Test No. 411 : Subchronic Dermal Toxicity

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. This method is composed of the main test and the limit test. This Test Guideline is intended for use with the adult rat, rabbit or guinea pig. At least 20 animals (10 female and 10 male) with healthy skin should be used at each dose level (at least three). The highest dose level should result in toxic effects but not produce an incidence of fatalities. The limit test corresponds to one dose level of at least 1000 mg/kg body weight. The method is based on the repeated application of the substance of interest during one limited period (several hours daily during 90 days). The test substance should be applied over not less than 10 per cent of the body surface area. The results of this study include: measurements and daily and detailed observations (ophthalmological examination, haematology, clinical biochemistry and urinalysis), as well as gross necropsy and histopathology. A properly conducted subchronic test should provide a satisfactory estimation of a non effect level.