Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 240-589-3 | CAS number: 16521-38-3 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 73015 aluminium salt.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- 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 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 mentioned below
- Principles of method if other than guideline:
- Study is performed by using in vivo Patch-Test
- GLP compliance:
- not specified
- Type of study:
- patch test
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- Purity: No data available- Impurities (identity and concentrations): No data available
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- - Source: 204 workers from 15 northern itallian feed mills
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: No data available
- Vehicle:
- no data
- Concentration / amount:
- No data available
Challenge
- Concentration / amount:
- No data available
- No. of animals per dose:
- 204 worker from 15 Italian feed mills
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 34
- Total no. in group:
- 204
- Clinical observations:
- 13.7% with occupational contact dermatitis,16.7% with allergic contact dermatitis
- Remarks on result:
- other: Reading: 1st reading. Group: test group. No with. + reactions: 34.0. Total no. in groups: 204.0. Clinical observations: 13.7% with occupational contact dermatitis,16.7% with allergic contact dermatitis.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The indigo carmine compound was patch tested for the allergy in the 204 worker from 15 Italian feed mills. The prevalence of occupational contact dermatitis was 13.7%, 16.7% with contact dermatitis and 6.8% of asymptomatic subjects patch tested with indigo carmine. It shows that indigo carmine is skin sensitizing compound.
- Executive summary:
The indigo carmine compound was patch tested for the allergy in the 204 worker from 15 Italian feed mills. The prevalence of occupational contact dermatitis was 13.7%, 16.7% with contact dermatitis and 6.8% of asymptomatic subjects patch tested with indigo carmine. It shows that indigo carmine is skin sensitizing compound.
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