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

• Published in: Regulatory toxicology and pharmacology 2016-02, Vol.74, p.147-160
• Main Authors: Rasmussen, Kirsten, González, Mar, Kearns, Peter, Sintes, Juan Riego, Rossi, François, Sayre, Phil
• Format: Article
• Language: English
• Subjects: Animals; Consensus; Guidelines as Topic - standards; History, 21st Century; Humans; Manufactured nanomaterials; Nanostructures - adverse effects; Nanostructures - history; Nanostructures - standards; Nanotechnology - history; Nanotechnology - standards; OECD test guidelines; OECD WPMN testing programme; Policy Making; Program Development; Regulatory testing; Risk Assessment; Toxicity Tests - history; Toxicity Tests - standards; Working Party on Manufactured Nanomaterials
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1016/j.yrtph.2015.11.004

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. •Overview the OECD Programme on Testing and Assessment of Manufactured Nanomaterials.•Overview of 11 nanomaterials tested for physchem properties, (eco)toxicity and fate.•Indications that many existing OECD test guidelines are suitable for nanomaterials.•The legally binding Mutual Acceptance of Data covers nanomaterial data via OECD TGs.•Overview of areas of development for new OECD test guidelines for nanomaterials.