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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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971/1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
- 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)
- Reference Type:
- publication
- Title:
- Teratogenic Studies with Certified Colors in Rats and Rabbits.
- Author:
- Burnett CM et al.
- Year:
- 1 974
- Bibliographic source:
- Toxicol Appl Pharmacol. 1974;29:121-122
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- no maternal toxicity observed
- GLP compliance:
- not specified
- Limit test:
- 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-(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
- Details on test material:
- - Name of test material (as cited in study report): D&C Blue No. 6
- Substance type: active compound
- Physical state: solid
- Analytical purity: 96%
- Lot/batch No.: Y-2206 and Y-2678
- FDA certification no.: Y-PMA-1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (obtained as weanlings)
- Age at study initiation: satisfactory age for mating (about 8 weeks)
- Weight at study initiation: -
- Fasting period before study: -
- Housing: single
- Diet: Purina Laboratory Chow ad libitum
- Water: tap ad libitum
- Acclimation period: ca. 5 weeks
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: methylcellulose 0.5%
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
suspension in 0.5% methylcellulose
VEHICLE
- Dow Methocel 90 HG, 15000 CPS
- Justification for use and choice of vehicle (if other than water): TS is insoluble in water
- Concentration in vehicle: 50 mg/mL
- Amount of vehicle: 10 mL/kg (control and high dose), 3.2 mL/kg, 1 mL/kg
- Lot/batch no.: MM 101012K
POSITIVE CONTROL
- Acetylsalicylic acid (Aspirin)
- Supplier: Mallinckrodt - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- 1 M/1 F per cage
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Day 6 through 15 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- 21 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50, 160, 500 mg/kg/day
Basis:
other: nominal in vehicle
- No. of animals per sex per dose:
- 20 pregnant females
- Control animals:
- yes, concurrent vehicle
- other: positive control: aspirin
- Details on study design:
- 3 dosage levels were run concurrently with 2 negative (vehicle) and one positive (Aspirin) control groups
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: -
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 6, 15, 20 of gestation
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: uterus - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: No data
- Number of implantations: Yes
- Number of resorptions: Yes
- Number viable and dead fetuses: Yes
- Distribution by sex: Yes
- Mean litter size: Yes - Fetal examinations:
- - Mean fetal weight
- Determination of sex
- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: one-third per litter
- Skeletal examinations: Yes: two-third per litter - Statistics:
- Frequency of occurrence and seriousness of anomaly compared to control groups
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
-
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
-
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- D&C Blue No. 6 administered by gavage to groups of 20 female rats each during days 6 through 15 of gestation at dose levels of 50, 160, and 500 mg/kg/day was without effect on reproductive performance, maternal weight gain, and fetal development.
- Executive summary:
Groups of 20 pregnant female Charles River CD rats received suspensions of D&C Blue No. 6 by stomach tube at doses of 500, 160 and 50 mg/kg/day from day 6 through day 15 of gestation. Comparable groups received either the methylcellulose suspending vehicle as negative controls or aspirin, 250 mg/kg/day as positive controls. On day 20 of gestation Caesarean section was performed, the uterus examined and fetuses processed for subsequent examination for skeletal or visceral anomalies.
On the basis of numbers of viable and dead fetuses, resorption sites, mean fetal weight, distribution by sex, mean litter size, frequency of skeletal and visceral or structural anomalies; weight gain of pregnant females: Indigo was without effect on reproductive performance, maternal weight gain and fetal development.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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