Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 608-209-4 | CAS number: 284461-73-0
BAY 54-9085 is the tosylate salt of BAY 43-9006 (sorafenib), which is used as an anti-cancer drug.
Within the 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.
The 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.
At 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.
Thus, under 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again