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Please be aware that the REACH registration parts of this Brief Profile are no longer maintained; they remain frozen as of 19th May 2023.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.:
224-832-0
CAS no.:
4511-42-6
Index number:
Molecular formula:
C6H8O4
SMILES:
C[C@@H]1OC(=O)[C@H](C)OC1=O
InChI:
InChI=1S/C6H8O4/c1-3-5(7)10-4(2)6(8)9-3/h3-4H,1-2H3/t3-,4-/m0/s1
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
5
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

Warning! According to the classification provided by companies to ECHA in REACH registrations this substance causes serious eye irritation.

Additionally, the classification provided by companies to ECHA in CLP notifications identifies that this substance causes severe skin burns and eye damage.

Breakdown of all 165 C&L notifications submitted to ECHA

Eye Irrit. 2 H319
Skin Corr. 1B H314
Skin Irrit. 2 H315
STOT SE 3 H335
Eye Irrit. 2A H319
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

Regulatory context

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

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 5 active registrations under REACH, 1 Joint Submission(s) and 1 Individual Submission(s).
Please see Registrants/Suppliers details.
Evaluation
Dossier Evaluation:
Registration dossiers submitted to ECHA for this substance have been evaluated under REACH.
Substance Evaluation:
Authorisation
Candidate List:
Annex XIV (Authorisation List):
Restriction
Annex XVII (Restriction List):

Persistent Organic Pollutants Regulation (POPs)

List of substances subject to the POPs Regulation:
List of substances proposed as POPs:

Classification Labelling & Packaging (CLP)

Harmonised C&L:
Seveso Annex I:
Notified C&L:
Classification & Labelling has been notified by industry to ECHA for this substance.

Biocidal Products Regulation (BPR)

Active Substance:
Biocidal Products:

Prior Informed Consent (PIC)

Annex I:
Annex V:

European Union Observatory for Nanomaterials (EUON)

EUON:

About this substance

This substance is registered under the REACH Regulation and is manufactured in and / or imported to the European Economic Area, at ≥ 1 000 tonnes per annum.

This substance is used by consumers, in formulation or re-packing, at industrial sites and in manufacturing.

This substance is used in the following products: cosmetics and personal care products.

Other release to the environment of this substance is likely to occur from: indoor use 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 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: cosmetics and personal care products.

This substance is used in the following activities or processes at workplace: transfer of chemicals, closed processes with no likelihood of exposure, closed, continuous processes with occasional controlled exposure, closed batch processing in synthesis or formulation, mixing in open batch processes 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: biocides (e.g. disinfectants, pest control products), pH regulators and water treatment products, laboratory chemicals, pharmaceuticals, polymers, cosmetics and personal care products and adhesives and sealants.

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, closed batch processing in synthesis or formulation, batch processing in synthesis or formulation with opportunity for exposure, closed, continuous processes with occasional controlled exposure, transfer of substance into small containers, laboratory work and manual maintenance (cleaning and repair) of machinery.

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 for thermoplastic manufacture.

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

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

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

Prevention statements

When handling this substance: wash parts of the body (as specified by manufacturer/supplier)in contact with substance thoroughly after handling; wear protective gloves and/or clothing, and eye and/or face protection as specified by manufacturer/supplier.

Response statements

In case of incident: If eye irritation persists get medical advice/attention. If in eyes: rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.

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

Registrants/suppliers

  • Evonik Operations GmbH, Rellinghauser Straße 1-11 45128 Essen Germany
  • Futerro SA, Rue du Renouveau 7760 Escannafles Belgium
  • Purac Biochem bv, Arkelsedijk 46 4206AC Gorinchem Netherlands
  • Purac Bioquímica S.A.U., Gran Vial 19-25 08160 Montmeló (Barcelona) Spain
  • TotalEnergies Corbion BV, Stadhuisplein 70 4203 NS Gorinchem Netherlands
  • Santrol Europe ApS, Aagade 103 Pjedsted 7000 Fredericia Denmark

Substance names and other identifiers

(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione
EC Inventory
(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione
REACH pre-registration
(3S,6S)-3,6-Dimethyl-1,4-dioxane-2,5-dione
C&L Inventory, Registration dossier, Other
(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione
Registration dossier
(S,S)-cis-3,6-Dimethyl-1,4-dioxane-2,5-dione
C&L Inventory
1,4-Dioxane-2,5-dione, 3,6-dimethyl-, (3S,6S)-
C&L Inventory
3,6-dimethyl-1,4-dioxane-2,5-dione
C&L Inventory, Registration dossier
3,6-dimethyl-1,4-dioxane-2,5-dione
Registration dossier
3,6-Dimethyl-[1,4]dioxane-2,5-dione
C&L Inventory
L-(-)-Lactide
C&L Inventory
L-Lactid
C&L Inventory
L-lactide
Registration dossier
(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione
Registration dossier
L-lactide
Registration dossier
4511-42-6
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
Flakes (100%) [1]
C Substance type
Organic (100%) [1]

