Nicholas Ball
The Dow Chemical Company, Midland, MI, USA and Dow AgroSciences, Indianapolis, IN, USA
Mark T. D. Cronin
School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK
Jie Shen
Research Institute for Fragrance Materials, Inc., Woodcliff Lake, NJ, USA
Karen Blackburn
The Procter and Gamble Co., Cincinnati, OH, USA
Ewan D. Booth
Syngenta Ltd, Jealott’s Hill International Research Centre, Bracknell, Berkshire, UK
Mounir Bouhifd
Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA
Elizabeth Donley
Stemina Biomarker Discovery Inc., Madison, WI, USA
Laura Egnash
Stemina Biomarker Discovery Inc., Madison, WI, USA
Charles Hastings
BASF SE, Ludwigshafen am Rhein, Germany and Research Triangle Park, NC, USA
Daland R. Juberg
The Dow Chemical Company, Midland, MI, USA and Dow AgroSciences, Indianapolis, IN, USA
Andre Kleensang
Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA
Nicole Kleinstreuer
National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA
E. Dinant Kroese
Risk Analysis for Products in Development, TNO Zeist, Zeist, The Netherlands
Adam C. Lee
Du Pont Haskell Global Centers for Health and Environmental Sciences, Newark, NJ, USA
Thomas Luechtefeld
Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA
Alexandra Maertens
Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA
Sue Marty
The Dow Chemical Company, Midland, MI, USA and Dow AgroSciences, Indianapolis, IN, USA
Jorge M. Naciff
The Procter and Gamble Co., Cincinnati, OH, USA
Jessica Palmer
Stemina Biomarker Discovery Inc., Madison, WI, USA
David Pamies
Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA
Mike Penman
Penman Consulting, Brussels, Belgium
Andrea-Nicole Richarz
School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK
Daniel P. Russo
Department of Chemistry and Center for Computational and Integrative Biology, Rutgers University, Camden, NJ, USA
Sharon B. Stuard
The Procter and Gamble Co., Cincinnati, OH, USA
Grace Patlewicz
US EPA/ORD, National Center for Computational Toxicology, Research Triangle Park, NC, USA
Bennard van Ravenzwaay
BASF SE, Ludwigshafen am Rhein, Germany and Research Triangle Park, NC, USA
Shengde Wu
The Procter and Gamble Co., Cincinnati, OH, USA
Hao Zhu
Department of Chemistry and Center for Computational and Integrative Biology, Rutgers University, Camden, NJ, USA
Thomas Hartung
Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA; University of Konstanz, CAAT-Europe, Konstanz, Germany
[hide affiliations]
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.
