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Registration Dossier
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EC number: 290-714-0 | CAS number: 90218-39-6
Eye irritation
Administrative data
- Endpoint:
- eye 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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3 - 4 kg
- Housing: individually
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 50 mg
- Duration of treatment / exposure:
- 1 treatment at 0 h
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- Observations daily
No washing performed
Scoring: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Weak signs of irritation (conjunctivae redness in 2/2 animals, chemosis in 1/2 animals) occurred within 24 h and were fully reversible within 7 d.
Any other information on results incl. tables
| endpoint | average score per observation time and endpoint | |||
| 24h | 48h | 72h | ||
| cornea | opacity | 0.0 | 0.0 | 0.0 |
| iris | value | 0.0 | 0.0 | 0.0 |
| conjuctiva | redness | 2.0 | 1.0 | 0.5 |
| chemosis | 0.5 | 0.0 | 0.0 | |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance did not cause significant signs of eye irritation in rabbits. Very weak signs were fully reversible within 7 d. The substance is not classifiable according to CLP criteria.
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