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EC number: 223-768-0 | CAS number: 4062-46-8
- 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
There is no acute toxicity studies with ZK 5894; read-across to results of studies with mesterolone (ZK 9226):
Oral (Mouse-NMRI, non-GLP): LD50 > 4000 mg/kg
[Schering AG, report dated 1968-01-10]
Subcutaneous (Mouse-NMRI, non-GLP): LD50 > 4000 mg/kg
[Schering AG, report dated 1968-01-10]
Intraperitoneal (Mouse-NMRI, non-GLP): LD50 > 4000 mg/kg
[Schering AG, report dated 1968-01-10]
Oral (Rat-Wistar, non-GLP): LD50 > 5000 mg/kg (aqueous suspension)
[Schering AG, report dated 1966-03-02]
Oral (Rat-Wistar, non-GLP): LD50 > 5000 mg/kg (oily solution)
[Schering AG, report dated 1968-05-16]
Oral (Dog-Beagle, non-GLP): LD50 > 1000 mg/kg
[Schering AG, Report No. 1498; 1974-10-28]
Intravenous (Monkey-Cynomolgus, non-GLP): LD50 > 1 mg/kg
[Schering AG, Report No. 6154; 1984-07-24]
Key value for chemical safety assessment
Additional information
There is no acute toxicity studies with ZK 5894 (mesterolone acetate). Results of studies conducted with mesterolone (ZK 9226) are regarded as representative as most likely ester-cleavage occurs in vivo after administration.
The single oral administration of an aqueous microcristalline suspension of ZK 9226 to male and female mice was tolerated without any compound-related clinical or macroscopic pathological findings. The acute oral toxicity of ZK 9226 in mice is above 4000 mg/kg body weight. [Schering AG, report dated 1968-01-10]
The single subcutaneous administration of an aqueous suspension of ZK 9226 to male and female mice was tolerated without any compound-related clinical or macroscopic pathological findings. The acute subcutaneous toxicity of ZK 9226 in mice is above 4000 mg/kg body weight. [Schering AG, report dated 1968-01-10]
After single intraperitoneal administration of an aqueous suspension of ZK 9226 to male and female mice 2/5 females died on Days 1 and 2 at the dose of 4000 mg/kg. All males (5) survived the observation period. Associated clinical signs were apathy immediatetly after treatment up to Day 2. Macroscopic findings were described in individual animals at necropsy. The LD50 after intraperitoneal administration of ZK 9226 in mice is above 4000 mg/kg body weight. [Schering AG, report dated 1968-01-10]
The single oral administration of an aqueous microcristalline suspension of ZK 9226 to male and female rats was tolerated without any compound-related clinical or macroscopic pathological findings. The acute oral toxicity of ZK 9226 in mice is above 4000 mg/kg body weight. [Schering AG, report dated 1966-03-02]
The single oral administration of an oily solution of ZK 9226 to male and female rats led to mortality in 1/5 females on Day 8 at 5000 mg/kg, whereas all males (5) survived the observation period. Clinical findings in the moribund animal were cachexia and signs of local intolerance reactions in the gastrointestinal tract. The LD50 after oral administration of an oily solution of ZK 9226 to rats is above 5000 mg/kg body weight. [Schering AG, report dated 1968-05-16]
The single oral administration of ZK 9226 to male and female Beagle dogs was tolerated without any compound-related clinical findings. Acute oral toxicity of ZK 9226 is Beagle dogs is above 1000 mg/kg body weight. [Schering AG, Report No. 1498; 1974-10-28]
The single intravenous administration of ZK 9226 to male and female Cynomolgus monkeys was tolerated without any compound-related clinical findings. Acute intravenous toxicity of ZK 9226 in Cynomolgus monkeys is above 1 mg/kg body weight. [Schering AG, Report No. 6154; 1984-07-24]
Justification for classification or non-classification
Since LD50 > 2000 mg/kg after oral administration there is no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).
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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