Repeated Dose Toxicity on Material Containing 23% Notified Chemical (Thomford, 1996) rat/Cr1: CD(SD)BR Species/strain: 5/sex/group Number/sex of animals: oral (gavage) Method of administration: 0, 6.9, 69 or 460 mg/kg/day for 4 weeks (vehicle: duration:: water) all animals survived, excessive salivation was Clinical observations: immediately after dosing for all high dose animals, from day 13 and continuing throughout treatment slight to moderate increase in AST and ALT in high Clinical chemistry/Haematology dose rats, slight increase in absolute neutrophil count in high dose males, and slight decrease in glucose and total protein and moderate increase in inorganic phosphorus in high dose females; these changes could not be correlated with histopathology no histopathological changes were associated Histopathology: with the test substance; an increase of adrenal gland weight in high dose males could not be related to pathological changes similar to OECD TG 407 (Organisation for Test method: Economic Co-operation and Development, 1995- 1996) Based on the slight increase in adrenal weights Result: and slight changes in clinical chemistry parameters at the high dose, the no observable effect level (NOEL) for the test material (23% notified chemical) is 69 mg/kg/day
Repeated Dose Toxicity on Material Containing 23% Notified Chemical (Thomford, 1996) Species/strain: rat/Cr1: CD(SD)BR Number/sex of animals: 5/sex/group Method of administration: oral (gavage) duration:: 0, 6.9, 69 or 460 mg/kg/day for 4 weeks (vehicle: water) Clinical observations: all animals survived, excessive salivation was immediately after dosing for all high dose animals, from day 13 and continuing throughout treatment Clinical chemistry/Haematology slight to moderate increase in AST and ALT in high dose rats, slight increase in absolute neutrophil count in high dose males, and slight decrease in glucose and total protein and moderate increase in inorganic phosphorus in high dose females; these changes could not be correlated with histopathology Histopathology: no histopathological changes were associated with the test substance; an increase of adrenal gland weight in high dose males could not be related to pathological changes Test method: similar to OECD TG 407 (Organisation for Economic Co-operation and Development, 1995- 1996) Result: Based on the slight increase in adrenal weights and slight changes in clinical chemistry parameters at the high dose, the no observable effect level (NOEL) for the test material (23% notified chemical) is 69 mg/kg/day
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