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EC number: 224-675-8 | CAS number: 4443-26-9
Results of repeated dose toxicity study:
number of animals examined
Salivation, fur loss
Described in table A6_4_1-1
Bilirubin in urine of 8 and 5 animals after 6 and 12 weeks of treatment, respectively
organ relative weight*
Hepatic centrilobular hypertrophy in 4/10
Hepatic centrilobular hypertrophy in 5/10
organ absolute weight
Slight hypertrophy of zona glumerulosa in 3/10
Slight hypertrophy of zona glumerulosa in 4/10
Results of clinical chemistry, haematology and urinalysis:
weeks after start of treatment
10 rats/sex/group were exposed to 0, 50, 100, 300 mg/kg/day PAC by gavage for 13-consecutive weeks. Further groups of 10 rats/sex/groups were exposed to 0 and 300 mg/kg/day PAC for 13 weeks and allowed for a recovery period of 6 weeks.
Clinical signs, mortality, body weights, food and water consumption were monitored regularly during the study. Ophtalmological examinations were performed at week 7 of treatment and at the end of the treatment and recovery periods.
Blood chemistry analysis, haematology and urinalysis, were performed at week 6 and at the end of the treatment and recovery periods.
Gross pathology and histopathology examinations were carried out at the end of the treatment period for the main groups and at the end of the recovery period for the recovery groups.
Administration of the active substance’s main degradation product for 90 consecutive days in rats induced changes in clinical chemistry and liver.
At the highest dose tested (300 mg/kg be day) several changes in chemical chemistry parameters,possibly related to altered hepatic functionality, were observed:
· Increased LDH activity in both sexes
· Increased creatinine levels in both sexes
· Increased bilirubine levels in both sexes
· Decreased total cholesterol levels in both sexes
· Increased urea levels in males
· Increased alkaline phosphatase activity in females
· Increased glucose levels in females
Increased LDH and creatinine levels were observed also at 100 mg/kg bw/day, and increased bilirubine levels were observed at 50 and 100 mg/kg bw/day.
All the measured parameters were judged to be of low severity. The increase in total bilirubine was judged as incidental by the study director, since it was not dose-related and all the individual values were considered to fall under the physiological norm.
With the exception of reduced total cholesterol values in both sexes and increased glucose levels in females, none of the differences observed in the clinical chemistry parameters during treatment were observed at the end of the recovery period.
The urinalysis showed an increased incidence of animals with positive results for bilirubin was observed in females of the high-dose group during the exposure period.
Hepatic effects were limited to a slight increase in organ weight relative to body weight observed in both sexes treated at 300 mg/kg bw/day, and to an increased incidence of centrilobular hepatic hypertrophy of low severity observed at ≥ 100 mg/kg bw/day.
No effects in liver weight and histopathology were observed at the end of the recovery period.
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