Cited by 150Nanoparticles: synthesis and applicationsAnimal testing and alternativesImmunotoxicology and immune responses

Review of achievements of the OECD Working Party on Manufactured Nanomaterials' Testing and Assessment Programme. From exploratory testing to test guidelines

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Rasmussen, Kirsten, González, Mar, Kearns, Peter, Sintes, Juan Riego, Rossi, François, Sayre, Phil·2016·Regulatory Toxicology and Pharmacology

Abstract

This paper charts the almost ten years of history of OECD's work on nanosafety, during which the programme of the OECD on the Testing and Assessment of Manufactured Nanomaterials covered the testing of eleven nanomaterials for about 59 end-points addressing physical-chemical properties, mammalian and environmental toxicity, environmental fate and material safety. An overview of the materials tested, the test methods applied and the discussions regarding the applicability of the OECD test guidelines, which are recognised methods for regulatory testing of chemicals, are given. The results indicate that many existing OECD test guidelines are suitable for nanomaterials and consequently, hazard data collected using such guidelines will fall under OECD's system of Mutual Acceptance of Data (MAD) which is a legally binding instrument to facilitate the international acceptance of information for the regulatory safety assessment of chemicals. At the same time, some OECD test guidelines and guidance documents need to be adapted to address nanomaterials while new test guidelines and guidance documents may be needed to address endpoints that are more relevant to nanomaterials. This paper presents examples of areas where test guidelines or guidance for nanomaterials are under development.

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  • The OECD, primarily through WPMN, is identified as a key body in governance of nanotechnology issues.

    “The OECD, primarily through the subsidiary WPMN, is identified as being a key body in the governance of nanotechnology issues”
  • In 2013, the OECD and member countries concluded that current testing and assessing procedures of traditional chemicals are generally appropriate for assessing safety of nanomaterials.

    “In 2013, utilising the results gathered from the WPMN testing programme, related OECD subsidiaries, and the general development in understanding of nanomaterials independent of the WPMN, the OECD and member countries concluded that the current testing and assessing procedures of traditional chemicals are generally appropriate for assessing the safety of nanomaterials [102].”

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Authors
Rasmussen, K., González, M., Kearns, P., Sintes, J. R., Rossi, F., & Sayre, P.
Affiliations
  • European Commission (BE)
  • Organisation de Coopération et de Développement Economiques (FR)
Corresponding author
Rasmussen, Kirsten
Venue
Regulatory Toxicology and Pharmacology
Publisher
Elsevier BV
Published
2016-02
Volume
74
Pages
147-160
ISSN
0273-2300 (ISSN-L)
OpenAlex
W2180765816
Cited by
150
References
34
Citations by year
2026: 12 · 2025: 10 · 2024: 4 · 2023: 13 · 2022: 16 · 2021: 6 · 2020: 16 · 2019: 17 · 2018: 34 · 2017: 18 · 2016: 4
FWCI
0.90
Type
journal article
Language
en
Open access
Locations
  • Regulatory Toxicology and Pharmacology (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • Joint Research Centre (European Commission) (submittedVersion)
Topics
  • Physical Sciences › Materials Science › Materials Chemistry › Nanoparticles: synthesis and applications
  • Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
  • Life Sciences › Immunology and Microbiology › Immunology › Immunotoxicology and immune responses
Keywords
engineered nanomaterials, nanomaterial safety, OECD test guidelines, hazard assessment, ecotoxicity, mammalian toxicity, environmental fate, material safety, regulatory safety assessment
MeSH terms
Animals, Humans, Policy Making, Program Development, Guidelines as Topic, Risk Assessment, Toxicity Tests, Consensus, Nanotechnology, Nanostructures, History, 21st Century

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