Brief Profile

Diss Brief Profile

The Brief Profile summarizes the non-confidential data on substances as it is held in the databases of the European Chemicals Agency (ECHA), including data provided by third parties. The Brief Profile is automatically generated; note that it does not currently distinguish between harmonised classification and minimum classification; information requirements under different legislative frameworks may therefore not be fully up to date or complete. For accuracy reasons, substance manufacturers and imports have the responsibility to consult official sources, e.g. the electronic edition of the Official Journal of the European Union.
This Brief Profile is covered by the ECHA Legal Notice.

Substance Description

Substance identity

No image available
EC / List no.:
212-728-8
CAS no.:
860-22-0
Index number:
Molecular formula:
SMILES:
InChI:
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
4
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:
EINECS (European INventory of Existing Commercial chemical Substances) List

Hazard classification & labelling

Warning! According to the classification provided by companies to ECHA in REACH registrations this substance may cause an allergic skin reaction.

Additionally, the classification provided by companies to ECHA in CLP notifications identifies that this substance is toxic to aquatic life with long lasting effects and is harmful if swallowed.

Breakdown of all 313 C&L notifications submitted to ECHA

Not Classified
Skin Sens. 1 H317
Aquatic Chronic 2 H411
Acute Tox. 4 H302
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

https://echa.europa.eu/o/diss-blank-theme/images/cnl/graph/tick.png Harmonised Classification

https://echa.europa.eu/o/diss-blank-theme/images/cnl/graph/Reach.png REACH registration dossiers notifications

https://echa.europa.eu/o/diss-blank-theme/images/cnl/graph/CLP.png CLP notifications

At least one notifier has indicated that an impurity or an additive present in the substance impacts the notified classification.

Properties of concern

  • Ss
There is broad agreement in that a majority of data submitters agree this substance is Skin sensitising (100% of REACH registrations).

Regulatory context

Registration, Evaluation, Authorisation & Restriction of Chemicals (REACH)

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 3 active registrations under REACH, 1 Joint Submission(s) and 0 Individual Submission(s).
Please see Registrants/Suppliers details.
Evaluation
Dossier Evaluation:
Substance Evaluation:
Authorisation
Candidate List:
Annex XIV (Authorisation List):
Restriction
Annex XVII (Restriction List):

Persistent Organic Pollutants Regulation (POPs)

List of substances subject to the POPs Regulation:
List of substances proposed as POPs:

Classification Labelling & Packaging (CLP)

Harmonised C&L:
Seveso Annex I:
Notified C&L:
Classification & Labelling has been notified by industry to ECHA for this substance.

Biocidal Products Regulation (BPR)

Active Substance:
Biocidal Products:

Prior Informed Consent (PIC)

Annex I:
Annex V:

European Union Observatory for Nanomaterials (EUON)

EUON:

About this substance

This substance is registered under the REACH Regulation and is manufactured in and / or imported to the European Economic Area, at ≥ 1 to < 10 tonnes per annum.

This substance is used by consumers, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing.

This substance is used in the following products: biocides (e.g. disinfectants, pest control products), fertilisers, plant protection products and cosmetics and personal care products.

Other release to the environment of this substance is likely to occur from: indoor use (e.g. machine wash liquids/detergents, automotive care products, paints and coating or adhesives, fragrances and air fresheners) and outdoor use.

ECHA has no public registered data on the use of this substance in activities or processes at the workplace.

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

ECHA has no public registered data indicating whether or into which articles the substance might have been processed.

This substance is used in the following products: biocides (e.g. disinfectants, pest control products), fertilisers and plant protection products.

This substance is used in the following areas: agriculture, forestry and fishing. This substance is used for the manufacture of: .

This substance is used in the following activities or processes at workplace: transfer of chemicals, transfer of substance into small containers and hand mixing with intimate contact only with personal protective equipment available.

Other release to the environment of this substance is likely to occur from: outdoor use and indoor use (e.g. machine wash liquids/detergents, automotive care products, paints and coating or adhesives, fragrances and air fresheners).

This substance is used in the following products: biocides (e.g. disinfectants, pest control products), fertilisers, plant protection products and cosmetics and personal care products.

This substance is used in the following activities or processes at workplace: transfer of chemicals, closed batch processing in synthesis or formulation, mixing in open batch processes, transfer of substance into small containers, production of mixtures or articles by tabletting, compression, extrusion or pelletisation, batch processing in synthesis or formulation with opportunity for exposure and hand mixing with intimate contact only with personal protective equipment available.

Release to the environment of this substance can occur from industrial use: formulation of mixtures and formulation in materials.

