Registration Dossier
Registration Dossier
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EC number: 425-000-1 | CAS number: 61718-80-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to recommended guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- human
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg of the test material
- Duration of treatment / exposure:
- 3 minutes and 1 hour for the first animal.
4 hours for the other ones. - Observation period:
- 1, 24, 48 and 72 hours after application of the test material.
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, 2 and 3
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: #1, 2 and 3
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- No clinical signs, either general or local (at the application sites), were noted in any rabbit.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for skin irritation.
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