Toward Good Read-Across Practice (GRAP) guidance

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2016
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Ball, Nicholas
Cronin, Mark T. D.
Shen, Jie
Blackburn, Karen
Booth, Ewan D.
Bouhifd, Mounir
Donley, Elizabeth
Egnash, Laura
Hastings, Charles
Juberg, Daland R.
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ALTEX ; 33 (2016), 2. - pp. 149-166. - ISSN 0946-7785. - eISSN 1868-8551
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.
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ISO 690BALL, Nicholas, Mark T. D. CRONIN, Jie SHEN, Karen BLACKBURN, Ewan D. BOOTH, Mounir BOUHIFD, Elizabeth DONLEY, Laura EGNASH, Charles HASTINGS, Daland R. JUBERG, Thomas HARTUNG, 2016. Toward Good Read-Across Practice (GRAP) guidance. In: ALTEX. 33(2), pp. 149-166. ISSN 0946-7785. eISSN 1868-8551. Available under: doi: 10.14573/altex.1601251
BibTex
@article{Ball2016Towar-36596,
  year={2016},
  doi={10.14573/altex.1601251},
  title={Toward Good Read-Across Practice (GRAP) guidance},
  number={2},
  volume={33},
  issn={0946-7785},
  journal={ALTEX},
  pages={149--166},
  author={Ball, Nicholas and Cronin, Mark T. D. and Shen, Jie and Blackburn, Karen and Booth, Ewan D. and Bouhifd, Mounir and Donley, Elizabeth and Egnash, Laura and Hastings, Charles and Juberg, Daland R. and Hartung, Thomas}
}
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    <dcterms:abstract xml:lang="eng">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.</dcterms:abstract>
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