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t(4) report: Toward Good Read-Across Practice (GRAP) Guidance
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)...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5581000/ https://www.ncbi.nlm.nih.gov/pubmed/26863606 http://dx.doi.org/10.14573/altex.1601251 |
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author | Ball, Nicholas Cronin, Mark T. D. Shen, Jie Blackburn, Karen Booth, Ewan D. Bouhifd, Mounir Donley, Elizabeth Egnash, Laura Hastings, Charles Juberg, Daland R. Kleensang, Andre Kleinstreuer, Nicole Kroese, E. Dinant Lee, Adam C. Luechtefeld, Thomas Maertens, Alexandra Marty, Sue Naciff, Jorge M. Palmer, Jessica Pamies, David Penman, Mike Richarz, Andrea-Nicole Russo, Daniel P. Stuard, Sharon B. Patlewicz, Grace van Ravenzwaay, Bennard Wu, Shengde Zhu, Hao Hartung, Thomas |
author_facet | Ball, Nicholas Cronin, Mark T. D. Shen, Jie Blackburn, Karen Booth, Ewan D. Bouhifd, Mounir Donley, Elizabeth Egnash, Laura Hastings, Charles Juberg, Daland R. Kleensang, Andre Kleinstreuer, Nicole Kroese, E. Dinant Lee, Adam C. Luechtefeld, Thomas Maertens, Alexandra Marty, Sue Naciff, Jorge M. Palmer, Jessica Pamies, David Penman, Mike Richarz, Andrea-Nicole Russo, Daniel P. Stuard, Sharon B. Patlewicz, Grace van Ravenzwaay, Bennard Wu, Shengde Zhu, Hao Hartung, Thomas |
author_sort | Ball, Nicholas |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5581000 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
record_format | MEDLINE/PubMed |
spelling | pubmed-55810002017-09-01 t(4) report: Toward Good Read-Across Practice (GRAP) Guidance Ball, Nicholas Cronin, Mark T. D. Shen, Jie Blackburn, Karen Booth, Ewan D. Bouhifd, Mounir Donley, Elizabeth Egnash, Laura Hastings, Charles Juberg, Daland R. Kleensang, Andre Kleinstreuer, Nicole Kroese, E. Dinant Lee, Adam C. Luechtefeld, Thomas Maertens, Alexandra Marty, Sue Naciff, Jorge M. Palmer, Jessica Pamies, David Penman, Mike Richarz, Andrea-Nicole Russo, Daniel P. Stuard, Sharon B. Patlewicz, Grace van Ravenzwaay, Bennard Wu, Shengde Zhu, Hao Hartung, Thomas ALTEX Article 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. 2016-02-11 2016 /pmc/articles/PMC5581000/ /pubmed/26863606 http://dx.doi.org/10.14573/altex.1601251 Text en This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 International license (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the original work is appropriately cited. |
spellingShingle | Article Ball, Nicholas Cronin, Mark T. D. Shen, Jie Blackburn, Karen Booth, Ewan D. Bouhifd, Mounir Donley, Elizabeth Egnash, Laura Hastings, Charles Juberg, Daland R. Kleensang, Andre Kleinstreuer, Nicole Kroese, E. Dinant Lee, Adam C. Luechtefeld, Thomas Maertens, Alexandra Marty, Sue Naciff, Jorge M. Palmer, Jessica Pamies, David Penman, Mike Richarz, Andrea-Nicole Russo, Daniel P. Stuard, Sharon B. Patlewicz, Grace van Ravenzwaay, Bennard Wu, Shengde Zhu, Hao Hartung, Thomas t(4) report: Toward Good Read-Across Practice (GRAP) Guidance |
title | t(4) report: Toward Good Read-Across Practice (GRAP) Guidance |
title_full | t(4) report: Toward Good Read-Across Practice (GRAP) Guidance |
title_fullStr | t(4) report: Toward Good Read-Across Practice (GRAP) Guidance |
title_full_unstemmed | t(4) report: Toward Good Read-Across Practice (GRAP) Guidance |
title_short | t(4) report: Toward Good Read-Across Practice (GRAP) Guidance |
title_sort | t(4) report: toward good read-across practice (grap) guidance |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5581000/ https://www.ncbi.nlm.nih.gov/pubmed/26863606 http://dx.doi.org/10.14573/altex.1601251 |
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