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EC number: 202-992-2
CAS number: 101-96-2
1. The oral toxicity of Kerobit BPD was examined in a 28-day oral
toxicity study. The test substance was dissolved in a HCl solution and
further diluted in demineralized water. The Kerobit BPD solutions were
administered daily by gavage to groups of 5 male and 5 female rats for
28 consecutive days at dose levels of 0 (control), 3, 10 and 30 mg/kg
2. One male of the mid-dose group died on day 24 of the study, probably
due to a dosing error and/or regurgitation and aspiration of the dosing
solution. The death of this animal was not ascribed to any toxicity of
the test substance. An increased incidence of focal alopecic areas was
observed in females of the top-dose group. Otherwise, there were no
relevant differences in appearance or behaviour between the treated rats
and the controls.
3. Body weights and food and water intake were not significantly
affected by the treatment.
4. The total number of white blood cells was increased in females of the
low and top-dose group, which was mainly due to an increase in
lymphocytes. This effect was not dose-related.
5. Clinical chemistry showed increased glucose and albumine levels in
the plasma of females in the mid- and top-dose groups. Plasma
gamma-glutamyltransferase (GGT) activity and concentrations of the total
protein, bilirubin, cholesterol and calcium were significantly increased
in females of the top-dose group.
6. At the end of the treatment the absolute and relative weight of the
liver were increased in the top-dose group of both sexes. In addition,
the relative weight of the kidney was increased in females in the top
7. There were no treatment-related gross abnormalities. Upon microscopy,
hepatocellular alterations in the periportal area of the liver (ground
glass cytoplasm) was observed in the mid- and top-dose rats in both
sexes. The incidence and severity of these alterations was
8. Because no treatment-related changes were observed at the low-dose
level, the no-toxic effect level of Kerobit BPD in this study was 3
mg/kg body weight / day.
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