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: Sorbitan tristearate
  • IUPAC name:
  • Other names
EC / List no.:
247-891-4
CAS no.:
26658-19-5
Index number:
Molecular formula:
SMILES:
InChI:
Type of substance:
UVCB
Origin:
Organic
Registered compositions:
10
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:
EINECS (European INventory of Existing Commercial chemical Substances) List

Hazard classification & labelling

According to the majority of notifications provided by companies to ECHA in CLP notifications no hazards have been classified.

Breakdown of all 238 C&L notifications submitted to ECHA

Not Classified
Skin Irrit. 2 H315
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

Regulatory activities

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

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 10 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:
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, at industrial sites and in manufacturing.

This substance is used in the following products: washing & cleaning products, plant protection products, lubricants and greases, adhesives and sealants, polishes and waxes, fertilisers and coating products.

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), outdoor use, indoor use in close systems with minimal release (e.g. cooling liquids in refrigerators, oil-based electric heaters) and outdoor use in close systems with minimal release (e.g. hydraulic liquids in automotive suspension, lubricants in motor oil and break fluids).

This substance is used in the following activities or processes at workplace: the low energy manipulation of substances bound in materials or articles.

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), outdoor use in long-life materials with low release rate (e.g. metal, wooden and plastic construction and building materials), outdoor use in long-life materials with high release rate (e.g. tyres, treated wooden products, treated textile and fabric, brake pads in trucks or cars, sanding of buildings (bridges, facades) or vehicles (ships)) and indoor use in long-life materials with high release rate (e.g. release from fabrics, textiles during washing, removal of indoor paints).

This substance can be found in complex articles, with no release intended: vehicles. This substance can be found in products with material based on: plastic (e.g. food packaging and storage, toys, mobile phones) and rubber (e.g. tyres, shoes, toys). This substance is intended to be released from scented: clothes.

This substance is used in the following products: washing & cleaning products, polishes and waxes and plant protection products.

This substance is used in the following areas: formulation of mixtures and/or re-packaging.

This substance is used in the following activities or processes at workplace: transfer of chemicals, roller or brushing applications, non-industrial spraying, closed processes with no likelihood of exposure, closed, continuous processes with occasional controlled exposure, treatment of articles by dipping and pouring, closed batch processing in synthesis or formulation and batch processing in synthesis or formulation with opportunity for exposure.

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) and outdoor use.

This substance is used in the following products: polymers, lubricants and greases, textile treatment products and dyes and cosmetics and personal care products.

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

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: washing & cleaning products, metal surface treatment products, polymers, textile treatment products and dyes, pH regulators and water treatment products and leather treatment products.

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: transfer of chemicals, batch processing in synthesis or formulation with opportunity for exposure, closed, continuous processes with occasional controlled exposure, closed processes with no likelihood of exposure, closed batch processing in synthesis or formulation, industrial spraying, transfer of substance into small containers, treatment of articles by dipping and pouring, roller or brushing applications and mixing in open batch processes.

Release to the environment of this substance can occur from industrial use: in processing aids at industrial sites, in the production of articles, 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, closed processes with no likelihood of exposure, closed batch processing in synthesis or formulation, closed, continuous processes with occasional controlled exposure, batch processing in synthesis or formulation with opportunity for exposure, transfer of substance into small containers, laboratory work and mixing in open batch processes.

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

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

  • Chemours Netherlands B.V., Baanhoekweg 22 3313 LA Dordrecht Netherlands
  • Croda EU B.V. (OR2), Buurtje 1 2802 BE Gouda Netherlands
  • Croda Iberica SA, Mevisa Site Carretera C-35 Km 72 (Hostalric-Blanes) 08495 Fogars de la Selva Barcelona Spain
  • Dr. W. Kolb Nederland B.V. (OR), Industrieterrein Moerdijk Westelijke Randweg 5 4791 RT Klundert Provincie Noord Brabant Netherlands
  • DuPont Nutrition Biosciences ApS, Langebrogade 1 DK-1001 Copenhagen Denmark
  • Esterchem Limited, Brooklands Way Leekbrook ST137QF Leek Staffordshire United Kingdom
  • Mosselman s.a., route de wallonie 4 B-7011 Ghlin Belgium
  • Oleon N.V., Assenedestraat 2 9940 Ertvelde Belgium
  • OLEON N.V., Industriezone "ter straten" Vaartstraat 220 2520 Oelegem Belgium
  • [Confidential], [Confidential]

