Registration Dossier
Registration Dossier
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EC number: 207-096-5 | CAS number: 434-03-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 20. Jan to 16. Feb 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Ethisterone
- EC Number:
- 207-096-5
- EC Name:
- Ethisterone
- Cas Number:
- 434-03-7
- Molecular formula:
- C21H28O2
- IUPAC Name:
- (1R,3aS,3bR,9aR,9bS,11aS)-1-ethynyl-1-hydroxy-9a,11a-dimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
- Details on test material:
- - Name of test material (as cited in study report): ethisterone (ZK 4957)
- Analytical purity: 100.1%
- Lot/batch No.: 8115-13/08
- Expiration date of the lot/batch: 22 Oct 2011
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3/sex
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
No compound-related findings were observed with regard to clinical observations, in determination of body weight and at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 of ethisterone is > 2000 mg/kg, classification is not required
- Executive summary:
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.
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