Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives
Journal article
Authors | Hristozov, D., Badetti, E., Bigini, P., Brunelli, A., Dekkers, S., Diomede, L., Doak, S. K., Fransman, W., Gajewicz-Skretna, A., Giubilato, E., Gómez-Cuadrado, L., Grafström, R., Gutleb, R. C., Halappanavar, S., Hischier, R., Hunt, N., Katsumiti, A., Kermanizadeh, A., Marcomini, A., Moschini, E., Oomen, E., Pizzol, L., Rumbo, C., Schmid, O., Shandilya, N., Stone, V., Stoycheva, S, Stoeger, T., Merino, B. S., Tran, L., Tsiliki, G., Vogel, U. B., Wohlleben, W. and Zabeo, A. |
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Abstract | 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 |
Keywords | Next Generation Risk Assessment (NGRA); New Approach Methodologies (NAMs); Advanced materials; Nanomaterials; Regulatory readiness; Grouping; In vitro approaches; In vitro-in vivo extrapolation (IVIVE); In silico approaches; In chemico approaches |
Year | 2024 |
Journal | NanoImpact |
Journal citation | pp. 1-48 |
Publisher | Elsevier |
ISSN | 2452-0748 |
Digital Object Identifier (DOI) | https://doi.org/10.1016/j.impact.2024.100523 |
Web address (URL) | https://www.sciencedirect.com/science/article/pii/S2452074824000338?via%3Dihub |
Accepted author manuscript | License File Access Level Open |
Output status | Published |
Publication dates | |
Online | 24 Jul 2024 |
Publication process dates | |
Accepted | 17 Jul 2024 |
Deposited | 29 Jul 2024 |
https://repository.derby.ac.uk/item/q78v5/next-generation-risk-assessment-approaches-for-advanced-nanomaterials-current-status-and-future-perspectives
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