Registration Dossier
Registration Dossier
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EC number: 607-988-8 | CAS number: 2668-75-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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 volume1.0-1.1 ml) to male and female rats; semi-occlusive exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 30-60 min 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-Acetoxy-1,4,6-pregnatriene-3,20-dione
- EC Number:
- 607-988-8
- Cas Number:
- 2668-75-9
- Molecular formula:
- C23 H28 O4
- IUPAC Name:
- 17-Acetoxy-1,4,6-pregnatriene-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:
- 14 days
- Number of animals:
- 3 males and 3 females
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
Any other information on results incl. tables
The mean values of findings (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the test item is not irritating to skin
- Executive summary:
A combined study on acute dermal toxicity and on local tolerance was conducted. The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of this endpoint.
Approximately 209 mg/male rat and 192 mg/female rat was applied as a paste on the skin and left for 24 hours under occlusive conditions. Subsequently the bandage and the test substance was removed, and the skin areas were assessed according to the system recommended in directive 67/548/EEC. The mean values of findings (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.
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