Registration Dossier
Registration Dossier
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EC number: 617-707-0 | CAS number: 85390-93-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- May 1998
- 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:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one
- EC Number:
- 617-707-0
- Cas Number:
- 85390-93-8
- Molecular formula:
- C19 H28 O4
- IUPAC Name:
- 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 91535
- Batch No.: EW320/98A
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: physiol. saline + Myrj 53
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- 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
The main clinical finding after administration of ZK 91535 was slight to moderate apathy on the first day after administration. All animals were without findings from day 2 onwards. No compound-related findings were observed in body weight gain or autopsy.
Applicant's summary and conclusion
- Executive summary:
The single oral administration of the test substance 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one (ZK 91535) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. On the first day after administration slight to moderate apathy was observed, from day 2 onwards all animals were without clinical signs. Autopsy revealed no compound-related findings. The acute oral toxicity of 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one in rats is therefore above 2000 mg/kg body weight.
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