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Chemical Safety Assessment Using Read-Across: Assessing the Use of Novel Testing Methods to Strengthen the Evidence Base for Decision Making
BACKGROUND: Safety assessment for repeated dose toxicity is one of the largest challenges in the process to replace animal testing. This is also one of the proof of concept ambitions of SEURAT-1, the largest ever European Union research initiative on alternative testing, co-funded by the European Co...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
National Institute of Environmental Health Sciences
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4671246/ https://www.ncbi.nlm.nih.gov/pubmed/25956009 http://dx.doi.org/10.1289/ehp.1409342 |
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author | Berggren, Elisabet Amcoff, Patric Benigni, Romualdo Blackburn, Karen Carney, Edward Cronin, Mark Deluyker, Hubert Gautier, Francoise Judson, Richard S. Kass, Georges E.N. Keller, Detlef Knight, Derek Lilienblum, Werner Mahony, Catherine Rusyn, Ivan Schultz, Terry Schwarz, Michael Schüürmann, Gerrit White, Andrew Burton, Julien Lostia, Alfonso M. Munn, Sharon Worth, Andrew |
author_facet | Berggren, Elisabet Amcoff, Patric Benigni, Romualdo Blackburn, Karen Carney, Edward Cronin, Mark Deluyker, Hubert Gautier, Francoise Judson, Richard S. Kass, Georges E.N. Keller, Detlef Knight, Derek Lilienblum, Werner Mahony, Catherine Rusyn, Ivan Schultz, Terry Schwarz, Michael Schüürmann, Gerrit White, Andrew Burton, Julien Lostia, Alfonso M. Munn, Sharon Worth, Andrew |
author_sort | Berggren, Elisabet |
collection | PubMed |
description | BACKGROUND: Safety assessment for repeated dose toxicity is one of the largest challenges in the process to replace animal testing. This is also one of the proof of concept ambitions of SEURAT-1, the largest ever European Union research initiative on alternative testing, co-funded by the European Commission and Cosmetics Europe. This review is based on the discussion and outcome of a workshop organized on initiative of the SEURAT-1 consortium joined by a group of international experts with complementary knowledge to further develop traditional read-across and include new approach data. OBJECTIVES: The aim of the suggested strategy for chemical read-across is to show how a traditional read-across based on structural similarities between source and target substance can be strengthened with additional evidence from new approach data—for example, information from in vitro molecular screening, “-omics” assays and computational models—to reach regulatory acceptance. METHODS: We identified four read-across scenarios that cover typical human health assessment situations. For each such decision context, we suggested several chemical groups as examples to prove when read-across between group members is possible, considering both chemical and biological similarities. CONCLUSIONS: We agreed to carry out the complete read-across exercise for at least one chemical category per read-across scenario in the context of SEURAT-1, and the results of this exercise will be completed and presented by the end of the research initiative in December 2015. CITATION: Berggren E, Amcoff P, Benigni R, Blackburn K, Carney E, Cronin M, Deluyker H, Gautier F, Judson RS, Kass GE, Keller D, Knight D, Lilienblum W, Mahony C, Rusyn I, Schultz T, Schwarz M, Schüürmann G, White A, Burton J, Lostia AM, Munn S, Worth A. 2015. Chemical safety assessment using read-across: assessing the use of novel testing methods to strengthen the evidence base for decision making. Environ Health Perspect 123:1232–1240; http://dx.doi.org/10.1289/ehp.1409342 |
format | Online Article Text |
id | pubmed-4671246 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | National Institute of Environmental Health Sciences |
record_format | MEDLINE/PubMed |
