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Posted: June 8, 2010
OECD revises Guidance Manual for the testing of manufactured nanomaterials
(Nanowerk News) This is the first revision of the Guidance Manual for the Testing of Manufactured Nanomaterials, first published in 2009, accompanied with Annex III (Data Sharing Template Format) and Annex IV (Alternative Test Methods). This document is intended to support the testing undertaken in the context of OECD's Sponsorship Programme and to ensure that the information collected from this testing programme be reliable, accurate and consistent. It was always envisaged that this would be a living document and will be updated/amended in an iterative manner.
The Working Party on Manufactured Nanomaterials (WPMN) project Safety Testing of a Representative Set of Manufactured Nanomaterials builds upon the concept that much valuable information on the safety of manufactured nanomaterials (MNs), as well as the methods to assess safety, can be derived by testing certain nanomaterials for human health and environmental safety related effects. This project led to a Sponsorship Programme for testing a set of manufactured nanomaterials using appropriate test methods, which would include OECD Test Guidelines
or other internationally agreed methods.
As a first step, the WPMN agreed a list of fourteen representative manufactured nanomaterials and a
list of endpointsincluding nanomaterial information/identification, physical-chemical properties and
material characterisation, environmental fate, environmental toxicology, mammalian toxicology and
material safety, which would be addressed for the hazard assessment of those nanomaterials. As a second
stage, the WPMN launched the OECD's Sponsorship Programme on the Testing on Manufactured
Nanomaterials, to generate information on the safety of the specific manufactured nanomaterials through
testing for human health and environmental safety endpoints.
The "Sponsorship Programme" is a process to conduct, as appropriate, specific tests for manufactured
nanomaterials. It involves OECD member countries, as well as some non-member economies and other
stakeholders solely or in partnership with other entities, to pool expertise and to fund the safety testing of
specific Manufactured Nanomaterials (MNs).
In order to assist sponsors in the development of dossier development plans (DDPs) which describes
the testing programme for a specified MN, the WPMN agreed to develop this Guidance Manual. It is
intended to ensure that the information collected from the Sponsorship Programme be reliable, accurate
The Guidance Manual builds upon the work already achieved by the WPMN. The work of the
WPMN project on the Safety Testing of a Representative Set of Manufactured Nanomaterials (SG3) was
complemented by other WPMN projects. In particular, by the projects on: Manufactured Nanomaterials
and Test Guidelines (SG4); and The Role of Alternative Methods in Nano Toxicology (SG7).
Manufactured Nanomaterials and Test Guidelines: This project addresses whether
existing test guidelines (used for "traditional chemicals") can be successfully applied to
manufactured nanomaterials. Thus, this project is reviewing existing test guidelines [especially
the OECD Test Guidelines (TGs)] with view to establishing whether they are suitable for
manufactured nanomaterials. Test Guidelines include: physical chemical properties; effects on
biotic systems; degradation and accumulation; and health effects. In addition, a document,
Preliminary Review of OECD Test Guidelines for their Applicability to Manufactured
Nanomaterials, was published in 2009 and another document, Preliminary Guidance Notes on
Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials, has
also been recently published in 2010, as an outcome of this project.
The Role of Alternative Methods in Nanotoxicology: This project is looking into
alternative test methods (to reduce the use of animals in the hazard evaluation of nanomaterials)
and will analyse how they might be used in an overall assessment plan for hazard testing of manufactured nanomaterials. In addition, this project is developing text on testing strategies and in vitro methods for human health hazard identification to complement the Guidance Manual.
This Guidance Manual includes the appropriate protocols and methodologies. It also: i) describes the
three modes of sponsorship involvement (lead-Sponsors, co-Sponsors and Contributors); ii) explains the
distinction between a Phase 1 (exploratory) and a Phase 2 of the Sponsorship Programme; iii) provides
considerations on how to develop a sufficient set of information to address endpoints; iv) outlines the
WPMN review and oversight approaches, including a two-year review; and v) outlines those expected
outputs from the testing programmes of each sponsored manufactured nanomaterial (MN).
This document was first developed by a Task Group on Guidance Manual for Sponsors, which was
established under the projects Safety Testing of a Representative Set of Manufactured Nanomaterials (SG3)
and Manufactured Nanomaterials and Test Guidelines (SG4). Also, the project on The Role of Alternative
Methods in Nanotoxicology (SG7) provided specific inputs regarding in vitro methods for human health
hazard identification. More information is available on Alternative Methods in the Sponsorship Programme
in Annex IV. Finally, the main text was prepared in an iterative manner with sponsors as the work
progressed and was endorsed by the WPMN at its 5th meeting in March 2009. A Data Sharing Template
Format was finalised at the 6th meeting in October 2009 and it was agreed to its inclusion to this document
as an annex (Annex III).
It is important to note that this Guidance Manual for the Testing of Manufactured Nanomaterials
will continue to be updated and amended in an iterative manner based upon the accumulation of
knowledge, as well as evolving communication and coordination needs as the testing programme and
the development of DDPs moves forward.