Registration Dossier
Registration Dossier
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EC number: 600-487-5 | CAS number: 103799-56-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan to Feb 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Comparable to guideline study with acceptable restrictions: A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion. The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
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)
- Deviations:
- yes
- Remarks:
- exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, few details in test description and reporting
- GLP compliance:
- yes
- Remarks:
- - but a QA check was not performed
Test material
- Reference substance name:
- 1,4-Androstadiene-3,17-dione, 2-Naphthol-Complex
- EC Number:
- 600-487-5
- Cas Number:
- 103799-56-0
- Molecular formula:
- C19 H24 O2 . C10 H8 O
- IUPAC Name:
- 1,4-Androstadiene-3,17-dione, 2-Naphthol-Complex
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- physiological saline
- Controls:
- other: the untreated skin served as control
- Amount / concentration applied:
- 192-236 mg/male animal or 190-194 mg/female animal
- 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:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Executive summary:
A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg (192 -236 mg/male and 190 -194 mg/female applied as a paste) was tolerated without any local irritations. The mean values of findings relevant for classification (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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