title: Toward Good Read-Across Practice (GRAP) guidance.
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.
authors: The Dow Chemical Company, Midland, MI, USA.
authors: Nicholas
authors: N
authors: Ball
authors: School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK.
authors: Mark T D
authors: MT
authors: Cronin
authors: Research Institute for Fragrance Materials, Inc. Woodcliff Lake, NJ, USA.
authors: Jie
authors: J
authors: Shen
authors: The Procter and Gamble Co., Cincinatti, OH, USA.
authors: Karen
authors: K
authors: Blackburn
authors: Syngenta Ltd, Jealott's Hill International Research Centre, Bracknell, Berkshire, UK.
authors: Ewan D
authors: ED
authors: Booth
authors: Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA.
authors: Mounir
authors: M
authors: Bouhifd
authors: Stemina Biomarker Discovery Inc., Madison, WI, USA.
authors: Elizabeth
authors: E
authors: Donley
authors: Stemina Biomarker Discovery Inc., Madison, WI, USA.
authors: Laura
authors: L
authors: Egnash
authors: BASF SE, Ludwigshafen am Rhein, Germany, and Research Triangle Park, NC, USA.
authors: Charles
authors: C
authors: Hastings
authors: The Dow Chemical Company, Midland, MI, USA.
authors: Daland R
authors: DR
authors: Juberg
authors: Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA.
authors: Andre
authors: A
authors: Kleensang
authors: National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
authors: Nicole
authors: N
authors: Kleinstreuer
authors: Risk Analysis for Products in Development, TNO Zeist, The Netherlands.
authors: E Dinant
authors: ED
authors: Kroese
authors: DuPont Haskell Global Centers for Health and Environmental Sciences, Newark, DE, USA.
authors: Adam C
authors: AC
authors: Lee
authors: Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA.
authors: Thomas
authors: T
authors: Luechtefeld
authors: Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA.
authors: Alexandra
authors: A
authors: Maertens
authors: The Dow Chemical Company, Midland, MI, USA.
authors: Sue
authors: S
authors: Marty
authors: The Procter and Gamble Co., Cincinatti, OH, USA.
authors: Jorge M
authors: JM
authors: Naciff
authors: Stemina Biomarker Discovery Inc., Madison, WI, USA.
authors: Jessica
authors: J
authors: Palmer
authors: Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA.
authors: David
authors: D
authors: Pamies
authors: Penman Consulting, Brussels, Belgium.
authors: Mike
authors: M
authors: Penman
authors: School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK.
authors: Andrea-Nicole
authors: AN
authors: Richarz
authors: Department of Chemistry and Center for Computational and Integrative Biology, Rutgers University, Camden, NJ, USA.
authors: Daniel P
authors: DP
authors: Russo
authors: The Procter and Gamble Co., Cincinatti, OH, USA.
authors: Sharon B
authors: SB
authors: Stuard
authors: US EPA/ORD, National Center for Computational Toxicology, Research Triangle Park, NC, USA.
authors: Grace
authors: G
authors: Patlewicz
authors: Risk Analysis for Products in Development, TNO Zeist, The Netherlands.
authors: Bennard
authors: B
authors: van Ravenzwaay
authors: The Procter and Gamble Co., Cincinatti, OH, USA.
authors: Shengde
authors: S
authors: Wu
authors: Department of Chemistry and Center for Computational and Integrative Biology, Rutgers University, Camden, NJ, USA.
authors: Hao
authors: H
authors: Zhu
authors: Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA.|University of Konstanz, CAAT-Europe, Konstanz, Germany.
authors: Thomas
authors: T
authors: Hartung
mesh_terms: D000818:Animals; D062067:Chemical Safety / Q000379:methods*; D016208:Databases, Factual; D015386:Hazardous Substances / Q000633:toxicity*; D006801:Humans; D018570:Risk Assessment / Q000379:methods; D017751:Safety Management / Q000379:methods; D014116:Toxicology / Q000379:methods; D035501:Uncertainty
chemical_list: D015386:Hazardous Substances
keywords: chemical similarity; computational toxicology; hazard assessment; read-across; uncertainty