Brief Profile

Diss Brief Profile

The Brief Profile summarizes the non-confidential data on substances as it is held in the databases of the European Chemicals Agency (ECHA), including data provided by third parties. The Brief Profile is automatically generated; note that it does not currently distinguish between harmonised classification and minimum classification; information requirements under different legislative frameworks may therefore not be fully up to date or complete. For accuracy reasons, substance manufacturers and imports have the responsibility to consult official sources, e.g. the electronic edition of the Official Journal of the European Union.
This Brief Profile is covered by the ECHA Legal Notice.

Substance Description

Substance identity

No image available
EC / List no.:
226-378-9
CAS no.:
5384-21-4
Index number:
Molecular formula:
SMILES:
InChI:
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
4
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 very toxic to aquatic life, causes serious eye irritation, causes skin irritation and may cause respiratory irritation.

Breakdown of all 43 C&L notifications submitted to ECHA

Aquatic Acute 1 H400
Eye Irrit. 2 H319
Skin Irrit. 2 H315
STOT SE 3 H335
Not Classified
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

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

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

Properties of concern

  • ED
Under assessment as Endocrine Disrupting (ED list).

Regulatory context

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

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 3 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 ≥ 100 to < 1 000 tonnes per annum.

This substance is used in articles, 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: the low energy manipulation of substances bound in materials or articles.

Release to the environment of this substance can occur from industrial use: industrial abrasion processing with low release rate (e.g. cutting of textile, cutting, machining or grinding of metal).

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.

This substance is used in the following products: laboratory chemicals and polymers.

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

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

This substance is used in the following products: polymers.

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 and transfer of substance into small containers.

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) and in processing aids at industrial sites.

This substance is used in the following activities or processes at workplace: closed processes with no likelihood of exposure, closed, continuous processes with occasional controlled exposure, closed batch processing in synthesis or formulation, 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: Collect spillage.

Guidance on the safe use of the substance provided by manufacturers and importers of this substance.

Registrants/suppliers

  • SI Group Germany (DEAB) GmbH, Teplitzer Strasse 14-16 84478 Waldkraiburg Germany
  • The Valspar (France) Corporation, S.A.S., Boite Postale 51 14, Rue Chanay 71700 Tournus Saone & Loire France
  • Valspar BV-1, Zuiveringweg 89 8243 PE Lelystad Netherlands
  • Global Product Compliance (Europe) AB, IDEON, Beta 5, Scheelevägen 17 22363 Lund Sweden

Substance names and other identifiers

4,4'-methylenedi-2,6-xylenol
EC Inventory
4,4'-methylenedi-2,6-xylenol
REACH pre-registration
4,4'-methylen-bis-(2,6-xylenol)
C&L Inventory
4,4'-Methylenebis(2,6-dimethylphenol)
C&L Inventory, Registration dossier
4,4'-Methylenedi-2,6-xylenol
C&L Inventory
4,4'-Methylenedi-2,6-xylenol
Registration dossier
4-[(4-hydroxy-3,5-dimethylphenyl)methyl]-2,6-dimethylphenol
Registration dossier, Other
Tetramethyl Bisphenol F
C&L Inventory
5384-21-4
CAS number
EC Inventory, C&L Inventory, Registration dossier, REACH pre-registration

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
  • 1 study processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [1]
C Form
Other (100%) [1]
C Odour
Odourless (100%) [1]
C Substance type
Organic (100%) [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 1
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
  • 3 studies submitted
  • 1 study processed
R Melting / freezing point
170 - 175 °C @ 97.83 kPa [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Melting / freezing point at 101 325 Pa
170 °C

Boiling point

Study results
  • 1 study submitted
  • 1 study processed
R Boiling point
240 °C @ 97.89 kPa [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Boiling point at 101 325 Pa
240 °C

Density

Study results
  • 1 study submitted
  • 1 study processed
R Bulk density
0.744 g/cm³ @ 25 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
0.744

Vapour pressure

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

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Vapour pressure
0 Pa @ 25 °C

Partition coefficient

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Log Kow (Log Pow)
3.75 @ 25 °C

Water solubility

Study results
  • 1 study submitted
  • 1 study processed
R Water solubility (mass/vol.)
100 mg/L @ 25 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Water solubility
100 mg/L @ 25 °C

Solubility in organic solvents / fat solubility

Study results
  • 2 studies submitted
  • 1 study processed
R Methanol
3.95 g/L @ 25 °C [1]

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
Solubility in organic solvents at 20 °C
3.95 g/L

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

No automatically processable data submitted

Flash point

Study results
  • 2 studies submitted
  • 2 studies processed
R Flash point
121.6 - 131.5 °C @ 97.88 - 99.5 kPa [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
Flash point at 101 325 Pa
121.6 °C

Auto 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

Flammability

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

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

Explosiveness

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
C Summaries
  • 1 summary submitted
  • 1 summary processed
Explosiveness
Non-explosive (100%)

Oxidising

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
C Summaries
  • 1 summary submitted
  • 1 summary processed
Oxidising
No (100%)

