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Current status and future challenges of genotoxicity OECD test guidelines (TGs) for nanomaterials: a workshop report

Shareen Doak Orcid Logo, Cristina Andreoli, Michael J Burgum, Qasim Chaudhry, Eric A J Bleeker, Cecilia Bossa, Josefa Domenech, Damjana Drobne, Valerie Fessard, Nina Jeliazkova, Eleonora Longhin, Elise Rundén-Pran, Maciej Stepnik, Naouale El Yamani, Julia Catalán, Maria Dusinska

Mutagenesis

Swansea University Author: Shareen Doak Orcid Logo

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DOI (Published version): 10.1093/mutage/gead017

Abstract

Genotoxicity testing for nanomaterials remains challenging as standard testing approaches require some adaptation, and further development of nano-specific OECD Test Guidelines (TGs) and Guidance Documents (GDs) are needed. However, the field of genotoxicology continues to progress and new approach...

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Published in: Mutagenesis
ISSN: 0267-8357 1464-3804
Published: Oxford University Press (OUP) 2023
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URI: https://cronfa.swan.ac.uk/Record/cronfa63542
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spelling v2 63542 2023-05-30 Current status and future challenges of genotoxicity OECD test guidelines (TGs) for nanomaterials: a workshop report 8f70286908f67238a527a98cbf66d387 0000-0002-6753-1987 Shareen Doak Shareen Doak true false 2023-05-30 BMS Genotoxicity testing for nanomaterials remains challenging as standard testing approaches require some adaptation, and further development of nano-specific OECD Test Guidelines (TGs) and Guidance Documents (GDs) are needed. However, the field of genotoxicology continues to progress and new approach methodologies (NAMs) are being developed that could provide relevant information on the range of mechanisms of genotoxic action that may be imparted by nanomaterials. There is a recognition of the need for implementation of new and/or adapted OECD TGs, new OECD GDs, and utilization of NAMs within a genotoxicity testing framework for nanomaterials. As such, the requirements to apply new experimental approaches and data for genotoxicity assessment of nanomaterials in a regulatory context is neither clear, nor used in practice. Thus, an international workshop with representatives from regulatory agencies, industry, government, and academic scientists was convened to discuss these issues. The expert discussion highlighted the current deficiencies that exist in standard testing approaches within exposure regimes, insufficient physicochemical characterization, lack of demonstration of cell or tissue uptake and internalization, and limitations in the coverage of genotoxic modes of action. Regarding the latter aspect, a consensus was reached on the importance of using NAMs to support the genotoxicity assessment of nanomaterials. Also highlighted was the need for close engagement between scientists and regulators to (i) provide clarity on the regulatory needs, (ii) improve the acceptance and use of NAM-generated data, and (iii) define how NAMs may be used as part of weight of evidence approaches for use in regulatory risk assessments. Journal Article Mutagenesis Oxford University Press (OUP) 0267-8357 1464-3804 Nanomaterials, nanosafety, genotoxicity, in vitro 3D models, OECD, new approach methodologies (NAMs) 26 5 2023 2023-05-26 10.1093/mutage/gead017 http://dx.doi.org/10.1093/mutage/gead017 COLLEGE NANME Biomedical Sciences COLLEGE CODE BMS Swansea University Other The authors wish to acknowledge that this work was supported by the European Union’s Horizon 2020 research and innovation program for the RiskGONE (grant agreement no. 814425), Gov4Nano (grant agreement no.814401), NANORIGO (grant agreement no. 814530), and CompSafeNano (grant agreement no. 101008099) projects 2023-07-24T12:40:49.5477647 2023-05-30T08:12:29.1303141 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Shareen Doak 0000-0002-6753-1987 1 Cristina Andreoli 2 Michael J Burgum 3 Qasim Chaudhry 4 Eric A J Bleeker 5 Cecilia Bossa 6 Josefa Domenech 7 Damjana Drobne 8 Valerie Fessard 9 Nina Jeliazkova 10 Eleonora Longhin 11 Elise Rundén-Pran 12 Maciej Stepnik 13 Naouale El Yamani 14 Julia Catalán 15 Maria Dusinska 16 63542__27832__1cb8b2ac140c46a79b1ed368d59fb2f0.pdf 63542.pdf 2023-06-13T14:26:28.3146904 Output 239656 application/pdf Version of Record true © The Author(s) 2023. Published by Oxford University Press on behalf of the UK Environmental Mutagen Society. This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. true eng https://creativecommons.org/licenses/by/4.0/
title Current status and future challenges of genotoxicity OECD test guidelines (TGs) for nanomaterials: a workshop report
spellingShingle Current status and future challenges of genotoxicity OECD test guidelines (TGs) for nanomaterials: a workshop report
Shareen Doak
title_short Current status and future challenges of genotoxicity OECD test guidelines (TGs) for nanomaterials: a workshop report
title_full Current status and future challenges of genotoxicity OECD test guidelines (TGs) for nanomaterials: a workshop report
title_fullStr Current status and future challenges of genotoxicity OECD test guidelines (TGs) for nanomaterials: a workshop report
title_full_unstemmed Current status and future challenges of genotoxicity OECD test guidelines (TGs) for nanomaterials: a workshop report
title_sort Current status and future challenges of genotoxicity OECD test guidelines (TGs) for nanomaterials: a workshop report
author_id_str_mv 8f70286908f67238a527a98cbf66d387
author_id_fullname_str_mv 8f70286908f67238a527a98cbf66d387_***_Shareen Doak
author Shareen Doak
author2 Shareen Doak
Cristina Andreoli
Michael J Burgum
Qasim Chaudhry
Eric A J Bleeker
Cecilia Bossa
Josefa Domenech
Damjana Drobne
Valerie Fessard
Nina Jeliazkova
Eleonora Longhin
Elise Rundén-Pran
Maciej Stepnik
Naouale El Yamani
Julia Catalán
Maria Dusinska
format Journal article
container_title Mutagenesis
publishDate 2023
institution Swansea University
issn 0267-8357
1464-3804
doi_str_mv 10.1093/mutage/gead017
publisher Oxford University Press (OUP)
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
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 - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
url http://dx.doi.org/10.1093/mutage/gead017
document_store_str 1
active_str 0
description Genotoxicity testing for nanomaterials remains challenging as standard testing approaches require some adaptation, and further development of nano-specific OECD Test Guidelines (TGs) and Guidance Documents (GDs) are needed. However, the field of genotoxicology continues to progress and new approach methodologies (NAMs) are being developed that could provide relevant information on the range of mechanisms of genotoxic action that may be imparted by nanomaterials. There is a recognition of the need for implementation of new and/or adapted OECD TGs, new OECD GDs, and utilization of NAMs within a genotoxicity testing framework for nanomaterials. As such, the requirements to apply new experimental approaches and data for genotoxicity assessment of nanomaterials in a regulatory context is neither clear, nor used in practice. Thus, an international workshop with representatives from regulatory agencies, industry, government, and academic scientists was convened to discuss these issues. The expert discussion highlighted the current deficiencies that exist in standard testing approaches within exposure regimes, insufficient physicochemical characterization, lack of demonstration of cell or tissue uptake and internalization, and limitations in the coverage of genotoxic modes of action. Regarding the latter aspect, a consensus was reached on the importance of using NAMs to support the genotoxicity assessment of nanomaterials. Also highlighted was the need for close engagement between scientists and regulators to (i) provide clarity on the regulatory needs, (ii) improve the acceptance and use of NAM-generated data, and (iii) define how NAMs may be used as part of weight of evidence approaches for use in regulatory risk assessments.
published_date 2023-05-26T12:40:19Z
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