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

EC / List no.:
431-920-4
CAS no.:
835912-68-0
Index number:
Molecular formula:
C32H20K4N4O4
SMILES:
[K+].[K+].[K+].[K+].[O-]C1=C(NC2=CC=CC=C12)C1=C([O-])C2=C(N1)C=CC=C2.[O-]C1=C(NC2=C1C=CC=C2)[C-]1NC2=CC=CC=C2C1=O
InChI:
InChI=1S/C16H12N2O2.C16H11N2O2.4K/c2*19-15-9-5-1-3-7-11(9)17-13(15)14-16(20)10-6-2-4-8-12(10)18-14;;;;/h1-8,17-20H;1-8,17-19H;;;;/q;-1;4*+1/p-3
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
1
Of which contain:
0 impurities relevant for classification
1 additives relevant for classification
Substance Listed:
ELINCS (European LIst of Notified Chemical Substances) List

Hazard classification & labelling

Danger! According to the classification provided by companies to ECHA in REACH registrations this substance causes severe skin burns and eye damage and causes serious eye damage.

Breakdown of all 1 C&L notifications submitted to ECHA

Skin Corr. 1A H314
Eye Dam. 1 H318
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

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

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

Properties of concern

Regulatory activities

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

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 1 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):

Classification Labelling & Packaging (CLP)

Harmonised C&L:
Notification:
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 manufactured and/or imported in the European Economic Area in 10+ tonnes per year.

This substance is used in formulation or re-packing, at industrial sites and in manufacturing.

ECHA has no public registered data indicating whether or in which chemical products the substance might be used.

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 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.

ECHA has no public registered data indicating whether or in which chemical products the substance might be used.

ECHA has no public registered data on the types of manufacture using this substance.

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 in which chemical products the substance might be used.

This substance is used in the following activities or processes at workplace: closed batch processing in synthesis or formulation, transfer of chemicals at dedicated facilities and transfer of substance into small containers.

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

ECHA has no public registered data indicating whether or in which chemical products the substance might be used.

This substance is used for the manufacture of: textile, leather or fur.

This substance is used in the following activities or processes at workplace: transfer of chemicals at dedicated facilities and treatment of articles by dipping and pouring.

Release to the environment of this substance can occur from industrial use: in the production of articles.

This substance is used in the following activities or processes at workplace: closed batch processing in synthesis or formulation.

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

Precautions for using this substance have been recommended by its registrants under REACH, as follows:

Prevention statements

When handling this substance: do not breathe the dust, fume, gas, mist, vapours or spray; wear protective gloves and/or clothing, and eye and/or face protection as specified by manufacturer/supplier.

Response statements

In case of incident: Wash contaminated clothing before reuse. If on skin (or hair): take off immediately all contaminated clothing. Rinse skin with water or shower. If inhaled: remove victim to fresh air and keep at rest in a position comfortable for breathing. If swallowed: rinse mouth. Do not induce vomiting. If in eyes: rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing. Immediately call a poison center or doctor/physician.

Storage statements

Store this substance locked up.

Disposal statements

The substance must be disposed in accordance with local/regional/national/international regulation.

Guidance on the safe use of the substance provided by manufacturers and importers of this substance.

Registrants/suppliers

  • DyStar Colours Distribution GmbH, Am Prime-Parc 12 65479 Raunheim Germany

Substance names and other identifiers

1H,1'H-[2,2'-biindole]-3,3'-diol
Other
PRODUKT 1998
REACH pre-registration
dipotassium 1H,1'H-2,2'-biindole-3,3'-diolate
Registration dossier
tetrapotassium 1H,1'H-[2,2'-biindole]-3,3'-bis(olate) 3-oxo-2,3-dihydro-1H,1'H-[2,2'-biindol]-2-id-3'-olate
Other
835912-68-0
CAS number
Registration dossier

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

Type of Study provided
Studies with data
Key study 1
Supporting study
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
  • 2 studies processed
R Melting / freezing point
165 - 392 °C @ 101.3 kPa [2]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 2
Other
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

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
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Density

Study results
  • 2 studies submitted
  • 1 study processed
R Density
1.35 g/cm³ @ 20 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible 1
Sci. unjustified
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
1.35

Vapour pressure

Study results
  • 2 studies submitted
  • 1 study processed
R Vapour pressure
0 Pa @ 100 °C [1]

Type of Study provided
Studies with data
Key study 1
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

