New Approach Methods (NAMs) for genotoxicity assessment of nano- and advanced materials; Advantages and challenges [* Cross-Reference *]

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Gutleb, Arno C.; Murugadoss, Sivakumar; Stępnik, Maciej; SenGupta, Tanima; El Yamani, Naouale; Longhin, Eleonora Marta; Olsen, Ann Karin Hardie; Wyrzykowska, Ewelina; Jagiello, Karolina; Judzinska, Beata; Cambier, Sebastien; Honza, Tatiana; McFadden, Erin; Shaposhnikov, Sergey; Puzyn, Tomasz; Serchi, Tommaso; Weber, Pamina; Arnesdotter, Emma; Skakalova, Vier; Jirsova, Katerina; Grudzinski, Ireneusz P.; Collins, Andrew; Rundén-Pran, Elise; Dusinska, Maria, 2026, "New Approach Methods (NAMs) for genotoxicity assessment of nano- and advanced materials; Advantages and challenges [* Cross-Reference *]", https://lore.list.lu/citation?persistentId=perma:LIST.DXXLMJ, LIST Open Repository, V1
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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. (2025-05-01)
***This entry has been automatically imported via Infodoc(ASO) CSV by LIST harvest scripts. Please refer to https://doi.org/10.1016/j.mrgentox.2025.503867 for the original and latest version of the dataset and data downloads*** (2026-06-09)
Subject Earth and Environmental Sciences
Keyword Advanced in vitro models, Advanced materials, Genotoxicity, Nano- and microplastics, nanomaterials, New Approach Methods (NAMs), risk assessment
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