Chronic / carcinogenicity studies

Study Purpose and Introduction:
The objective of this study is to obtain information on the possible health hazards likely to arise from repeated exposure of test item a 90/91-day period of time covering post-weaning maturation and growth well into adulthood. The test compound is administered by gavage or via the diet or drinking water. The study  intends to provide information on the major toxic effects, indicate target organs and the possibility of accumulation and an estimate of a no-observed-adverse-effect level (NOAEL) of exposure. Alternatively, this study yields dose related response data that may be used to estimate point of departure for hazard assessment using appropriate modelling methods (e.g., benchmark dose analysis).

Guidelines and literature:
OECD Guidelines for the Testing of Chemicals, Section 4, No. 408, “Repeated Dose 90-Day Oral Toxicity Study in Rodents” (link: https://www.oecd-ilibrary.org/environment/test-no-408-repeated-dose-90-day-oral-toxicity-study-in-rodents_9789264070707-en)

Study Purpose and Introduction:
The objective of this study is to obtain information on the possible health hazards likely to arise from repeated exposure of test item a 90/91-day period of time covering post-weaning maturation and growth well into adulthood. The test compound is administered by gavage or via the diet or drinking water. The study  intends to provide information on the major toxic effects, indicate target organs and the possibility of accumulation and an estimate of a no-observed-adverse-effect level (NOAEL) of exposure. Alternatively, this study yields dose related response data that may be used to estimate point of departure for hazard assessment using appropriate modelling methods (e.g., benchmark dose analysis).

Guidelines and literature:
OECD Guidelines for the Testing of Chemicals, Section 4, No. 408, “Repeated Dose 90-Day Oral Toxicity Study in Rodents” (link: https://www.oecd-ilibrary.org/environment/test-no-408-repeated-dose-90-day-oral-toxicity-study-in-rodents_9789264070707-en)

Study Purpose and Introduction:
This method provides information on health hazard likely to arise from short-term exposure to test substance. The method is based on the repeated oral administration of the substance of interest over a prolonged period (one dose level daily during 90 days). The commonly used non-rodent species is the dog. The test compound is administered in the diet or in the drinking water, by gavage or in capsules. A properly conducted 90-day subchronic test should provide a satisfactory estimation of a no-effect level.

Guidelines and literature:
OECD Guidelines for the Testing of Chemicals, Section 4, No. 409, “Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents” (link: https://www.oecd-ilibrary.org/environment/test-no-409-repeated-dose-90-day-oral-toxicity-study-in-non-rodents_9789264070721-en)

Study Purpose and Introduction:
This study relates to the analysis, via dermal application, of the health hazards of solid or liquid test substance. It may be carried out after initial information obtained by acute testing. The commonly used rodent species are the adult rat, rabbit or guinea pig. A properly conducted subchronic test should provide a satisfactory estimation of a non effect level.

Guidelines and literature:
OECD Guidelines for the Testing of Chemicals, Section 4, No. 411, “Subchronic Dermal Toxicity: 90-day Study” (link: https://www.oecd-ilibrary.org/environment/test-no-411-subchronic-dermal-toxicity-90-day-study_9789264070769-en)