Partition coefficient

Study results
  • 4 studies submitted
  • 3 studies processed
R Log Pow
-1.1 - 2.7 @ 23 °C [3]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 1 2
Other
Data waiving
Not feasible 1
Sci. unjustified
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
Log Kow (Log Pow)
-1.1

Water solubility

Study results
  • 2 studies submitted
  • 2 studies processed
R Water solubility (mass/vol.)
50 - 400 000 000 µg/L @ 23 - 25 °C and pH 7 - 13 [2]

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

No automatically processable data submitted

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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Flash 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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Auto flammability

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

Flammability

Study results
  • 1 study submitted
  • 1 study processed
C Interpretation of results
Non flammable (100%) [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Flammability
Non flammable (100%)

Explosiveness

Study results
  • 2 studies submitted
  • 1 study processed
C Interpretation of results
Non-explosive (100%) [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
C Summaries
  • 1 summary submitted
  • 1 summary processed
Explosiveness
Non-explosive (100%)

Oxidising

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
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
C Summaries
  • 1 summary submitted
  • 1 summary processed
Oxidising
No (100%)

Oxidation reduction potential

Data not provided by the registrant

pH

Data not provided by the registrant

Dissociation constant

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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Viscosity

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
  • 0 summaries submitted
  • 0 summaries processed

No data available

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

Study results
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Phototransformation in water

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

Phototransformation in soil

Study results
  • 0 studies submitted
  • 0 studies processed

No data available

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

No automatically processable data submitted

Biodegradation in water - screening tests

Study results
  • 8 studies submitted
  • 3 studies processed
R BOD5
5 - 9 mg O2/g test material [2]
R COD
400 - 1 900 mg O2/g test material [2]
C Interpretation of results
Under test conditions no biodegradation observed (100%) [3]

Type of Study provided
Studies with data
Key study
Supporting study 1
Weight of evidence 6
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
C Summaries
  • 1 summary submitted
  • 1 summary processed
Biodegradation in water
Inherently biodegradable, not fulfilling specific criteria (100%)

Biodegradation in water & sediment - simulation tests

Data not provided by the registrant

Biodegradation in soil

Study results
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Bioaccumulation: aquatic / sediment

Study results
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible 1
Sci. unjustified
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation Factor (BCF) - dimensionless
4.5

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 3 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
Not feasible 1
Sci. unjustified
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
Koc at 20°C
707.95

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)

R Summaries
  • 1 summary submitted
  • 1 summary processed

The Predicted No-Effect Concentration (PNEC) value is the concentration of a substance below which adverse effects in the environment are not expected to occur. Please note that when more than one summary is provided, PNEC values may refer to constituents of the substance and not to the substance as a whole. More detailed information is available in the dossiers.

Hazard for Aquatic Organisms
Freshwater No hazard identified (1)
Intermittent releases (freshwater) No hazard identified (1)
Marine water No hazard identified (1)
Intermittent releases (marine water) No hazard identified (1)
Sewage treatment plant (STP) No hazard identified (1)
Sediment (freshwater) No hazard identified (1)
Sediment (marine water) No hazard identified (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil No hazard identified (1)
Hazard for Predators
Secondary poisoning No potential for bioaccumulation (1)

Short–term toxicity to fish

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
LC50 (4 days) 10 g/L [1]
LC50 (72 h) 10 g/L [1]
LC50 (48 h) 10 g/L [1]
LC50 (24 h) 10 g/L [1]
LC100 (4 days) 10 g/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible 1
Sci. unjustified
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
LC50 for freshwater fish
10 g/L

Long–term toxicity to fish

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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Short–term toxicity to aquatic invertebrates

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
EC50 (48 h) 500 mg/L [1]
EC50 (24 h) 500 mg/L [1]
EC100 (48 h) 500 mg/L [1]
NOEC (48 h) 125 mg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible 1
Sci. unjustified
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 / LC50 for freshwater invertebrates
500 mg/L

Long–term toxicity to aquatic invertebrates

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
NOEC (21 days) 350 µg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other 1
Data waiving
Not feasible 1
Sci. unjustified
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC10 / LC10 or NOEC for freshwater invertebrates
350 µg/L

Toxicity to aquatic algae and cyanobacteria

Study results
  • 5 studies submitted
  • 1 study processed
P/RResults
EC50 (72 h) 100 mg/L [2]

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other 2
Data waiving
Not feasible 1
Sci. unjustified
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 for freshwater algae
100 mg/L
EC10 or NOEC for freshwater algae
100 mg/L

