ANALYST PROJECT
Published March 30, 2025 | Version v1
Journal article Open

New Approach Methods (NAMs) for genotoxicity assessment of nano- and advanced materials; Advantages and challenges

Authors/Creators

  • 1. Environmental Sustainability Assessment and Circularity (SUSTAIN) Unit, Luxembourg Institute of Science and Technology (LIST), Luxembourg
  • 2. INVITROLIZE sarl, Wellenstein, Luxembourg
  • 3. Health Effects Laboratory, Department of Environmental Chemistry and Health Effects, NILU The Climate and Environmental Research Institute, Norway
  • 4. QSAR Lab Ltd, Trzy Lipy 3, Gda´nsk, Poland
  • 5. Department of Toxicology, Faculty of Pharmacy, Medical University of Ł´od´z, Poland
  • 6. University of Gda´nsk, Faculty of Chemistry, Laboratory of Environmental Chemoinformatics, Wita Stwosza, Gda´nsk 63, 80-308, Poland
  • 7. NorGenoTech, Norway
  • 8. DANUBIA NANOTECH SRO, Bratislava, Slovakia
  • 9. Laboratory of Biology and Pathology of the Eye, Institute of Biology and Medical Genetics, 1st Faculty of Medicine and General Teaching Hospital, Charles University, Prague, Czech Republic
  • 10. Department of Toxicology and Food Science, Faculty of Pharmacy, Medical University of Warsaw, Banacha Str. 1, Warsaw 02-097, Poland
  • 11. Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway

Description

Genotoxicity assessment is essential for ensuring chemical safety and mitigating risks to human health and the environment. Traditional methods, reliant on animal models, are time-consuming, costly, and raise ethical concerns. New Approach Methods (NAMs) offer innovative, cost-effective, and ethical alternatives, playing a pivotal role in both traditional and next-generation risk assessment (NGRA) by minimizing the need for animal testing, particularly in genotoxicity evaluations. However, the development of NAMs often overlooks the particular physicochemical properties of nanomaterials (NMs), which significantly influence their toxicological behaviour and can interfere with genotoxicity evaluation. This underscores an urgent need for the standardization and adaptation of NAMs to address nano- and advanced material-specific genotoxicity challenges. In this review, we summarize the challenges associated with genotoxicity testing of NMs and highlight the suitability of existing in vitro and in silico NAMs for NMs and advanced materials, enabling genotoxicity testing across various exposure routes and organ systems. Despite considerable progress, regulatory validation remains constrained by the absence of approved test guidelines and standardized protocols. To achieve regulatory acceptance, it is crucial to adapt NAMs to NM-specific exposure scenarios, refine test systems to better mimic human biology, develop tailored in vitro protocols, and ensure thorough characterisation of NMs both in pristine form and dispersed in culture medium. Collaborative efforts among scientists, regulators, industry, and advocacy groups are vital to improving the reliability and regulatory acceptance of NAMs. By addressing these challenges, NAMs have the potential to revolutionize genotoxicity risk assessment, advancing it towards a more sustainable, efficient and ethical framework.

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Additional details

Funding

European Commission
ANALYST - STRENGTHENING THE INTEGRATED APPROACH OF HOLISTIC IMPACT ASSESSMENTS FOR SAFE AND SUSTAINABLE BY DESIGN PLASTIC VALUE CHAIN 101138548
European Commission
CompSafeNano - NanoInformatics Approaches for Safe-by-Design NanoMaterials 101008099
European Commission
RiskGONE - Risk Governance of Nanotechnology 814425
European Commission
NanoHarmony - Towards harmonised test methods for nanomaterials 885931
European Commission
DIAGONAL - Development and scaled Implementation of sAfe by design tools and Guidelines for multicOmponent aNd hArn nanomateriaLs 953152
European Commission
SABYDOMA - Safety BY Design Of nanoMaterials - From Lab Manufacture to Governance and Communication: Progressing Up the TRL Ladder 862296
European Commission
PROPLANET - Enhanced Safe and Sustainable coatings for supporting the Planet 101091842
European Commission
NanoSolveIT - Innovative Nanoinformatics models and tools: towards a Solid, verified and Integrated Approach to Predictive (eco)Toxicology (NanoSolveIT) 814572
European Commission
PARC - Partnership for the Assessment of Risks from Chemicals 101057014
Norwegian Institute for Air Research
SIS ChemHealth
EEA and Norway Grants
TEPCAN (NCBR Funding No. NOR/POLNOR/TEPCAN/ 0057/2019–00)
EEA and Norway Grants
BBMRI_CZ LM2023033