Registration Dossier
Registration Dossier
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EC number: 601-431-2 | CAS number: 1164-92-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 01. to 21. Jul 1997
- 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:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 17 beta-Acetoxy-5 alpha-androstan-3-one
- EC Number:
- 601-431-2
- Cas Number:
- 1164-92-7
- Molecular formula:
- C21 H32 O3
- IUPAC Name:
- 17 beta-Acetoxy-5 alpha-androstan-3-one
- Details on test material:
- - Name of test material (as cited in study report): adrostanolone acetate (5180)
- Lot/batch No.: 11630702
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 clinical or macroscopic pathological signs
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD 50 is above 2000 mg/kg body weight. No classification required.
- Executive summary:
The single oral administration of androstanolone acetate (ZK 5180) to 3 male and 3 female rats at a dose of 2000 mg/kg was tolerated without compound-related clinical findings. No substance-related macroscopic pathological signs were observed. The acute oral toxicity of androstanolone acetate in rats is above 2000 mg/kg body weight.
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