Registration Dossier
Registration Dossier
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EC number: 299-370-6 | CAS number: 93859-32-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment report
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 FEEDAP Panel
- 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:
- An eye irritation test was performed to assess the eye irritation potential of chemical Indigo carmine (CAS No: 860-22-0) in rabbits by using Draize 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 :C16H8N2Na2O8S2- Molecular weight (if other than submission substance):466.35- Substance type:Organic- Physical state:Solid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material (IUPAC name): 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-Indole-5-sulfonic acid, disodium salt- Common name: Indigo Carmine- Molecular formula: C16H8N2Na2O8S2- Molecular weight: 466.3572g/mol-Smiles: C1(=C2\C(=O)c3c(N2)ccc(c3)S(=O)(=O)[O-])/C(=O)c2c(N1)ccc(c2)S(=O)(=O)[O-].[Na+].[Na+]- InChl: 1S/C16H10N2O8S2.2Na/c19-15-9-5-7(27(21,22)23)1-3-11(9)17-13(15)14-16(20)10-6-8(28(24,25)26)2-4-12(10)18-14;;/h1-6,17-18H,(H,21,22,23)(H,24,25,26);;/q;2*+1/p-2/b14-13+;;- Substance type: Organic- Physical state: Solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
- 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: Slight transient irritation was produced which was reversible.
- Irritant / corrosive response data:
- Slight transient irritation was produced which was reversible.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The test chemical Indigo carmine chemical (CAS No: 860-22-0) was considered to be not irritating to the rabbits’ eye.
- Executive summary:
An eye irritation test was performed to assess the eye irritation potential of chemical Indigo carmine (CAS No: 860-22-0) in rabbits by using Draize method.
In the given study, when 0.2mL of 10% aqueous solution was applied twice daily for five days per week for four weeks to the eye of six rabbits slight transient irritation was observed. Three days after the last administration, there were no signs of eye irritation in any of the treated animals.
Hence the chemical Indigo carmine (CAS No: 860-22-0) was considered to be not irritating to the rabbits’ eye.
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