Registration Dossier
Registration Dossier
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Reaction mass of 6-(2-ethyl-6-methylanilino)-5-(4-{4-[ethyl(3-sulfobenzyl) amino] phenylazo} phenylazo)-4-hydroxynaphthalene-2-sulfonic acid, sodium and/or disodium salt(s) and 6-(2-ethyl-6-methylanilino)-5-(4-{4-[ethyl(4-sulfobenzyl) amino] phenylazo} phenylazo)-4-hydroxynaphthalene-2-sulfonic acid, sodium and/or disodium salt(s)
EC number: 475-080-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- GLP compliance:
- yes
Test material
- Reference substance name:
- Acid Navy RN-2682
- IUPAC Name:
- Acid Navy RN-2682
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h, then the dressing was removed and the skin was flushed with lukewarm tap water.
- Observation period:
- 1, 24, 48, 72 h up to 7 d
- Number of animals:
- 3
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
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Other effects:
- No clinical signs of systemic toxicity were noted and no
mortality occurred.
The test item did not elicit any skin reactions at the application site.
The test item caused black staining of the treated skin in all animals from the 1-hour reading up to the 48-hour or 72- hour reading. Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
The body weights of all rabbits were within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified within the CLP Regulation (EC 1272/2008)
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