Registration Dossier
Registration Dossier
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EC number: 612-953-5 | CAS number: 6218-29-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Jul 2006 to Feb 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- (1S,3aS,3bS,11aS)-1-hydroxy-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
- EC Number:
- 612-953-5
- Cas Number:
- 6218-29-7
- Molecular formula:
- C18 H24 O2
- IUPAC Name:
- (1S,3aS,3bS,11aS)-1-hydroxy-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 47359
- Batch No.: 54512003
- puritiy: 100%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: physiol. saline + Myrj 53 + Klucel LF
- Doses:
- 2000 mg/kg (application volume 10 mL/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
No animal died in the course of the study.
On administration day slight apathy, curved back, eyelid closure, serous secretion and ruffled fur were observed in female animals. At later observation time points all female animals as well as all males over the whole study period were without clinical findings.
No abnormalities were observed at necropsy and in body weight gain.
Applicant's summary and conclusion
- Executive summary:
The single oral administration of the test substance (ZK 47359) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. No compound-related clinical signs were observed in males, in females only very slight and transient signs of impaired general condition were observed on the day of administration. There were no macroscopic pathological signs. The acute oral toxicity of Hydroxyestradienon in rats is therefore above 2000 mg/kg body weight.
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