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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Three Generation Study With Indigo In Rats:
10 males and 20 females of each generation were dosed with 0, 0, 0, 5,
50, 150, 500 mg/kg bw/day of D&C Blue #6 and mated. The parent
generation (F0) rats were bred twice, the F1b were bred thrice, and the
F2b were bred once. The criteria of effect included the following
indices: fertility, gestation, gestation survival, 4-/14-/21-day
survival. Furthermore, the diet consumption and body weights of the
parent rats and their progeny data were examined as were the number of
resorption sites and corpora lutea at the 19-day kill of the third
mating of half of the F1b dams. The differences between dosed and
control groups were neither dose-related, nor progressive, nor were they
indicative of mean or median values exceeding those of the controls. It
is therefore concluded that only random, not deleterious effects were
associated with the inclusion of indigo in the diet of rats for
3 generations.
Short description of key information:
No effects on reproduction process observed
Effects on developmental toxicity
Description of key information
No effects on intra-uterine development observed
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Teratogenicity Indigo Rat:
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.
Teratogenicity Indigo Rabbit:
Groups of 10 pregnant female New
Zealand white rabbits 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 18 of
gestation. Comparable groups received either the methylcellulose
suspending vehicle as negative controls or thalidomide at 100 mg/kg/day
as positive controls. On day 29 of gestation Caesarean section was
performed, the uterus examined and fetuses autopsied for detection of
visceral anomalies. Subsequently, the eviscerated carcasses were
processed for examination of skeletal 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.
Justification for classification or non-classification
No effects on reproduction observed, no classification necessary
Additional information
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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