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.:
434-430-9
CAS no.:
-
Index number:
Molecular formula:
C42H84N2O4
SMILES:
CCCCCCC(O)CCCCCCCCCCC(=O)NCCCCCCNC(=O)CCCCCCCCCCC(O)CCCCCC
InChI:
InChI=1/C42H84N2O4/c1-3-5-7-23-31-39(45)33-25-17-13-9-11-15-19-27-35-41(47)43-37-29-21-22-30-38-44-42(48)36-28-20-16-12-10-14-18-26-34-40(46)32-24-8-6-4-2/h39-40,45-46H,3-38H2,1-2H3,(H,43,47)(H,44,48)
Type of substance:
Multi constituent substance, UVCB
Origin:
Organic
Registered compositions:
3
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:
ELINCS (European LIst of Notified Chemical Substances) List

Hazard classification & labelling

Warning! According to the classification provided by companies to ECHA in REACH registrations this substance may cause damage to organs through prolonged or repeated exposure, may cause long lasting harmful effects to aquatic life and may cause an allergic skin reaction.

Breakdown of all 180 C&L notifications submitted to ECHA

Aquatic Chronic 4 H413
Skin Sens. 1 H317
STOT RE 2 H373
Skin Sens. 1B H317
Not Classified
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

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

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

Properties of concern

  • Ss
There is broad agreement in that a majority of data submitters agree this substance is Skin sensitising (66.67% of REACH registrations).

Regulatory context

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):

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 has not been registered under the REACH Regulation, therefore as yet ECHA has not received any data about this substance from registration dossiers.

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.

This substance is used in the following products: coating products and inks and toners.

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, closed, continuous processes with occasional controlled exposure, closed batch processing in synthesis or formulation, batch processing in synthesis or formulation with opportunity for exposure, mixing in open batch processes, roller or brushing applications, non-industrial spraying and hand mixing with intimate contact only with personal protective equipment available.

Other release to the environment of this substance is likely to occur from: indoor use as reactive substance and outdoor use as reactive substance.

This substance is used in the following products: coating products, adhesives and sealants, fillers, putties, plasters, modelling clay, inks and toners and welding & soldering products.

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 and closed batch processing in synthesis or formulation.

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

This substance is used in the following products: coating products and inks and toners.

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, closed, continuous processes with occasional controlled exposure, closed batch processing in synthesis or formulation, batch processing in synthesis or formulation with opportunity for exposure, mixing in open batch processes, industrial spraying, roller or brushing applications, treatment of articles by dipping and pouring and laboratory work.

Release to the environment of this substance can occur from industrial use: as processing aid.

This substance is used in the following activities or processes at workplace: transfer of chemicals, closed processes with no likelihood of exposure, closed batch processing in synthesis or formulation, laboratory work and manual maintenance (cleaning and repair) of machinery.

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

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

Prevention statements

When handling this substance: do not breathe the dust, fume, gas, mist, vapours or spray; 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: Take off contaminated clothing and wash it before reuse. If skin irritation or a rash occurs: get medical advice/attention. Get medical advice/attention if you feel unwell. If on skin: wash with soap and water.

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

  • Elementis UK Ltd., Caroline House 55 - 57 High Holborn WC1V 6DX London United Kingdom
  • Polynt Composites France, Route d'Arras 62320 Drocourt France

Substance names and other identifiers

E96096
REACH pre-registration
12-hydroxy-N-[6-(12-hydroxyoctadecanamido)hexyl]octadecanamide
Other
Polyamide wax
C&L Inventory
Reaction products of polyaminoalkane and substitutedoctadecanoic acid
Registration dossier
EA-3098
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
  • 2 studies submitted
  • 2 studies processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [2]
C Form
Crystalline (50%), Powder (50%) [2]
C Substance type
Organic (100%) [2]

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

Melting/freezing point

Study results
  • 2 studies submitted
  • 2 studies processed
R Melting / freezing point
128 - 137.3 °C [4]

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
Melting / freezing point at 101 325 Pa
128 - 134.4 °C

Boiling point

Study results
  • 2 studies submitted
  • 1 study processed
R Boiling point
400 °C [1]

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
  • 1 summary processed
Boiling point at 101 325 Pa
400 °C

