Registration Dossier
Registration Dossier
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EC number: 290-714-0 | CAS number: 90218-39-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- 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:
- 1 976
- Report date:
- 1976
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: ETAD guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, reduced, oxidized, potassium sodium salts
- EC Number:
- 290-714-0
- EC Name:
- Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, reduced, oxidized, potassium sodium salts
- Cas Number:
- 90218-39-6
- Molecular formula:
- C38H24N8Na4O12S4
- IUPAC Name:
- tetrasodium 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate
- Test material form:
- solid
- Details on test material:
- Direct Orange 57
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3 - 4 kg
- Housing: individually
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/animal - Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: inside if the ear
- Type of wrap if used: patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with water and soap or plant oil
- Time after start of exposure: 24h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) at removal of the patch, 2 days after removal of the patch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No signs of irritation related to the substance were observed on rabbit ear skin (patch test). The substance is not classifiable according to CLP criteria.
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