This substance is used in the following products: laboratory chemicals. This substance has an industrial use resulting in manufacture of another substance (use of intermediates).

This substance is used in the following areas: formulation of mixtures and/or re-packaging. This substance is used for the manufacture of: and chemicals.

This substance is used in the following activities or processes at workplace: transfer of chemicals, transfer of substance into small containers, closed processes with no likelihood of exposure, closed, continuous processes with occasional controlled exposure, closed batch processing in synthesis or formulation, batch processing in synthesis or formulation with opportunity for exposure, roller or brushing applications and laboratory work.

Release to the environment of this substance can occur from industrial use: as an intermediate step in further manufacturing of another substance (use of intermediates), in processing aids at industrial sites and as processing aid.

This substance is used in the following activities or processes at workplace: transfer of chemicals, closed processes with no likelihood of exposure, closed, continuous processes with occasional controlled exposure, closed batch processing in synthesis or formulation, batch processing in synthesis or formulation with opportunity for exposure, mixing in open batch processes, transfer of substance into small containers, roller or brushing applications and laboratory work.

Release to the environment of this substance can occur from industrial use: manufacturing of the substance.

ECHA has no data from registration dossiers on the precautionary measures for using this substance. Guidance on the safe use of the substance provided by manufacturers and importers of this substance.

Registrants/suppliers

  • CSI-OR28DUB, Block C Ardilaun Court 112-114 St. Stephen’s Green D02 TD28 Dublin Ireland
  • Global Product Compliance (Europe) AB, IDEON, Beta 5, Scheelevägen 17 22363 Lund Sweden
  • Stafford-Miller (Ireland) Limited, Clocherane Youghal Road _ Dungarvan Waterford Ireland

Substance names and other identifiers

Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
EC Inventory, REACH pre-registration
Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
REACH pre-registration, Cosmetic Products Regulation, Annex IV - Allowed Colorants
Indigotindisulfonate sodium
Other
1H-Indole-5-sulfonic acid, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2- ylidene)-2,3-dihydro-3-oxo-, disodium salt
C&L Inventory
1H-Indole-5-sulfonic acid, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-, disodium salt
C&L Inventory
2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-Indole-5-sulfonic acid, disodium salt
C&L Inventory
3,3'-dioxo-2,2'-bis-indolyden-5,5'-disulfonic acid disodium salt
C&L Inventory
disodium (2E)-3-oxo-2-(3-oxo-5-sulfonato-1H-indol-2-ylidene)-1H-indole-5-sulfonate
C&L Inventory
disodium 3,3'-dioxo-1,1',3,3'-tetrahydro-2,2'-biindole-5,5'-disulfonate
C&L Inventory, Registration dossier
disodium 3-oxo-2-(3-oxo-5-sulfonato-2,3-dihydro-1H-indol-2-ylidene)-2,3-dihydro-1H-indole-5-sulfonate
Other
Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
C&L Inventory, Registration dossier
Disodium 5,5’-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one) disulphonate
Registration dossier
disodium;(2E)-3-oxo-2-(3-oxo-5-sulfonato-1H-indol-2-ylidene)-1H-indole-5-sulfonate
Other
FD+C Blue No. 2 powder
Registration dossier
Indigo Carmine
C&L Inventory
860-22-0
CAS number
EC Inventory, C&L Inventory, Registration dossier, REACH pre-registration, Other, Cosmetic Products Regulation, Annex IV - Allowed Colorants

Scientific properties

Physical and chemical properties

This section provides physicochemical information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Appearance/physical state / colour

Study results
  • 3 studies submitted
  • 1 study processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [1]
C Form
Powder (100%) [1]
C Substance type
Organic (100%) [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Physical state at 20°C and 1013 hPa
Solid (100%)

Melting/freezing point

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Melting / freezing point at 101 325 Pa
340 °C

Boiling point

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible 1
Sci. unjustified
Exposure cons.
Other
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Density

Study results
  • 1 study submitted
  • 1 study processed
R Pour density
0.666 g/cm³ @ 29.05 °C [1]
R Tap density
0.714 g/cm³ @ 29.05 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
0.666

Vapour pressure

Study results
  • 1 study submitted
  • 1 study processed
R Vapour pressure
0 Pa @ 25 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Partition coefficient

Study results
  • 1 study submitted
  • 1 study processed
R Log Pow
-3.57 [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Log Kow (Log Pow)
-3.57

Water solubility

Study results
  • 2 studies submitted
  • 1 study processed
R Water solubility (mass/vol.)
1 000 g/L @ 26.6 °C and pH 3.9 [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Water solubility
1 g/L @ 26.6 °C

