化学品风险评估新技术方法的发展及应用

Development and application of new approach methodologies in chemical risk assessment

新的化合物不断涌现,替代方法产生了大量体外测试数据,迫切需要开发快速高效的用于化学品风险评估的新技术方法(NAM)。NAM的大规模开展和实施为化学品的危害表征和风险评估提供了适合的科学基础,为更多与人类相关的安全评估提供信息。近年来,在计算方法学、体外测试法及体外生物动力学等方面已开发出大量的NAM,具有广泛的应用前景。但单一的NAM有其局限性,需要将多种NAM及不同来源的信息整合使用以更精准地完成风险评估,且目前很多NAM可信度的规则和标准仍未得到规范。本文介绍了目前国内外重点关注的计算方法学、体外测试方法和体外生物动力学方法等领域开发的NAM,及其主要在环境混合污染物及复杂/未知化学物等风险评估中的应用,同时对NAM整合测试策略的进展及存在的问题等方面进行讨论,为我国化学品风险评估NAM的开发及应用提供参考。

Abstrsct:As new compounds continue to emerge,alternative methods have generated a large amount of in vitro test data.There is an urgent need to develop fast and efficient new approach methodologies(NAMs)for chemical risk assessment.The large-scale development and implementation of NAMs underlie hazard characterization and risk assessment of chemicals,and provide information for more human-related safety assessments.In recent years,a large number of NAMs have been developed in computational methodology,in vitro testing and in vitro biodynamics,which promise wide applications.However,a single NAM has its limitations,which requires the integration and use of multiple NAMs and information from different sources to make risk assessment more accurate.Many NAMs still lack rules and standards to regulate their credibility.This paper introduces the NAMs developed in the fields of computational methodology,in vitro testing methods,and in vitro biodynamic methods,which are currently focuses of study at home and abroad,and their applications in risk assessment of environmental mixed pollutants and complex/unknown chemicals.The progress in and existing problems with integration testing strategies of NAMs are reviewed so as to provide reference for the development and application of NAMs in chemical risk assessment in China.