Registration Dossier
Registration Dossier
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EC number: 617-708-6 | CAS number: 85390-94-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Jun to Jul 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
- Principles of method if other than guideline:
- combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume 0.3 - 0.45 ml) to male and female rats; occlusively; exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 1 h after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 7 beta-Hydroxy-3 beta,15 alpha-dipivaloyloxy-5-androsten-17-one
- EC Number:
- 617-708-6
- Cas Number:
- 85390-94-9
- Molecular formula:
- C29 H44 O6
- IUPAC Name:
- 7 beta-Hydroxy-3 beta,15 alpha-dipivaloyloxy-5-androsten-17-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 92136
- Batch No.: 21604812
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: paraffin oil
- 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: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
No compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.
No local intolerance reactions at the application sites were observed.
Applicant's summary and conclusion
- Executive summary:
The single dermal administration of Dipivalat to male and female rats at the dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The test substance was tolerated without any local skin irritations.
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