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Current status and future challenges of genotoxicity OECD test guidelines (TGs) for nanomaterials: a workshop report
,
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
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© 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.
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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...
| Published in: | Mutagenesis |
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| ISSN: | 0267-8357 1464-3804 |
| Published: |
Oxford University Press (OUP)
2023
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| Online Access: |
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| URI: | https://cronfa.swan.ac.uk/Record/cronfa63542 |
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| 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 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. |
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| Keywords: |
Nanomaterials, nanosafety, genotoxicity, in vitro 3D models, OECD, new approach methodologies (NAMs) |
| College: |
Faculty of Medicine, Health and Life Sciences |
| Funders: |
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 |