OECD 452/OCSPP 870.4100: Chronic toxicity studies

OECD 452/OCSPP 870.4100: Chronic Toxicity studies provide guidance to establish the chronic effects of a test substance over 12 months of dose-response observations. Testing should be performed with two mammalian species – usually 40 rats and eight dogs – with at least three dose levels plus the control group, depending on the limit test result. Administration routes (oral, dermal or inhalation) depend on the toxicokinetic profile/physical characteristics of the test substance. Daily or weekly (more thorough) observation reports include animal weight, skin/fur evaluation and respiratory patterns. Blood counts, urinalysis, ophthalmological examinations, gross necropsy and histopathology are also performed.