Registration Dossier
Registration Dossier
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EC number: 207-586-9 | CAS number: 482-89-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited data on test substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Federal Register 38, No 187
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one
- EC Number:
- 207-586-9
- EC Name:
- 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one
- Cas Number:
- 482-89-3
- Molecular formula:
- C16H10N2O2
- IUPAC Name:
- 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one
- Details on test material:
- - Name of test material (as cited in study report): Indigo-N-Lumps
- Substance type: active ingredient
- Physical state: solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 72 hours
readings at 1, 24, 48, 72 hours after instillation - Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: -
SCORING SYSTEM:
see Tab. 1 and Tab. 2
Index for Assessment
0-10 non irritating
11-25 slightly irritating
26-56 moderately irritating
57-110 severely irritating
Results and discussion
In vivo
Results
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 2.9
- Max. score:
- 110
- Remarks on result:
- other: Initial pain reaction: 2
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US CPSC / US FDA
- Conclusions:
- Indigo N Lumps should not cause significant eye irritation
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