Brief Profile

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

Substance Description

Substance identity

  • EC / List name: Benzene-1,2:4,5-tetracarboxylic dianhydride
  • IUPAC name: 5,11-dioxatricyclo[7.3.0.0^{3,7}]dodeca-1,3(7),8-triene-4,6,10,12-tetrone
  • Other names
EC / List no.:
201-898-9
CAS no.:
89-32-7
Index number:
607-098-00-X
Molecular formula:
C10H2O6
SMILES:
O=C1OC(=O)C2=CC3=C(C=C12)C(=O)OC3=O
InChI:
InChI=1S/C10H2O6/c11-7-3-1-4-6(10(14)16-8(4)12)2-5(3)9(13)15-7/h1-2H
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
9
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 harmonised classification and labelling (CLP00) approved by the European Union, this substance causes serious eye damage, may cause an allergic skin reaction and may cause allergy or asthma symptoms or breathing difficulties if inhaled.

Breakdown of all 724 C&L notifications submitted to ECHA

Eye Dam. 1 H318 Harmonised Classification
Skin Sens. 1 H317 Harmonised Classification
Resp. Sens. 1 H334 Harmonised Classification
Acute Tox. 4 H302
Acute Tox. 4 H332
Skin Irrit. 2 H315
STOT SE 3 H335
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

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

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

Properties of concern

  • Ss
  • Sr

Regulatory activities

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

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 8 active registrations under REACH, 1 Joint Submission(s) and 0 Individual Submission(s).
Please see Registrants/Suppliers details.
Evaluation
Dossier Evaluation:
Substance Evaluation:
Authorisation
Candidate List:
Annex XIV (Authorisation List):
Restriction
Annex XVII (Restriction List):

Classification Labelling & Packaging (CLP)

Harmonised C&L:
A European Union Harmonised Classification & Labelling has been assigned to this substance.
Notification:
Classification & Labelling has been notified by industry to ECHA for this substance.

Biocidal Products Regulation (BPR)

Active Substance:
Biocidal Products:

Prior Informed Consent (PIC)

Annex I:
Annex V:

European Union Observatory for Nanomaterials (EUON)

EUON:

About this substance

This substance is manufactured and/or imported in the European Economic Area in 100 - 1 000 tonnes per year.

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

This substance is used in the following products: coating products.

Other release to the environment of this substance is likely to occur from: indoor use and outdoor use resulting in inclusion into or onto a materials (e.g. binding agent in paints and coatings or adhesives).

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). Other release to the environment of this substance is likely to occur from: indoor use in long-life materials with low release rate (e.g. flooring, furniture, toys, construction materials, curtains, foot-wear, leather products, paper and cardboard products, electronic equipment).

This substance can be found in complex articles, with no release intended: vehicles, machinery, mechanical appliances and electrical/electronic products (e.g. computers, cameras, lamps, refrigerators, washing machines), vehicles not covered by End of Life Vehicles (ELV) directive (e.g. boats, trains, metro or planes) and Machinery, mechanical appliances, electrical/electronic products covered by the Waste Electrical and Electronic Equipment (WEEE) directive (e.g. refrigerators, washing machines, vacuum cleaners, computers, telephones, drills, saws, smoke detectors, thermostats, radiators). This substance can be found in products with material based on: plastic (e.g. food packaging and storage, toys, mobile phones), stone, plaster, cement, glass or ceramic (e.g. dishes, pots/pans, food storage containers, construction and isolation material), stone, plaster, cement, glass and ceramic used for large surface area articles (e.g. construction and building materials for floor coverings, isolation articles), plastic used for large surface area articles (e.g. construction and building materials for flooring, insulation), plastic used for toys and other articles intended for children’s use, including baby-bottles, plastic used for packaging (excluding food packaging), plastic used for articles intended for food contact (e.g. plastic dinner ware, food storage) and plastic used for furniture & furnishings, including furniture coverings.

This substance is used in the following products: coating products, fillers, putties, plasters, modelling clay, finger paints and inks and toners.

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

This substance is used in the following activities or processes at workplace: mixing in open batch processes, transfer of chemicals at non-dedicated facilities, closed batch processing in synthesis or formulation, closed, continuous processes with occasional controlled exposure, roller or brushing applications and non-industrial spraying.

Other release to the environment of this substance is likely to occur from: indoor use and outdoor use resulting in inclusion into or onto a materials (e.g. binding agent in paints and coatings or adhesives).

This substance is used in the following products: coating products, fillers, putties, plasters, modelling clay, finger paints, inks and toners and polymers.

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

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: polymers, coating products, fillers, putties, plasters, modelling clay, finger paints and inks and toners.

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

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

Release to the environment of this substance can occur from industrial use: for thermoplastic manufacture, in the production of articles, as processing aid and as processing aid.

