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

EC / List no.:
205-758-8
CAS no.:
150-38-9
Index number:
Molecular formula:
SMILES:
InChI:
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

Danger! According to the classification provided by companies to ECHA in REACH registrations this substance causes serious eye damage, may cause damage to organs through prolonged or repeated exposure, is harmful if swallowed and is harmful if inhaled.

Breakdown of all 180 C&L notifications submitted to ECHA

Acute Tox. 4 H302
Eye Dam. 1 H318
STOT RE 2 H373
Acute Tox. 4 H332
Eye Irrit. 2 H319
Skin Irrit. 2 H315
STOT SE 3 H335
Not Classified
Aquatic Chronic 3 H412
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

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

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

Properties of concern

Regulatory context

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

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

Persistent Organic Pollutants Regulation (POPs)

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

Classification Labelling & Packaging (CLP)

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

Biocidal Products Regulation (BPR)

Active Substance:
Biocidal Products:

Prior Informed Consent (PIC)

Annex I:
Annex V:

European Union Observatory for Nanomaterials (EUON)

EUON:

About this substance

This substance is registered under the REACH Regulation and is manufactured in and / or imported to the European Economic Area, at ≥ 10 to < 100 tonnes per annum.

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

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

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

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.

This substance is used in the following products: pharmaceuticals, cosmetics and personal care products, pH regulators and water treatment products and laboratory chemicals.

This substance is used in the following areas: health services and scientific research and development.

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, batch processing in synthesis or formulation with opportunity for exposure, mixing in open batch processes, transfer of substance into small containers and laboratory work.

Other release to the environment of this substance is likely to occur from: indoor use (e.g. machine wash liquids/detergents, automotive care products, paints and coating or adhesives, fragrances and air fresheners).

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

This substance is used in the following activities or processes at workplace: transfer of chemicals, closed batch processing in synthesis or formulation, closed processes with no likelihood of exposure, closed, continuous processes with occasional controlled exposure, mixing in open batch processes, transfer of substance into small containers, production of mixtures or articles by tabletting, compression, extrusion or pelletisation and laboratory work.

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

This substance is used in the following products: pH regulators and water treatment products and laboratory chemicals.

This substance is used in the following areas: health services and scientific research and development. This substance is used for the manufacture of: chemicals.

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, batch processing in synthesis or formulation with opportunity for exposure, mixing in open batch processes, transfer of substance into small containers and laboratory work.

Release to the environment of this substance can occur from industrial use: in processing aids at industrial sites, as an intermediate step in further manufacturing of another substance (use of intermediates) and as processing aid.

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

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

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

Prevention statements

When handling this substance: do not breathe the dust, fume, gas, mist, vapours or spray; do not get in eyes, on skin, or on clothing; wear protective gloves and/or clothing, and eye and/or face protection as specified by manufacturer/supplier.

Response statements

In case of incident: If swallowed: call a poison center or doctor/physician if you feel unwell. If in eyes: rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.

Disposal statements

The substance must be disposed in accordance with local/regional/national/international regulation.

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

Registrants/suppliers

  • Beiersdorf Customer Supply GmbH, Unnastrasse 48 20253 Hamburg Germany
  • Beiersdorf Manufacturing Berlin GmbH, Franklinstrasse 1 10587 Berlin Germany
  • Beiersdorf Manufacturing Hamburg GmbH, Troplowitzstraße 10 22529 Hamburg Germany
  • Beiersdorf Manufacturing Poznan Sp. z o.o., ul. Gnieznienska 32 61 - 021 Poznan Poland
  • Beiersdorf Manufacturing Tres Cantos SL, Avda. de la Industria 31 28760 Tres Cantos Spain
  • Beiersdorf Manufacturing Waldheim GmbH, Am Eichberg 04736 Waldheim Germany
  • Codi International BV, Turbinestraat 19 3903 LV Veenendaal Netherlands
  • Merck KGaA, Frankfurter Strasse 250 64293 Darmstadt Germany

