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Identifiers

Overton ID
oecddiscovery-4eb05e142b89c65ae35a6e5fd67983b1
doi
10.1787/9789264071223-en

Test No. 453: Combined Chronic Toxicity/Carcinogenicity Studies

Flag for IGO OECD on June 27th 2018
The objective of a combined chronic toxicity/carcinogenicity study is to identify carcinogenic and the majority of chronic effects, and to determine dose-response relationships following prolonged and repeated exposure. The rat is typically used for this study. For rodents, each dose group and concurrent control group intended for the carcinogenicity phase of the study should contain at least 50 animals of each sex, while for the chronic toxicity phase of the study should contain at least 10 animals of each sex. At least three dose levels should be used, in addition to the concurrent control group for both the chronic toxicity phase and the carcinogenicity phase of the study. The three main routes of administration are oral, dermal, and inhalation. The Test Guideline focuses on the oral route of administration. The period of dosing and duration of the study is normally 12 months for the chronic phase, and 24 months for the carcinogenicity phase. The study report should include: measurements (weighing) and ...

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Citations

Cited by 46 other policy documents (44 of them are from other policy sources)