Registration Dossier
Registration Dossier
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EC number: 278-103-7 | CAS number: 75198-93-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium 5-[[4-acetamido-2-(trifluoromethyl)phenyl]azo]-6-amino-4-hydroxynaphthalene-2-sulphonate
- EC Number:
- 278-103-7
- EC Name:
- Sodium 5-[[4-acetamido-2-(trifluoromethyl)phenyl]azo]-6-amino-4-hydroxynaphthalene-2-sulphonate
- Cas Number:
- 75198-93-5
- Molecular formula:
- C19H15F3N4O5S.Na
- IUPAC Name:
- sodium 5-{[4-acetamido-2-(trifluoromethyl)phenyl]diazenyl}-6-amino-4-hydroxynaphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3.0 - 3.3 kg (all female)
- Housing: polyethylene cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): approx. 40 - 60% rh
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: powder slightly moistened with water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage: 2.5 cm²
- Type of wrap if used: gauze, elastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48, 72 h, 7, 14 d after removal
SCORING SYSTEM:
- Method of calculation: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corrosive effects were noted on treated skin at any time.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not cause signs of irritation/corrosion on rabbit skin. Slight erythema (below classification cut-off value) was fully reversible within 7 d. The substance is not classifiable according to the CLP Regulation.
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