Brief Profile

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Please be aware that the REACH registration parts of this Brief Profile are no longer maintained; they remain frozen as of 19th May 2023. All other data parts (substance identity, C&L, key regulatory lists etc. are up to date).

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.:
213-424-8
CAS no.:
947-04-6
Index number:
Molecular formula:
C12H23NO
SMILES:
O=C1CCCCCCCCCCCN1
InChI:
InChI=1S/C12H23NO/c14-12-10-8-6-4-2-1-3-5-7-9-11-13-12/h1-11H2,(H,13,14)
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
6
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:
EINECS (European INventory of Existing Commercial chemical Substances) List

Hazard classification & labelling

According to the notifications provided by companies to ECHA in REACH registrations no hazards have been classified.

Additionally, the classification provided by companies to ECHA in CLP notifications identifies that this substance is harmful to aquatic life with long lasting effects.

Breakdown of all 14 C&L notifications submitted to ECHA

Not Classified
Aquatic Chronic 3 H412
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:
Substance pre-registered under REACH.
Registration:
This substance has 7 active registrations under REACH, 1 Joint Submission(s) and 0 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 is registered under the REACH Regulation and is manufactured in and / or imported to the European Economic Area, at ≥ 10 000 to < 100 000 tonnes per annum.

This substance is used at industrial sites and in manufacturing.

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

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

ECHA has no public registered data on the use of this substance in activities or processes at the workplace.

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

ECHA has no public registered data indicating whether or into which articles the substance might have been processed.

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

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

ECHA has no public registered data on the use of this substance in activities or processes at the workplace.

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

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

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 products: polymers. This substance has an industrial use resulting in manufacture of another substance (use of intermediates).

This substance is used for the manufacture of: chemicals, plastic products and .

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, transfer of substance into small containers and laboratory work.

Release to the environment of this substance can occur from industrial use: as an intermediate step in further manufacturing of another substance (use of intermediates), for thermoplastic manufacture and manufacturing of the substance.

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, 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, as an intermediate step in further manufacturing of another substance (use of intermediates) and for thermoplastic manufacture.

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

  • AGIPLAST ITALIA SRL, Via Principe Amedeo 3 20121 Milano Italy
  • ARKEMA FRANCE, 420 rue d'Estienne d'Orves 92700 COLOMBES France
  • BorsodChem Zrt. - OR, Bolyai ter 1. H-3700 Kazincbarcika Hungary
  • Evonik Operations GmbH, Rellinghauser Straße 1-11 45128 Essen Germany
  • Intertek Deutschland GmbH 27, Stangenstrasse 1 70771 Leinfelden-Echterdingen Germany
  • NAM & NAM Europe GmbH, Am Kronberger Hang 2 65824 Schwalbach Germany
  • [Confidential], [Confidential]

Substance names and other identifiers

1-Aza-2-cyclotridecanone
Other
2-Azacyclotridecanone
Other
2-Oxo-dodecamethylenimine
Other
Cyclododecalactam
Other
Dodecane-12-lactam
EC Inventory, REACH pre-registration
Dodecane-12-lactam
REACH pre-registration, Other
Dodecanoic acid, 12-amino-, lactam
Other
Dodecyllactam
Other
Laurin lactam
Other
Laurinolactam
Other
laurolactam
Other, FCM and Articles Regulation, Annex I - Authorised Substances, FCMs Recycled Plastic & Articles Regulation - Annex I - Authorised Use, Recycled Plastic FCMs - Regulation (EU) 2022/1616
Lauryl lactam
Other
omega-Dodecalactam
Other
omega-Dodecanolactam
Other
omega-Laurolactam
Other
1-azacyclotridecan-2-one
Other
Azacyclotridecan-2-on
C&L Inventory
Azacyclotridecan-2-one
C&L Inventory, Registration dossier, Other
Dodecane-12-lactam
C&L Inventory, Registration dossier
Dodecane-12-lactam
C&L Inventory, Registration dossier
omega-Laurinlactam
C&L Inventory
ANYBES
Registration dossier
Dodecane-12-lactam
Registration dossier
Laurinlactam
Registration dossier
lauryl lactame
Registration dossier
115296-76-9
CAS number
Other
125081-69-8
CAS number
Other
148308-40-1
CAS number
Other
161865-23-2
CAS number
Other
70099-82-0
CAS number
Other
947-04-6
CAS number
EC Inventory, C&L Inventory, Registration dossier, REACH pre-registration, Other, FCM and Articles Regulation, Annex I - Authorised Substances, FCMs Recycled Plastic & Articles Regulation - Annex I - Authorised Use, Recycled Plastic FCMs - Regulation (EU) 2022/1616

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
Pellets (100%) [1]
C Odour
Slight (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
  • 7 studies submitted
  • 2 studies processed
R Melting / freezing point
149 - 151.8 °C @ 101.3 kPa [2]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 7
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Melting / freezing point at 101 325 Pa
151.8 °C

Boiling point

Study results
  • 2 studies submitted
  • 2 studies processed
R Boiling point
348 - 361.75 °C @ 101.3 kPa [2]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 1 1
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Boiling point at 101 325 Pa
348 °C

Density

Study results
  • 2 studies submitted
  • 1 study processed
R Density
0.906 - 0.973 g/cm³ @ 20 - 160 °C [4]

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
Relative density at 20°C
0.973

Vapour pressure

Study results
  • 3 studies submitted
  • 1 study processed
R Vapour pressure
0.001 Pa @ 20 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other 1
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Vapour pressure
0.001 Pa @ 20 °C

