European Commission, Joint Research Centre, Ispra, Via E. Fermi 2749, 21027 Ispra, VA, Italy.
Organisation for Economic Co-operation and Development (OECD), Environment Directorate, 75775 Paris CEDEX 16, France.
Regul Toxicol Pharmacol. 2018 Feb;92:8-28. doi: 10.1016/j.yrtph.2017.10.019. Epub 2017 Oct 23.
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.
与一般化学品相比，识别和表征纳米材料需要更多关于物理化学性质和测试方法的信息。此外，化学品的监管决策通常基于某些毒理学性质，而这些影响可能与纳米材料的影响不同。然而，监管机构缺乏一个权威的纳米材料决策框架，将某些物理化学终点与毒理学效应联系起来。本文研究了各种物理化学终点和可用的测试方法，这些方法可用于为纳米材料制定这样的决策框架。本文概述了监管相关性以及在经合组织制造业纳米材料工作组测试计划中用于测试 11 种纳米材料的 15 种拟议物理化学特性的方法，并补充了文献中的方法，评估了这些方法的充分性和应用限制。大多数终点与监管有关，但具体参数取决于纳米材料和评估类型。尺寸（分布）是所有纳米材料的共同特征，是将材料分类为纳米材料的决定性信息。形状是一个重要的颗粒描述符。辛醇-水分配系数对于颗粒状纳米材料是不明确的。包括样品制备在内的方法需要进一步标准化，并且需要一些新的方法。本文强调了经合组织测试指南计划在物理化学性质方面的当前工作。
