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EC number: 429-280-6
CAS number: 151900-44-6
Clinical observations: No mortality occurred during the study period.
There were no changes in clinical appearance, functional observations,
body weights, and food consumption
The functional observations showed no signs or symptoms indicating
evidence for systemic toxic and neurotoxic potential. Grip strength and
motor activity measurements exhibited no treatment-related changes in
both sexes at doses of 1000 mg/kg bw/d and below.
Laboratory findings: There were no biological significant effects of
treatment on hematological and biochemical parameters. For a small
number of parameters the differences between control and test groups
attained a degree of statistical significance. However, the differences
were small, not dose-related and inconsistent between the sexes.
Effects in organs: There were no treatment-related findings in organ
weights, gross or microscopic pathology in rats of both sexes given 1000
mg/kg bw/d and below. Histopathological changes seen were of a minor
nature and at a similar level to those seen in the controls.
In a subacute toxicity study the test substance Vulcuren Trial Product
KA 9188 was administered orally via gavage to male and female Wistar
rats at target concentrations of 0, 40, 200 and 1000 mg/kg body weight
for about 4 weeks. In parallel male and female rats (5 per sex and
group) were treated with 0 and 1000 mg/kg body weight. These rats were
observed for reversibility, continuance or delay occurrence of toxic
effects during a recovery period of about 2 weeks. No differences
regarding the survival rat or general behaviour were noted compared to
the untreated animals. In addition, no relevant differences were
observed in mean feed intake and weight gain in any of the treatment
groups evaluated compared to the negative control. No neuronal behavior
effects were noted in any of the treatment groups. There were no
toxicologically relevant changes in haematology and clinical chemistry
in animals treated with the test compound. No biologically relevant
effects on the organ weights were found in any of the rats treated with
the test substance compared to the control animals. In addition, there
was no evidence of any gross pathological and histopathological findings
associated to dosing with the test compound up to the highest dose group
(1000 mg/kg body weight) in both genders. The author concluded that the
administration of Vulcuren Trial Product KA 9188 to male and female
Wistar rats for about 4 weeks was tolerated without adverse effects up
to and including 1000 mg/kg. No delayed occurrence of toxic effects was
observed during a recovery period of about 2 weeks (Bayer AG 2000d).
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