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Please be aware that the REACH registration parts of this Brief Profile are no longer maintained; they remain frozen as of 19th May 2023.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.:
258-649-2
CAS no.:
53585-53-8
Index number:
Molecular formula:
SMILES:
InChI:
Type of substance:
UVCB
Origin:
Organic
Registered compositions:
3
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:
EINECS (European INventory of Existing Commercial chemical Substances) List

Hazard classification & labelling

Danger! According to the classification provided by companies to ECHA in REACH registrations this substance may be fatal if swallowed and enters airways, is very toxic to aquatic life with long lasting effects and may damage fertility or the unborn child.

Additionally, the classification provided by companies to ECHA in CLP notifications identifies that this substance may damage fertility and may damage the unborn child.

Breakdown of all 130 C&L notifications submitted to ECHA

Asp. Tox. 1 H304
Repr. 1B H360FD
Aquatic Chronic 1 H410
Aquatic Chronic 4 H413
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

  • R
There is broad agreement in that a majority of data submitters agree this substance is Toxic to Reproduction (80% of REACH registrations).
  • PBT
There is broad agreement in that a majority of data submitters agree this substance is Persistent, Bioaccumulative and Toxic (50% 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 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 ≥ 1 000 to < 10 000 tonnes per annum.

This substance is used in articles, 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.

This substance is used in the following activities or processes at workplace: production of mixtures or articles by tabletting, compression, extrusion or pelletisation 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. Other release to the environment of this substance is likely to occur from: outdoor use in long-life materials with low release rate (e.g. metal, wooden and plastic construction and building materials) and 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).

This substance can be found in complex articles, with no release intended: vehicles. This substance can be found in products with material based on: rubber (e.g. tyres, shoes, toys).

This substance is used in the following products: heat transfer fluids.

This substance is used for the manufacture of: electrical, electronic and optical equipment.

This substance is used in the following activities or processes at workplace: mixing in open batch processes, heat / pressure transfer fluids in closed systems and hand mixing with intimate contact only with personal protective equipment available.

Release to the environment of this substance can occur from industrial use: of substances in closed systems with minimal release. Other release to the environment of this substance is likely to occur from: indoor use in close systems with minimal release (e.g. cooling liquids in refrigerators, oil-based electric heaters) and outdoor use in close systems with minimal release (e.g. hydraulic liquids in automotive suspension, lubricants in motor oil and break fluids).

This substance is used in the following products: polymers.

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

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

This substance is used in the following products: heat transfer fluids and air care products.

This substance is used in the following areas: mining. This substance is used for the manufacture of: chemicals, rubber products, electrical, electronic and optical equipment and machinery and vehicles.

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, closed, continuous processes with occasional controlled exposure, 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: of substances in closed systems with minimal release and in the production of articles.

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

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

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

Prevention statements

When handling this substance: avoid release to the environment.

Response statements

In case of incident: If swallowed: immediately call a poison center or doctor/physician. Do not induce vomiting. Collect spillage.

Storage statements

Store this substance locked up.

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

  • ARKEMA FRANCE, 420 rue d'Estienne d'Orves 92700 COLOMBES France
  • Eastman Chemical HTF GmbH, Paul-Baumannstraße 1 Bau 822/ PB09 45772 Marl Germany

Substance names and other identifiers

Dibenzylbenzene, ar-methyl derivative
EC Inventory, REACH pre-registration
Dibenzylbenzene, ar-methyl derivative
REACH pre-registration, Other
1,2-dibenzyl-3-methylbenzene
Other
Benzene, bis(phenylmethyl)-, ar-methyl deriv.
C&L Inventory
dibenzylbenzene, ar-methyl derivative
C&L Inventory, Registration dossier
dibenzyltoluene
Registration dossier
Benzene, methylbis(phenylmethyl)-
Registration dossier
Dibenzyl toluene
Registration dossier
MARLOTHERM SH
Registration dossier
Methylbis(phenylmethyl)benzene; Dibenzyltoluene
Registration dossier
53585-53-8
CAS number
EC Inventory, C&L Inventory, Registration dossier, REACH pre-registration, Other