Density

Study results
  • 2 studies submitted
  • 2 studies processed
R Relative density
0.962 - 1.03 @ 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
0.962 - 1.03

Vapour pressure

Study results
  • 2 studies submitted
  • 2 studies processed
R Vapour pressure
0 - 0.33 Pa @ 20 - 38.59 °C [5]

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
Vapour pressure
0 - 0.025 Pa @ 20 - 25 °C

Partition coefficient

Study results
  • 5 studies submitted
  • 1 study processed
R Log Pow
6.5 @ 22 °C and pH 7 [1]

Type of Study provided
Studies with data
Key study 2
Supporting study 3
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 1 summary processed
Log Kow (Log Pow)
6.5 @ 22 °C

Water solubility

Study results
  • 3 studies submitted
  • 2 studies processed
R Water solubility (mass/vol.)
5.5 - 100 000 ng/L @ 20 °C and pH 6.5 - 7.1 [5]

Type of Study provided
Studies with data
Key study 2
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Water solubility
5.5 - 100 000 ng/L @ 20 - 20.4 °C

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
Surface tension at 20 °C
71.5 mN/m

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

No data available

Auto flammability

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

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

Flammability

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

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Flammability
Non flammable (100%)

Explosiveness

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

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
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 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
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
  • 1 study processed
C Dissociating properties
No (100%) [1]
R Dissociation constant
-0.12 - 16.9 [4]

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

No automatically processable data submitted

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

No data available

Environmental fate and pathways

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

Phototransformation in air

Data not provided by the registrant

Hydrolysis

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

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Biodegradation in water
Not biodegradable (50%), Under test conditions no biodegradation observed (50%)

Biodegradation in water & sediment - simulation tests

Data not provided by the registrant

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

No data available

Bioaccumulation: aquatic / sediment

Study results
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

No automatically processable data submitted

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 4 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1 3
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 1 summary processed
Koc at 20°C
430 000

Henrys law constant (H)

Data not provided by the registrant

Distribution modelling

Data not provided by the registrant

Ecotoxicological information

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

Predicted No-Effect Concentration (PNEC)

R Summaries
  • 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 200 µg/L (1)
Intermittent releases (freshwater) 180 µg/L (1)
Marine water 20 µg/L (1)
Intermittent releases (marine water) No hazard identified (1)
Sewage treatment plant (STP) 10 mg/L (1)
Sediment (freshwater) 860 mg/kg sediment dw (1)
Sediment (marine water) 86 mg/kg sediment dw (1)
Hazard for Air
Air No hazard identified (2)
Hazard for Terrestrial Organism
Soil 171.5 mg/kg soil dw (1)
Hazard for Predators
Secondary poisoning 27.8 mg/kg food (1)

Short–term toxicity to fish

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
LC50 (4 days) 100 µg/L [1]
NOEC (4 days) 100 µg/L [1]
LL50 (4 days) 100 mg/L [1]
LL100 (4 days) 100 mg/L [1]
NOELR (4 days) 100 mg/L [1]

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
  • 1 summary processed
LC50 for freshwater fish
100 µg/L

Long–term toxicity to fish

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 1
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Short–term toxicity to aquatic invertebrates

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
EL50 (48 h) 100 mg/L [1]
EL100 (48 h) 100 mg/L [1]
NOELR (48 h) 100 mg/L [1]

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
  • 1 summary processed
EC50 / LC50 for freshwater invertebrates
100 µg/L

Long–term toxicity to aquatic invertebrates

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
EC10 (21 days) 10 mg/L [1]
NOELR (21 days) 10 - 100 mg/L [2]
EL50 (21 days) 100 mg/L [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
  • 1 summary processed
EC10 / LC10 or NOEC for freshwater invertebrates
100 mg/L

Toxicity to aquatic algae and cyanobacteria

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
EL50 (72 h) 100 mg/L [2]

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

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
EC50 (3 h) 100 mg/L [1]
EC50 (30 min) 100 mg/L [1]
NOEC (3 h) 100 mg/L [1]
NOEC (30 min) 100 mg/L [1]

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
  • 1 summary processed
EC50 for microorganisms
100 mg/L
EC10 or NOEC for microorganisms
100 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
  • 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. 1
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Toxicity to terrestrial arthropods

