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EC number: 246-562-2
CAS number: 25013-15-4
study was conducted to determine the repeated dose oral toxicity of the
test substance when administered to rats daily for 13 weeks. Male and
female Fisher rats (15/sex/group) received the substance by oral gavage
at dose levels of 0, 50, 100, 300, 700 and 1500 mg/kg bw/day, in olive
oil. One group of 15/sex served as the control and received only the
vehicle, in volumes comparable to those received by treated groups.
Animals were observed daily, body weight and food consumption were
measured weekly. Clinical pathology investigations (haematology,
clinical chemistry and urinalysis) were conducted prior to termination
in Week 13. All animals were subject to a full necropsy and
histopathological examination of a comprehensive range of tissues.
Following mortalities were recorded during the course of the study: one
male in dose group 300 mg/kg bw/day, one male in dose group 700 mg/kg
bw/day, two females in dose group 700 mg/kg bw/day, nine females in dose
group 1500 mg/kg bw/day. The survival rate of the 1500 mg/kg bw/day dose
group males and females was significantly lower than that of the
respective control group. Gross pathology findings of lung
(hypersecretion of mucous) and stomach alterations were the most notable
observations in this dose group. The lung was identified as a target
organ and there was no NOEL for the exacerbation of multifocal chronic
pneumonitis and focal hyperplasia of bronchial and bronchiolar
epithelium, which as observed in all treated groups at a greater
severity than in the controls. Comparison of the hematology data between
the control and treated groups revealed significantly higher than
control value in the mean hematocrit value in the highest dose group
males and females and in the mean erythrocyte count in the highest dose
group in females. Male body weight was lower than control in all treated
groups, there was no similar effect in females. Liver weight was
increased at 300 mg/kg bw/day and greater and kidney weight at 700 mg/kg
bw/day and greater. No treatment–related effects were noted in
comparison of the urinalysis. Under the study conditions, no NOAEL was
identified. The LOAEL was considered to be 50 mg/kg bw/day, the lowest
dose tested (Wolfe, 1980).
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