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: Calcium distearate
  • IUPAC name: calcium dioctadecanoate
  • Other names
EC / List no.:
216-472-8
CAS no.:
1592-23-0
Index number:
Molecular formula:
C36H70CaO4
SMILES:
[Ca++].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O
InChI:
InChI=1S/2C18H36O2.Ca/c2*1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20;/h2*2-17H2,1H3,(H,19,20);/q;;+2/p-2
Type of substance:
Mono constituent substance
Origin:
Registered compositions:
8
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:
EINECS (European INventory of Existing Commercial chemical Substances) List

Hazard classification & labelling

According to the notifications provided by companies to ECHA in REACH registrations no hazards have been classified.

Additionally, the classification provided by companies to ECHA in CLP notifications identifies that this substance causes serious eye irritation and may cause respiratory irritation.

Breakdown of all 3934 C&L notifications submitted to ECHA

Not Classified
STOT SE 3 H335
Eye Irrit. 2 H319
Acute Tox. 4 H302
Acute Tox. 4 H312
Acute Tox. 4 H332
Skin Irrit. 2 H315
Eye Dam. 1 H318
Skin Corr. 1C H314
Skin Corr. 1B H314
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

At least one notifier has indicated that an impurity or an additive present in the substance impacts the notified classification.

Properties of concern

Regulatory activities

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

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 7 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: lubricants and greases.

Other release to the environment of this substance is likely to occur from: indoor use as processing aid, outdoor 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).

This substance is used in the following activities or processes at workplace: production of mixtures or articles by tabletting, compression, extrusion or pelletisation, closed, continuous processes with occasional controlled exposure, closed batch processing in synthesis or formulation and mixing in open batch processes.

Other release to the environment of this substance is likely to occur from: outdoor use in long-life materials with low release rate (e.g. metal, wooden and plastic construction and building materials).

This substance can be found in products with material based on: plastic (e.g. food packaging and storage, toys, mobile phones), stone, plaster, cement, glass or ceramic (e.g. dishes, pots/pans, food storage containers, construction and isolation material) and paper (e.g. tissues, feminine hygiene products, nappies, books, magazines, wallpaper).

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.

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, roller or brushing applications, non-industrial spraying, treatment of articles by dipping and pouring, greasing at high energy conditions and heat / pressure transfer fluids in closed systems.

Other release to the environment of this substance is likely to occur from: indoor use as processing aid, outdoor 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).

This substance is used in the following products: polymers, lubricants and greases and pharmaceuticals. This substance has an industrial use resulting in manufacture of another substance (use of intermediates).

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

This substance is used in the following products: laboratory chemicals, cosmetics and personal care products and polymers. This substance has an industrial use resulting in manufacture of another substance (use of intermediates).

This substance is used in the following areas: formulation of mixtures and/or re-packaging and building & construction work. This substance is used for the manufacture of: chemicals and pulp, paper and paper products.

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

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), as processing aid and of substances in closed systems with minimal release.

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

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

  • AXEL France SAS, 30 Rue de Pied de Fond - Z.I. St Liguaire / CS 98821 79028 Niort France
  • B-Lands Consulting (811385-0), World Trade Center, 5 Place Robert Schuman - BP 1516 38025 Grenoble France France
  • Conqord Oil Srl, Centro Il Girasole Palazzo Marcopolo 20084 Lacchiarella Milano Italy
  • Sustainability Support Services (Europe) AB, Markaskälsvägen 6 22647 Lund Sweden

Other names

  • -
  • calcium dioctadecanoate
  • Calcium Distearate
  • calcium octadecanoate
  • Calcium stearate
  • calcium-distearat
  • Calcium distearate
  • Calcium distearate
  • Calcium stearate

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
  • 48 studies submitted
  • 9 studies processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [9]
C Form
Solid: particulate/powder (44%), Powder (44%), Not specified (11%) [9]
C Odour
Other (100%) [4]
C Substance type
Organic (100%) [4]

Type of Study provided
Studies with data
Key study 4 5
Supporting study 32 7
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 5 summaries submitted
  • 5 summaries processed
Physical state at 20°C and 1013 hPa
Solid (100%)

Melting/freezing point

Study results
  • 40 studies submitted
  • 8 studies processed
R Melting / freezing point
120 - 180 °C @ 97.46 - 101.3 kPa [8]

