld
Alexandra Maertens
Sue Marty
Jorge M. Naciff
Jessica Palmer
David Pamies
Mike Penman
Andrea-Nicole Richarz
Daniel P. Russo
Sharon B. Stuard
Grace Patlewicz
Bennard van Ravenzwaay
Shengde Wu
Hao Zhu
Thomas Hartung

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 legislation 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 presents the state of the art, summarizes insights learned from reviewing ECHA published decisions regarding the relative successes/pitfalls surrounding read-across under REACH, and compiles 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.

Article Details

How to Cite
[1]
Ball, N., Cronin, M., Shen, J., Blackburn, K., Booth, E., Bouhifd, M., Donley, E., Egnash, L., Hastings, C., Juberg, D., Kleensang, A., Kleinstreuer, N., Kroese, E., Lee, A., Luechtefeld, T., Maertens, A., Marty, S., Naciff, J., Palmer, J., Pamies, D., Penman, M., Richarz, A.-N., Russo, D., Stuard, S., Patlewicz, G., van Ravenzwaay, B., Wu, S., Zhu, H. and Hartung, T. 2016. Toward Good Read-Across Practice (GRAP) guidance. ALTEX - Alternatives to animal experimentation. 33, 2 (May 2016), 149-166. DOI:https://doi.org/10.14573/altex.1601251.
Section
Articles

Most read articles by the same author(s)