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EC number: 206-596-0
CAS number: 355-93-1
substance in the vehicle, corn oil, was administered orally by gavage
once daily for 7 consecutive days to 3 groups (Groups 2-3) of rats.
Dosage levels were 100, 300 and 1000 mg/kg/day. A concurrent control
group (Group 1) received the vehicle on a comparable regimen. The dose
volume was 5 mL/kg for all groups. Each group (Groups 1-4) consisted of
5 animals/sex. Following 7 days of dose administration, all rats were
were observed twice daily for mortality and moribundity. Clinical
examinations were performed daily at the time of dosing and
approximately 1 and 4 hours post-dosing, and detailed physical
examinations were performed weekly. Individual body weight and food
consumption were recorded on study days 0 and 7. All carcasses were
discarded following examination and collection of gross lesions.
survived to the scheduled necropsy. There were no test article-related
effects on food consumption and there were no significant macroscopic
findings. There were no significant clinical observations in the 100 and
300 mg/kg/day groups.
article-related clinical observations noted in the 1000 mg/kg/day group
as early as study day 0 and throughout the 7-day dosing period included
impaired muscle coordination and/or impaired equilibrium in males and
females; hypoactivity, decreased respiration rate, and prostration were
also noted in females on study day 0. These effects did not persist to
the 4-hour post-dose observation on study days 0-6 for males and study
days 4-6 for females. These clinical observations were considered
adverse, especially since they persisted throughout the 7-day dosing
period at approximately 1-hour post-dosing.
article-related effect on body weight included a trend towards slightly
lower body weight gains noted in all test article-treated groups
compared to the control group. However, the changes in body weights were
not of a magnitude to be considered adverse.
on the results of this study, adverse toxicity of the test substance
administered orally (gavage) to rats for 7 consecutive days was observed
at 1000 mg/kg/day as evidenced by clinical observations noted following
dosing throughout the 7-day dosing period. The test article was well
tolerated in male and female rats at 100 and 300 mg/kg/day.
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