Registration Dossier
Registration Dossier
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EC number: 212-728-8 | CAS number: 860-22-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Scientific Opinion on the safety and efficacy of indigo carmine (E 132) for cats and dogs and ornamental fish
- Author:
- EFSA Journal
- Year:
- 2 015
- Bibliographic source:
- EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), European Food Safety Authority (EFSA), Parma, Italy; EFSA Journal 2015; 13(5):4108
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- study is performed by using In vivo( Draize test) method
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
- EC Number:
- 212-728-8
- EC Name:
- Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
- Cas Number:
- 860-22-0
- Molecular formula:
- C16H10N2O8S2.2Na
- IUPAC Name:
- disodium 3,3'-dioxo-1,1',3,3'-tetrahydro-2,2'-biindole-5,5'-disulfonate
- Reference substance name:
- Indigo carmine
- IUPAC Name:
- Indigo carmine
- Details on test material:
- - Name of test material (as cited in study report):Indigo carmine- Molecular formula (if other than submission substance):C16H8N2Na2O8S2- Molecular weight (if other than submission substance):466.35- Substance type:Organic- Physical state:Solid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data available
Test system
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 0.2mL of 10% aqueous solution
- Duration of treatment / exposure:
- Twice daily for five days per week for four weeks
- Observation period (in vivo):
- 72 hours after the last administration
- Number of animals or in vitro replicates:
- Six rabbits
- Details on study design:
- No data available
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 Hr
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Substance is not an eye irritant
- Irritant / corrosive response data:
- Slight transient irritation is produced which is reversible, hence indigo carmine is not irritating to the eye.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Slight transient irritation is produced which is reversible, hence indigo carmine is not irritating to the eye.
- Executive summary:
In the given study Indigo carmine was tested for eye irritation in albino rabbits using Draize test, produced slight transient irritation ,when 0.2mL of 10% aqueous solutionwas applied twice daily for five days per week for four weeks to the eye of six rabbits. Three days after the last administration, there were no signs of eye irritation in any of the treated animals. This indicates that Indigo carmine is not an eye irritant.
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