Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 207-096-5 | CAS number: 434-03-7
- 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
Oral (Rat, GLP): LD50 > 2000 mg/kg
[Bayer Schering Pharma AG, Report No. A49530, 2010-06-08]
Dermal (Rat, GLP): LD50 > 2000 mg/kg
[Bayer Schering Pharma AG, Report No. A49584, 2010-06-17]
Key value for chemical safety assessment
Additional information
The single oral administration of ethisterone (ZK 5957) to male and female rats at a dose of 2000 mg/kg was tolerated without any compound-related clinical or macroscopical pathological signs. The acute oral toxicity of ethisterone in rats is > 2000 mg/kg body weight. (Bayer Schering Pharma AG, Report No. A49530, 2010-06-08 )
The single dermal administration of ethisterone to male and female rats in the doses of 2000 mg/kg resulted in hair loss in 1/3 female rat. No other compound-related clinical or macroscopic pathological signs were observed. LD50 > 2000 mg/kg (Bayer Schering Pharma AG, Report No. A49584, 2010-06-17)
Justification for classification or non-classification
Due to the results (LD50 > 2000 mg/kg) in the dermal and oral acute toxicity tests classification according to Directive 67/548/EEC and Regulation 1272/2008/EC is not required.
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