4. Standardized carcinogenesis tests

4.1 Example of OCED 451: carcinogenesis studies in rodents

The aim of a long-term carcinogenesis study is to observe test animals over most of their life span, to monitor the possible development of neoplastic lesions during or after exposure to various doses of a test substance by an appropriate route of administration.

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

Each dose 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 orally (dermally or by inhalation), and the mode of exposure is adjusted according to the toxicokinetic profile of the test substance....