Registration Dossier
Registration Dossier
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EC number: 223-768-0 | CAS number: 4062-46-8
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported pre-guidline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): 1alpha-methylandrostane-17beta-ol-3on
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- physiological saline
- Doses:
- 4000 mg/kg
- No. of animals per sex per dose:
- 5/sex
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Effect level:
- > 4 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
2/5 females died on Days 1 and 2 at 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 residues of test substance in abdominal cavity, miliar grey red foci in liver and fibrinous peritonitis in individual animals at necropsy.
Applicant's summary and conclusion
- Conclusions:
- The LD50 after intraperitoneal administration of mesterolone (ZK 9226) in mice is above 4000 mg/kg body weight.
- Executive summary:
No acute toxicity studies were conducted with mesterolone acetate. Results of studies conducted with mesterolone (ZK 9226) are regarded as representative as most likely ester-cleavage occurs in vivo after administration.
After single intraperitoneal administration of an aqueous suspension of mesterolone to male and female mice 2/5 females died on Days 1 and 2 at 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 mesterolone (ZK 9226) in mice is above 4000 mg/kg body weight.
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