Substance names and other identifiers

Edetate Trisodium
Other
Trisodium hydrogen ethylenediaminetetraacetate
EC Inventory
trisodium hydrogen ethylenediaminetetraacetate
REACH pre-registration
Glycine, N,N'-1,2-ethanediylbis(N-(carboxymethyl)-, trisodium salt
C&L Inventory
trisodium hydrogen 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
C&L Inventory, Registration dossier
Trisodium Hydrogen Ethylenediamine tetraacetate
C&L Inventory
trisodium hydrogen ethylenediaminetetraacetate
C&L Inventory
Trisodium EDTA
C&L Inventory
150-38-9
CAS number
EC Inventory, C&L Inventory, Registration dossier, REACH pre-registration, Other
8014-66-2
CAS number
Other
97928-92-2
CAS number
Other

Scientific properties

Physical and chemical properties

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

Appearance/physical state / colour

Study results
  • 1 study submitted
  • 1 study processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [1]
C Form
Solid (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
  • 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

Boiling point

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

Density

Study results
  • 1 study submitted
  • 1 study processed
R Relative density
1.69 @ 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
1.69

Vapour pressure

Study results
  • 1 study submitted
  • 1 study processed
R Vapour pressure
0.007 Pa @ 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
Vapour pressure
0.007 Pa @ 50 °C

Partition coefficient

Study results
  • 2 studies submitted
  • 1 study processed
R Log Pow
-3.8 @ pH 7.2 - 8.7 [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)
-3.8 @ 25 °C

Water solubility

Study results
  • 1 study submitted
  • 1 study processed
R Water solubility (mass/vol.)
201.3 - 212.9 g/L @ pH 7.2 - 8.7 [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
212.9 g/L @ 20 °C

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
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
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

Flammability

Study results
  • 4 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
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
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
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
  • 3 studies submitted
  • 3 studies processed
C Dissociating properties
Yes (100%) [3]
R Dissociation constant
-0.12 - 10.44 @ 20 °C [24]

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

No automatically processable data submitted

Viscosity

Data not provided by the registrant

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
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

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
  • 26 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 25 1
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Biodegradation in water
Inherently biodegradable (100%)
Type of water
Freshwater (100%)

Biodegradation in water & sediment - simulation tests

Data not provided by the registrant

Biodegradation in soil

Data not provided by the registrant

Bioaccumulation: aquatic / sediment

Study results
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

No automatically processable data submitted

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

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
R Summaries
  • 1 summary submitted
  • 1 summary processed
Koc at 20°C
758.58

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 440 µg/L (1)
Intermittent releases (freshwater) 1.2 mg/L (1)
Marine water 44 µg/L (1)
Intermittent releases (marine water) 120 µg/L (1)
Sewage treatment plant (STP) 43 mg/L (1)
Sediment (freshwater) 34.584 mg/kg sediment dw (1)
Sediment (marine water) 3.458 mg/kg sediment dw (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 157 µg/kg soil dw (1)
Hazard for Predators
Secondary poisoning No potential for bioaccumulation (1)

Short–term toxicity to fish

Study results
  • 4 studies submitted
  • 2 studies processed
P/RResults
LC50 (4 days) 41 - 1 592 mg/L [6]
LC100 (4 days) 75 - 1 846 mg/L [6]

Type of Study provided
Studies with data
Key study
Supporting study 1
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

Data not provided by the registrant

Short–term toxicity to aquatic invertebrates

Study results
  • 4 studies submitted
  • 3 studies processed
P/RResults
EC50 (48 h) 140 mg/L [1]
EC50 (24 h) 610 - 625 mg/L [2]
EC0 (48 h) 100 mg/L [1]
EC0 (24 h) 310 mg/L [1]
EC100 (48 h) 180 mg/L [1]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 3 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
  • 2 studies submitted
  • 1 study processed
P/RResults
NOEC (21 days) 25 mg/L [1]
LOEC (21 days) 50 mg/L [1]

