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Current status and future challenges of genotoxicity OECD Test Guidelines for nanomaterials: a workshop report.
Doak, Shareen H; Andreoli, 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.
Afiliación
  • Doak SH; Institute of Life Science, Swansea University Medical School, Singelton Park, Swansea, SA2 8PP Wales, United Kingdom.
  • Andreoli C; Department of Environment and Health, Istituto Superiore di Sanità, Rome, Italy.
  • Burgum MJ; Institute of Life Science, Swansea University Medical School, Singelton Park, Swansea, SA2 8PP Wales, United Kingdom.
  • Chaudhry Q; University of Chester, Parkgate Road, Chester, United Kingdom.
  • Bleeker EAJ; National Institute for Public Health and the Environment (RIVM), PO Box 1, 3720 BA Bilthoven, The Netherlands.
  • Bossa C; Department of Environment and Health, Istituto Superiore di Sanità, Rome, Italy.
  • Domenech J; Finnish Institute of Occupational Health, Box 40, Työterveyslaitos, 00032 Helsinki, Finland.
  • Drobne D; University of Ljubljana, Biotechnical Faculty, Department of Biology, Vecan pot 111, 1000 Ljubljana, Slovenia.
  • Fessard V; ANSES French Agency for Food, Environmental and Occupational Health and Safety, Fougères Laboratory, Toxicology of Contaminants Unit, 10b rue Claude Bourgelat, Fougères 35306, France.
  • Jeliazkova N; Ideaconsult Ltd., Sofia, Bulgaria.
  • Longhin E; NILU-Norwegian Institute for Air Research, Instituttveien 18, Kjeller 2002, Norway.
  • Rundén-Pran E; NILU-Norwegian Institute for Air Research, Instituttveien 18, Kjeller 2002, Norway.
  • Stepnik M; QSAR Lab Ltd., Trzy Lipy 3 St., Gdansk, Poland.
  • El Yamani N; NILU-Norwegian Institute for Air Research, Instituttveien 18, Kjeller 2002, Norway.
  • Catalán J; Finnish Institute of Occupational Health, Box 40, Työterveyslaitos, 00032 Helsinki, Finland.
  • Dusinska M; Department of Anatomy, Embryology, and Genetics, University of Zaragoza, 50013 Zaragoza, Spain.
Mutagenesis ; 38(4): 183-191, 2023 08 24.
Article en En | MEDLINE | ID: mdl-37234002
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Nanoestructuras / Organización para la Cooperación y el Desarrollo Económico Tipo de estudio: Etiology_studies / Guideline / Qualitative_research / Risk_factors_studies Idioma: En Revista: Mutagenesis Asunto de la revista: GENETICA MEDICA / SAUDE AMBIENTAL Año: 2023 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Reino Unido
Texto completo
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XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Nanoestructuras / Organización para la Cooperación y el Desarrollo Económico Tipo de estudio: Etiology_studies / Guideline / Qualitative_research / Risk_factors_studies Idioma: En Revista: Mutagenesis Asunto de la revista: GENETICA MEDICA / SAUDE AMBIENTAL Año: 2023 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Reino Unido