Registration Dossier
Registration Dossier
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EC number: 617-707-0 | CAS number: 85390-93-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- May 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 0.4 ml; 2000 mg/kg) to male and female rats; 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:
- 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one
- EC Number:
- 617-707-0
- Cas Number:
- 85390-93-8
- Molecular formula:
- C19 H28 O4
- IUPAC Name:
- 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 91535
- Batch No.: EW320/98A
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Test system
- Preparation of test site:
- not specified
- Vehicle:
- physiological saline
- 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
- Other effects:
- After administration of ZK 91535 skin discoloration was observed in all animals at the application site. This effect was reversible within 48 hours after treatment and most probably caused by the intensive green color of the compound.
No compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.
Applicant's summary and conclusion
- Executive summary:
The single dermal administration of 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one 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. After administration of ZK 91535 skin discoloration was observed in all animals at the application site. This effect was reversible within 48 hours after treatment and most probably caused by the intensive green color of the compound. The test substance was tolerated without any local skin irritations.
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