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急性毒性分级法(口服)的生物统计学评估

The biometric evaluation of the acute-toxic-class method (oral).

作者信息

Diener W, Siccha L, Mischke U, Kayser D, Schlede E

机构信息

Abteilung Chemikalienbewertung, Max von Pettenkofer-Institut, Berlin, Germany.

出版信息

Arch Toxicol. 1994;68(10):599-610. doi: 10.1007/BF03208339.

Abstract

The acute toxic class method (ATC method) is an alternative to the LD50 test, with the use of substantially fewer animals needed for the classification of substances. Like the classical LD50 test the biometry of the ATC method is based on the probit model. The biometric calculations of the ATC method were carried out not only for the classification categories of the European Union but also for the classification criteria of various countries and organizations, currently in use. It is demonstrated that in comparison with the LD50 test in general the same classification is obtained with the ATC method and with the use of substantially fewer animals. Substances with high slopes are likely to be allocated to the predicted toxicity class in comparison with substances having low slopes, with both the ATC method and the LD50 test. Substances are more likely to be allocated into a lower toxicity class with the LD50 test than with the ATC method.

摘要

急性毒性分级法(ATC法)是半数致死剂量(LD50)测试的一种替代方法,在物质分类时所需动物数量大幅减少。与经典的LD50测试一样,ATC法的生物统计学基于概率模型。ATC法的生物统计学计算不仅针对欧盟的分类类别,还针对当前使用的各国及各组织的分类标准。结果表明,总体而言,与LD50测试相比,使用ATC法能得出相同的分类结果,且所需动物数量大幅减少。与斜率低的物质相比,无论是采用ATC法还是LD50测试,斜率高的物质都更有可能被归入预测毒性等级。与ATC法相比,采用LD50测试时物质更有可能被归入较低的毒性等级。

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