Type of Study provided
Studies with data
Key study 4 4
Supporting study 28 4
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 5 summaries submitted
  • 4 summaries processed
Melting / freezing point at 101 325 Pa
145.5 °C

Boiling point

Study results
  • 11 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 6
Supporting study
Weight of evidence
Other
Data waiving
Not feasible 4
Sci. unjustified 1
Exposure cons.
Other
Summaries
  • 5 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Density

Study results
  • 17 studies submitted
  • 9 studies processed
R Density
0.241 - 1.12 g/cm³ @ 20 °C [6]
R Relative density
1.08 - 1.1 @ 20 °C [3]

Type of Study provided
Studies with data
Key study 5 4
Supporting study 7
Weight of evidence
Other 1
Data waiving
no waivers
R Summaries
  • 5 summaries submitted
  • 4 summaries processed
Relative density at 20°C
0.24

Vapour pressure

Study results
  • 14 studies submitted
  • 10 studies processed
R Vapour pressure
0 - 0 Pa @ 25 °C [10]

Type of Study provided
Studies with data
Key study 10
Supporting study 4
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 5 summaries submitted
  • 4 summaries processed
Vapour pressure
0 Pa @ 25 °C

Partition coefficient

Study results
  • 12 studies submitted
  • 10 studies processed
R Log Pow
3.82 - 18.27 @ 20 - 25 °C and pH 7 [10]

Type of Study provided
Studies with data
Key study 10
Supporting study
Weight of evidence
Other 1
Data waiving
Not feasible 1
Sci. unjustified
Exposure cons.
Other
R Summaries
  • 4 summaries submitted
  • 4 summaries processed
Log Kow (Log Pow)
3.82 - 14.34 @ 25 °C

Water solubility

Study results
  • 24 studies submitted
  • 7 studies processed
R Water solubility (mass/vol.)
150 - 53 183 µg/L @ 20 - 25 °C and pH 6.2 - 7.8 [10]

Type of Study provided
Studies with data
Key study 4 4
Supporting study 12 1
Weight of evidence
Other 3
Data waiving
no waivers
R Summaries
  • 5 summaries submitted
  • 4 summaries processed
Water solubility
53.183 mg/L @ 25 °C

Solubility in organic solvents / fat solubility

Study results
  • 4 studies submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Surface tension

Study results
  • 7 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 3
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 4
Summaries
  • 5 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Flash point

Study results
  • 10 studies submitted
  • 4 studies processed
R Flash point
175.6 °C @ 97.41 kPa [4]

Type of Study provided
Studies with data
Key study 5
Supporting study 4
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
R Summaries
  • 4 summaries submitted
  • 4 summaries processed
Flash point at 101 325 Pa
175.6 °C

Auto flammability

Study results
  • 7 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 4 3
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 5 summaries submitted
  • 4 summaries processed
Autoflammability / self-ignition at 101 325 Pa
460 °C

Flammability

Study results
  • 7 studies submitted
  • 3 studies processed
C Interpretation of results
Non flammable (100%) [3]

Type of Study provided
Studies with data
Key study 3
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 4
C Summaries
  • 5 summaries submitted
  • 4 summaries processed
Flammability
Not classified (100%)

Explosiveness

Study results
  • 5 studies submitted
  • 4 studies processed
C Interpretation of results
Non-explosive (100%) [4]

Type of Study provided
Studies with data
Key study 4
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
C Summaries
  • 4 summaries submitted
  • 4 summaries processed
Explosiveness
Non-explosive (100%)

Oxidising

Study results
  • 5 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 4
C Summaries
  • 4 summaries submitted
  • 4 summaries processed
Oxidising
No (100%)

Oxidation reduction potential

Data not provided by the registrant

pH

Study results
  • 4 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 4
Supporting study
Weight of evidence
Other
Data waiving
no waivers

No summary exists for this scientific endpoint

Dissociation constant

Study results
  • 3 studies submitted
  • 3 studies processed
C Dissociating properties
Yes (100%) [3]
R Dissociation constant
-6.82 - -6.405 [3]

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

No automatically processable data submitted

Viscosity

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
Sci. unjustified
Exposure cons.
Other 4
Summaries
  • 4 summaries 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
  • 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

