Registration Dossier
Registration Dossier
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EC number: 436-000-6 | CAS number: 159010-67-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 6th to 21st, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Blue REg 6080
- IUPAC Name:
- Blue REg 6080
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- test item was moistened with bi-distilled water before application
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, 72 h and 7 d after removal of the dressing
- Number of animals:
- 1 male and 2 females
- Details on study design:
- Skin reactions assessed according to Draize score system (EEC Comission Directive 92/69/EEC).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- COLORATION:
slight grey staining of the treated skin was noted
one day after treatment up to 48 hours (one male) and 72
hours respectively.
MORTALITY/CLINICAL SIGNS: no mortality and no clinical signs observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified within the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant to skin.
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