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 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

  • CHEMICAL INSPECTION & REGULATION SERVICE LIMITED, Room 002, Regus Harcourt Centre D02 HW77 Dublin Ireland
  • Evonik Fibres GmbH, Werkstrasse 3 A-4860 Lenzing Austria
  • Henkel Global Supply Chain B.V., Gustav Mahlerlaan 2970 1081 LA Amsterdam Netherlands
  • Lonza Cologne GmbH, Nattermannallee 1 50829 Cologne Germany
  • Nexam Chemical AB, Industrigatan 27 SE 234 35 Lomma Sweden
  • Nexam Chemical AB, Industrigatan 27 SE23435 Lomma Sweden
  • Sumitomo France SAS, 125 Avenue des Champs-Élysées 75008 Paris France
  • [Confidential], [Confidential]

Other names

  • -
  • 1,2,4,5-Benzenetetracarboxylic 1,2:4,5-dianhydride
  • 1,2,4,5-Benzenetetracarboxylic anhydride
  • 1H,3H-benzo[1,2-c:4,5-c']difuran-1,3,5,7-tetrone
  • 1H,3H-Furo[3,4-f][2]benzofuran-1,3,5,7-tetrone
  • 5,11-dioxatricyclo[7.3.0.0^{3,7}]dodeca-1,3(7),8-triene-4,6,10,12-tetrone
  • 5,11-dioxatricyclo[7.3.0.0³,-]dodeca-1,3(7),8-triene-4,6,10,12-tetrone
  • 5,11-dioxatricyclo[7.3.0.0³,⁷]dodeca-1,3(7),8-triene-4,6,10,12-tetrone
  • benzene-1,2 4,5-tetracarboxylic dianhydride
  • Benzene-1,2,4,5-tetracarboxylic dianhydride
  • Benzene-1,2:4,5-tetracarboxylic dianhydride
  • benzene-1,2:4,5-tetracarboxylic dianhydride pyromellitic dianhydride
  • furo[3,4-f][2]benzofuran-1,3,5,7-tetrone
  • NEXAMITE B02
  • Pyromellitic acid dianhydride
  • PYROMELLITIC ANHYDRIDE
  • Pyromellitic Dianhydride
  • Pyromellitsäuredianhydrid
  • Benzene-1,2:4,5-tetracarboxylic dianhydride
  • pyromellitic dianhydride
  • Benzene-1,2:4,5-tetracarboxylic dianhydride
  • PMDA
  • Pyromellitic dianhydride

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
Solid: crystalline (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
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
286 °C [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
286 °C

Boiling point

Study results
  • 3 studies submitted
  • 1 study processed
R Boiling point
400 °C @ 100.91 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
Boiling point at 101 325 Pa
400 °C

Density

Study results
  • 1 study submitted
  • 1 study processed
R Density
1.68 g/cm³ @ 20 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
1.68

Vapour pressure

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

Type of Study provided
Studies with data
Key study 1
Supporting study 3
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
  • 2 studies submitted
  • 1 study processed
R Log Pow
-2.03 @ 21.5 °C and pH 5 [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Log Kow (Log Pow)
-2.03 @ 21.5 °C

Water solubility

Study results
  • 2 studies submitted
  • 1 study processed
R Water solubility (mass/vol.)
8.56 - 8.83 g/L @ 20 °C and pH 8.56 [2]

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
Water solubility
8.56 g/L @ 20 °C

Solubility in organic solvents / fat solubility

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

Surface tension

Study results
  • 3 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study 2
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

Flash point

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

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
R Summaries
  • 1 summary submitted
  • 1 summary processed
Autoflammability / self-ignition at 101 325 Pa
400 °C

Flammability

Study results
  • 1 study submitted
  • 1 study processed
C Interpretation of results
Not classified based on GHS criteria (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
Not classified (100%)

Explosiveness

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

Oxidation reduction potential

Data not provided by the registrant

pH

Data not provided by the registrant

Dissociation constant

Study results
  • 1 study submitted
  • 1 study processed
C Dissociating properties
Yes (100%) [1]
R Dissociation constant
2.18 - 5.45 @ 25 °C [4]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
pKa at 20 °C
5.45

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
  • 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 for hydrolysis
20 min @ 25 °C

Phototransformation in water

Data not provided by the registrant

Phototransformation in soil

Data not provided by the registrant

Biodegradation in water - screening tests

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

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Biodegradation in water
Readily biodegradable (100%)

Biodegradation in water & sediment - simulation tests

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
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Biodegradation in soil

Study results
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

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

No automatically processable data submitted

Bioaccumulation: aquatic / sediment

Study results
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation Factor (BCF) - dimensionless
1

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 1 study submitted
  • 1 study processed
R Koc
1 dimensionless @ 25 °C [1]
R log Koc
0.155 dimensionless @ 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
Koc at 20°C
1