Other names

  • -
  • 1,3,6-tri-O-stearoylhexitol
  • KOSTERAN-S/3KOSTERAN-S/3, UG
  • Sorbitan tristearate
  • Sorbitan, trioctadecanoate
  • Sorbitan tristearate
  • Crill 36E
  • RADIAMULS SORB 2345K
  • RADIAMULS SORB 2346K
  • RADIASURF 7345
  • Span 65
  • Span 65V

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
  • 3 studies submitted
  • 2 studies processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [2]
C Form
Not specified (100%) [2]
C Substance type
Organic (100%) [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Physical state at 20°C and 1013 hPa
Solid (100%)

Melting/freezing point

Study results
  • 2 studies submitted
  • 1 study processed
R Melting / freezing point
54 °C @ 101.3 kPa [1]

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

Density

Study results
  • 3 studies submitted
  • 1 study processed
R Density
0.89 g/cm³ @ 100 °C [1]

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

No automatically processable data submitted

Vapour pressure

Study results
  • 2 studies submitted
  • 2 studies processed
R Vapour pressure
0 - 0 Pa @ 20 °C [2]

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

No automatically processable data submitted

Partition coefficient

Study results
  • 2 studies submitted
  • 2 studies processed
R Log Pow
20.26 - 21.2 [2]

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

No automatically processable data submitted

Water solubility

Study results
  • 1 study submitted
  • 1 study processed
R Water solubility (mass/vol.)
50 µg/L @ 20 °C and pH 6.4 - 6.9 [1]

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

No automatically processable data submitted

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

No automatically processable data submitted

Flash point

Study results
  • 2 studies submitted
  • 2 studies processed
R Flash point
230 °C @ 101.3 kPa [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
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
  • 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
Data waiving
Not feasible
Sci. unjustified 3
Exposure cons.
Other
C Summaries
  • 1 summary submitted
  • 1 summary processed
Flammability
Non flammable (100%)

Explosiveness

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
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
Exposure cons.
Other 1
C Summaries
  • 1 summary submitted
  • 1 summary processed
Oxidising
No (100%)

Oxidation reduction potential

Data not provided by the registrant

pH

Data not provided by the registrant

Dissociation constant

Study results
  • 2 studies submitted
  • 2 studies processed
C Dissociating properties
Yes (100%) [2]
R Dissociation constant
12.42 - 13.23 @ 20 °C [2]

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

No automatically processable data submitted

Viscosity

Study results
  • 1 study submitted
  • 1 study processed
R kinematic viscosity (in mm²/s)
22 [1]

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

No automatically processable data submitted

Environmental fate and pathways

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

Phototransformation in air

Study results
  • 2 studies submitted
  • 2 studies processed
R Dissipation half life (DT50)
3.703 - 4.371 h [2]

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

No automatically processable data submitted

Hydrolysis

Study results
  • 3 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

Phototransformation in water

Study results
  • 0 studies submitted
  • 0 studies processed

No data available

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

Phototransformation in soil

Study results
  • 0 studies submitted
  • 0 studies processed

No data available

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 water - screening tests

Study results
  • 2 studies submitted
  • 2 studies processed
C Interpretation of results
Readily biodegradable (100%) [2]

Type of Study provided
Studies with data
Key study 2
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
Exposure cons.
Other 1
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Bioaccumulation: aquatic / sediment

Study results
  • 9 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 2 4 3
Other
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Bioaccumulation: terrestrial

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

Adsorption/desorption

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 4
Other
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Henrys law constant (H)

Study results
  • 0 studies submitted
  • 0 studies processed

No data available

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

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 320 µg/L (1)
Intermittent releases (freshwater) -
Marine water 32 µg/L (1)
Intermittent releases (marine water) -
Sewage treatment plant (STP) No hazard identified (1)
Sediment (freshwater) 1.141 mg/kg sediment dw (1)
Sediment (marine water) 1.141 mg/kg sediment dw (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
  • 1 study submitted
  • 1 study processed
P/RResults
LL50 (4 days) 1 g/L [1]

