title: Review of achievements of the OECD Working Party on Manufactured Nanomaterials' Testing and Assessment Programme. From exploratory testing to test guidelines.
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.
authors.affiliation: European Commission, Joint Research Centre, Institute for Health and Consumer Protection, via E. Fermi 2749, 21027, Ispra, VA, Italy. Electronic address: kirsten.rasmussen@ec.europa.eu.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Rasmussen
authors.affiliation: Organisation for Economic Co-operation and Development (OECD), Environment Directorate, 75775, Paris Cedex 16, France.
authors.forename: Mar
authors.initials: M
authors.lastname: González
authors.affiliation: Organisation for Economic Co-operation and Development (OECD), Environment Directorate, 75775, Paris Cedex 16, France.
authors.forename: Peter
authors.initials: P
authors.lastname: Kearns
authors.affiliation: European Commission, Joint Research Centre, Institute for Health and Consumer Protection, via E. Fermi 2749, 21027, Ispra, VA, Italy.
authors.forename: Juan Riego
authors.initials: JR
authors.lastname: Sintes
authors.affiliation: European Commission, Joint Research Centre, Institute for Health and Consumer Protection, via E. Fermi 2749, 21027, Ispra, VA, Italy.
authors.forename: François
authors.initials: F
authors.lastname: Rossi
authors.affiliation: U.S. Environmental Protection Agency, formerly with Office of Pollution Prevention and Toxics, Washington DC, 20460, USA. Electronic address: phil.sayre@verizon.net.
authors.forename: Phil
authors.initials: P
authors.lastname: Sayre
mesh_terms: D000818:Animals; D032921:Consensus; D017408:Guidelines as Topic / Q000592:standards; D049674:History, 21st Century; D006801:Humans; D049329:Nanostructures / Q000009:adverse effects* / Q000266:history / Q000592:standards; D036103:Nanotechnology / Q000266:history / Q000592:standards; D011050:Policy Making; D016730:Program Development; D018570:Risk Assessment; D018675:Toxicity Tests / Q000266:history / Q000592:standards
keywords: Manufactured nanomaterials; OECD WPMN testing programme; OECD test guidelines; Regulatory testing; Working Party on Manufactured Nanomaterials