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EC number: 608-209-4
CAS number: 284461-73-0
is the tosylate salt of BAY 43-9006 (sorafenib), which is used as an
scope of a carcinogenicity study the systemic toxicity of BAY 54-9085
was investigated after oral treatment over 2 years (OECD TG 451). For
this purpose BAY 54-9085 was administered orally dose-adjusted via diet
to 50 male and 50 female Wistar rats per main dose group in daily doses
of 0, 0.1, 0.3 or 1.0 mg/kg bw for a period of up to 747 days. Dose
selection was based on MTD criteria in a 13-week dose finding study.
treatment with BAY 54-9085 was well tolerated as e.g. no relevant
treatment-related clinical findings, effects on body weight development
or on parameters of clinical pathology were observed.
histopathology, in the abdominal organs such as stomach, spleen,
pancreas and mesentery lymph nodes, age-related vascular changes
arteritis/periarteritis and vasculopathy occurred at an increased
incidence in both sexes at a dose of 1.0 mg/kg bw /day. Furthermore, in
the teeth, fracture/dysplasia was slightly more frequent in males at the
dose of 1.0 mg/kg bw /day. Dental findings are likely of no relevance in
humans since permanent growth of teeth is lacking.
the conditions described the no observed adverse effect level (NOAEL)
for oral administration
of BAY 54-9085 via the diet was 0.3 mg/kg bw /day in male and female rats
with regard to systemic toxicity.
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