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

EC / List no.:
941-174-6
CAS no.:
-
Index number:
Molecular formula:
SMILES:
InChI:
Type of substance:
UVCB
Origin:
Organic
Registered compositions:
3
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:

Hazard classification & labelling

Warning! According to the classification provided by companies to ECHA in REACH registrations this substance causes serious eye irritation, is harmful to aquatic life with long lasting effects and causes skin irritation.

Breakdown of all 3 C&L notifications submitted to ECHA

Eye Irrit. 2 H319
Aquatic Chronic 3 H412
Skin Irrit. 2 H315
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

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

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

Properties of concern

Regulatory context

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

Registration
Pre-registration:
Registration:
This substance has 2 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 ≥ 1 000 to < 10 000 tonnes per annum.

This substance is used by consumers and in manufacturing.

This substance is used in the following products: washing & cleaning products.

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

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.

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.

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.

This substance is used in the following activities or processes at workplace: closed processes with no likelihood of exposure, closed batch processing in synthesis or formulation, mixing in open batch processes, transfer of chemicals at dedicated facilities, transfer of substance into small containers 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: wash parts of the body (as specified by manufacturer/supplier)in contact with substance thoroughly after handling; avoid release to the environment; wear protective gloves and/or clothing, and eye and/or face protection as specified by manufacturer/supplier.

Response statements

In case of incident: If eye irritation persists get medical advice/attention. Take off contaminated clothing and wash before reuse. If skin irritation occurs: Get medical advice/attention. Collect spillage. If on skin: wash with soap and water. If in eyes: rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing. Follow specific treatment (see label).

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

  • Evonik Operations GmbH, Rellinghauser Straße 1-11 45128 Essen Germany
  • Evonik Operations GmbH - ME02, Rellinghauser Straße 1-11 45128 Essen Germany
  • Banner Chemicals Benelux NV, Science Park Incubator Darwin, Office A212 Galileilaan 15 2845 Niel Antwerpen Belgium
  • Granollers Química, S.L.U., Av. Sant Julià 156-166 08403 Granollers Spain

Substance names and other identifiers

1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
Registration dossier
1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
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
  • 8 studies submitted
  • 2 studies processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [2]
C Form
Other (100%) [2]
C Odour
Other (100%) [2]
C Substance type
Organic (100%) [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 3 3
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Physical state at 20°C and 1013 hPa
Liquid (100%)

Melting/freezing point

Study results
  • 10 studies submitted
  • 5 studies processed
R Melting / freezing point
36 - 54 °C @ 101.3 kPa [5]

Type of Study provided
Studies with data
Key study
Supporting study 3 2
Weight of evidence 4 1
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Melting / freezing point at 101 325 Pa
36 °C

Boiling point

Study results
  • 8 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 2
Supporting study 3 3
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Density

Study results
  • 2 studies submitted
  • 2 studies processed
R Density
1.02 g/cm³ @ 20 °C [2]
R Relative density
1.02 @ 20 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Relative density at 20°C
1.02

Vapour pressure

Study results
  • 8 studies submitted
  • 2 studies processed
R Vapour pressure
0 - 0 Pa @ 20 - 25 °C [4]

Type of Study provided
Studies with data
Key study 2
Supporting study 3 3
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Vapour pressure
0 Pa @ 20 °C

Partition coefficient

Study results
  • 8 studies submitted
  • 6 studies processed
R Log Pow
2.97 - 5.8 @ 20 - 25 °C and pH 4 [6]

Type of Study provided
Studies with data
Key study
Supporting study 1 1
Weight of evidence 4 2
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Log Kow (Log Pow)
4.43 @ 20 °C

Water solubility

Study results
  • 12 studies submitted
  • 6 studies processed
R Water solubility (mass/vol.)
1.01 - 7.4 mg/L @ 20 °C and pH 6.3 - 6.4 [6]

Type of Study provided
Studies with data
Key study
Supporting study 3 3
Weight of evidence 6
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Water solubility
3.4 mg/L @ 20 °C

Solubility in organic solvents / fat solubility

Study results
  • 2 studies submitted
  • 2 studies processed
R N-octanol
632 g/L @ 20 °C [2]

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

No automatically processable data submitted

Surface tension

Study results
  • 8 studies submitted
  • 2 studies processed
R Surface tension
72 mN/m @ 900 mg/L and 20 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 3 3
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Surface tension at 20 °C
72 mN/m @ 0.9 mg/L

Flash point

Study results
  • 2 studies 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 2
Exposure cons.
Other
Summaries
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Auto flammability

Study results
  • 4 studies submitted
  • 2 studies processed
R Autoflammability / self-ignition
340 °C @ 101.2 kPa [2]

Type of Study provided
Studies with data
Key study 2 1 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Autoflammability / self-ignition at 101 325 Pa
340 °C

Flammability

Study results
  • 3 studies submitted
  • 1 study processed
C Interpretation of results
GHS criteria not met (100%) [1]

