Registration Dossier
Registration Dossier
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EC number: 280-163-4 | CAS number: 83027-61-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 1976
- 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:
- 1 976
- Report date:
- 1976
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 2 instead of 3 animals
- Qualifier:
- according to guideline
- Guideline:
- other: ETAD Method
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium [(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[ethyltoluenesulphonate]
- EC Number:
- 280-163-4
- EC Name:
- Disodium [(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[ethyltoluenesulphonate]
- Cas Number:
- 83027-61-6
- Molecular formula:
- C32H28N2Na2O8S2
- IUPAC Name:
- Reaction mass of disodium 2-ethyl-3-({4-[(2-ethyl-6-methyl-3-sulfonatophenyl)amino]-9,10-dioxo-9,10-dihydroanthracen-1-yl}amino)-4-methylbenzene-1-sulfonate, disodium 4-ethyl-3-({4-[(2-ethyl-6-methyl-3-sulfonatophenyl)amino]-9,10-dioxo-9,10-dihydroanthracen-1-yl}amino)-2-methylbenzene-1-sulfonate and disodium 4-ethyl-3-({4-[(6-ethyl-2-methyl-3-sulfonatophenyl)amino]-9,10-dioxo-9,10-dihydroanthracen-1-yl}amino)-2-methylbenzene-1-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:
- - Weight at study initiation: 3-4 kg
- Sex: male & female
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg/µl/animal
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 d
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: inside ear, size not defined
- Type of wrap if used: patch bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water/soap
- Time after start of exposure: 24 h
OBSERVATION TIME POINTS
24, 48, 72 h, 7 d
SCORING SYSTEM:
- Method of calculation: Draize score
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
- Irritant / corrosive response data:
- No effects observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance did not cause any signs of skin irritation in vivo. The substance is not classifiable according to CLP criteria.
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