Registration Dossier
Registration Dossier
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EC number: 427-230-8 | CAS number: 5571-36-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EC Directive 67/548/EEC, B.1 tris OECD Guideline no. 423: Acute oral Toxicity - Acute Toxic class Method
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 427-230-8
- EC Name:
- -
- Cas Number:
- 5571-36-8
- Molecular formula:
- C20H26O3
- IUPAC Name:
- (3bS,11aS)-11a-methyl-1,2,3,3a,3b,4,5,6,8,9,11,11a-dodecahydrospiro[cyclopenta[a]phenanthrene-7,2'-[1,3]dioxolan]-1-one
Constituent 1
Test animals
- Species:
- other: Rat, Wistar strain Crl: (WI) BR (outbred, SPF-Quality)
Administration / exposure
- Vehicle:
- propylene glycol
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: No mortality occured Lethargy was noted in all males on day 1. The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same
- Gross pathology:
- Effects on organs:
No treatment related abnormalities were found at macroscopic
post mortem examination of the animals. Watery fluid in the
uterus, found in two females, is related to a stage in the
oestrous cycle and is a normal finding.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
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