Registration Dossier
Registration Dossier
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EC number: 213-552-4 | CAS number: 976-70-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 25 Sep to 13 Oct 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
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 (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-oxopregn-4-ene-21,17α-carbolactone
- EC Number:
- 213-552-4
- EC Name:
- 3-oxopregn-4-ene-21,17α-carbolactone
- Cas Number:
- 976-70-5
- Molecular formula:
- C22H30O3
- IUPAC Name:
- (1R,3aS,3bR,9aR,9bS,11aS)-9a,11a-dimethyl-2,3,3a,3b,4,5,7,8,9,9a,9b,10,11,11a-tetradecahydrospiro[cyclopenta[a]phenanthrene-1,2'-oxolane]-5',7-dione
- Details on test material:
- - Name of test material (as cited in study report): aldona (ZK57564)
- Analytical purity: 95.5% HPLC
- Lot/batch No.: 59035042
- Expiration date of the lot/batch: Aug 2002
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% (m/v) Tylose MH 1000
- 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
Transient rough hair coat, apathy, squatting position, decreased body temperature only in females.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 >2000 mg/kg, no classification required
- Executive summary:
The single oral administration of aldona (ZK57564) to male and female Wistar rats (3/sex) at the dose of 2000 mg/kg resulted in transient rough hair coat, apathy, squatting position, decreased body temperature only in females. No compound-related macroscopic findings were seen.LD50 >2000 mg/kg
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