English: PART V. REQUIREMENTS FOR HUMAN SAFETY--------------------------------------------------------------3 9.1 LABORATORY ANIMAL TOXICITY STUDIES -------------------------------------------------------------------------------3 9.1.1 Comprehensive Summary ---------------------------------------------------------------------------------------------3 9.1.2 Sectional Reports-------------------------------------------------------------------------------------------------------3 9.1.2.1 Subchronic Oral Toxicity Studies---------------------------------------------------------------------------------------------- 3 9.1.2.2 Chronic Toxicity Studies-------------------------------------------------------------------------------------------------------- 3 9.1.2.3 Carcinogenicity Studies --------------------------------------------------------------------------------------------------------- 3 9.1.2.4 Combined Chronic Toxicity and Carcinogenicity Studies ----------------------------------------------------------------- 3 9.1.2.5 Multigeneration Reproductive Studies ---------------------------------------------------------------------------------------- 3 9.1.2.6 Teratogenicity Testing----------------------------------------------------------------------------------------------------------- 3 9.1.2.7 Short-term Tests for Genetic Toxicity Studies ------------------------------------------------------------------------------- 3 9.1.2.8 Pharmacological Studies -------------------------------------------------------------------------------------------------------- 3 9.1.2.9 Immunotoxicity Studies --------------------------------------------------------------------------------------------------------- 3 9.1.2.10 Neurotoxicity Studies ---------------------------------------------------------------------------------------------------------- 3 9.1.2.11 Hormonal Studies in Primates ------------------------------------------------------------------------------------------------ 3 9.1.2.12 Observations in Humans------------------------------------------------------------------------------------------------------- 3 9.1.2.13 Other Studies -------------------------------------------------------------------------------------------------------------------- 3
French: PARTIE V. EXIGENCES RELATIVES À L’INNOCUITÉ HUMAINE -------------------------------------- 96 9.1 ÉTUDES DE TOXICITÉ SUR DES ANIMAUX DE LABORATOIRE ----------------------------------------------------------- 96 9.1.1 Sommaire détaillé ---------------------------------------------------------------------------------------------------- 96 9.1.2 Rapports de section -------------------------------------------------------------------------------------------------- 97 9.1.2.1 Études de toxicité orale subchronique--------------------------------------------------------------------------------------- 97 9.1.2.2 Études de toxicité chronique-------------------------------------------------------------------------------------------------- 98 9.1.2.3 Études de cancérogénicité ---------------------------------------------------------------------------------------------------- 99 9.1.2.4 Études combinées de toxicité chronique et de cancérogénicité --------------------------------------------------------- 100 9.1.2.5 Études de reproduction sur plusieurs générations ------------------------------------------------------------------------ 101 9.1.2.6 Test de tératogénicité --------------------------------------------------------------------------------------------------------- 101 9.1.2.7 Études à court terme menées dans le cadre d’études de toxicité génétique ------------------------------------------- 102 9.1.2.8 Études pharmacologiques ---------------------------------------------------------------------------------------------------- 103 9.1.2.9 Études d’immunotoxicité ---------------------------------------------------------------------------------------------------- 103 9.1.2.10 Études de neurotoxicité ----------------------------------------------------------------------------------------------------- 103 9.1.2.11 Études hormonales chez les primates ------------------------------------------------------------------------------------- 103 9.1.2.12 Observations chez les humains -------------------------------------------------------------------------------------------- 104 9.1.2.13 Autres études ----------------------------------------------------------------------------------------------------------------- 104