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

No automatically processable data submitted

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
Exposure cons.
Other 1
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
EL50 (48 h) 1 g/L [1]

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

No automatically processable data submitted

Long–term toxicity to aquatic invertebrates

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
LC50 (21 days) 1.82 mg/L [1]
NOELR (21 days) 16 mg/L [1]

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

No automatically processable data submitted

Toxicity to aquatic algae and cyanobacteria

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
EL50 (72 h) 1 g/L [1]
NOELR (72 h) 560 mg/L [1]

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

No automatically processable data submitted

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 3 studies submitted
  • 3 studies processed
P/RResults
EC50 (3 h) 100 mg/L [1]
NOEC (28 days) 100 mg/L [1]
NOEC (14 days) 14.4 mg/L [1]

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

No automatically processable data submitted

Sediment toxicity

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
LC50 (10 days) 1 141 - 12 391 mg/kg sediment dw [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
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
  • 2 studies processed
P/RResults
NOEC (14 days) 1 g/kg soil dw [2]
EC50 (14 days) 1 g/kg soil dw [1]
LC50 (14 days) 1 g/kg soil dw [1]
LC50 (14 days) 1 g/kg soil ww [1]
LC50 (7 days) 1 g/kg soil dw [1]

Type of Study provided
Studies with data
Key study 2
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

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Toxicity to terrestrial plants

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Toxicity to soil microorganisms

Study results
  • 6 studies submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Toxicity to birds

Study results
  • 0 studies submitted
  • 0 studies processed

No data available

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

Toxicity to mammals

Study results
  • 0 studies submitted
  • 0 studies processed

No data available

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

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: Hazard unknown (no further information necessary)
Acute /short term: No hazard identified
Local Effects
Long-term: Hazard unknown (no further information necessary)
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: No hazard identified
Acute /short term: No hazard identified
EYE Exposure
No hazard identified
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: Hazard unknown (no further information necessary)
Acute /short term: No hazard identified
Local Effects
Long-term: Hazard unknown (no further information necessary)
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: 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: No hazard identified
EYE Exposure
No hazard identified

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
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

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

No automatically processable data submitted

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
Not classified [1]

Type of Study provided
oral
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
inhalation
  • 2 studies submitted
  • 2 studies processed
P/RResults
LC50 (4 h) 5 - 5.27 mg/L air (rat) [2]
M/CInterpretations of results
Not classified [2]

inhalation
Studies with data
Key study
Supporting study
Weight of evidence 2
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
Exposure cons.
Other 1
other routes
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

other routes
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

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 2
Supporting study
Weight of evidence 2
Other
Data waiving
no waivers
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 2
Other 3
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin
No adverse effect observed (not irritating)
Eye
No adverse effect observed (not irritating)
Respiratory
No study available

Sensitisation

Study results
Study data: skin
  • 1 study 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
no waivers
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
  • 49 studies submitted
  • 7 studies processed
P/RResults
NOAEL (rat): 1 000 mg/kg bw/day [4]
NOAEL (mouse): 2 600 mg/kg bw/day [2]
NOAEL (dog): 638 mg/kg bw/day [1]

Type of Study provided
Study data: oral
Studies with data
Key study 2
Supporting study 1
Weight of evidence 15 24
Other 7
Data waiving
no waivers
Study data: inhalation
  • 0 studies submitted
  • 0 studies processed

No data available

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

No data available

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

No automatically processable data submitted

Genetic toxicity

Study results
Study data: in vitro
  • 22 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
Weight of evidence 5 12
Other 2 1
Data waiving
no waivers
Study data: in vivo
  • 3 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 3
Other
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Carcinogenicity

Data not provided by the registrant

Toxicity to reproduction

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

Study data not processed for brief profile

Type of Study provided
Study data: reproduction
Studies with data
Key study 2
Supporting study
Weight of evidence 2 5
Other 1
Data waiving
no waivers
Study data: developmental
  • 14 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 2
Supporting study 1
Weight of evidence 4 7
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
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