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Interpretation of in vitro concentration-response data for risk assessment and regulatory decision-making: Report from the 2022 IWGT quantitative analysis expert working group meeting

Marc A. Beal Orcid Logo, Guangchao Chen, Kerry L. Dearfield, Min Gi, Bhaskar Gollapudi, Robert H. Heflich, Katsuyoshi Horibata, Alexandra S. Long, David P. Lovell, Barbara L. Parsons Orcid Logo, Stefan Pfuhler Orcid Logo, John Wills, Andreas Zeller Orcid Logo, George Johnson Orcid Logo, Paul A. White

Environmental and Molecular Mutagenesis

Swansea University Author: George Johnson Orcid Logo

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DOI (Published version): 10.1002/em.22582

Abstract

Quantitative risk assessments of chemicals are routinely performed using in vivo data from rodents; however, there is growing recognition that non-animal approaches can be human-relevant alternatives. There is an urgent need to build confidence in non-animal alternatives given the international supp...

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Published in: Environmental and Molecular Mutagenesis
ISSN: 0893-6692 1098-2280
Published: Wiley 2024
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URI: https://cronfa.swan.ac.uk/Record/cronfa65988
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spelling v2 65988 2024-04-09 Interpretation of in vitro concentration-response data for risk assessment and regulatory decision-making: Report from the 2022 IWGT quantitative analysis expert working group meeting 37d0f121db69fd09f364df89e4405e31 0000-0001-5643-9942 George Johnson George Johnson true false 2024-04-09 MEDS Quantitative risk assessments of chemicals are routinely performed using in vivo data from rodents; however, there is growing recognition that non-animal approaches can be human-relevant alternatives. There is an urgent need to build confidence in non-animal alternatives given the international support to reduce the use of animals in toxicity testing where possible. In order for scientists and risk assessors to prepare for this paradigm shift in toxicity assessment, standardization and consensus on in vitro testing strategies and data interpretation will need to be established. To address this issue, an Expert Working Group (EWG) of the 8th International Workshop on Genotoxicity Testing (IWGT) evaluated the utility of quantitative in vitro genotoxicity concentration-response data for risk assessment. The EWG first evaluated available in vitro methodologies and then examined the variability and maximal response of in vitro tests to estimate biologically relevant values for the critical effect sizes considered adverse or unacceptable. Next, the EWG reviewed the approaches and computational models employed to provide human-relevant dose context to in vitro data. Lastly, the EWG evaluated risk assessment applications for which in vitro data are ready for use and applications where further work is required. The EWG concluded that in vitro genotoxicity concentration-response data can be interpreted in a risk assessment context. However, prior to routine use in regulatory settings, further research will be required to address the remaining uncertainties and limitations. Journal Article Environmental and Molecular Mutagenesis 0 Wiley 0893-6692 1098-2280 clastogen; genetic toxicology; mutation; new approach methodologies 1 2 2024 2024-02-01 10.1002/em.22582 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Another institution paid the OA fee 2024-11-01T15:52:41.8405968 2024-04-09T15:21:28.2198440 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Biomedical Science Marc A. Beal 0000-0003-2760-4368 1 Guangchao Chen 2 Kerry L. Dearfield 3 Min Gi 4 Bhaskar Gollapudi 5 Robert H. Heflich 6 Katsuyoshi Horibata 7 Alexandra S. Long 8 David P. Lovell 9 Barbara L. Parsons 0000-0002-3005-2552 10 Stefan Pfuhler 0000-0001-8869-5975 11 John Wills 12 Andreas Zeller 0000-0002-3565-6347 13 George Johnson 0000-0001-5643-9942 14 Paul A. White 15 65988__29963__d125808f56494e22b3ef9c287c1ca672.pdf 65988.pdf 2024-04-09T15:54:40.8874954 Output 2977041 application/pdf Version of Record true This is an open access article under the terms of the Creative Commons Attribution NonCommercial-NoDerivs License. true eng http://creativecommons.org/licenses/by-nc- nd/4.0/
title Interpretation of in vitro concentration-response data for risk assessment and regulatory decision-making: Report from the 2022 IWGT quantitative analysis expert working group meeting
spellingShingle Interpretation of in vitro concentration-response data for risk assessment and regulatory decision-making: Report from the 2022 IWGT quantitative analysis expert working group meeting
George Johnson
title_short Interpretation of in vitro concentration-response data for risk assessment and regulatory decision-making: Report from the 2022 IWGT quantitative analysis expert working group meeting
title_full Interpretation of in vitro concentration-response data for risk assessment and regulatory decision-making: Report from the 2022 IWGT quantitative analysis expert working group meeting
title_fullStr Interpretation of in vitro concentration-response data for risk assessment and regulatory decision-making: Report from the 2022 IWGT quantitative analysis expert working group meeting
title_full_unstemmed Interpretation of in vitro concentration-response data for risk assessment and regulatory decision-making: Report from the 2022 IWGT quantitative analysis expert working group meeting
title_sort Interpretation of in vitro concentration-response data for risk assessment and regulatory decision-making: Report from the 2022 IWGT quantitative analysis expert working group meeting
author_id_str_mv 37d0f121db69fd09f364df89e4405e31
author_id_fullname_str_mv 37d0f121db69fd09f364df89e4405e31_***_George Johnson
author George Johnson
author2 Marc A. Beal
Guangchao Chen
Kerry L. Dearfield
Min Gi
Bhaskar Gollapudi
Robert H. Heflich
Katsuyoshi Horibata
Alexandra S. Long
David P. Lovell
Barbara L. Parsons
Stefan Pfuhler
John Wills
Andreas Zeller
George Johnson
Paul A. White
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container_title Environmental and Molecular Mutagenesis
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publishDate 2024
institution Swansea University
issn 0893-6692
1098-2280
doi_str_mv 10.1002/em.22582
publisher Wiley
college_str Faculty of Medicine, Health and Life Sciences
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hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Biomedical Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Biomedical Science
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description Quantitative risk assessments of chemicals are routinely performed using in vivo data from rodents; however, there is growing recognition that non-animal approaches can be human-relevant alternatives. There is an urgent need to build confidence in non-animal alternatives given the international support to reduce the use of animals in toxicity testing where possible. In order for scientists and risk assessors to prepare for this paradigm shift in toxicity assessment, standardization and consensus on in vitro testing strategies and data interpretation will need to be established. To address this issue, an Expert Working Group (EWG) of the 8th International Workshop on Genotoxicity Testing (IWGT) evaluated the utility of quantitative in vitro genotoxicity concentration-response data for risk assessment. The EWG first evaluated available in vitro methodologies and then examined the variability and maximal response of in vitro tests to estimate biologically relevant values for the critical effect sizes considered adverse or unacceptable. Next, the EWG reviewed the approaches and computational models employed to provide human-relevant dose context to in vitro data. Lastly, the EWG evaluated risk assessment applications for which in vitro data are ready for use and applications where further work is required. The EWG concluded that in vitro genotoxicity concentration-response data can be interpreted in a risk assessment context. However, prior to routine use in regulatory settings, further research will be required to address the remaining uncertainties and limitations.
published_date 2024-02-01T15:52:39Z
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