Registration Dossier
Registration Dossier
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EC number: 207-096-5 | CAS number: 434-03-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 27. Jan to 23. Feb 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethisterone
- EC Number:
- 207-096-5
- EC Name:
- Ethisterone
- Cas Number:
- 434-03-7
- Molecular formula:
- C21H28O2
- IUPAC Name:
- (1R,3aS,3bR,9aR,9bS,11aS)-1-ethynyl-1-hydroxy-9a,11a-dimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
- Details on test material:
- - Name of test material (as cited in study report): ethisterone (ZK 4957)
- Analytical purity: 100.1%
- Lot/batch No.: 8115-13/08
- Expiration date of the lot/batch: 22 Oct 2011
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- no
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 21 days
- Number of animals:
- 3/sex
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Other effects:
- Loss of hair was noted in one out of three female animals at fore- and hind leg from day 15 onwards.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Ethisterone is not irritating to the skin, therefore classifiaction is not required.
- Executive summary:
The single dermal administration of ethisterone(ZK 4957) to male and female rats in the doses of 2000 mg/kg was tolerated without any local skin irritations.
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