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 7.9 µg/L (1)
Intermittent releases (freshwater) 79 µg/L (1)
Marine water 790 ng/L (1)
Intermittent releases (marine water) 7.9 µg/L (1)
Sewage treatment plant (STP) 23 mg/L (1)
Sediment (freshwater) 29.2 µg/kg sediment dw (1)
Sediment (marine water) 2.92 µg/kg sediment dw (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 1.21 µg/kg soil dw (1)
Hazard for Predators
Secondary poisoning No potential for bioaccumulation (1)

Short–term toxicity to fish

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
LC50 (4 days) 100 mg/L [1]
NOEC (4 days) 100 mg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
LC50 for freshwater fish
100 mg/L

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

No automatically processable data submitted

Short–term toxicity to aquatic invertebrates

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
EC50 (48 h) 63 mg/L [1]
EC50 (24 h) 65 mg/L [1]
NOEC (48 h) 32 mg/L [1]
NOEC (24 h) 32 mg/L [1]

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

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 1
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
  • 1 study processed
P/RResults
EC50 (72 h) 7.9 - 8.8 mg/L [3]
NOEC (72 h) 6.25 mg/L [3]
LOEC (72 h) 12.5 mg/L [3]

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
7.9 mg/L
EC10 or NOEC for freshwater algae
6.25 mg/L

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
EC10 (18 h) 23 mg/L [1]

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

Sediment toxicity

Data not provided by the registrant

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Toxicity to birds

Data not provided by the registrant

Toxicity to mammals

Data not provided by the registrant

Toxicological information

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

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

M/C Summaries
  • 1 summary submitted
  • 1 summary processed

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

Data for WORKERS
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 70.4 mg/m³ repeated dose toxicity
Acute /short term: No hazard identified
Local Effects
Long-term: High hazard (no threshold derived)
Acute /short term: High hazard (no threshold derived)
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 10 mg/kg bw/day repeated dose toxicity
Acute /short term: No hazard identified
Local Effects
Long-term: High hazard (no threshold derived)
Acute /short term: High hazard (no threshold derived)
EYE Exposure
Medium hazard (no threshold derived)
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 17.4 mg/m³ repeated dose toxicity
Acute /short term: No hazard identified
Local Effects
Long-term: High hazard (no threshold derived)
Acute /short term: High hazard (no threshold derived)
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 5 mg/kg bw/day repeated dose toxicity
Acute /short term: No hazard identified
Local Effects
Long-term: High hazard (no threshold derived)
Acute /short term: High hazard (no threshold derived)
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 5 mg/kg bw/day repeated dose toxicity
Acute /short term: No hazard identified
EYE Exposure
Medium hazard (no threshold derived)

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: basic toxicokinetics
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
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:
Low bioaccumulation potential

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
Category 5 based on GHS criteria [1]

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

No automatically processable data submitted

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

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

No data available

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

Irritation / corrosion

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

Study data not processed for brief profile

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

Study data not processed for brief profile

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

Sensitisation

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

Study data not processed for brief profile

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

Study data not processed for brief profile

Study data: respiratory
Studies with data
Key study
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin sensitisation
Adverse effect observed (sensitising)
Respiratory sensitisation
Adverse effect observed (sensitising)

Repeated dose toxicity

Study results
Study data: oral
  • 10 studies submitted
  • 5 studies processed
P/RResults
NOAEL (rat): 250 - 1 670 mg/kg bw/day [3]
NOAEL (mouse): 7 140 mg/kg bw/day [1]
LOAEL (rat): 750 - 1 000 mg/kg bw/day [2]
LOAEL (mouse): 1 717 - 2 340 mg/kg bw/day [2]
NOEL (rat): 1 000 mg/kg bw/day [1]

Type of Study provided
Study data: oral
Studies with data
Key study 5 4
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
Study data: inhalation
  • 1 study submitted
  • 1 study processed
P/RResults
LOAEL (rat): 21 - 91 mg/m³ air [1]

Study data: inhalation
Studies with data
Key study 1
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
  • 1 summary submitted
  • 1 summary processed
Oral route - systemic effects:
Adverse effect observed NOAEL 500 mg/kg bw/day (chronic, rat)
Inhalation route - systemic effects:
No adverse effect observed NOAEC 91 mg/m³ (subacute, rat)
Inhalation route - local effects:
Adverse effect observed LOAEC 21 mg/m³ (subacute, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 3 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 3
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: in vivo
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

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

Carcinogenicity

Study results
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

No automatically processable data submitted

Toxicity to reproduction

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

Study data not processed for brief profile

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

Study data not processed for brief profile

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

Study data not processed for brief profile

Study data: other studies
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Effect on fertility
Oral route:
Adverse effect observed NOAEL 250 mg/kg bw/day (subchronic, rat)
Effect on developmental toxicity
Oral route:
No adverse effect observed NOAEL 750 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

Data not provided by the registrant