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 name: N-(2-hydroxyethyl)stearamide
  • IUPAC name: N-(2-hydroxyethyl)octadecanamide
  • Other names
EC / List no.:
203-883-2
CAS no.:
111-57-9
Index number:
Molecular formula:
C20H41NO2
SMILES:
CCCCCCCCCCCCCCCCCC(=O)NCCO
InChI:
InChI=1S/C20H41NO2/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-20(23)21-18-19-22/h22H,2-19H2,1H3,(H,21,23)
Type of substance:
UVCB
Origin:
Organic
Registered compositions:
15
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

Danger! According to the classification provided by companies to ECHA in CLP notifications this substance is toxic to aquatic life with long lasting effects, causes serious eye damage and causes skin irritation.

Breakdown of all 63 C&L notifications submitted to ECHA

Eye Dam. 1 H318
Skin Irrit. 2 H315
Aquatic Chronic 2 H411
Not Classified
Aquatic Chronic 3 H412
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 14 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 1 000 - 10 000 tonnes per year.

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

This substance is used in the following products: cosmetics and personal care products.

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

This substance is used in the following activities or processes at workplace: the low energy manipulation of substances bound in materials or articles.

Other release to the environment of this substance is likely to occur from: indoor use in long-life materials with low release rate (e.g. flooring, furniture, toys, construction materials, curtains, foot-wear, leather products, paper and cardboard products, electronic equipment), outdoor use in long-life materials with low release rate (e.g. metal, wooden and plastic construction and building materials) and outdoor use in long-life materials with high release rate (e.g. tyres, treated wooden products, treated textile and fabric, brake pads in trucks or cars, sanding of buildings (bridges, facades) or vehicles (ships)).

This substance can be found in products with material based on: rubber (e.g. tyres, shoes, toys) and fabrics, textiles and apparel (e.g. clothing, mattress, curtains or carpets, textile toys).

This substance is used in the following products: cosmetics and personal care products.

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 non-dedicated facilities, mixing in open batch processes and treatment of articles by dipping and pouring.

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

This substance is used in the following products: polymers and lubricants and greases.

This substance is used in the following activities or processes at workplace: transfer of substance into small containers, production of mixtures or articles by tabletting, compression, extrusion or pelletisation, transfer of chemicals, mixing in open batch processes, roller or brushing applications and the low energy manipulation of substances bound in materials or articles.

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

This substance is used in the following products: polymers, polishes and waxes, washing & cleaning products, biocides (e.g. disinfectants, pest control products), pH regulators and water treatment products and textile treatment products and dyes. This substance has an industrial use resulting in manufacture of another substance (use of intermediates).

This substance is used in the following areas: formulation of mixtures and/or re-packaging and building & construction work. This substance is used for the manufacture of: rubber products, plastic products, electrical, electronic and optical equipment, machinery and vehicles and furniture.

This substance is used in the following activities or processes at workplace: transfer of chemicals, batch processing in synthesis or formulation with opportunity for exposure, roller or brushing applications, mixing in open batch processes, treatment of articles by dipping and pouring, production of mixtures or articles by tabletting, compression, extrusion or pelletisation, transfer of substance into small containers and closed batch processing in synthesis or formulation.

Release to the environment of this substance can occur from industrial use: in the production of articles, formulation of mixtures, in processing aids at industrial sites, formulation in materials, as an intermediate step in further manufacturing of another substance (use of intermediates), as processing aid and as processing aid. Other release to the environment of this substance is likely to occur from: indoor use (e.g. machine wash liquids/detergents, automotive care products, paints and coating or adhesives, fragrances and air fresheners).

