Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents (OECD TG 409)

TG 409 is an OECD validated test providing information on health hazard likely to arise from short-term exposure to test chemical. The determination of sub-chronic oral toxicity using repeated doses may be carried out after initial information on toxicity has been obtained from acute or repeated dose 28-day toxicity tests. The method is based on the repeated oral administration of the chemical of interest over a prolonged period (one dose level daily during 90 days). This Test Guideline is intended primarily for use with non-rodents species. The commonly used non-rodent species is the dog (the beagle is frequently used). At least 8 animals (4 female and 4 male) should be used for each test group. At least three concentrations of test chemical should be used. The test chemical is administered in the diet or in the drinking water, by gavage or in capsules. A limit test may be performed if no effects would be expected at a dose of 1000 mg/kg bw/d. The results of this study include: measurements (body weight measured at least once a week, food/water consumption) and daily (preferably at the same time) and detailed observations (ophtalmological examination, haematology, clinical biochemistry and urinalysis), as well as gross necropsy and histopathology.