Type of Study provided
Studies with data
Key study 1 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%)
Form
Solid: flakes (100%)
Colour
white (100%)

Melting/freezing point

Study results
  • 2 studies submitted
  • 2 studies processed
R Melting / freezing point
97 °C @ 10.19 - 1 019 hPa [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
Melting / freezing point at 101 325 Pa
97 °C

Boiling point

Study results
  • 2 studies submitted
  • 2 studies processed
R Boiling point
266 °C @ 101.9 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
Boiling point at 101 325 Pa
266 °C

Density

Study results
  • 2 studies submitted
  • 2 studies processed
R Density
1.33 g/cm³ @ 20 °C [1]
R Relative density
1.33 @ 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
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
1.33

Vapour pressure

Study results
  • 2 studies submitted
  • 1 study processed
R Vapour pressure
0.311 Pa @ 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
Vapour pressure
0.311 Pa @ 25 °C

Partition coefficient

Study results
  • 3 studies submitted
  • 1 study processed
R Pow
2.7 @ 25 °C [1]
R Log Pow
0.4 @ 25 °C [1]

Type of Study provided
Studies with data
Key study 1 1 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Log Kow (Log Pow)
0.4 @ 25 °C

Water solubility

Study results
  • 2 studies submitted
  • 2 studies processed
R Water solubility (mass/vol.)
16.7 g/L @ 20.1 °C and pH 2 [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
Water solubility
16.7 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
  • 2 studies processed
R Surface tension
70.7 mN/m @ 1 g/L and 20 °C [2]

Type of Study provided
Studies with data
Key study 2 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Surface tension at 20 °C
70.7 mN/m @ 1 000 mg/L

Flash point

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Auto flammability

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Flammability

Study results
  • 7 studies submitted
  • 2 studies processed
C Interpretation of results
GHS criteria not met (50%), Non flammable (50%) [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
Not feasible 2
Sci. unjustified 3
Exposure cons.
Other
C Summaries
  • 1 summary submitted
  • 1 summary processed
Flammability
Non flammable (100%)

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
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Oxidising

Study results
  • 4 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 2
Sci. unjustified 2
Exposure cons.
Other
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Oxidation reduction potential

Data not provided by the registrant

pH

Data not provided by the registrant

Dissociation constant

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Viscosity

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Environmental fate and pathways

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

Phototransformation in air

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 1
Supporting study 1
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

Phototransformation in water

Data not provided by the registrant

Phototransformation in soil

Data not provided by the registrant

Biodegradation in water - screening tests

Study results
  • 2 studies submitted
  • 2 studies processed
R BOD5
450 mg O2/g test material [1]
R COD
850 mg O2/g test material [1]
C Interpretation of results
Readily biodegradable (50%), Readily biodegradable but failing the 10-day window (50%) [2]

Type of Study provided
Studies with data
Key study 1 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
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 6 studies submitted
  • 1 study processed
R Koc
1 L/kg [1]

Type of Study provided
Studies with data
Key study 1 1 1
Supporting study 2
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
Koc at 20°C
1

Henrys law constant (H)

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Henry's law constant
0 Pa.m³.mol-1

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 1 mg/L (1)
Intermittent releases (freshwater) No hazard identified (1)
Marine water No hazard identified (1)
Intermittent releases (marine water) No hazard identified (1)
Sewage treatment plant (STP) 10 mg/L (1)
Sediment (freshwater) No hazard identified (1)
Sediment (marine water) No hazard identified (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil No hazard identified (1)
Hazard for Predators
Secondary poisoning No potential for bioaccumulation (1)

Short–term toxicity to fish

Study results
  • 9 studies submitted
  • 5 studies processed
P/RResults
LC50 (4 days) 130 - 320 mg/L [7]
NOEC (4 days) 180 - 320 mg/L [3]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence 4 4
Other
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Long–term toxicity to fish

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

No automatically processable data submitted

Short–term toxicity to aquatic invertebrates

Study results
  • 7 studies submitted
  • 2 studies processed
P/RResults
EC50 (48 h) 130 - 250 mg/L [4]
NOEC (48 h) 180 mg/L [1]

