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Tier 2
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Original research — experimental, observational, or case-control study. Direct primary evidence.
Human Health Effects
Policy & Risk
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Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives
NanoImpact2024
31 citations
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Citation count from OpenAlex, updated daily. May differ slightly from the publisher's own count.
Score: 65
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0–100 AI score estimating relevance to the microplastics field. Papers below 30 are filtered from public browse.
Wendel Wohlleben,
Luisa Diomede
Wendel Wohlleben,
Wendel Wohlleben,
Andrea Brunelli,
Andrea Brunelli,
Arno C Gutleb,
Susan Dekkers,
Wendel Wohlleben,
Alberto Katsumiti,
Alberto Katsumiti,
Luisa Diomede
Sabina Halappanavar,
Danail Hristozov,
Alberto Katsumiti,
Elena Badetti,
Roland Hischier,
Wendel Wohlleben,
Wendel Wohlleben,
Wendel Wohlleben,
Wendel Wohlleben,
Wendel Wohlleben,
Alberto Katsumiti,
Roland Hischier,
Elena Badetti,
Roland Hischier,
Roland Hischier,
Wendel Wohlleben,
Wendel Wohlleben,
Shareen H. Doak,
Wendel Wohlleben,
Paolo Bigini,
Wendel Wohlleben,
Alberto Katsumiti,
Andrea Brunelli,
Alberto Katsumiti,
Alberto Katsumiti,
Tobias Stoeger,
Agnes G. Oomen,
Agnes G. Oomen,
Wendel Wohlleben,
Sabina Halappanavar,
Elisa Moschini,
Alberto Katsumiti,
Wendel Wohlleben,
Tobias Stoeger,
Vicki Stone,
Shareen H. Doak,
Andrea Brunelli,
Roland Hischier,
Sabina Halappanavar,
Sabina Halappanavar,
Sabina Halappanavar,
Elisa Giubilato,
Elisa Moschini,
Carlos Rumbo,
Carlos Rumbo,
Vicki Stone,
Susan Dekkers,
Georgia Tsiliki,
Andrea Brunelli,
Wendel Wohlleben,
Roland Hischier,
Ulla Vogel,
Antonio Marcomini,
Alex Zabeo,
Antonio Marcomini,
Ali Kermanizadeh,
Luisa Diomede
Luisa Diomede
Roland Hischier,
Wendel Wohlleben,
Roland Hischier,
Sabina Halappanavar,
Elisa Moschini,
Lang Tran,
Elisa Moschini,
Wendel Wohlleben,
Wendel Wohlleben,
Wendel Wohlleben,
Wendel Wohlleben,
Alberto Katsumiti,
Wouter Fransman,
Elena Badetti,
Elena Badetti,
Paolo Bigini,
Shareen H. Doak,
Shareen H. Doak,
Agnieszka Gajewicz,
Lang Tran,
Georgia Tsiliki,
Wouter Fransman,
Roland Hischier,
Wendel Wohlleben,
Wendel Wohlleben,
Agnes G. Oomen,
Wendel Wohlleben,
Wendel Wohlleben,
Wendel Wohlleben,
Danail Hristozov,
Agnieszka Gajewicz,
Vicki Stone,
Shareen H. Doak,
Antonio Marcomini,
Wendel Wohlleben,
Wendel Wohlleben,
Wendel Wohlleben,
Elisa Giubilato,
Vicki Stone,
Wendel Wohlleben,
Wendel Wohlleben,
Otmar Schmid,
Laura Gómez-Cuadrado,
Wendel Wohlleben,
Alberto Katsumiti,
Laura Gómez-Cuadrado,
Wendel Wohlleben,
Wendel Wohlleben,
Tobias Stoeger,
Otmar Schmid,
Neil Hunt,
Wendel Wohlleben,
Roland Grafström,
Elena Badetti,
Antonio Marcomini,
Arno C Gutleb,
Agnes G. Oomen,
Arno C Gutleb,
Sabina Halappanavar,
Danail Hristozov,
Wendel Wohlleben,
Alberto Katsumiti,
Alberto Katsumiti,
Roland Hischier,
Neil Hunt,
Alberto Katsumiti,
Ali Kermanizadeh,
Antonio Marcomini,
Wendel Wohlleben,
Agnes G. Oomen,
Elisa Moschini,
Otmar Schmid,
Agnes G. Oomen,
Otmar Schmid,
Lisa Pizzol,
Carlos Rumbo,
Carlos Rumbo,
Otmar Schmid,
Neeraj Shandilya,
Wendel Wohlleben,
Vicki Stone,
Stella Stoycheva,
Agnes G. Oomen,
Wendel Wohlleben,
Stella Stoycheva,
Tobias Stoeger,
Blanca Suarez Merino,
Blanca Suarez Merino,
Lang Tran,
Georgia Tsiliki,
Ulla Vogel,
Wendel Wohlleben,
Alex Zabeo,
Luisa Diomede
Summary
This paper proposes a framework for assessing the safety of advanced nanomaterials using newer testing methods that reduce the need for animal studies. The tiered approach combines existing data with targeted testing to evaluate health risks cost-effectively. While focused on engineered nanomaterials broadly, the framework is relevant to understanding the risks of nanoplastics and could help regulators develop safety standards for these emerging contaminants.
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 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 appropriateness for AdNMs is 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.