Scientific properties

Physical and chemical properties

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

Appearance/physical state / colour

Study results
  • 2 studies submitted
  • 2 studies processed
C Physical state at 20°C and 1013 hPa
Liquid (100%) [2]
C Odour
Faint (100%) [2]
C Substance type
Organic (100%) [2]

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
Physical state at 20°C and 1013 hPa
Liquid (100%)

Melting/freezing point

Study results
  • 2 studies submitted
  • 2 studies processed
R Melting / freezing point
-38.5 - -32.8 °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
  • 1 summary processed
Melting / freezing point at 101 325 Pa
-38.5 °C

Boiling point

Study results
  • 4 studies submitted
  • 2 studies processed
R Boiling point
390.1 °C @ 101 kPa [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Boiling point at 101 325 Pa
390.1 °C

Density

Study results
  • 2 studies submitted
  • 2 studies processed
R Density
1.04 g/cm³ @ 20 °C [1]
R Relative density
1.04 @ 20 °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
  • 2 summaries processed
Relative density at 20°C
1.044

Vapour pressure

Study results
  • 2 studies submitted
  • 2 studies processed
R Vapour pressure
0.001 - 0.002 Pa @ 20 - 25 °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
Vapour pressure
0.001 Pa @ 20 °C

Partition coefficient

Study results
  • 2 studies submitted
  • 2 studies processed
R Log Pow
6 @ 22 °C and pH 7 [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
Log Kow (Log Pow)
6 @ 22 °C

Water solubility

Study results
  • 2 studies submitted
  • 2 studies processed
R Water solubility (mass/vol.)
18 µg/L @ 20 °C and pH 7 [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
Water solubility
18 µg/L @ 20 °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
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Flash point

Study results
  • 2 studies submitted
  • 2 studies processed
R Flash point
212 °C @ 101.3 kPa [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
Flash point at 101 325 Pa
212 °C

Auto flammability

Study results
  • 2 studies submitted
  • 2 studies processed
R Autoflammability / self-ignition
500 °C @ 99 - 100 kPa [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
Autoflammability / self-ignition at 101 325 Pa
500 °C

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
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Explosiveness

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Oxidising

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Viscosity

Study results
  • 4 studies submitted
  • 4 studies processed
R kinematic viscosity (in mm²/s)
16.35 - 47.94 [4]

Type of Study provided
Studies with data
Key study 4
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Static viscosity at 20 °C
47.94 mm²/s

Environmental fate and pathways

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

Phototransformation in air

Study results
  • 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
  • 0 summaries submitted
  • 0 summaries processed

No data available

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
Sci. unjustified 2
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
  • 10 studies submitted
  • 6 studies processed
C Interpretation of results
Inherently biodegradable (67%), Under test conditions no biodegradation observed (33%) [6]

Type of Study provided
Studies with data
Key study
Supporting study 4
Weight of evidence 6
Other
Data waiving
no waivers
C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Biodegradation in water
Inherently biodegradable, not fulfilling specific criteria (100%)
Type of water
Freshwater (100%)

Biodegradation in water & sediment - simulation tests

Study results
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Half-life in freshwater
56.9 days @ 12 °C

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

No data available

Bioaccumulation: aquatic / sediment

Study results
  • 5 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study 2
Supporting study 2
Weight of evidence 1
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Bioaccumulation Factor (BCF) - L/kg ww
7 525 L/kg ww

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 2 studies submitted
  • 2 studies processed
R log Koc
3.548 - 5.578 dimensionless [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
Koc at 20°C
3 532

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 140 ng/L (1)
Intermittent releases (freshwater) No data: aquatic toxicity unlikely (1)
Marine water 14 ng/L (1)
Intermittent releases (marine water) No data: aquatic toxicity unlikely (1)
Sewage treatment plant (STP) 1 g/L (2)
Sediment (freshwater) 50 - 110 µg/kg sediment dw (2)
Sediment (marine water) 5 - 110 µg/kg sediment dw (2)
Hazard for Air
Air No hazard identified (2)
Hazard for Terrestrial Organism
Soil 1 - 2 mg/kg soil dw (2)
Hazard for Predators
Secondary poisoning 11.1 mg/kg food (2)