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

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

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

Registrants/suppliers

  • Arcerion GmbH, Gabrielenstr. 15 80636 München Germany
  • DOG Deutsche Oelfabrik Gesellschaft für chemische Erzeugnisse mbH & Co. KG, Ellerholzdamm 50 20457 Hamburg Germany
  • DyStar Colours Distribution GmbH, Am Prime-Parc 12 65479 Raunheim Germany
  • Envigo Research Limited 65, Shardlow Business Park London Road DE72 2GD Shardlow Derbyshire United Kingdom
  • Evonik Goldschmidt Rewo GmbH, Max-Wolf-Straße 7 36396 Steinau an der Straße Germany
  • NAM & NAM Europe GmbH, Emil-Figge-Str. 80 44227 Dortmund(060) Germany
  • RHODIA OPERATIONS, 40 rue de la Haie Coq 93306 AUBERVILLIERS France
  • Schill & Seilacher "Struktol" GmbH, Moorfleeter Straße 28 22113 Hamburg Germany
  • Schill + Seilacher GmbH, Schoenaicher Str. 205 71032 Boeblingen Germany
  • Schill+Seilacher "Struktol" GmbH Hamburg, Moorfleeter Straße 28 22113 Hamburg Germany
  • SO.G.I.S. Industria Chimica S.p.A., Via Giuseppina, 132 26048 Sospiro (CR) Italy
  • WTH Walter Thieme Handel GmbH, Beguinenstrasse 13 21682 Stade Niedersachsen Germany

Other names

  • -
  • 15791_111-57-9
  • Amides, C 16-18 (even-numbered), N-hydroxyethyl
  • Amides, C16-18 (even-numbered) N-2-hydroxyethyl
  • Amides, C16-18 (even-numbered), N-hydroxyethyl
  • Amides, C16-18, N-(hydroxyethyl)
  • Amides, C16-C18 (even-numbered), N-(hydroxyethyl)
  • N-(2-hydroxyethyl)octadecanamide
  • N-(2-Hydroxyethyl)stearamide
  • Octadecanamide, N-(2-hydroxyethyl)-
  • Stearamide MEA
  • N-(2-hydroxyethyl)stearamide

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
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
Solid (100%)

Melting/freezing point

Study results
  • 1 study submitted
  • 1 study processed
R Melting / freezing point
88.8 °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
Melting / freezing point at 101 325 Pa
88.8 °C

Boiling point

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1
Supporting study
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 Density
0.997 g/cm³ @ 20 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
0.997

Vapour pressure

Study results
  • 1 study submitted
  • 1 study processed
R Vapour pressure
0 - 0 Pa @ 20 - 25 °C [4]

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
0 Pa @ 20 °C

Partition coefficient

Study results
  • 2 studies submitted
  • 2 studies processed
R Pow
28 500 @ 20 °C [1]
R Log Pow
4.46 - 5.55 @ 20 °C [2]

Type of Study provided
Studies with data
Key study 1 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Log Kow (Log Pow)
5.55 @ 20 °C

Water solubility

Study results
  • 2 studies submitted
  • 2 studies processed
R Water solubility (mass/vol.)
1 - 453.58 mg/L @ 20 - 25 °C [3]

Type of Study provided
Studies with data
Key study 1 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Water solubility
1 mg/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 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Surface tension at 20 °C
34.57 mN/m

Flash point

Study results
  • 1 study submitted
  • 1 study processed
R Flash point
238.07 °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
Flash point at 101 325 Pa
238 °C

Auto flammability

Study results
  • 1 study submitted
  • 1 study processed
R Autoflammability / self-ignition
370 °C @ 101.2 - 101.63 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
370 °C

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
  • 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 dynamic viscosity (in mPa s)
20 [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
Dynamic viscosity at 20 °C
20 mPa.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

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

No data available

Phototransformation in water

Data not provided by the registrant

Phototransformation in soil

Data not provided by the registrant

Biodegradation in water - screening tests

Study results
  • 1 study submitted
  • 1 study processed
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 1
Exposure cons.
Other
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
172.36 L/kg ww

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

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
R Summaries
  • 1 summary submitted
  • 1 summary processed
Koc at 20°C
6 418.42

Henrys law constant (H)

Study results
  • 1 study submitted
  • 1 study processed
R H - (pressure) m³/mol
0 Pa m³/mol @ 25 °C and 101.325 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
Henry's law constant
0 Pa.m³.mol-1 @ 25 °C

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 30 µg/L (1)
Intermittent releases (freshwater) 30 µg/L (1)
Marine water 3 µg/L (1)
Intermittent releases (marine water) -
Sewage treatment plant (STP) 830 mg/L (1)
Sediment (freshwater) 19.36 ng/kg sediment dw (1)
Sediment (marine water) 1.94 mg/kg sediment dw (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 3.84 mg/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) 3 mg/L [1]
NOEC (4 days) 3 mg/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
3 mg/L

