Registration Dossier
Registration Dossier
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EC number: 606-682-1 | CAS number: 2098-65-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November to December 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- 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 ml) to male and female rats; occlusive exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained immediately 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:
- 17-Hydroxy-1 alpha,2 alpha-methylene-4,6-pregnadiene-3,20-dione
- EC Number:
- 606-682-1
- Cas Number:
- 2098-65-9
- Molecular formula:
- C22 H28 O3
- IUPAC Name:
- 17-Hydroxy-1 alpha,2 alpha-methylene-4,6-pregnadiene-3,20-dione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Test system
- Type of coverage:
- occlusive
- Controls:
- no
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- for local effects 72 hours, whole study 14 days
- Number of animals:
- 3/sex
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- No mortalities occurred and no compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the test item revealed no skin irritating properties
- Executive summary:
The single dermal administration of the test substance (ZK 12126) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. Moreover, no local intolerance reactions at the application sites were observed. The mean values of findings relevant for dermal classification (reddening, scab formation and swelling of the skin) at the time-points immediately after removal of the bandage and the substance, 24, 48 and 72 h after the end of administration were 0.
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