Open AccessToward Good Read-Across Practice (GRAP) guidance
Author(s) -
Nicholas Ball,
Mark T.D. Cronin,
Jie Shen,
Karen Blackburn,
Ewan D. Booth,
Mounir Bouhifd,
Elizabeth L.R. Donley,
Laura A. Egnash,
Charles Hastings,
Daland R. Juberg,
André 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 Richarz,
Daniel P. Russo,
Sharon B. Stuard,
Grace Patlewicz,
Bennard van Ravenzwaay,
Shengde Wu,
Hao Zhu,
Thomas Hartung
Publication year - 2016
Publication title -
altex/alternatives to animal experimentation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.975
H-Index - 51
eISSN - 1868-8551
pISSN - 1868-596X
DOI - 10.14573/altex.1601251
Subject(s) - computer science , legislation , similarity (geometry) , data science , best practice , risk analysis (engineering) , management science , medicine , political science , artificial intelligence , engineering , law , image (mathematics)
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.