English: REQUIREMENTS FOR ANIMAL SAFETY -----------------------------------------------------------3 7.1 LABORATORY ANIMAL STUDIES -------------------------------------------------------------------------------------------3 7.1.1 Comprehensive Summary ---------------------------------------------------------------------------------------------3 7.1.2 Sectional Reports-------------------------------------------------------------------------------------------------------3 7.1.2.1 Acute Toxicity Studies ---------------------------------------------------------------------------------------------------------- 3 7.1.2.2 Subchronic Toxicity Studies---------------------------------------------------------------------------------------------------- 3 7.1.2.3 Chronic Toxicity Studies-------------------------------------------------------------------------------------------------------- 3 7.1.2.4 Irritation Studies------------------------------------------------------------------------------------------------------------------ 3 7.1.2.4.1 Dermal Sensitization Studies --------------------------------------------------------------------------------------------- 3 7.1.2.4.2 Primary Skin/Dermal Irritation Studies --------------------------------------------------------------------------------- 3 7.1.2.4.3 Primary Ocular Irritation Studies----------------------------------------------------------------------------------------- 3 7.1.2.4.4 Tissue Irritation Studies --------------------------------------------------------------------------------------------------- 3 7.1.2.5 Reproduction and Teratogenicity Studies ------------------------------------------------------------------------------------ 3 7.1.2.5.1 Reproductive Function Studies ------------------------------------------------------------------------------------------- 3 7.1.2.5.2 Teratogenicity Studies ----------------------------------------------------------------------------------------------------- 3 7.1.2.6 Other Studies --------------------------------------------------------------------------------------------------------------------- 3
French: EXIGENCES RELATIVES L’INNOCUITÉ ANIMALE -------------------------------------- 80 7.1 ÉTUDES SUR DES ANIMAUX DE LABORATOIRE -------------------------------------------------------------------------- 80 7.1.1 Sommaire détaillé ---------------------------------------------------------------------------------------------------- 80 7.1.2 Rapports de section -------------------------------------------------------------------------------------------------- 80 7.1.2.1 Études de toxicité aiguë ------------------------------------------------------------------------------------------------------- 80 7.1.2.2 Études de toxicité subchronique --------------------------------------------------------------------------------------------- 81 7.1.2.3 Études de toxicité chronique-------------------------------------------------------------------------------------------------- 81 7.1.2.4 Études d’irritation -------------------------------------------------------------------------------------------------------------- 81 7.1.2.4.1 Études de sensibilisation cutanée (dermique) primaire-------------------------------------------------------------- 82 7.1.2.4.2 Études d’irritation cutanée primaire ----------------------------------------------------------------------------------- 82 7.1.2.4.3 Études d’irritation oculaire primaire ----------------------------------------------------------------------------------- 82 7.1.2.4.4 Études d’irritation des tissus -------------------------------------------------------------------------------------------- 83 7.1.2.5 Étude de reproduction et de tératogénicité---------------------------------------------------------------------------------- 83 7.1.2.5.1 Études des fonctions de reproduction---------------------------------------------------------------------------------- 83 7.1.2.5.2 Études de tératogénicité ------------------------------------------------------------------------------------------------- 84 7.1.2.6 Autres études ------------------------------------------------------------------------------------------------------------------- 84