交叉参照中的不确定性的探讨  

Assessment of uncertainty in 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3期189-193,198,共6页Journal of Toxicology

摘　　要：科学评估中,评估过程中的不确定性的识别和评估是影响交叉参照置信度和接受度的重要因素。不确定性的可接受程度在不同的应用目的和领域并不一致。交叉参照作为填充毒性数据缺口的重要方法,在监管机构和工业界中越来越受到关注。不同的监管机构和学术界在交叉参照方法不确定性的评估方面都有一些探索。本文综合介绍了相关的研究进展,包括不确定性的来源(监管目的,数据质量,相似性的评估和论证过程)、类型以及如何综合、系统的评估不确定性的方法。如针对评估每种不确定性,提出了一系列问题,来帮助具体识别和评估每种不确定性。这些信息可以用来帮助制定评估不确定性的指南,促进交叉参照这一方法取得进一步发展和应用。The identification and evaluation of uncertainty is an important factor that affects the acceptance of read-across.As an alternative assessment method for evaluating the toxicity potentials of chemical substances,read-across has attracted more and more attentions of the regulatory and industry.The acceptable levels of uncertainty are different under different regulatory context.Various regulatory agencies and academia have explored the assessment of uncertainty.This article reviews the recent progress,including the sources of uncertainty(the regulatory use,the data quality,similarity justification and the read-across argumentation),types,and approaches for comprehensive and systematic evaluation of uncertainty.A series of questions are proposed for identifying and evaluating each type of uncertainty.This information can be used to help developing guidelines for assessing uncertainty,and to promote further progress and application of read-across.

关 键 词：交叉参照 不确定性分析 RAAF 证据权重 

分 类 号：R114[医药卫生—卫生毒理学]