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dc.contributor.authorDoak, Shareen H.
dc.contributor.authorAndreoli, Cristina
dc.contributor.authorBurgum, Michael J.
dc.contributor.authorChaudhry, Qasim
dc.contributor.authorBleeker, Eric
dc.contributor.authorBossa, Cecilia
dc.contributor.authorDomenech, Josefa
dc.contributor.authorDrobne, Damjana
dc.contributor.authorFessard, Valérie
dc.contributor.authorJeliazkova, Nina
dc.contributor.authorLonghin, Eleonora Marta
dc.contributor.authorRundén-Pran, Elise
dc.contributor.authorStepnik, Maciej
dc.contributor.authorEl Yamani, Naouale
dc.contributor.authorCatalán, Julia
dc.contributor.authorDusinska, Maria
dc.date.accessioned2023-07-18T06:50:16Z
dc.date.available2023-07-18T06:50:16Z
dc.date.created2023-07-17T11:30:06Z
dc.date.issued2023
dc.identifier.citationMutagenesis. 2023.en_US
dc.identifier.issn0267-8357
dc.identifier.urihttps://hdl.handle.net/11250/3079665
dc.description.abstractGenotoxicity 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.en_US
dc.language.isoengen_US
dc.rightsNavngivelse 4.0 Internasjonal*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/deed.no*
dc.titleCurrent status and future challenges of genotoxicity OECD Test Guidelines for nanomaterials: a workshop reporten_US
dc.title.alternativeCurrent status and future challenges of genotoxicity OECD Test Guidelines for nanomaterials: a workshop reporten_US
dc.typePeer revieweden_US
dc.typeJournal articleen_US
dc.description.versionpublishedVersionen_US
dc.rights.holder© The Author(s) 2023.en_US
dc.source.journalMutagenesisen_US
dc.identifier.doi10.1093/mutage/gead017
dc.identifier.cristin2162475
dc.relation.projectEC/H2020/814425en_US
dc.relation.projectEC/H2020/101008099en_US
dc.relation.projectEC/H2020/814401en_US
dc.relation.projectEC/H2020/814530en_US
dc.relation.projectNILU: 119011
dc.relation.projectNILU: 121041
cristin.ispublishedfalse
cristin.fulltextoriginal
cristin.qualitycode1


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Navngivelse 4.0 Internasjonal
Except where otherwise noted, this item's license is described as Navngivelse 4.0 Internasjonal