20.500.12556/RUL-159120 Current status and future challenges of genotoxicity OECD Test Guidelines for nanomaterials: a workshop report 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. nanomaterials nanosafety genotoxicity in vitro 3D models OECD new approach methodologies NAMs true false true Angleški jezik Ni določen Članek v reviji 2024-07-01 09:07:20 2024-07-01 09:07:26 2024-07-12 03:35:41 0000-00-00 00:00:00 2023 0 0 Str. 183-191 iss. 4 Vol. 38 2023 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 0267-8357 10.1093/mutage/gead017 gead017.pdf gead017.pdf 1 1FD055C39A319F1A23C679DA8D2F7B84 c8a7818e1d01948be4e879c13523763ad31737fdec775b88de07c31d0e0cb7bc 7db32b21-377b-11ef-a093-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=187013 https://academic.oup.com/mutage/article/38/4/183/7180365 0 8b2f640a-377b-11ef-a093-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=187014 Biotehniška fakulteta 0 0 0