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化学物质致癌性测试简化方案评估:美国环境保护局/美国国立环境卫生科学研究所联合研讨会报告

Evaluation of reduced protocols for carcinogenicity testing of chemicals: report of a joint EPA/NIEHS workshop.

作者信息

Lai D Y, Baetcke K P, Vu V T, Cotruvo J A, Eustis S L

机构信息

Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency, Washington, DC 20460.

出版信息

Regul Toxicol Pharmacol. 1994 Apr;19(2):183-201. doi: 10.1006/rtph.1994.1017.

DOI:10.1006/rtph.1994.1017
PMID:8041916
Abstract

The current U.S. Environmental Protection Agency (EPA) and other national/international guidelines specify the use of two species and two sexes rodents (usually the rat and the mouse) for carcinogenicity testing of chemicals. In view of the enormous number of chemicals to be tested, the high cost of testing, and the large number of animals used in the present protocol, many academic, industrial, and government authorities are examining the possibility of using a reduced protocol (less than two species and two sexes of rodents) for carcinogenicity testing of chemicals. The use of a reduced protocol offers many advantages as well as some disadvantages. To pursue further the potential implications and impacts of using a reduced protocol for carcinogenicity testing on the processes of hazard identification and risk assessment, a workshop entitled "Evaluation of Reduced Protocols for Carcinogenicity Testing of Chemicals" was held at the Embassy Suites Hotel in Alexandria, Virginia on September 22 and 23, 1992. It was cosponsored by EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS) and the National Toxicology Program of the National Institutes of Environmental Health Sciences (NTP/NIEHS) and attended by more than 60 participants from government, industry, academia, and the general public. The Expert Consensus Panel and most of the participants supported the use of reduced protocols in carcinogenicity testing. However, it was recognized that reduced protocols may not be appropriate for the testing of all chemicals and that additional analyses/data may be needed for selection of the most appropriate reduced protocol for certain chemicals/chemical classes.

摘要

美国环境保护局(EPA)现行以及其他国家/国际指南规定,在化学品致癌性测试中使用两种物种、两种性别的啮齿动物(通常是大鼠和小鼠)。鉴于待测试的化学品数量庞大、测试成本高昂以及当前方案中使用的动物数量众多,许多学术机构、企业和政府部门正在研究采用简化方案(少于两种物种、两种性别的啮齿动物)进行化学品致癌性测试的可能性。采用简化方案有诸多优点,但也存在一些缺点。为进一步探讨使用简化方案进行致癌性测试对危害识别和风险评估过程的潜在影响,1992年9月22日和23日在弗吉尼亚州亚历山大市的 Embassy Suites 酒店举办了一场题为“化学品致癌性测试简化方案评估”的研讨会。该研讨会由EPA的预防、农药和有毒物质办公室(OPPTS)以及国立环境卫生科学研究所(NTP/NIEHS)的国家毒理学计划共同主办,来自政府、企业、学术界和公众的60多名参与者出席了会议。专家共识小组和大多数参与者支持在致癌性测试中使用简化方案。然而,人们认识到简化方案可能并不适用于所有化学品的测试,对于某些化学品/化学类别,可能需要进行额外的分析/数据来选择最合适的简化方案。

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