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Flash point

Study results
  • 1 study submitted
  • 1 study processed
R Flash point
250 °C @ 96.535 kPa [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Flash point at 101 325 Pa
250 °C

Auto flammability

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Flammability

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Explosiveness

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Oxidising

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Oxidation reduction potential

Data not provided by the registrant

pH

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers

No summary exists for this scientific endpoint

Dissociation constant

Data not provided by the registrant

Viscosity

Data not provided by the registrant

Environmental fate and pathways

This section provides environmental fate and pathways information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Phototransformation in air

Data not provided by the registrant

Hydrolysis

Data not provided by the registrant

Phototransformation in water

Data not provided by the registrant

Phototransformation in soil

Data not provided by the registrant

Biodegradation in water - screening tests

Study results
  • 5 studies submitted
  • 1 study processed
C Interpretation of results
Readily biodegradable (100%) [1]

Type of Study provided
Studies with data
Key study 1 1
Supporting study 3
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Biodegradation in water
Readily biodegradable (100%)

Biodegradation in water & sediment - simulation tests

Data not provided by the registrant

Biodegradation in soil

Data not provided by the registrant

Bioaccumulation: aquatic / sediment

Data not provided by the registrant

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Data not provided by the registrant

Henrys law constant (H)

Data not provided by the registrant

Distribution modelling

Data not provided by the registrant

Ecotoxicological information

This section provides ecotoxicological information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Predicted No-Effect Concentration (PNEC)

Data not provided by the registrant

Short–term toxicity to fish

Data not provided by the registrant

Long–term toxicity to fish

Data not provided by the registrant

Short–term toxicity to aquatic invertebrates

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
EC50 (48 h) 2.384 g/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 1 1
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Long–term toxicity to aquatic invertebrates

Data not provided by the registrant

Toxicity to aquatic algae and cyanobacteria

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
EC50 (72 h) 2.079 mg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 for freshwater algae
2.09 mg/L

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Data not provided by the registrant

Sediment toxicity

Data not provided by the registrant

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

Data not provided by the registrant

Toxicity to terrestrial arthropods

Data not provided by the registrant

Toxicity to terrestrial plants

Data not provided by the registrant

Toxicity to soil microorganisms

Data not provided by the registrant

Toxicity to birds

Data not provided by the registrant

Toxicity to mammals

Data not provided by the registrant

Toxicological information

This section provides toxicological information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Derived No- or Minimal Effect Level (DN(M)EL)

Data not provided by the registrant

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: basic toxicokinetics
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: dermal absorption
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: dermal absorption
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Acute toxicity

Study results
oral
  • 7 studies submitted
  • 1 study processed
P/RResults
LD50 2 000 mg/kg bw (mouse) [1]
M/CInterpretations of results
Practically nontoxic [1]

Type of Study provided
oral
Studies with data
Key study 1
Supporting study 4 2
Weight of evidence
Other
Data waiving
no waivers
inhalation
  • 0 studies submitted
  • 0 studies processed

No data available

inhalation
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
dermal
  • 0 studies submitted
  • 0 studies processed

No data available

dermal
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
other routes
  • 0 studies submitted
  • 0 studies processed

No data available

other routes
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route:
No adverse effect observed LD50 2 000 mg/kg bw

Irritation / corrosion

Study results
Study data: skin
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: eye
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study
Supporting study
Weight of evidence 1 1
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin
No adverse effect observed (not irritating)
Eye
No adverse effect observed (not irritating)

Sensitisation

Study results
Study data: skin
  • 4 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 1
Supporting study 2 1
Weight of evidence
Other
Data waiving
no waivers
Study data: respiratory
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: respiratory
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin sensitisation
Adverse effect observed (sensitising)

Repeated dose toxicity

Data not provided by the registrant

Genetic toxicity

Study results
Study data: in vitro
  • 9 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: in vitro
Studies with data
Key study 1
Supporting study 8
Weight of evidence
Other
Data waiving
no waivers
Study data: in vivo
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: in vivo
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Toxicity - InVitro
No adverse effect observed (negative)

Carcinogenicity

Data not provided by the registrant

Toxicity to reproduction

Study results
Study data: reproduction
  • 5 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: reproduction
Studies with data
Key study
Supporting study 5
Weight of evidence
Other
Data waiving
no waivers
Study data: developmental
  • 4 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study
Supporting study 4
Weight of evidence
Other
Data waiving
no waivers
Study data: other studies
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: other studies
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Neurotoxicity

Data not provided by the registrant

Immunotoxicity

Data not provided by the registrant

Endocrine disrupter mammalian screening - in vivo

Data not provided by the registrant