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Hristozov, D.* ; Badetti, E.* ; Bigini, P.* ; Brunelli, A.* ; Dekkers, S.* ; Diomede, L.* ; Doak, S.H.* ; Fransman, W.* ; Gajewicz-Skretna, A.* ; Giubilato, E.* ; Gómez-Cuadrado, L.* ; Grafström, R.C.* ; Gutleb, A.C.* ; Halappanavar, S.* ; Hischier, R.* ; Hunt, N.* ; Katsumiti, A.* ; Kermanizadeh, A.* ; Marcomini, A.* ; Moschini, E.* ; Oomen, A.G.* ; Pizzol, L.* ; Rumbo, C.* ; Schmid, O. ; Shandilya, N.* ; Stone, V.* ; Stoycheva, S.* ; Stöger, T. ; Merino, B.S.* ; Tran, L.* ; Tsiliki, G.* ; Vogel, U.B.* ; Wohlleben, W.* ; Zabeo, A.*

Next generation risk assessment approaches for advanced nanomaterials: current status and future perspectives.

NanoImpact 35:100523 (2024)

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	Open Access Gold (Paid Option)

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This manuscript discusses the challenges of applying New Approach Methodologies (NAMs) for safe by design and regulatory risk assessment of advanced nanomaterials (AdNMs). The authors propose a framework for Next Generation Risk Assessment of AdNMs involving NAMs that is aligned to the conventional risk assessment paradigm. This framework is exposure-driven, endpoint-specific, makes best use of pre-existing information, and can be implemented in tiers of increasing specificity and complexity of the adopted NAMs. The tiered structure of the approach, which effectively combines the use of existing data with targeted testing will allow safety to be assessed cost-effectively and as far as possible with an even more limited use of vertebrates. The regulatory readiness of state-of-the-art emerging NAMs is assessed in terms of Transparency, Reliability, Accessibility, Applicability, Relevance and Completeness, and their relevance for AdNMs are discussed in relation to each step of the risk assessment paradigm along with providing perspectives for future developments in the respective scientific and regulatory areas.

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Publication type Article: Journal article

Document type Scientific Article

Corresponding Author

Keywords Advanced Materials ; Grouping ; In Chemico Approaches ; In Silico Approaches ; In Vitro Approaches ; In Vitro-in Vivo Extrapolation (ivive) ; Nanomaterials ; New Approach Methodologies (nams) ; Next Generation Risk Assessment (ngra) ; Regulatory Readiness; Engineered Nanoparticles; Toxicity; Exposure; Limitations; Particles; Quality; Model

ISSN (print) / ISBN 2452-0748

e-ISSN 2452-0748

Journal NanoImpact

Quellenangaben Volume: 35, Article Number: 100523

Publisher Elsevier

Publishing Place Amsterdam

Non-patent literature Publications

Reviewing status Peer reviewed

Institute(s) Lung Health and Immunity (LHI)

Grants European Union