Registration Dossier
Registration Dossier
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EC number: 927-431-5 | CAS number: 1178896-82-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Feb to Mar 2002
- 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:
- 2 004
- Report date:
- 2004
Materials and methods
- Principles of method if other than guideline:
- combined acute dermal toxicity and dermal irritation/corrosion study; single dermal application of test substance (application volume 0.1 ml) to male and female rats; occludive conditions; exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 1, 24, 48 and 72 h after removal of the bandage and the substance determined according to the grading system (OECD TG 404)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-Acetoxy-17,17-(2,2-dimethyltrimethylenedioxy)-androst-3,5-diene
- IUPAC Name:
- 3-Acetoxy-17,17-(2,2-dimethyltrimethylenedioxy)-androst-3,5-diene
- Details on test material:
- - Name of test material (as cited in study report): ZK 67985
- Batch No.: 51537013.021
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: liquid parrafin
- Controls:
- no
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3/sex
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Other effects:
- 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 Dienolacetat-ketal 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. No local intolerance reactions at the application sites were observed. The mean value grades across the time points (24, 48 and 72 h after removal of the pad) were 0 both for reddening/scab formation and for swelling.
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