Short–term toxicity to fish

Study results
  • 14 studies submitted
  • 2 studies processed
P/RResults
LC50 (4 days) 50 µg/L [2]
NOEC (4 days) 50 µg/L [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 4
Weight of evidence
Other 8
Data waiving
no waivers
Summaries
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Long–term toxicity to fish

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
NOEC (32 days) 5.5 - 17 µg/L [7]

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

No automatically processable data submitted

Short–term toxicity to aquatic invertebrates

Study results
  • 12 studies submitted
  • 4 studies processed
P/RResults
LC50 (48 h) 20.6 - 29 µg/L [4]
LC0 (48 h) 29 µg/L [2]
NOEC (48 h) 9 µg/L [2]

Type of Study provided
Studies with data
Key study 4
Supporting study 2
Weight of evidence
Other 6
Data waiving
no waivers
Summaries
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Long–term toxicity to aquatic invertebrates

Study results
  • 3 studies submitted
  • 3 studies processed
P/RResults
NOEC (21 days) 1.4 - 30 µg/L [3]
LOEC (21 days) 100 µg/L [2]

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

No automatically processable data submitted

Toxicity to aquatic algae and cyanobacteria

Study results
  • 10 studies submitted
  • 2 studies processed
P/RResults
EC50 (72 h) 9.23 - 16 µg/L [3]
NOEC (72 h) 9.23 - 16 µg/L [3]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other 6 2
Data waiving
no waivers
Summaries
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

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
EC10 (4.92 h) 1 g/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
  • 2 summaries processed
EC10 or NOEC for microorganisms
1 g/L

Sediment toxicity

Study results
  • 5 studies submitted
  • 4 studies processed
P/RResults
NOEC (10 days) 40.2 - 45.1 mg/kg sediment dw [4]
LC50 (10 days) 99.9 - 119.3 mg/kg sediment dw [4]

Type of Study provided
Studies with data
Key study 4
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons. 1
Other
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
EC50 / LC50 for marine water sediment
110 mg/kg sediment dw
EC10 / LC10 or NOEC for marine water sediment
42 mg/kg sediment dw

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
  • 2 studies processed
P/RResults
LC50 (14 days) 850 mg/kg soil dw [2]
LC50 (7 days) 1 g/kg soil dw [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Short-term EC50 / LC50
850 mg/kg soil dw

Toxicity to terrestrial arthropods

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
LOEC (28 days) 320 - 1 000 mg/kg soil ww [4]
NOEC (28 days) 100 - 320 mg/kg soil ww [4]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Short-term EC50 / LC50
100 mg/kg soil dw

Toxicity to terrestrial plants

Study results
  • 3 studies submitted
  • 2 studies processed
P/RResults
NOEC (20 days) 100 mg/kg soil dw [4]
NOEC (19 days) 100 mg/kg soil dw [2]
EC50 (20 days) 100 mg/kg soil dw [4]
EC50 (19 days) 100 mg/kg soil dw [2]
LC50 (20 days) 100 mg/kg soil dw [4]

Type of Study provided
Studies with data
Key study 2
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 soil microorganisms

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
NOEC (28 days) 515.4 mg/kg soil dw [1]

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

No automatically processable data submitted

Toxicity to birds

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Toxicity to mammals

Data not provided by the registrant

Toxicological information

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

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

M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed

The derived no- or minimum effect level (DN(M)EL) is the level of exposure above which a human should not be exposed to a substance. Please note that when more than one summary is provided, DN(M)EL values may refer to constituents of the substance and not to the substance as a whole. More detailed information is available in the dossiers.

