交叉参照的基本原理及研究进展  

The principles and development of read-across

作　　者：管娜 王莹 戎志毅 高仁君[1] 黄梅 马书霞 苏毅 张霞 GUAN Na;WANG Ying;RONG Zhi-yi;GAO Ren-jun;HUANG Mei;MA Shu-xia;SU Yi;ZHANG Xia(Dow Chemical(China)Investment Co.,Ltd.,Shanghai 201203,China;P&G Technology(Beijing)Co.,Ltd.,Beijing 101312,China;Lubrizol management(Shanghai)Co.,Ltd.,Shanghai 200126,China;BASF(China)Company Ltd.,Shanghai 200137,China;DuPont(China)Research&Development and Management Co.,Ltd.,Shanghai 201203,China;Symrise AG,Holzminden 37603 Germany;Intertek Shanghai Testing Service Ltd.,Shanghai 200233,China)

机构地区：[1]陶氏化学中国投资有限公司,上海201203 [2]北京宝洁技术有限公司,北京101312 [3]路博润管理上海有限公司,上海200126 [4]巴斯夫中国有限公司,上海200137 [5]杜邦中国研发管理有限公司,上海201203 [6]德国德之馨,德国霍尔茨明登37603 [7]上海天祥质量技术服务有限公司,上海200233

出　　处：《毒理学杂志》2022年第2期96-101,共6页Journal of Toxicology

摘　　要：交叉参照是用于填补毒理学终点数据缺口的一种非测试方法,它通过已知化学物质的毒性数据终点预测具有“相似”特性或化学特征化学物质的相同的毒性终点。基于减少测试时间和费用的目的,动物伦理等原因,对交叉参照的倡导和使用近年来不断增多。工业界、科学界和各国政府机构和相关组织也通过法规和指南文件来积极推动其在化学品安全评估和监管中的使用。因为交叉参照是一个需要专家判断、不断迭代自检的多步骤复杂过程,在实际使用中仍然面临一些如有效性、不确定性等问题。本文简要的介绍了交叉参照的基本原理和步骤,法规监管框架,应用指南和研究进展,并讨论了实际应用中的挑战。Read-across is a non-testing method to fill the data gap and provides information for toxicological end points. It predicts the toxicological potential of target chemical substances by inferring from the toxicity of the chemical substances with "similar" chemical profile. Due to the timing and the costs associated with in vivo testing, as well as animal ethics concerns etc., industry, academia, regulatory agencies and some other organizations are actively promoting the usage of read-across in safety assessment of chemical substances through publishing guidance documents and regulations. However, read-across is a multi-step complex process that requires expert judgment and iterations. Several challenges such as effectiveness and uncertainty require further discussion. A review here is to provide the principles and steps of read-across, regulatory frameworks, the guidance for applications and scientific progress. Meanwhile practical hurdles and open challenges have also been discussed.

关 键 词：交叉参照 不确定性分析 相似性 NAM 证据权重 

分 类 号：R114[医药卫生—卫生毒理学] R99[医药卫生—公共卫生与预防医学]