Standardized carcinogenicity tests
Action of chemical substances on organs: carcinogenesis

The objective of a long-term carcinogenicity study is to observe test animals throughout most of their lifetime to monitor the possible development of neoplastic lesions during or after exposure to various doses of a test substance via an appropriate route of administration.

This guideline mainly concerns tests on rats and mice, and oral administration. Both sexes are used.

Each dose group and control group contains at least 50 animals of each sex. At least three dose levels and one control are used.

The test substance is administered daily by oral (dermal or inhalation) route, and the mode of exposure is adjusted according to the toxicokinetic profile of the test substance.

The duration of the study...