Title
Toward good read-across practice (GRAP) guidance
Author
Ball, N.
Cronin, M.T.D.
Shen, J.
Blackburn, K.
Booth, E.D.
Bouhifd, M.
Donley, E.
Egnash, L.
Hastings, C.
Juberg, D.R.
Kleensang, A.
Kleinstreuer, N.
Kroese, E.D.
Lee, A.C.
Luechtefeld, T.
Maertens, A.
Marty, S.
Naciff, J.M.
Palmer, J.
Pamies, D.
Penman, M.
Richarz, A.N.
Russo, D.P.
Stuard, S.B.
Patlewicz, G.
van Ravenzwaay, B.
Wu, S.
Zhu, H.
Hartung, T.
Publication year
2016
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. Funding Details: T32 ES007141, NIEHS, National Institute of Environmental Health Sciences
Subject
ELSS - Earth, Life and Social Sciences
Life
Healthy Living
Biomedical Innovation
Chemical similarity
Computational toxicology
Hazard assessment
Read-across
Uncertainty
Chemical safety
Consensus
Consensus development
Law
Organization
Uncertainty
RAPID - Risk Analysis for Products in Development
To reference this document use:
http://resolver.tudelft.nl/uuid:a5235833-c826-4192-b1d8-ecab67c426a3
DOI
https://doi.org/10.14573/altex.1601251
TNO identifier
534874
ISSN
1868-596X
Source
Altex, 33 (33), 149-166
Document type
article