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

Explosiveness

Study results
  • 2 studies 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 1
C Summaries
  • 2 summaries submitted
  • 2 summaries 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
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other 1
C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Oxidising
No (100%)

Oxidation reduction potential

Data not provided by the registrant

pH

Data not provided by the registrant

Dissociation constant

Study results
  • 2 studies 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 2
Exposure cons.
Other
Summaries
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Viscosity

Study results
  • 2 studies 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 2
Exposure cons.
Other
Summaries
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

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
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Half-life for hydrolysis
28.5 days @ 20 °C

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
  • 10 studies submitted
  • 6 studies processed
C Interpretation of results
Readily biodegradable but failing the 10-day window (67%), Readily biodegradable (33%) [6]

Type of Study provided
Studies with data
Key study
Supporting study 3 1
Weight of evidence 6
Other
Data waiving
no waivers
C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Biodegradation in water
Readily biodegradable (100%)
Type of water
Freshwater (100%)

Biodegradation in water & sediment - simulation tests

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
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Biodegradation in soil

Study results
  • 2 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
Not feasible
Sci. unjustified 1
Exposure cons.
Other 1
Summaries
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Bioaccumulation: aquatic / sediment

Study results
  • 9 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study
Supporting study 2 1 2 2
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other 1
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Bioaccumulation Factor (BCF) - L/kg ww
13 L/kg ww

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 6 studies submitted
  • 2 studies processed
R Koc
54.6 - 360 594 L/kg @ 20 °C and 1 - 40.2 % organic carbon [10]

Type of Study provided
Studies with data
Key study 2
Supporting study 2 2
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Koc at 20°C
4 914.79

Henrys law constant (H)

Study results
  • 2 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
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Henry's law constant
0 Pa.m³.mol-1 @ 25 °C

Distribution modelling

Study results
  • 2 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
no waivers

No summary exists for this scientific endpoint

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
  • 2 summaries submitted
  • 2 summaries 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 68.6 µg/L (2)
Intermittent releases (freshwater) 67 µg/L (2)
Marine water 6.86 µg/L (2)
Intermittent releases (marine water) -
Sewage treatment plant (STP) 6.8 mg/L (2)
Sediment (freshwater) 57.97 mg/kg sediment dw (2)
Sediment (marine water) 5.797 mg/kg sediment dw (2)
Hazard for Air
Air No hazard identified (2)
Hazard for Terrestrial Organism
Soil 75.4 mg/kg soil dw (2)
Hazard for Predators
Secondary poisoning No potential for bioaccumulation (2)

Short–term toxicity to fish

Study results
  • 4 studies submitted
  • 2 studies processed
P/RResults
LC50 (4 days) 11.7 mg/L [2]
LC50 (72 h) 13 mg/L [2]
LC50 (48 h) 10.4 mg/L [2]
LC50 (24 h) 9.81 mg/L [2]

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

No automatically processable data submitted

Long–term toxicity to fish

Study results
  • 3 studies submitted
  • 2 studies processed
P/RResults
NOEC (35 days) 686 µg/L [6]
NOEC (5 days) 9.76 mg/L [4]
LOEC (35 days) 1.41 mg/L [2]
LC50 (35 days) 1.67 mg/L [2]

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

No automatically processable data submitted

Short–term toxicity to aquatic invertebrates

Study results
  • 6 studies submitted
  • 2 studies processed
P/RResults
EC50 (48 h) 6.7 mg/L [2]
EC50 (24 h) 13 mg/L [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 3 1
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Long–term toxicity to aquatic invertebrates

Study results
  • 3 studies submitted
  • 2 studies processed
P/RResults
NOEC (21 days) 1 mg/L [6]
LOEC (21 days) 2 mg/L [6]
EC50 (21 days) 1.7 mg/L [2]

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

No automatically processable data submitted

Toxicity to aquatic algae and cyanobacteria

Study results
  • 4 studies submitted
  • 2 studies processed
P/RResults
EC50 (72 h) 4.4 - 8.1 mg/L [4]
NOEC (72 h) 910 - 2 700 µg/L [4]
EC10 (72 h) 1.3 - 3.2 mg/L [4]

Type of Study provided
Studies with data
Key study 2
Supporting study 1 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
EC50 for freshwater algae
8.1 mg/L
EC10 or NOEC for freshwater algae
3.2 mg/L

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 8 studies submitted
  • 6 studies processed
P/RResults
NOEC (14 days) 28.2 - 460 mg/L [4]
NOEC (11 days) 17 - 24.3 mg/L [4]

Type of Study provided
Studies with data
Key study
Supporting study 1 1
Weight of evidence 6
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
EC10 or NOEC for microorganisms
68 mg/L

