Registration Dossier
Registration Dossier
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EC number: 692-722-3 | CAS number: 835621-07-3
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
After repeated daily oral treatment of animals with BAY 73-4506 (dogs up to 12 months, rats up to 6 months, mice up to 5 weeks), adverse effects were observed in multiple organs (kidneys, liver, reproductive organs, heart, skin, bones, teeth, digestive organs as well as organs of hematopoietic/lymphoreticular and endocrine system) - consistent with degenerative processes in cells/tissues as a consequence of the (exaggerated) pharmacological activity of BAY 73-4506. Compared to dogs, rats and mice appear to be more sensitive regarding effects particularly on kidneys, gastrointestinal tract and teeth, but less sensitive regarding effects particularly on skin and liver. The severity and extent of adverse effects in the repeat-dose studies were dependent on dose and duration of exposure. Full reversibility or a tendency for recovery within a 4 week off-drug period was observed by laboratory analysis or histopathology for most changes noted at the end of the 4-week treatment period in dogs and the 13-week treatment period in rats.
Since no repeated dose toxicity data are available for BAY 73-4506 HCl, and based on the observed adverse effects after repeated oral administration of BAY 73-4506 the aboved mentioned data were used for the classification of BAY 73-4506 HCl. Due to the high structure similarity of the two compounds an identical toxicity profile of BAY 73-4506 and BAY 73-4506 HCl is to be expected. BAY 73-4506 is approved as an oral anticancer drug under the tradename Stivarga®.
Justification for classification or non-classification
Based on the classification of BAY 73-4506 a self classification of BAY 73-4506 HCl according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is recommended as follows:
DSD: R48/25 (Toxic: danger of serious damage to health by prolonged exposure if swallowed)
GHS: STOT Rep. Exp. 1 (H372: Causes damage to organs if swallowed)
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