Registration Dossier
Registration Dossier
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EC number: 601-431-2 | CAS number: 1164-92-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 24. Jun to 13. Jul 1998
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- combined acute toxicity and local tolerance study
- Deviations:
- not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- 17 beta-Acetoxy-5 alpha-androstan-3-one
- EC Number:
- 601-431-2
- Cas Number:
- 1164-92-7
- Molecular formula:
- C21 H32 O3
- IUPAC Name:
- 17 beta-Acetoxy-5 alpha-androstan-3-one
- Details on test material:
- - Name of test material (as cited in study report): adrostanolone acetate (5180)
- Lot/batch No.: 11630702
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3/sex
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 75 hours
- Score:
- 0
- Reversibility:
- other: not appropriate
- Other effects:
- no
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Androstanolone acetate is not skin irritating
- Executive summary:
After single dermal administration of androstanolone acetate (ZK 5180) to 3 male and 3 female rats at a dose of 570 -594 mg/male rat and 436 -448 mg/female rat of the original compound, no compound related local findings were observed after removing of the bandages at the time points 1, 24, 48 and 72 hours.
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