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EC number: 212-974-6 | CAS number: 894-86-0
- 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

Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- March 1982 to May 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- No GLP study, oxidized form of the test item, acceptable, well-documented study report which meets basic scientific principles. The test substance is synthesized and handled as a 15% to 50% aqueous sodium hydroxide solution (pH 13) only under inert gas atmosphere. It is instable in an aqueous phase at neutral pH or as solid material on air and oxidises rapidly to indigo CAS 482-89-3.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
- Principles of method if other than guideline:
- Method as requested by the National Institute of Environmental Health Sciences, USA
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one
- EC Number:
- 207-586-9
- EC Name:
- 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one
- Cas Number:
- 482-89-3
- Molecular formula:
- C16H10N2O2
- IUPAC Name:
- 2,2'-biindole-3,3'(1H,1'H)-dione
- Reference substance name:
- 2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one
- IUPAC Name:
- 2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one
- Details on test material:
- - Name of test material (as cited in study report): CI Vat Blue #1: Indigo
- Molecular formula (if other than submission substance): C16H10N2O2
- Molecular weight (if other than submission substance): 262.3
- 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 7.1.1
- Substance type: active substance
- Physical state: blue solid
- Analytical purity: essentially pure
- Lot/batch No. unlabeled: #A1A Eastman Kodak
- Purity test date: 19. October 1981
- Lot/batch No. labeled: 1555-105 New England Nuclear
- Radiochemical purity (if radiolabelling): ca. 70%
- Specific activity (if radiolabelling): 13.4 mCi/mmol
- Radioactivity: 5.88 mCi
- Locations of the label (if radiolabelling): [phenyl-14C(U)]-
Constituent 1
Constituent 2
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Kingston, NY
- Age at study initiation: adult
- Housing: singly
- Individual metabolism cages: yes
- Diet: Purina Rat Chow ad libitum
- Water: furnished water ad libitum
- Acclimation period: at least 2 weeks
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: 1. ointment from PEG 1540+PEG 400+propylene glycol; 2. unchanged
- Duration of exposure:
- 168 and 192 hours
- Doses:
- Dermal 1: 3.7 mg/kg bw
Dermal 2: 1.5 mg/kg bw - No. of animals per group:
- 3
- Control animals:
- no
- Details on study design:
- Dose selection as requested by NIEHS
DOSE PREPARATION / APPLICATION
Dermal 1:
Vehicle: ointment
Composition: 9 g PEG 1540, 6 g PEG 400, 3 g propylene glycol
Concentration: 28 mg ointment + 2 mg labeled indigo (2.53 x 10E8 DPM)
Dosage: 1 cm² ointment: 3.7 mg/kg bw
Dermal 2:
applied as dry powder: 0.5 mg (6.3 x 10E7 DPM)
Dosage: 1 cm² dry powder: 1.5 mg/kg bw
TEST SITE
- Preparation of test site: clipping of fur on the back 20 to 24 hours prior treatment
- Area of exposure: 1 cm²
- Type of cover / wrap if used: occlusive hardback waxed paper + adhesive tape
- Time intervals for shavings or clipplings: 20 to 24 hours
SITE PROTECTION / USE OF RESTRAINERS FOR PREVENTING INGESTION: yes: occlusive hardback waxed paper + adhesive tape glued to the animals' skin covered with elastic bandage also glued to the animals' skin
SAMPLE COLLECTION
- Tissues and body fluids sampled: urine, faeces, blood (plasma and red blood cells), selected tissues (see attached table)
- Time and frequency of sampling: see attached tables
- Time of sacrifice:
- Dermal 1: 192 hours
- Dermal 2: 1 rat - 168 hours; 2 rats - 192 hours
SAMPLE PREPARATION
- Preparation details: dermal 1: 28 mg ointment (9 g PEG 1540, 6 g PEG 400, 3 g propylene glycol) were molten at 40°C, 2 mg 14C-indigo were added and mixed with spatula
dermal 2: applied unchanged as dry powder
ANALYSIS
- Method type(s) for identification: Liquid scintillation counting; HPLC/scintillation spectrometry
Results and discussion
- Signs and symptoms of toxicity:
- no effects
- Dermal irritation:
- no effects
- Absorption in different matrices:
- see attached table
- Total recovery:
- dermal 1: 92.4% +/- 4.2%
dermal 2: 75.2% +/- 3.4%
Percutaneous absorptionopen allclose all
- Dose:
- 1.18 mg/cm²
- Parameter:
- percentage
- Absorption:
- 2 %
- Remarks on result:
- other: 0-72 h
- Remarks:
- dermal 1: 3.7 mg/kg in ointment
- Dose:
- 0.42 mg/cm²
- Parameter:
- percentage
- Absorption:
- 0.7 %
- Remarks on result:
- other: 0-72 h
- Remarks:
- dermal 2: 1.5 mg/kg dry powder
- Conversion factor human vs. animal skin:
- no data
Any other information on results incl. tables
NA
Applicant's summary and conclusion
- Conclusions:
- Very low dermal absorption of indigo. Excretion via urine > feces. Only about 2% of indigo was excreted unchanged..
No potential for bioaccumulation of indigo or its metabolites was observed. - Executive summary:
The toxicokinetic properties of Indigo has been investigated in male rats (Research Triangle Institute: Absorption,
Distribution, Metabolism and Excretion of CI Vat Blue#I; Indigo; RTI/2227/00-04P, September 1983). For this purpose, radioactive labeled (14C) Indigo (radiochemical purity ca. 70%) was administered as a single intravenous injection (0.23 mg/kg bw), a single oral gavage (3.0; 31; 305 mg/kg bw) and a single dermal application (1.5 and 3.7 mg/kg bw).
The highest tissue levels after oral administration were found in liver and kidneys
Dermal administration: After dermal application of the ointment, 0.8% of the administered radioactivity were found in urine, feces and cage washes; after application of the dry powder, only 0.3% were found, leading to a very limited dermal absorption of indigo.
There were no hints for a possible bioaccumulation of indigo
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