School of Geography, Earth and Environmental Sciences, University of Birmingham, Edgbaston, Birmingham, West Midlands, UK.
Environ Int. 2013 Feb;52:41-50. doi: 10.1016/j.envint.2012.11.009. Epub 2012 Dec 29.
Appropriate characterisation of manufactured nanomaterials (NMs) is vital for many aspects of their synthesis, product formulation, toxicological testing and regulation. As the range and quantity of NMs in production has expanded, the interest in their potential environmental and toxicological consequences has grown. With this growth, there is increased need for clarity and rigour in characterising appropriate physicochemical parameters. Which physicochemical parameters should be characterised and under what conditions remains a topic of debate, along with the most appropriate techniques and methodologies to best describe any one characteristic. This review assesses the characterisation requirements of current and future regulatory frameworks for NMs, with specific focus on the incoming REACH framework of the EU. For regulatory compliance, characterisation requirements will be necessarily prescriptive. The minimum physicochemical parameters required to adequately describe NMs for regulatory purposes are proposed, along with a discussion of the most appropriate mechanisms to obtain those data in terms of the overarching delivery mechanism. Guiding principles for particle characterisation during the hazard testing required to comply with regulations are examined.
制造纳米材料（NMs）的适当表征对于其合成、产品配方、毒理学测试和监管的许多方面都至关重要。随着生产中纳米材料的种类和数量不断增加，人们对其潜在的环境和毒理学后果的兴趣也在不断增加。随着这种增长，对于在表征适当的物理化学参数方面需要更加清晰和严格的要求。哪些物理化学参数需要进行表征，以及在什么条件下进行表征，仍然是一个争论的话题，同时还需要最适当的技术和方法来最好地描述任何一个特征。本综述评估了当前和未来的纳米材料监管框架的表征要求，特别是针对欧盟即将出台的 REACH 框架。为了符合法规要求，在表征要求方面必须具有规定性。本文提出了为监管目的充分描述纳米材料所需的最低物理化学参数，并讨论了在总体传递机制方面获得这些数据的最合适机制。本文还探讨了在遵守法规所需的危害测试过程中进行颗粒表征的指导原则。
