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Diss Factsheets
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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.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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