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

Toxicity to terrestrial plants

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

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. 1
Other
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
  • 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: (DNEL) 35.24 mg/m³ repeated dose toxicity
Acute /short term: (DNEL) 35.24 mg/m³ repeated dose toxicity
Local Effects
Long-term: (DNEL) 156 µg/m³ repeated dose toxicity
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 10 mg/kg bw/day repeated dose toxicity
Acute /short term: (DNEL) 10 mg/kg bw/day repeated dose toxicity
Local Effects
Long-term: (Medium hazard (no threshold derived)) -
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) 8.69 mg/m³ repeated dose toxicity
Acute /short term: (DNEL) 8.69 mg/m³ repeated dose toxicity
Local Effects
Long-term: (DNEL) 38 µg/m³ repeated dose toxicity
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 5 mg/kg bw/day repeated dose toxicity
Acute /short term: (DNEL) 5 mg/kg bw/day repeated dose toxicity
Local Effects
Long-term: (Medium hazard (no threshold derived)) -
Acute /short term: (No hazard identified) -
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 1.67 mg/kg bw/day repeated dose toxicity
Acute /short term: (DNEL) 5 mg/kg bw/day repeated dose toxicity
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
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: dermal absorption
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Bioaccumulation potential:
Low bioaccumulation potential
Absorption values
Oral: 100 %
Dermal: 10 %
Inhalation: 100 %

Acute toxicity

Study results
oral
  • 2 studies submitted
  • 2 studies processed
P/RResults
LD50 2 000 mg/kg bw (rat) [1]
LD0 2 000 mg/kg bw (rat) [1]
M/CInterpretations of results
Not classified [1]

Type of Study provided
oral
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
inhalation
  • 2 studies submitted
  • 1 study processed
P/RResults
LC0 (4 h) 4.06 mg/L air (rat) [1]

inhalation
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
dermal
  • 2 studies submitted
  • 2 studies processed
P/RResults
LD50 2 000 mg/kg bw (rat) [1]
LD0 2 000 mg/kg bw (rat) [1]
M/CInterpretations of results
Not classified [1]

dermal
Studies with data
Key study 2
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
  • 2 summaries submitted
  • 2 summaries processed
Oral route:
No adverse effect observed LD50 2 000 mg/kg bw
Inhalation route:
No adverse effect observed Discriminating conc. 4 060 mg/m³
Dermal route:
No adverse effect observed LD50 2 000 mg/kg bw

Irritation / corrosion

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

Study data not processed for brief profile

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

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Skin
No adverse effect observed (not irritating)
Eye
No adverse effect observed (not irritating)
Respiratory
No adverse effect observed (not irritating)

Sensitisation

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

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 2
Supporting study
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
Adverse effect observed (sensitising)
Respiratory sensitisation
No study available

Repeated dose toxicity

Study results
Study data: oral
  • 6 studies submitted
  • 6 studies processed
P/RResults
NOAEL (rat): 1 000 mg/kg bw/day [5]
NOEL (rat): 1 000 mg/kg bw/day [1]

Type of Study provided
Study data: oral
Studies with data
Key study 4 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: inhalation
  • 3 studies submitted
  • 1 study processed
P/RResults
NOAEC (rat): 1.55 mg/m³ air [1]

Study data: inhalation
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other 1
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 1
Exposure cons.
Other 1
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Oral route - systemic effects:
No adverse effect observed NOAEL 1 000 mg/kg bw/day (subchronic, rat)
Inhalation route - systemic effects:
No adverse effect observed NOAEC 26 mg/m³ (subchronic, rat)
Inhalation route - local effects:
Adverse effect observed NOAEC 1.55 mg/m³ (subchronic, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 6 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 6
Supporting study
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
  • 2 summaries submitted
  • 2 summaries processed
Toxicity - InVitro
No adverse effect observed (negative)
Toxicity - InVivo
No study available

Carcinogenicity

Data not provided by the registrant

Toxicity to reproduction

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

Study data not processed for brief profile

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

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 3 2
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
  • 2 summaries submitted
  • 2 summaries processed
Effect on fertility
Oral route:
No adverse effect observed NOAEL 1 000 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