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.:
201-137-0
CAS no.:
78-73-9
Index number:
Molecular formula:
C6H15NO4
SMILES:
[H+].[O-]C([O-])=O.C[N+](C)(C)CCO
InChI:
InChI=1S/C5H14NO.CH2O3/c1-6(2,3)4-5-7;2-1(3)4/h7H,4-5H2,1-3H3;(H2,2,3,4)/q+1;/p-1
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
2
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

According to the classification provided by companies to ECHA in REACH registrations this substance causes serious eye irritation and causes skin irritation.

Additionally, the classification provided by companies to ECHA in CLP notifications identifies that this substance is harmful if swallowed and may cause respiratory irritation.

Breakdown of all 153 C&L notifications submitted to ECHA

Eye Irrit. 2 H319
Acute Tox. 4 H302
Skin Irrit. 2 H315
STOT SE 3 H335
Not Classified
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 2 active registrations under REACH, 1 Joint Submission(s) and 1 Individual Submission(s).
Please see Registrants/Suppliers details.
Evaluation
Dossier Evaluation:
Registration dossiers submitted to ECHA for this substance have been evaluated under REACH.
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 1 - 10 tonnes per year.

This substance is used by professional workers (widespread uses), 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.

This substance is used in the following activities or processes at workplace: transfer of chemicals and transfer of substance into small containers.

Other release to the environment of this substance is likely to occur from: outdoor use as processing aid.

This substance is used in the following products: metal surface treatment products, non-metal-surface treatment products, hydraulic fluids, pH regulators and water treatment products, laboratory chemicals, plant protection products, pharmaceuticals and welding & soldering products.

This substance is used in the following activities or processes at workplace: closed, continuous processes with occasional controlled exposure, closed batch processing in synthesis or formulation, mixing in open batch processes, transfer of substance into small containers and laboratory work.

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

This substance is used in the following products: metal surface treatment products, non-metal-surface treatment products, hydraulic fluids, pH regulators and water treatment products, laboratory chemicals and welding & soldering products. This substance has an industrial use resulting in manufacture of another substance (use of intermediates).

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

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

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

This substance is used in the following activities or processes at workplace: closed batch processing in synthesis or formulation, closed processes with no likelihood of exposure, transfer of chemicals at dedicated facilities and laboratory work.

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: wear protective gloves and/or clothing, and eye and/or face protection as specified by manufacturer/supplier.

Response statements

In case of incident: If in eyes: rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing. If eye irritation persists get medical advice/attention. If on skin: wash with soap and water.

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

Registrants/suppliers

  • ALGRY QUIMICA, S.L., Pol. Ind. Nuevo Puerto 21810 Palos de la Frontera Huelva Spain
  • BALCHEM Italia srl, Via del Porto snc 28040 Marano Ticino Novara Italy

Substance names and other identifiers

Choline hydrogen carbonate
EC Inventory, REACH pre-registration
Ethanaminium, 2-hydroxy-N,N,N-trimethyl-, carbonate (1:1)
Other
2-hydroxy-N,N,N-trimethylethanaminium hydrogen carbonate
Registration dossier
2-Hydroxyethyl)trimethylammonium bicarbonate
C&L Inventory
Choline Bicarbonate
C&L Inventory, Registration dossier
hydrogen (2-hydroxyethyl)trimethylazanium carbonate
Other
hydrogen carbonate; 2-hydroxyethyl(trimethyl)azanium
C&L Inventory
Choline Bicarbonate 75%, aqueous solution
Registration dossier
78-73-9
CAS number
EC Inventory, C&L Inventory, Registration dossier, REACH pre-registration, Other
942603-48-7
Deleted CAS number
Other

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
Liquid (100%) [1]
C Form
Other (100%) [1]
C Odour
Other (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
Liquid (100%)

Melting/freezing point

Study results
  • 1 study submitted
  • 1 study processed
R Melting / freezing point
-65 °C @ 101 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
Melting / freezing point at 101 325 Pa
-65 °C

Boiling point

Study results
  • 4 studies submitted
  • 1 study processed
R Boiling point
300 °C @ 101.3 kPa [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 3
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Density

Study results
  • 1 study submitted
  • 1 study processed
R Relative density
1.172 @ 20.1 °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
1.172

Vapour pressure

Study results
  • 1 study submitted
  • 1 study processed
R Vapour pressure
0 - 2 390.4 Pa @ 25 °C [2]

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
Vapour pressure
23.904 hPa @ 25 °C

Partition coefficient

Study results
  • 3 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study 2
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

Water solubility

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
R Summaries
  • 1 summary submitted
  • 1 summary processed
Water solubility
750 g/L @ 20 °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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Flash point

Study results
  • 1 study submitted
  • 1 study processed
R Flash point
100 °C @ 102.3 kPa [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

Auto flammability

Study results
  • 1 study submitted
  • 1 study processed
R Autoflammability / self-ignition
450 °C @ 101 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
Autoflammability / self-ignition at 101 325 Pa
450 °C

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

No data available

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

No data available

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

No data available

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

No data available

Viscosity

Study results
  • 1 study submitted
  • 1 study processed
R kinematic viscosity (in mm²/s)
19.61 - 44.03 [2]

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
Static viscosity at 20 °C
44.03 mm²/s