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 aquatic algae and cyanobacteria

Study results
  • 3 studies submitted
  • 2 studies processed
P/RResults
EC50 (72 h) 2.77 - 100 mg/L [2]
NOEC (72 h) 390 - 100 000 µg/L [2]
LOEC (72 h) 780 - 100 000 µg/L [2]
EC10 (72 h) 700 - 100 000 µg/L [2]
EC90 (72 h) 100 mg/L [2]

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

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 5 studies submitted
  • 2 studies processed
P/RResults
EC50 (30 min) 500 mg/L [1]
EC10 (30 min) 500 mg/L [1]

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

No automatically processable data submitted

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
  • 2 studies submitted
  • 1 study processed
P/RResults
LC50 (14 days) 156.46 mg/kg soil dw [1]

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 terrestrial arthropods

Data not provided by the registrant

Toxicity to terrestrial plants

Study results
  • 3 studies submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Toxicity to soil microorganisms

Data not provided by the registrant

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: No hazard identified
Acute /short term: No hazard identified
Local Effects
Long-term: (DNEL) 402 µg/m³ repeated dose toxicity
Acute /short term: (DNEL) 804 µg/m³ repeated dose toxicity
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
EYE Exposure
Medium hazard (no threshold derived)
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
Local Effects
Long-term: (DNEL) 300 µg/m³ repeated dose toxicity
Acute /short term: (DNEL) 600 µg/m³ repeated dose toxicity
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: No hazard identified
Acute /short term: Medium hazard (no threshold derived)
EYE Exposure
Medium hazard (no threshold derived)

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 0 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
Other
Data waiving
no waivers
Study data: dermal absorption
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

Acute toxicity

Study results
oral
  • 4 studies submitted
  • 2 studies processed
P/RResults
LD50 1 780 - 2 800 mg/kg bw (rat) [4]
M/CInterpretations of results
Other [2]

Type of Study provided
oral
Studies with data
Key study 1
Supporting study
Weight of evidence 2
Other 1
Data waiving
no waivers
inhalation
  • 2 studies submitted
  • 1 study processed
M/CInterpretations of results
Other [1]

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

No automatically processable data submitted

dermal
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
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:
Adverse effect observed LD50 1 780 mg/kg bw

Irritation / corrosion

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 1 1
Supporting study 1
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
Study data: eye
  • 5 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 3 1
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 (irreversible damage)
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 1 1
Supporting study 1
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
  • 1 study processed
P/RResults
NOAEL (rat): 500 mg/kg bw/day [1]

Type of Study provided
Study data: oral
Studies with data
Key study 1 1
Supporting study 2
Weight of evidence
Other 1
Data waiving
no waivers
Study data: inhalation
  • 3 studies submitted
  • 1 study processed
P/RResults
NOAEC (rat): 3 - 15 mg/m³ air [3]
LOAEC (rat): 15 mg/m³ air [1]

Study data: inhalation
Studies with data
Key study 1 1
Supporting study 1
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 (subchronic, rat)
Inhalation route - systemic effects:
No adverse effect observed NOAEC 15 mg/m³ (subchronic, rat)
Inhalation route - local effects:
Adverse effect observed NOAEC 3 mg/m³ (subchronic, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 6 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 3
Weight of evidence
Other
Data waiving
no waivers
Study data: in vivo
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: in vivo
Studies with data
Key study 1 1
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 adverse effect observed (negative)

Carcinogenicity

Study results
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study 2
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 NOAEL 495 mg/kg bw/day (chronic, rat)

Toxicity to reproduction

Study results
Study data: reproduction
  • 1 study 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 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 developmental toxicity
Oral route:
No adverse effect observed NOAEL 1 245 mg/kg bw/day (subacute, 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