Kenya total requirements 肯尼亚农药登记.doc

Kindly ensure that your registration dossier is fully accompanied by the following: Five batch analysis of the active ingredient. Certificate of full registration from the ministry of agriculture China All acute toxicity GLP STANDARD studies of the active ingredient as listed below: 3.1 ADI 3.2 Acute oral LD50 mg/kg rat/rabbit 3.3 Acute dermal LD50 mg/kg (rat) 3.4 Inhalation LC50 mg/l hour (rat) 3.5 Skin irritation (rabbit) 3.6 Eye irritation (rabbit) 3.7 Skin sensitisation (guinea pig) 3.8 Reproduction (specify species) Subchronic toxicity 90 day NOEL mg/kg/day 3.10 Chronic toxicity NOEL mg./kg/day 3.11 Carcinogenicity (life time) NOEL mg/kg/day 3.12 Neurotoxicity NOEL mg/kg/day 3.13 Teratogenicity NOEL mg/kg/day 3.14 Mutagenicity /Genotoxicity 3.15 Metabolism (rat) 3.16 Other studies Ecotoxicity GLP STANDARD studies of the active ingredient on the following: 4.1 Birds (2 species) LD50 mg/kg NOEL LD50 mg/kg NOEL Reproduction 4.2 Fish (2 species) LD50 mg/kg NOEL LD50 mg/kg NOEL Reproduction BCF 4.3 Daphnia LC50 mg/l NOEL 4.4 Algae LC50 mg/l NOEL 4.5 Bees LD50 (g/bee NOEL 4.6 Earthworms LC50 mg/kg 4.7 Soil micro-organisms Acute toxicity GLP STANDARD studies of the formulated product as listed below: 5.1 Rat Acute oral LD50 mg/kg 5.2 Acute dermal LD50 mg/kg 5.3 Inhalation LD50 mg/l /hour 5.4 Rabbit Skin irritation 5.5 Eye irritation 5.6 Sensitisation in guinea pig 5.7 WHO classification 5.8 Other studies Physical and chemical properties of the active ingredient as listed below: 6.1 Physical state 6.2 Colour 6.3 Odour 6.4 Density at 20oC 6.5 Vapour pressure at 20/25oC 6.6 Volatility 6.7 Hydrolysis DT50 ….. Days …… 0C …… pH 6.8 Photolysis 6.9 Solubility in water ………….0C ……….. pH 6.10 Solubility in organic solvents 6.11 n-octanol/water partition coefficient 6.12 Boiling point 0C 6.13 Melting point 0C 6.1