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

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

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

No data available

Phototransformation in water

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

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
  • 1 study submitted
  • 1 study processed
R COD
321 - 322 mg O2/g test material [1]
C Interpretation of results
Readily biodegradable (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
Biodegradation in water
Readily biodegradable (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
  • 1 study 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
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation Factor (BCF) - L/kg ww
3.16 L/kg ww

Bioaccumulation: terrestrial

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

Adsorption/desorption

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
Koc at 20°C
1.438

Henrys law constant (H)

Study results
  • 1 study submitted
  • 1 study processed
R H - (pressure) m³/mol
0 Pa m³/mol @ 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

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 604 µg/L (1)
Intermittent releases (freshwater) 5 mg/L (1)
Marine water 60.4 µg/L (1)
Intermittent releases (marine water) -
Sewage treatment plant (STP) 112.9 mg/L (1)
Sediment (freshwater) 500 µg/kg sediment dw (1)
Sediment (marine water) 50 µg/kg sediment dw (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 86 µg/kg soil dw (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]
NOEC (4 days) 10 g/L [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
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
Sci. unjustified 1
Exposure cons.
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Short–term toxicity to aquatic invertebrates

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
EC50 (48 h) 500 mg/L [1]
EC50 (24 h) 500 mg/L [1]
EC0 (48 h) 125 mg/L [1]
EC0 (24 h) 250 mg/L [1]
EC100 (48 h) 500 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 / LC50 for freshwater invertebrates
500 mg/L

Long–term toxicity to aquatic invertebrates

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
NOEC (21 days) 30.2 mg/L [1]
LOEC (21 days) 95.5 mg/L [1]
EC50 (21 days) 58.9 mg/L [1]
LC50 (21 days) 95.5 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
EC10 / LC10 or NOEC for freshwater invertebrates
30.2 mg/L

Toxicity to aquatic algae and cyanobacteria

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
EC50 (4 days) 500 mg/L [2]
EC50 (72 h) 500 mg/L [2]
EC10 (4 days) 500 mg/L [2]
EC10 (72 h) 500 mg/L [2]

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
500 mg/L
EC10 or NOEC for freshwater algae
500 mg/L

Toxicity to aquatic plants other than algae

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

Toxicity to microorganisms

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
EC50 (17 h) 132.8 mg/L [1]
EC10 (17 h) 112.9 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 microorganisms
132.8 mg/L
EC10 or NOEC for microorganisms
112.9 mg/L

Sediment toxicity

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

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except 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.
Other 1
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

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

No data available

Toxicity to terrestrial plants

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

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

No data available

Toxicity to birds

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

Toxicity to mammals

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

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: (DNEL) 200.29 mg/m³ repeated dose toxicity
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: (DNEL) 71 mg/kg bw/day repeated dose toxicity
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: (DNEL) 49.39 mg/m³ repeated dose toxicity
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: (DNEL) 35.5 mg/kg bw/day repeated dose toxicity
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: (DNEL) 7.1 mg/kg bw/day repeated dose toxicity
Acute /short term: No hazard identified
EYE Exposure
No hazard identified

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
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation potential:
No bioaccumulation potential
Absorption values
Oral: 50 %
Dermal: 10 %
Inhalation: 25 %

Acute toxicity

Study results
oral
  • 3 studies submitted
  • 2 studies processed
P/RResults
LD50 5 500 - 11 000 mg/kg bw (rat) [3]
approx. LD50 3 500 - 5 450 mg/kg bw (rat) [3]
M/CInterpretations of results
Practically nontoxic [1]

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

No automatically processable data submitted

inhalation
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
dermal
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

dermal
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
other routes
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

other routes
Studies with data
Key study
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route:
No adverse effect observed LD50 4 140 mg/kg bw

Irritation / corrosion

Study results
Study data: skin
  • 2 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
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 1
Supporting study 1
Weight of evidence
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)
Respiratory
No study available

Sensitisation

Study results
Study data: skin
  • 2 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
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
No adverse effect observed (not sensitising)
Respiratory sensitisation
No study available

Repeated dose toxicity

Study results
Study data: oral
  • 3 studies submitted
  • 3 studies processed
P/RResults
NOAEL (rat): 1 200 - 1 420 mg/kg bw/day [2]
LOAEL (rat): 1 290.3 - 5 915.2 mg/kg bw/day [4]
NOEL (rat): 19.6 - 1 583.5 mg/kg bw/day [4]
NOEL (mouse): 200 - 236.6 mg/kg bw/day [2]
LOEL (rat): 1 337.6 - 3 022.2 mg/kg bw/day [4]

Type of Study provided
Study data: oral
Studies with data
Key study
Supporting study
Weight of evidence 3
Other
Data waiving
no waivers
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
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Study data: dermal
Studies with data
Key study
Supporting study
Weight of evidence
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 1 420 mg/kg bw/day (chronic, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 3 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 2
Supporting study 1
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
  • 1 study 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
no waivers
Study data: developmental
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 1
Supporting study 1
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
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Effect on fertility
Oral route:
No adverse effect observed NOAEL 92.3 mg/kg bw/day (subacute, rat)
Effect on developmental toxicity
Oral route:
No adverse effect observed NOAEL 4 921 mg/kg bw/day (subacute, mouse)

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