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Diss Factsheets
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EC number: 431-920-4 | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1962
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Acceptable, well-documented study report which meets basic scientific principles The registered substance is the reduced form of the test item used in this study (Indigo:CAS-No. 482-89-3; commercial name: D&C Blue No. 6, certified by U.S. FDA for coloring surgical sutures). Indigo Vat potassium salt oxidizes rapidly to indigo in the pressence of water and airborne oxygen.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 962
- Report date:
- 1962
- Reference Type:
- publication
- Title:
- Toxicology of Indigo - a review
- Author:
- Ferber KH
- Year:
- 1 987
- Bibliographic source:
- J. Environ. Pathol. Toxicol. Oncol. 7, 73 -84 (1987)
Materials and methods
- Principles of method if other than guideline:
- US Food and Drug Administration
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Indigo
- IUPAC Name:
- Indigo
- Details on test material:
- - Name of test material (as cited in study report): D&C Blue 6
- Molecular formula (if other than submission substance): C16H10N2O2
- Molecular weight (if other than submission substance): 262.2628
- Smiles notation (if other than submission substance): O=C3c4ccccc4NC3=C2Nc1ccccc1C2=O
- InChl (if other than submission substance): InChI=1/C16H10N2O2/c19-15-9-5-1-3-7-11(9)17-13(15)14-16(20)10-6-2-4-8-12(10)18-14/h1-8,17-18H
- Structural formula attached as image file (if other than submission substance): see Fig. 1 section 4.1
- Substance type: active ingredient
- Physical state: solid
- Analytical purity: 95%
- Certified No. W4500
- Lot/batch No.: K7024
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: -
- Age at study initiation: -
- Weight at study initiation: 190 to 333 g
- Fasting period before study: 3 to 4 hours
- Housing: group-housing
- Diet: ad libitum
- Water: tap ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% MC (methyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1%, 10%, 25%
- Amount of vehicle (if gavage): 1, 3.16, 4, 12.64 ml/kg
- Justification for choice of vehicle: test item not soluble in water
MAXIMUM DOSE VOLUME APPLIED: 12.64 ml/kg - Doses:
- 10, 31.6, 100, 316, 1000, 3160 mg/kg bw nominal calculated to 100% pure indigo
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing:
- Mortality & toxic effects: immediately, 1, 4, 24 hours after dosing; daily thereafter
- BW: weekly
- Necropsy of survivors performed: yes - Statistics:
- NA
Results and discussion
- Preliminary study:
- NA
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 3 160 mg/kg bw
- Mortality:
- no deaths occurred
- Clinical signs:
- other: no effects besides blue feces at 24 hours fom 316 mg/kg onwards
- Gross pathology:
- no effects
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: US CPSC / US FDA
- Conclusions:
- There was no mortality and thus the acute oral LD50 was found to be greater than 3160 mg/kg bw
- Executive summary:
Six groups of 5 male SD rats received certified D&C Blue No 6 at dose levels of 10, 31.6, 100, 316, 1000, 3160 mg/kg bw suspended in 0.5% metyl cellulose per oral avage. After a 7 day observation period, animals were necropsied. No mortality occured, and there were no clinical signs besides blue colored feces in the three highest dose groups. No macroscopic effects were noted. The acute oral LD50 was found to be greater than 3160 mg/kg bw in male rats.
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