Oxidation reduction potential

Data not provided by the registrant

pH

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

No summary exists for this scientific endpoint

Dissociation constant

Study results
  • 1 study submitted
  • 1 study processed
C Dissociating properties
Yes (100%) [1]
R Dissociation constant
0 @ 25 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
pKa at 20 °C
0

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

Data not provided by the registrant

Hydrolysis

Study results
  • 3 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 2 1
Other
Data waiving
no waivers
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
  • 3 studies processed
C Interpretation of results
Not readily biodegradable (100%) [3]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 2 1
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Biodegradation in water
Under test conditions no biodegradation observed (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
37.5 days @ 25 °C
Half-life in freshwater sediment
11.25 months @ 25 °C

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 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Half-life in soil
75 days @ 25 °C

Bioaccumulation: aquatic / sediment

Study results
  • 4 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 2 2
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation Factor (BCF) - L/kg ww
1 340 L/kg ww

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 3 studies submitted
  • 3 studies processed
R Koc
1 - 108 600 dimensionless @ 25 °C [4]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 1 2
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Koc at 20°C
108 600

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
  • 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 720 ng/L (1)
Intermittent releases (freshwater) 3.46 µg/L (1)
Marine water 72 ng/L (1)
Intermittent releases (marine water) 346 ng/L (1)
Sewage treatment plant (STP) 11.616 mg/L (1)
Sediment (freshwater) 7.82 mg/kg sediment dw (1)
Sediment (marine water) 782 µg/kg sediment dw (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 1.56 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
  • 3 studies processed
P/RResults
LC50 (4 days) 1.77 - 5 mg/L [4]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 2 1
Other
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
  • 1 study processed
P/RResults
NOEC (28 days) 36 µg/L [1]

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

Short–term toxicity to aquatic invertebrates

Study results
  • 4 studies submitted
  • 4 studies processed
P/RResults
EC50 (48 h) 10 - 346 µg/L [5]
LC50 (48 h) 346 µg/L [1]

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

No automatically processable data submitted

Long–term toxicity to aquatic invertebrates

Study results
  • 4 studies submitted
  • 4 studies processed
P/RResults
NOEC (21 days) 5.7 - 44 µg/L [6]
EC50 (21 days) 20 µg/L [2]

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

No automatically processable data submitted

Toxicity to aquatic algae and cyanobacteria

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 3 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 2 1
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 for microorganisms
116.16 mg/L

Sediment toxicity

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
LC50 (48 h) 800 - 910 mg/L [1]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 3
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 / LC50 for freshwater sediment
800 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
  • 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

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

No automatically processable data submitted

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

No automatically processable data submitted

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

No automatically processable data submitted

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) 617 µg/m³ effect on fertility
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) 175 µg/kg bw/day effect on fertility
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) 109 µg/m³ effect on fertility
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) 62.5 µg/kg bw/day effect on fertility
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) 62.5 µg/kg bw/day effect on fertility
Acute /short term: Low hazard (no threshold derived)
EYE Exposure
Low hazard (no threshold derived)

Toxicokinetics, metabolism, and distribution

Data not provided by the registrant

Acute toxicity

Study results
oral
  • 2 studies submitted
  • 1 study processed
P/RResults
LD50 2 000 mg/kg bw (rat) [1]
M/CInterpretations of results
Other [1]

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

No automatically processable data submitted

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

dermal
Studies with data
Key study 1
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
  • 1 summary submitted
  • 1 summary processed
Oral route:
No adverse effect observed LD50 2 000 mg/kg bw
Dermal route:
No adverse effect observed LD50 2 000 mg/kg bw

Irritation / corrosion

Study results
Study data: skin
  • 3 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
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Study data: eye
  • 3 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
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
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
  • 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
Supporting study
Weight of evidence 2 1
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
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)

Repeated dose toxicity

Study results
Study data: oral
  • 4 studies submitted
  • 4 studies processed
P/RResults
NOAEL (rat): 750 - 1 000 mg/kg bw/day [7]

Type of Study provided
Study data: oral
Studies with data
Key study 4
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: inhalation
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Study data: inhalation
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
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
Exposure cons.
Other 1
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route - systemic effects:
No adverse effect observed NOAEL 750 mg/kg bw/day (subchronic, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 8 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
Supporting study
Weight of evidence 7 1
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

Data not provided by the registrant

Toxicity to reproduction

Study results
Study data: reproduction
  • 7 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 4 1
Other 1
Data waiving
no waivers
Study data: developmental
  • 4 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 1
Supporting study
Weight of evidence 3
Other
Data waiving
no waivers
Study data: other studies
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: other studies
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Effect on fertility
Oral route:
Adverse effect observed NOAEL 12.5 mg/kg bw/day (subchronic, rat)
Effect on developmental toxicity
Oral route:
Adverse effect observed NOAEL 50 mg/kg bw/day (subchronic, rat)

Neurotoxicity

Data not provided by the registrant

Immunotoxicity

Data not provided by the registrant

Endocrine disrupter mammalian screening - in vivo

Study results
  • 8 studies submitted
  • 6 studies processed
C Endocrine disrupting potential
not specified (67%), ambiguous (33%) [6]

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

No summary exists for this scientific endpoint