Long–term toxicity to fish

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
NOEC (28 days) 320 µg/L [1]
LOEC (28 days) 1 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 fish
320 µg/L

Short–term toxicity to aquatic invertebrates

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
EC50 (48 h) 3 mg/L [1]
EC50 (24 h) 3.2 mg/L [1]
NOEC (48 h) 1.8 mg/L [1]
NOEC (24 h) 1.8 mg/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
EC50 / LC50 for freshwater invertebrates
3 mg/L

Long–term toxicity to aquatic invertebrates

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
NOELR (21 days) 1 - 100 mg/L [3]
EL10 (21 days) 1 mg/L [1]
EL50 (21 days) 1 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
1 mg/L

Toxicity to aquatic algae and cyanobacteria

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
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 for freshwater algae
8.7 mg/L
EC10 or NOEC for freshwater algae
300 µg/L

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
EC50 (72 h) 6 g/L [1]
EC10 (72 h) 830 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
6 g/L
EC10 or NOEC for microorganisms
830 mg/L

Sediment toxicity

Data not provided by the registrant

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

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

Data not provided by the registrant

Toxicity to mammals

Data not provided by the registrant

Toxicological information

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

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

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) 73.44 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) 4.16 mg/kg bw/day repeated dose toxicity
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: (DNEL) 93.6 µg/cm² repeated dose toxicity
Acute /short term: Low hazard (no threshold derived)
EYE Exposure
Medium hazard (no threshold derived)
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 21.73 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) 2.5 mg/kg bw/day repeated dose toxicity
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: (DNEL) 18.7 µg/cm² repeated dose toxicity
Acute /short term: Low hazard (no threshold derived)
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 6.25 mg/kg bw/day repeated dose toxicity
Acute /short term: No hazard identified
EYE Exposure
Medium hazard (no threshold derived)

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 11 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 2
Supporting study 8 1
Weight of evidence
Other
Data waiving
no waivers
Study data: dermal absorption
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: dermal absorption
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation potential:
Low bioaccumulation potential
Absorption values
Dermal: 10 %

Acute toxicity

Study results
oral
  • 2 studies submitted
  • 1 study processed
P/RResults
LD50 2 000 mg/kg bw (rat) [1]
M/CInterpretations of results
Not classified [1]

Type of Study provided
oral
Studies with data
Key study 1
Supporting study 1
Weight of evidence
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
  • 1 study processed
P/RResults
LD50 2 000 mg/kg bw (rabbit) [1]
M/CInterpretations of results
Not classified [1]

dermal
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
other routes
  • 0 studies submitted
  • 0 studies processed

No data available

other routes
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route:
No adverse effect observed LD50 2 000 mg/kg bw
Dermal route:
No adverse effect observed LD50 2 000 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
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
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
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin
Adverse effect observed (irritating)
Eye
Adverse effect observed (irritating)
Respiratory
No study available

Sensitisation

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

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: 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
  • 2 studies submitted
  • 1 study processed
P/RResults
NOAEL (rat): 750 mg/kg bw/day [1]

Type of Study provided
Study data: oral
Studies with data
Key study 1
Supporting study 1
Weight of evidence
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
  • 4 studies submitted
  • 3 studies processed
P/RResults
NOAEL (rat): 50 mg/kg bw/day [2]
NOAEL (mouse): 100 mg/kg bw/day [1]

Study data: dermal
Studies with data
Key study 3
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route - systemic effects:
No adverse effect observed NOAEL 750 mg/kg bw/day (subacute, rat)
Dermal route - systemic effects:
Adverse effect observed NOAEL 50 mg/kg bw/day (chronic, rat)
Dermal route - local effects:
Adverse effect observed LOAEL 281 µg/cm² (chronic, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 4 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
Supporting study
Weight of evidence
Other
Data waiving
no waivers
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
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Toxicity - InVitro
No adverse effect observed (negative)
Toxicity - InVivo
No study available

Carcinogenicity

Study results
  • 6 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 1
Supporting study
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 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