Registration Dossier
Registration Dossier
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EC number: 256-457-3 | CAS number: 49744-26-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct 1975
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, 1500.42 (US)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-(2-methoxyethoxy)ethyl 4-[(5-cyano-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxopyridin-3-yl)azo]benzoate
- EC Number:
- 256-457-3
- EC Name:
- 2-(2-methoxyethoxy)ethyl 4-[(5-cyano-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxopyridin-3-yl)azo]benzoate
- Cas Number:
- 49744-26-5
- Molecular formula:
- C21H24N4O6
- IUPAC Name:
- 2-(2-methoxyethoxy)ethyl 4-[(5-cyano-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxopyridin-3-yl)azo]benzoate
- Test material form:
- solid: granular
- Details on test material:
- Disperse Yellow 126
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize system
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
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, 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1, 6
- 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
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2, 3, 4, 5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Slight signs of irritation occurred in 6/6 animals (conjunctivae redness, chemosis) but were fully reversible within 7 d. The irritation was very weak and does not fulfill the CLP criteria for classification.
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 | 0.3 | 0.5 | 0.3 |
| chemosis | 0.5 | 0.0 | 0.0 | |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance induced weak signs of eye irritation (conjunctivae redness, chemosis). However, the irritating effect was not sufficient to meet the GHS criteria for classification. All signs were fully reversible within 7 d. The substance is not considered an eye irritant in the sense of the CLP Regulation.
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