Registration Dossier
Registration Dossier
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EC number: 200-370-5 | CAS number: 58-22-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 15. to 28. Sep. 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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:
- no
Test material
- Reference substance name:
- Androst-4-ene-3,17-dione
- EC Number:
- 200-554-5
- EC Name:
- Androst-4-ene-3,17-dione
- Cas Number:
- 63-05-8
- Molecular formula:
- C19H26O2
- IUPAC Name:
- androst-4-ene-3,17-dione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Doses:
- 250 and 500 mg/kg bw
- No. of animals per sex per dose:
- 3/dose group
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 500 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
Compound-related transient clinical signs were apathy and atactic gait. All animals were without compound-related findings from Day 2 onwards.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- For oral administration, androstenedione is classified as harmful (Xn, R22) according to Directive 67/548/EEC criteria as LD50 >200 <2000 mg/kg.
Category 4 according to Regulation 1272/2008/EC criteria as LD 50 >300 <2000 mg/kg after oral administration, and therefore, based on read-across, testosterone is thus classified. - Executive summary:
There are no available acute oral toxicity studies on testosterone. Results of a study conducted with a structurally similar compound (androstendione, ZK5155) are reported and used for read-across.
The single oral administration of ZK 5155 to female rats at doses of 250 and 500 mg/kg caused compound-related transient clinical signs (apathy and atactic gait). All animals were without compound-related findings from Day 2 onwards. No compound-related macroscopic findings were seen. The LD50 after oral administration of ZK 5155 to female rats is above 500 mg/kg
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