Data for WORKERS
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 660 µg/m³ developmental toxicity / teratogenicity
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: Low hazard (no threshold derived)
Acute /short term: Low hazard (no threshold derived)
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 500 µg/kg bw/day repeated dose toxicity
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: Low hazard (no threshold derived)
Acute /short term: Low hazard (no threshold derived)
EYE Exposure
Low hazard (no threshold derived)
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 120 µg/m³ developmental toxicity / teratogenicity
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: Low hazard (no threshold derived)
Acute /short term: Low hazard (no threshold derived)
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 250 µg/kg bw/day repeated dose toxicity
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: Low hazard (no threshold derived)
Acute /short term: Low hazard (no threshold derived)
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 60 µg/kg bw/day developmental toxicity / teratogenicity
Acute /short term: Low hazard (no threshold derived)
EYE Exposure
Low hazard (no threshold derived)

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 3 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 3
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
Supporting study
Weight of evidence
Other 1
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 1 summary processed
Absorption values
Oral: 100 %
Dermal: 10 %
Inhalation: 100 %

Acute toxicity

Study results
oral
  • 6 studies submitted
  • 3 studies processed
P/RResults
LD50 2 000 mg/kg bw (rat) [1]
LD0 10 360 mg/kg bw (rat) [2]
M/CInterpretations of results
GHS criteria not met [1]

Type of Study provided
oral
Studies with data
Key study 3
Supporting study 3
Weight of evidence
Other
Data waiving
no waivers
inhalation
  • 4 studies submitted
  • 2 studies processed
P/RResults
LC0 (4 h) 240 mg/m³ air (rat) [2]
M/CInterpretations of results
Study cannot be used for classification [1]

inhalation
Studies with data
Key study 2
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
dermal
  • 4 studies submitted
  • 3 studies processed
P/RResults
LD50 2 000 mg/kg bw (rat) [1]
LD0 2 000 mg/kg bw (rabbit) [2]
M/CInterpretations of results
GHS criteria not met [1]

dermal
Studies with data
Key study 3
Supporting study 1
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
  • 1 summary processed
Oral route:
No adverse effect observed LD0 10 360 mg/kg bw
Inhalation route:
No adverse effect observed LC0 240 µg/m³ air
Dermal route:
No adverse effect observed LD0 2 000 mg/kg bw

Irritation / corrosion

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

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 2
Supporting study 6
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
Study data: eye
  • 8 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 3
Supporting study 3
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Skin
Adverse effect observed (irritating)
Eye
No adverse effect observed (not irritating)
Respiratory
No adverse effect observed (not irritating)

Sensitisation

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

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 1
Supporting study 3
Weight of evidence 4
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
Study data: respiratory
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: respiratory
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Skin sensitisation
No adverse effect observed (not sensitising)
Respiratory sensitisation
No study available

Repeated dose toxicity

Study results
Study data: oral
  • 5 studies submitted
  • 3 studies processed
P/RResults
NOAEL (rat): 50 mg/kg bw/day [2]
LOAEL (rat): 500 mg/kg bw/day [2]
NOEL (rat): 10 mg/kg bw/day [1]

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

No data available

Study data: inhalation
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: dermal
  • 0 studies submitted
  • 0 studies processed

No data available

Study data: dermal
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 - systemic effects:
Adverse effect observed NOAEL 50 mg/kg bw/day (subchronic, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 15 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 5
Supporting study 3
Weight of evidence
Other 6
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Study data: in vivo
  • 8 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: in vivo
Studies with data
Key study 4
Supporting study 2
Weight of evidence
Other 2
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Toxicity - InVitro
No adverse effect observed (negative)
Toxicity - InVivo
No adverse effect observed (negative)

Carcinogenicity

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

No automatically processable data submitted

Toxicity to reproduction

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

Study data not processed for brief profile

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

Study data not processed for brief profile

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

Study data not processed for brief profile

Study data: other studies
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 1 summary processed
Effect on fertility
Oral route:
Adverse effect observed NOAEL 250 mg/kg bw/day (subacute, rat)
Effect on developmental toxicity
Oral route:
Adverse effect observed LOAEL 10 mg/kg bw/day (subacute, rabbit)

Neurotoxicity

Data not provided by the registrant

Immunotoxicity

Data not provided by the registrant

Endocrine disrupter mammalian screening - in vivo

Study results
  • 1 study submitted
  • 1 study processed
C Endocrine disrupting potential
ambiguous (100%) [1]

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

No summary exists for this scientific endpoint