spelling | pubmed-46712462015-12-16 Chemical Safety Assessment Using Read-Across: Assessing the Use of Novel Testing Methods to Strengthen the Evidence Base for Decision Making Berggren, Elisabet Amcoff, Patric Benigni, Romualdo Blackburn, Karen Carney, Edward Cronin, Mark Deluyker, Hubert Gautier, Francoise Judson, Richard S. Kass, Georges E.N. Keller, Detlef Knight, Derek Lilienblum, Werner Mahony, Catherine Rusyn, Ivan Schultz, Terry Schwarz, Michael Schüürmann, Gerrit White, Andrew Burton, Julien Lostia, Alfonso M. Munn, Sharon Worth, Andrew Environ Health Perspect Review BACKGROUND: Safety assessment for repeated dose toxicity is one of the largest challenges in the process to replace animal testing. This is also one of the proof of concept ambitions of SEURAT-1, the largest ever European Union research initiative on alternative testing, co-funded by the European Commission and Cosmetics Europe. This review is based on the discussion and outcome of a workshop organized on initiative of the SEURAT-1 consortium joined by a group of international experts with complementary knowledge to further develop traditional read-across and include new approach data. OBJECTIVES: The aim of the suggested strategy for chemical read-across is to show how a traditional read-across based on structural similarities between source and target substance can be strengthened with additional evidence from new approach data—for example, information from in vitro molecular screening, “-omics” assays and computational models—to reach regulatory acceptance. METHODS: We identified four read-across scenarios that cover typical human health assessment situations. For each such decision context, we suggested several chemical groups as examples to prove when read-across between group members is possible, considering both chemical and biological similarities. CONCLUSIONS: We agreed to carry out the complete read-across exercise for at least one chemical category per read-across scenario in the context of SEURAT-1, and the results of this exercise will be completed and presented by the end of the research initiative in December 2015. CITATION: Berggren E, Amcoff P, Benigni R, Blackburn K, Carney E, Cronin M, Deluyker H, Gautier F, Judson RS, Kass GE, Keller D, Knight D, Lilienblum W, Mahony C, Rusyn I, Schultz T, Schwarz M, Schüürmann G, White A, Burton J, Lostia AM, Munn S, Worth A. 2015. Chemical safety assessment using read-across: assessing the use of novel testing methods to strengthen the evidence base for decision making. Environ Health Perspect 123:1232–1240; http://dx.doi.org/10.1289/ehp.1409342 National Institute of Environmental Health Sciences 2015-05-08 2015-12 /pmc/articles/PMC4671246/ /pubmed/25956009 http://dx.doi.org/10.1289/ehp.1409342 Text en http://creativecommons.org/publicdomain/mark/1.0/ Publication of EHP lies in the public domain and is therefore without copyright. All text from EHP may be reprinted freely. Use of materials published in EHP should be acknowledged (for example, “Reproduced with permission from Environmental Health Perspectives”); pertinent reference information should be provided for the article from which the material was reproduced. Articles from EHP, especially the News section, may contain photographs or illustrations copyrighted by other commercial organizations or individuals that may not be used without obtaining prior approval from the holder of the copyright. |
spellingShingle | Review Berggren, Elisabet Amcoff, Patric Benigni, Romualdo Blackburn, Karen Carney, Edward Cronin, Mark Deluyker, Hubert Gautier, Francoise Judson, Richard S. Kass, Georges E.N. Keller, Detlef Knight, Derek Lilienblum, Werner Mahony, Catherine Rusyn, Ivan Schultz, Terry Schwarz, Michael Schüürmann, Gerrit White, Andrew Burton, Julien Lostia, Alfonso M. Munn, Sharon Worth, Andrew Chemical Safety Assessment Using Read-Across: Assessing the Use of Novel Testing Methods to Strengthen the Evidence Base for Decision Making |
title | Chemical Safety Assessment Using Read-Across: Assessing the Use of Novel Testing Methods to Strengthen the Evidence Base for Decision Making |
title_full | Chemical Safety Assessment Using Read-Across: Assessing the Use of Novel Testing Methods to Strengthen the Evidence Base for Decision Making |
title_fullStr | Chemical Safety Assessment Using Read-Across: Assessing the Use of Novel Testing Methods to Strengthen the Evidence Base for Decision Making |
title_full_unstemmed | Chemical Safety Assessment Using Read-Across: Assessing the Use of Novel Testing Methods to Strengthen the Evidence Base for Decision Making |
title_short | Chemical Safety Assessment Using Read-Across: Assessing the Use of Novel Testing Methods to Strengthen the Evidence Base for Decision Making |
title_sort | chemical safety assessment using read-across: assessing the use of novel testing methods to strengthen the evidence base for decision making |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4671246/ https://www.ncbi.nlm.nih.gov/pubmed/25956009 http://dx.doi.org/10.1289/ehp.1409342 |
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