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Diss Factsheets
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EC number: 692-722-3 | CAS number: 835621-07-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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)
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.
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