Registration Dossier
Registration Dossier
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EC number: 250-882-8 | CAS number: 31981-44-9
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
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:
- no
Test material
- Reference substance name:
- Gestonorone caproate
- EC Number:
- 215-010-2
- EC Name:
- Gestonorone caproate
- Cas Number:
- 1253-28-7
- Molecular formula:
- C26H38O4
- IUPAC Name:
- 17-acetyl-3-oxoestr-4-en-17-yl hexanoate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- not specified
- Doses:
- 4000 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 000 mg/kg bw
Any other information on results incl. tables
Transient clinical signs (apathy) immediately after administration.
All animals were without compound-related clinical signs from Day 2 onwards.
Applicant's summary and conclusion
- Executive summary:
No acute toxicity studies were conducted with ZK 5624 (gestonorone acetate). Results of studies conducted with a different ester of gestonorone (gestonorone caproate, ZK 5623) are regarded as representative as most likely ester cleavage occurs in vivo after administration.
The single intraperitoneal administration of a microcristalline suspension of ZK 5623 (gestonorone caproate) to male mice at a dose of 4000 mg/kg caused transient clinical signs (apathy) immediately after administration. All animals were without compound-related clinical signs from Day 2 onwards. No compound-related macroscopic pathological signs were observed. The acute i.p. toxicity of ZK 5623 in male mice is above 4000 mg/kg body weight.
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