Registration Dossier
Registration Dossier
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EC number: 256-456-8 | CAS number: 49744-25-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 1975
- 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:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, 1500.42 (US)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-5-[(2-nitrophenyl)azo]-2-oxonicotinonitrile
- EC Number:
- 256-456-8
- EC Name:
- 1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-5-[(2-nitrophenyl)azo]-2-oxonicotinonitrile
- Cas Number:
- 49744-25-4
- Molecular formula:
- C15H13N5O4
- IUPAC Name:
- 1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-5-[(2-nitrophenyl)azo]-2-oxonicotinonitrile
- Test material form:
- solid
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:
- 60 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 d
- 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:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Remarks:
- except for one animal
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.05
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance induced weak signs of eye irritation (redness). However, the irritating effect was not sufficient to meet the GHS criteria for classification. All signs (except redness in 1/6 test animals) were fully reversible within 7 d.
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