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

作者：Arno C Gutleb, Sivakumar Murugadoss, M. Stępnik, Tanima SenGupta, Naouale El Yamani, Eleonora Longhin, Ann‐Karin Olsen, Ewelina Wyrzykowska, Karolina Jagiełło, Beata Judzińska, Sébastien Cambier, Tatiana Honza, Erin McFadden, Sergey Shaposhnikov, Tomasz Puzyn, Tommaso Serchi, Pamina Weber, Emma Arnesdotter, Viera Skakalova, Kateřina Jirsová, Ireneusz P. Grudziński, Andrew Collins, Elise Rundén‐Pran, Mária Dušinská · 发表于：Mutation Research/Genetic Toxicology and Environmental Mutagenesis · 年份：2025 · DOI：10.1016/j.mrgentox.2025.503867 · 被引用次数：10 · 研究领域：Nanoparticles: synthesis and applications、Microplastics and Plastic Pollution、Advanced biosensing and bioanalysis techniques

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 ...