Registration Dossier
Registration Dossier
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EC number: 251-868-4 | CAS number: 34184-82-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A study according to OECD guideline but not GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- no
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- 17-alpha-hydroxypregna-4,9(11)-diene-3,20-dione
- IUPAC Name:
- 17-alpha-hydroxypregna-4,9(11)-diene-3,20-dione
- Reference substance name:
- 17-hydroxypregna-4,9(11)-diene-3,20-dione
- EC Number:
- 251-868-4
- EC Name:
- 17-hydroxypregna-4,9(11)-diene-3,20-dione
- Cas Number:
- 34184-82-2
- Molecular formula:
- C21H28O3
- IUPAC Name:
- (1R,3aS,3bS,9aS,11aS)-1-acetyl-1-hydroxy-9a,11a-dimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,9aH,11H,11aH-cyclopenta[a]phenanthren-7-one
- Details on test material:
- Test article: Oxediene (raw material)
Batch: 0916860039
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- OFA Sprague Dawley rat, IOPS Caw
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 10 ml/kg in Methylcellulose
- Doses:
- 300 mg/kg. Other doses (50, 2000 mg/kg) are possibly studied depending on the results obtained.
- No. of animals per sex per dose:
- 3 females
- Details on study design:
- Single administration followed by a 15-day observation period
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this study conducted with Oxediene (batch 0916860039), the maximal dose tested was non-lethal (2000 mg/kg). The LD50 > 2000 mg/kg.
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