Partition coefficient

Study results
  • 5 studies submitted
  • 1 study processed
R Pow
471.09 - 531.25 @ 20 °C and pH 4.8 [1]
R Log Pow
2.71 @ 20 °C and pH 4.8 [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 2 1
Weight of evidence
Other 1
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Log Kow (Log Pow)
2.71 @ 20 °C

Water solubility

Study results
  • 5 studies submitted
  • 1 study processed
R Water solubility (mass/vol.)
223 mg/L @ 20 °C and pH 6.56 - 7.55 [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 3
Weight of evidence
Other 1
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Water solubility
223 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
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

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

No automatically processable data submitted

Auto flammability

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

No automatically processable data submitted

Flammability

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

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

No automatically processable data submitted

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

No automatically processable data submitted

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
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Viscosity

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible 1
Sci. unjustified
Exposure cons.
Other
Summaries
  • 1 summary 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
  • 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 1
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Half life in air
14.3 h

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

No automatically processable data submitted

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
  • 3 studies 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 2
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Biodegradation in water
Readily biodegradable (100%)

Biodegradation in water & sediment - simulation tests

Data not provided by the registrant

Biodegradation in soil

Study results
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

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

No data available

Bioaccumulation: aquatic / sediment

Study results
  • 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 1 1
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation Factor (BCF) - dimensionless
1.2

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

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

No automatically processable data submitted

Henrys law constant (H)

Study results
  • 2 studies submitted
  • 1 study processed
R H - (pressure) m³/mol
0.001 Pa m³/mol @ 20 °C and 101.325 kPa [1]

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

No automatically processable data submitted

Distribution modelling

Study results
  • 2 studies submitted
  • 1 study processed
% Distribution in Media:
R Air 0.033 % [1]
R Water 92.267 % [1]
R Soil 3.815 % [1]
R Sediment 3.858 % [1]
R Suspended sediment 0.025 % [1]
R Biota 0.002 % [1]
R Aerosol 0 % [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other 1
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
  • 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 59 µg/L (1)
Intermittent releases (freshwater) 590 µg/L (1)
Marine water 5.9 µg/L (1)
Intermittent releases (marine water) -
Sewage treatment plant (STP) No data: aquatic toxicity unlikely (1)
Sediment (freshwater) 13.53 mg/kg sediment dw (1)
Sediment (marine water) No exposure of sediment expected (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 2.67 mg/kg soil dw (1)
Hazard for Predators
Secondary poisoning No potential for bioaccumulation (1)

Short–term toxicity to fish

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
LC50 (4 days) 63 mg/L [1]
LC0 (4 days) 48 mg/L [1]
LC100 (4 days) 84 mg/L [1]

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

No automatically processable data submitted

Long–term toxicity to fish

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No data available

Short–term toxicity to aquatic invertebrates

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
EC50 (48 h) 59 mg/L [1]
EC50 (24 h) 59 mg/L [1]
EC0 (48 h) 23 mg/L [1]
EC100 (48 h) 245 mg/L [1]

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

No automatically processable data submitted

Long–term toxicity to aquatic invertebrates

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 aquatic algae and cyanobacteria

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
EC50 (72 h) 172 - 176 mg/L [2]
NOEC (72 h) 135 mg/L [1]
EC10 (72 h) 137 - 141 mg/L [2]

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

Toxicity to aquatic plants other than algae

Data not provided by the registrant

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

No automatically processable data submitted

Sediment toxicity

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No data available

Toxicity to terrestrial arthropods

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No data available

Toxicity to terrestrial plants

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No data available

Toxicity to soil microorganisms

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No data available

Toxicity to birds

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

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) 880 µg/m³ repeated dose toxicity
Acute /short term: (DNEL) 880 µg/m³ repeated dose toxicity
Local Effects
Long-term: (No hazard identified) -
Acute /short term: (No hazard identified) -
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 250 µg/kg bw/day repeated dose toxicity
Acute /short term: (DNEL) 250 µg/kg bw/day repeated dose toxicity
Local Effects
Long-term: (No hazard identified) -
Acute /short term: (No hazard identified) -
EYE Exposure
No hazard identified
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
EYE Exposure
No hazard identified

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

Study data not processed for brief profile

Study data: dermal absorption
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation potential:
No bioaccumulation potential

Acute toxicity

Study results
oral
  • 8 studies submitted
  • 1 study processed
P/RResults
LD50 2 330 mg/kg bw (rat) [1]

Type of Study provided
oral
Studies with data
Key study 1
Supporting study 7
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 1
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
dermal
  • 3 studies submitted
  • 1 study processed
P/RResults
LD50 2 000 mg/kg bw (rat) [1]

dermal
Studies with data
Key study 1
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
other routes
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

other routes
Studies with data
Key study
Supporting study 1
Weight of evidence
Other 1
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route:
No adverse effect observed LD50 2 330 mg/kg bw
Dermal route:
No adverse effect observed LD50 2 000 mg/kg bw

Irritation / corrosion

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

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other 2
Data waiving
Not feasible
Sci. unjustified 1
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 1
Supporting study 1
Weight of evidence
Other 1
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin
No adverse effect observed (not irritating)
Eye
No adverse effect observed (not irritating)
Respiratory
No study available

Sensitisation

Study results
Study data: skin
  • 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
  • 3 studies submitted
  • 1 study processed
P/RResults
NOAEL (rat): 25 mg/kg bw/day [1]

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

No automatically processable data submitted

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

No automatically processable data submitted

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
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

Carcinogenicity

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
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

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

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 2
Supporting study 2
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
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

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