Current status and future challenges of genotoxicity OECD test guidelines (TGs) for nanomaterials: a workshop report
Authors
Doak, ShareenAndreoli, Cristina
Burgum, Michael J.
Chaudhry, Qasim
Bleeker, Eric A. J.
Bossa, Cecilia
Domenech, Josefa
Drobne, Damjana
Fessard, Valérie
Jeliazkova, Nina
Longhin, Eleonora
Rundén-Pran, Elise
Stepnik, Maciej
El Yamani, Naouale
Catalán, Julia
Dusinska, Maria
Affiliation
Swansea University; Istituto Superiore di Sanità; University of Chester; National Institute for Public Health and the Environment (RIVM); Finnish Institute of Occupational Health; University of Ljubljana; ANSES French Agency for Food; Ideaconsut Ltd; NILU-Norwegian Institute for Air Research; QSAR Lab Ltd; University of ZaragozaPublication Date
2023-05-26
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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 utilisation 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 physico-chemical characterisation, lack of demonstration of cell or tissue uptake and internalisation, 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 1) provide clarity on the regulatory needs, 2) improve the acceptance and use of NAMs-generated data, and 3) define how NAMs may be used as part of Weight of Evidence approaches for use in regulatory risk assessments.Citation
Doak, S., Andreoli, C., Burgum, M. J., Chaudhry, Q., Bleeker, E. A. J., Bossa, C., Domenech, J., Drobne, D., Fessard, V., Jeliazkova, N., Longhin, E., Rundén-Pran, E., Stepnik, M., El Yamani, N., Catalán, J., & Dusinska, M. (2023). Current status and future challenges of genotoxicity OECD test guidelines (TGs) for nanomaterials: A workshop report. Mutagenesis, https://doi.org/10.1093/mutage/gead017Publisher
Oxford University PressJournal
MutagenesisType
ArticleDescription
© The Author(s) 2023. Published by Oxford University Press on behalf of the UK Environmental Mutagen Society.ISSN
0267-8357EISSN
1464-3804ae974a485f413a2113503eed53cd6c53
10.1093/mutage/gead017
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