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Diss Factsheets
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EC number: 207-586-9 | CAS number: 482-89-3
- 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
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Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
Data source
Reference
- 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:
- U.S. FDA 1962-1973
- GLP compliance:
- not specified
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-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
Results and discussion
- Details on results:
- No-toxic-effect-level (NOAEL = no observed adverse effect
level): not estimated
Results:
72 young, albino New Zealand rabbits of each sex were
used in end-use tests as colorant for surgical sutures.
The test substance, D&C Blue No. 6 was incorporated
into plain and chromic collagen eye sutures (size 6-0).
The dyed as well as undyed sutures were implanted into
the cornea, sclera, dorsal nectus muscle and
subconjunctiva of the rabbits of each sex. During a
total period of 180 days several investigations (no
more data) were performed.
The following test substance-related findings were
obtained:
1) Clinical examinations
No data available.
2) Clinical laboratory investigations
No data available.
3) Effect on the organs / Pathology
No data available.
4) No-effect-level (NOEL = no observed effect level):
not estimated
Applicant's summary and conclusion
- Conclusions:
- The eyes were examined daily for the first ten days and weekly thereafter for a total period of 180 days. A parallel experiment was also conducted using size 6-0 plain and chromic catgut sutures. All animals were sacrificed at termination of the study and the eyes and adjacent tissues examined grossly and microscopically. Evidence of reactions was graded on a scale of 1 to 4.
It was concluded that the use of the test substance D&C Blue No. 6 to color either collagen or catgut sutures does not affect their safe use in opthalmological procedures - Executive summary:
The eyes were examined daily for the first ten days and weekly thereafter for a total period of 180 days. A parallel experiment was also conducted using size 6-0 plain and chromic catgut sutures. All animals were sacrificed at termination of the study and the eyes and adjacent tissues examined grossly and microscopically. Evidence of reactions was graded on a scale of 1 to 4.
It was concluded that the use of the test substance D&C Blue No. 6 to color either collagen or catgut sutures does not affect their safe use in opthalmological procedures.
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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