Registration Dossier
Registration Dossier
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EC number: 250-882-8 | CAS number: 31981-44-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not applicable
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
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:
- female
- Details on test animals or test system and environmental conditions:
- weight 18 - 20 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1.2 g CMC ad 100 ml Aqua dest.
- Doses:
- 4000 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 4 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
The single oral administration of a microcristalline suspension of ZK 5623 (gestonorone caproate) to female 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. 2 of 10 animals showed miliary grey-white spots in the liver. 1 of 10 animals showed miliary grey-white spots in the cortex of the left kidney. Two mesenteric lymph nodes were increased in size.
The acute oral toxicity of ZK 5623 in mice is above 4000 mg/kg body weight.
Applicant's summary and conclusion
- Executive summary:
The single oral administration of a microcristalline suspension of ZK 5623 (gestonorone caproate) to female mice at a dose of 4000 mg/kg caused transient clinical signs (apathy) immediately after administration. The LD50 >4000 mg/kg was established after application of gestonoron caproate.
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