Type of Study provided
Studies with data
Key study 2 1
Supporting study 2 2
Weight of evidence
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
  • 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 aquatic algae and cyanobacteria

Study results
  • 3 studies submitted
  • 2 studies processed
P/RResults
EC50 (72 h) 2.8 - 3.5 g/L [3]
EC50 (70 h) 3.5 g/L [1]
NOEC (72 h) 533 - 1 900 mg/L [2]
NOEC (70 h) 1.9 g/L [1]

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

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 3 studies submitted
  • 2 studies processed
P/RResults
EC50 (3 h) 88.2 - 100 mg/L [2]
NOEC (3 h) 88.2 mg/L [1]

Type of Study provided
Studies with data
Key study 2 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC10 or NOEC for microorganisms
88.2 mg/L

Sediment toxicity

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

Study results
  • 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
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Toxicity to terrestrial arthropods

Study results
  • 3 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study 1 1
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
  • 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
  • 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
  • 7 studies submitted
  • 1 study processed
P/RResults
LC50 (14 days) 2 250 mg/kg bw [1]

Type of Study provided
Studies with data
Key study 1 1
Supporting study 2 2
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 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) 592 mg/m³ acute toxicity
Acute /short term: (DNEL) 592 mg/m³ -
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: Hazard unknown (no further information necessary)
Acute /short term: Hazard unknown (no further information necessary)
Local Effects
Long-term: Hazard unknown (no further information necessary)
Acute /short term: Hazard unknown (no further information necessary)
EYE Exposure
Low hazard (no threshold derived)
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 296 mg/m³ irritation (respiratory tract)
Acute /short term: (DNEL) 296 mg/m³ acute toxicity
Local Effects
Long-term: Hazard unknown (no further information necessary)
Acute /short term: Hazard unknown (no further information necessary)
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: Hazard unknown (no further information necessary)
Acute /short term: Hazard unknown (no further information necessary)
Local Effects
Long-term: Hazard unknown (no further information necessary)
Acute /short term: Hazard unknown (no further information necessary)
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 35 mg/kg bw/day acute toxicity
Acute /short term: No hazard identified
EYE Exposure
Low hazard (no threshold derived)

Toxicokinetics, metabolism, and distribution

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

Study data not processed for brief profile

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

Study data not processed for brief profile

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

Acute toxicity

Study results
oral
  • 2 studies submitted
  • 2 studies processed
P/RResults
LD50 2 000 mg/kg bw (rat) [2]
LD0 2 000 mg/kg bw (rat) [1]
M/CInterpretations of results
Practically nontoxic [1]

Type of Study provided
oral
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
inhalation
  • 3 studies submitted
  • 2 studies processed
P/RResults
LC50 (4 h) 7.94 mg/L air (rat) [2]
M/CInterpretations of results
Practically nontoxic [1]

inhalation
Studies with data
Key study 2 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
dermal
  • 2 studies submitted
  • 2 studies processed
P/RResults
LD50 2 000 mg/kg bw (rat) [2]
LD0 2 000 mg/kg bw (rat) [1]
M/CInterpretations of results
Practically nontoxic [1]

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

No data available

other routes
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route:
No adverse effect observed LD50 2 000 mg/kg bw
Inhalation route:
Adverse effect observed LC50 7.94 mg/L air
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 2
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
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 2
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin
No adverse effect observed (not irritating)
Eye
Adverse effect observed (irritating)
Respiratory
No study available

Sensitisation

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 2
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
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
  • 1 summary submitted
  • 1 summary processed
Skin sensitisation
No adverse effect observed (not sensitising)
Respiratory sensitisation
No study available

Repeated dose toxicity

Study results
Study data: oral
  • 5 studies submitted
  • 3 studies processed
P/RResults
NOAEL (rat): 50 000 mg/L drinking water [1]
NOAEL (dog): 20 - 1 000 mg/kg bw/day [4]
LOAEL (dog): 100 - 2 500 mg/kg bw/day [3]

Type of Study provided
Study data: oral
Studies with data
Key study 1
Supporting study
Weight of evidence 3 1
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 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route - systemic effects:
No adverse effect observed NOAEL 100 mg/kg bw/day (subchronic, dog)

Genetic toxicity

Study results
Study data: in vitro
  • 18 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 2
Supporting study 5 5
Weight of evidence 3 3
Other
Data waiving
no waivers
Study data: in vivo
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

Carcinogenicity

Study results
  • 4 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 1 1
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
  • 3 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
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
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Neurotoxicity

Data not provided by the registrant

Immunotoxicity

Data not provided by the registrant

Endocrine disrupter mammalian screening - in vivo

Data not provided by the registrant