Sediment toxicity

Study results
  • 2 studies 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 1
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
  • 5 studies submitted
  • 2 studies processed
P/RResults
LC50 (14 days) 47.4 mg/kg soil dw [2]
LC0 (14 days) 47.4 mg/kg soil dw [2]
LC100 (14 days) 47.4 mg/kg soil dw [2]

Type of Study provided
Studies with data
Key study 1 1 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other 1
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Short-term EC50 / LC50
47.4 mg/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.
Other 1
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Toxicity to terrestrial plants

Study results
  • 5 studies submitted
  • 2 studies processed
P/RResults
NOEC (17 days) 47.4 mg/kg soil dw [12]
EC50 (17 days) 47.4 mg/kg soil dw [4]

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

Toxicity to soil microorganisms

Study results
  • 2 studies 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 1
Summaries
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Toxicity to birds

Study results
  • 2 studies 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 2
Exposure cons.
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
  • 2 summaries submitted
  • 2 summaries 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: (Low hazard (no threshold derived)) -
Acute /short term: Low hazard (no threshold derived)
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 56.25 mg/kg bw/day effect on fertility
Acute /short term: No hazard identified
Local Effects
Long-term: (Low hazard (no threshold derived)) -
Acute /short term: (Low hazard (no threshold derived)) -
EYE Exposure
Low hazard (no threshold derived)
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: (Low hazard (no threshold derived)) -
Acute /short term: (Low hazard (no threshold derived)) -
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 28.13 mg/kg bw/day effect on fertility
Acute /short term: No hazard identified
Local Effects
Long-term: (Low hazard (no threshold derived)) -
Acute /short term: (Low hazard (no threshold derived)) -
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 630 µg/kg bw/day effect on fertility
Acute /short term: No hazard identified
EYE Exposure
Low hazard (no threshold derived)

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 13 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 1 1
Supporting study 5 5
Weight of evidence
Other
Data waiving
no waivers
Study data: dermal absorption
  • 4 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: dermal absorption
Studies with data
Key study 2
Supporting study 1 1
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Bioaccumulation potential:
No bioaccumulation potential
Absorption values
Oral: 48 %
Dermal: 1 %
Inhalation: 100 %

Acute toxicity

Study results
oral
  • 10 studies submitted
  • 2 studies processed
P/RResults
LD50 2 000 mg/kg bw (rat) [2]
M/CInterpretations of results
GHS criteria not met [2]

Type of Study provided
oral
Studies with data
Key study 2
Supporting study 4 4
Weight of evidence
Other
Data waiving
no waivers
inhalation
  • 2 studies 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 2
Exposure cons.
Other
dermal
  • 6 studies submitted
  • 4 studies processed
P/RResults
LD50 2 000 mg/kg bw (rat) [2]
LD50 2 000 mg/kg bw (rabbit) [2]
M/CInterpretations of results
GHS criteria not met [4]

dermal
Studies with data
Key study 2 1
Supporting study
Weight of evidence 2
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
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
  • 2 summaries submitted
  • 2 summaries processed
Oral route:
No adverse effect observed LD50 2 000 mg/kg bw
Dermal route:
No adverse effect observed LD50 2 000 mg/kg bw

Irritation / corrosion

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

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 2
Supporting study 4
Weight of evidence 2
Other
Data waiving
no waivers
Study data: eye
  • 11 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study
Supporting study 5 2
Weight of evidence 4
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Skin
Adverse effect observed (irritating)
Eye
Adverse effect observed (irritating)
Respiratory
No study available

Sensitisation

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

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 2
Supporting study 3 3
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
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
  • 2 summaries submitted
  • 2 summaries processed
Skin sensitisation
No adverse effect observed (not sensitising)
Respiratory sensitisation
No study available

Repeated dose toxicity

Study results
Study data: oral
  • 10 studies submitted
  • 3 studies processed
P/RResults
NOAEL (rat): 500 - 1 000 mg/kg bw/day [3]

Type of Study provided
Study data: oral
Studies with data
Key study 2 1 1
Supporting study 3 3
Weight of evidence
Other
Data waiving
no waivers
Study data: inhalation
  • 2 studies 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 2
Study data: dermal
  • 2 studies 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 2
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Oral route - systemic effects:
No adverse effect observed NOAEL 500 mg/kg bw/day (subchronic, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 12 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 4 2 2
Supporting study 2 2
Weight of evidence
Other
Data waiving
no waivers
Study data: in vivo
  • 3 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

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
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Toxicity to reproduction

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

Study data not processed for brief profile

Type of Study provided
Study data: reproduction
Studies with data
Key study 2 2
Supporting study 1 4
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons. 1
Other
Study data: developmental
  • 10 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 1 1 1
Supporting study 2 3
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons. 1
Other
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
  • 2 summaries submitted
  • 2 summaries processed
Effect on fertility
Oral route:
No adverse effect observed NOAEL 500 mg/kg bw/day (subchronic, rat)
Effect on developmental toxicity
Oral route:
No adverse effect observed NOAEL 1 000 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