Physico-chemical properties of manufactured nanomaterials - Characterisation and relevant methods. An outlook based on the OECD Testing Programme.

Identifying and characterising nanomaterials require additional information on physico-chemical properties and test methods, compared to chemicals in general. Furthermore, regulatory decisions for chemicals are usually based upon certain toxicological properties, and these effects may not be equivalent to those for nanomaterials. However, regulatory agencies lack an authoritative decision framework for nanomaterials that links the relevance of certain physico-chemical endpoints to toxicological effects. This paper investigates various physico-chemical endpoints and available test methods that could be used to produce such a decision framework for nanomaterials. It presents an overview of regulatory relevance and methods used for testing fifteen proposed physico-chemical properties of eleven nanomaterials in the OECD Working Party on Manufactured Nanomaterials' Testing Programme, complemented with methods from literature, and assesses the methods' adequacy and applications limits. Most endpoints are of regulatory relevance, though the specific parameters depend on the nanomaterial and type of assessment. Size (distribution) is the common characteristic of all nanomaterials and is decisive information for classifying a material as a nanomaterial. Shape is an important particle descriptor. The octanol-water partitioning coefficient is undefined for particulate nanomaterials. Methods, including sample preparation, need to be further standardised, and some new methods are needed. The current work of OECD's Test Guidelines Programme regarding physico-chemical properties is highlighted.

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

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.

The OECD expert meeting on ecotoxicology and environmental fate--towards the development of improved OECD guidelines for the testing of nanomaterials.

On behalf of the OECD Working Party on Manufactured Nanomaterials (WPMN) an expert meeting on ecotoxicology and environmental fate of nanomaterials (NMs) took place in January 2013 in Berlin. At this meeting experts from science, industry and regulatory bodies discussed the applicability of OECD test guidelines (TGs) for chemicals to nanomaterials. The objective was to discuss the current state of the relevant science and provide recommendations to the OECD WPMN on (1) the need for updating current OECD TGs and the need for developing new ones specific to nanomaterials; and (2) guidance needed for the appropriate and valid testing of environmental fate and ecotoxicity endpoints for NMs. Experts at the workshop agreed that the majority of the OECD TG for chemicals were generally applicable for the testing of NM, with the exception of TG 105 (water solubility) and 106 (adsorption-desorption). Additionally, the workshop also highlighted considerations when conducting OECD chemical TG on nanomaterials (e.g., sample preparation, dispersion, analysis, dosimetry and characterisation). These considerations will lead to the future development of proposals for new TG and guidance documents (GDs) to ensure that OECD TG give meaningful, repeatable, and accurate results when used for nanomaterials. This report provides a short overview of topics discussed during the meeting and the main outcomes. A more detailed report of the workshop will become available through the OECD, however, due to the urgency of having OECD TG relevant for nanomaterials, this brief report is being shared with the scientific community through this communication.