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
EC50 (3 h) 10 g/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible 1
Sci. unjustified
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 for microorganisms
10 g/L
EC10 or NOEC for microorganisms
10 g/L

Sediment toxicity

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. 1
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

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
Weight of evidence
Other
Data waiving
Not feasible 1
Sci. unjustified
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
Short-term EC50 / LC50
1 g/kg soil dw

Toxicity to terrestrial arthropods

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. 1
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Toxicity to terrestrial plants

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
NOEC (21 days) 1 g/kg soil ww [1]
EC50 (21 days) 1 g/kg soil ww [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
Not feasible 1
Sci. unjustified
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
Long-term EC10 / LC10 / NOEC
1 g/kg soil dw

Toxicity to soil microorganisms

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. 1
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Toxicity to birds

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. 1
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

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)

M/C Summaries
  • 1 summary submitted
  • 1 summary processed

The derived no- or minimum effect level (DN(M)EL) is the level of exposure above which a human should not be exposed to a substance. Please note that when more than one summary is provided, DN(M)EL values may refer to constituents of the substance and not to the substance as a whole. More detailed information is available in the dossiers.

Data for WORKERS
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
EYE Exposure
No hazard identified
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
EYE Exposure
No hazard identified

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 2 studies 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 1
Weight of evidence
Other
Data waiving
no waivers
Study data: dermal absorption
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: dermal absorption
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

Acute toxicity

Study results
oral
  • 11 studies submitted
  • 3 studies processed
P/RResults
LD50 2 000 - 5 000 mg/kg bw (rat) [3]
M/CInterpretations of results
Practically nontoxic [3]

Type of Study provided
oral
Studies with data
Key study
Supporting study 7
Weight of evidence 3
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
inhalation
  • 5 studies submitted
  • 4 studies processed
P/RResults
rat (2 000 - 5 000 mg/kg bw) () [1]
LC50 (4 h) 5 - 5.3 mg/L air (rat) [2]
M/CInterpretations of results
Practically nontoxic [4]

inhalation
Studies with data
Key study
Supporting study
Weight of evidence 4
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
dermal
  • 2 studies submitted
  • 1 study processed
P/RResults
LD50 2 500 mg/kg bw (rat) [1]
M/CInterpretations of results
Practically nontoxic [1]

dermal
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
other routes
  • 2 studies submitted
  • 1 study processed
P/RResults
LD50 30 mg/kg bw (mouse) [1]

other routes
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route:
No adverse effect observed LD50 4 430 mg/kg bw
Inhalation route:
No adverse effect observed LC50 5 000 mg/m³
Dermal route:
No adverse effect observed LD50 2 500 mg/kg bw

Irritation / corrosion

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

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study
Supporting study
Weight of evidence 10
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Study data: eye
  • 6 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 5
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin
Adverse effect observed (corrosive)
Eye
Adverse effect observed (irritating)
Respiratory
No study available

Sensitisation

Study results
Study data: skin
  • 3 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 1
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
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
No adverse effect observed (not sensitising)
Respiratory sensitisation
No adverse effect observed (not sensitising)

Repeated dose toxicity

Study results
Study data: oral
  • 5 studies submitted
  • 1 study processed
P/RResults
NOEL (rat): 1 200 mg/kg bw/day [1]

Type of Study provided
Study data: oral
Studies with data
Key study 1
Supporting study 3
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Study data: inhalation
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Study data: inhalation
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Study data: dermal
  • 3 studies submitted
  • 1 study processed
P/RResults
NOEL (rabbit): 5 mg/kg bw/day [1]

Study data: dermal
Studies with data
Key study
Supporting study
Weight of evidence 2
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route - systemic effects:
No adverse effect observed NOAEL 1 200 mg/kg bw/day (chronic, rat)
Dermal route - systemic effects:
No adverse effect observed NOAEL 25 mg/kg bw/day (chronic, mouse)

Genetic toxicity

Study results
Study data: in vitro
  • 15 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 5
Weight of evidence 2 5
Other 1
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
Study data: in vivo
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: in vivo
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

Carcinogenicity

Study results
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

No automatically processable data submitted

Toxicity to reproduction

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

Study data not processed for brief profile

Type of Study provided
Study data: reproduction
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Study data: developmental
  • 3 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study
Supporting study
Weight of evidence 2
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
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
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Effect on fertility
Oral route:
No adverse effect observed NOAEL 500 mg/kg bw/day (chronic, rat)
Effect on developmental toxicity
Oral route:
No adverse effect observed NOAEL 500 mg/kg bw/day (subacute, rat)

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