Hydrolysis

Study results
  • 5 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
Not feasible
Sci. unjustified 5
Exposure cons.
Other
Summaries
  • 4 summaries 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
  • 31 studies submitted
  • 7 studies processed
C Interpretation of results
Readily biodegradable (100%) [7]

Type of Study provided
Studies with data
Key study 5 3
Supporting study 16 7
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 5 summaries submitted
  • 5 summaries 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
R Summaries
  • 4 summaries submitted
  • 4 summaries processed
Half-life in freshwater
37.5 days @ 25 °C
Half-life in freshwater sediment
11.25 months @ 25 °C

Biodegradation in soil

Study results
  • 4 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study 4
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 4 summaries submitted
  • 4 summaries processed
Half-life in soil
75 days @ 25 °C

Bioaccumulation: aquatic / sediment

Study results
  • 12 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence 8 3
Other
Data waiving
no waivers
R Summaries
  • 5 summaries submitted
  • 4 summaries processed
Bioaccumulation Factor (BCF) - L/kg ww
3.377 L/kg ww

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 5 studies submitted
  • 4 studies processed
R log Koc
1.812 dimensionless @ 25 °C [4]

Type of Study provided
Studies with data
Key study 4
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
R Summaries
  • 5 summaries submitted
  • 4 summaries processed
Koc at 20°C
64.92 - 64.923

Henrys law constant (H)

Study results
  • 1 study submitted
  • 1 study processed
R H - (pressure) m³/mol
4.957 Pa m³/mol @ 25 °C [1]

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

No data available

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
  • 5 summaries submitted
  • 5 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 30 µg/L (1)
Intermittent releases (freshwater) 1 mg/L (1)
Marine water 3 µg/L (1)
Intermittent releases (marine water) 100 µg/L (1)
Sewage treatment plant (STP) 100 mg/L (1)
Sediment (freshwater) 303 µg/kg sediment dw (1)
Sediment (marine water) 30.3 µg/kg sediment dw (1)
Hazard for Air
Air No hazard identified (5)
Hazard for Terrestrial Organism
Soil 42.9 µg/kg soil dw (1)
Hazard for Predators
Secondary poisoning No potential for bioaccumulation (5)

Short–term toxicity to fish

Study results
  • 18 studies submitted
  • 11 studies processed
P/RResults
LC50 (4 days) 15 - 513.188 mg/L [5]
LC50 (24 h) 1.8 mg/L [4]
LC0 (4 days) 15 mg/L [4]
LL50 (4 days) 100 mg/L [2]
NOELR (4 days) 100 mg/L [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 3
Weight of evidence 12 1
Other
Data waiving
no waivers
R Summaries
  • 5 summaries submitted
  • 4 summaries processed
LC50 for freshwater fish
100 - 513.188 mg/L

Long–term toxicity to fish

Study results
  • 9 studies submitted
  • 6 studies processed
P/RResults
NOEC (14 days) 500 µg/L [6]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 6 3
Other
Data waiving
no waivers
R Summaries
  • 3 summaries submitted
  • 3 summaries processed
EC10 / LC10 or NOEC for freshwater fish
50 mg/L

Short–term toxicity to aquatic invertebrates

Study results
  • 17 studies submitted
  • 10 studies processed
P/RResults
EC50 (48 h) 5 - 166.3 mg/L [8]
LC50 (48 h) 454 mg/L [1]
EL50 (48 h) 100 mg/L [1]
NOELR (48 h) 100 mg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 3
Weight of evidence 12 1
Other
Data waiving
no waivers
R Summaries
  • 5 summaries submitted
  • 4 summaries processed
EC50 / LC50 for freshwater invertebrates
100 - 454 mg/L

Long–term toxicity to aquatic invertebrates

Study results
  • 9 studies submitted
  • 9 studies processed
P/RResults
EC50 (21 days) 550 - 2 100 µg/L [12]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 6 3
Other
Data waiving
no waivers
R Summaries
  • 3 summaries submitted
  • 3 summaries processed
EC10 / LC10 or NOEC for freshwater invertebrates
1.5 mg/L

Toxicity to aquatic algae and cyanobacteria

Study results
  • 17 studies submitted
  • 8 studies processed
P/RResults
EC50 (72 h) 4.1 - 344.481 mg/L [11]
NOEC (72 h) 4.1 - 56 mg/L [10]
EL50 (72 h) 160 - 1 081 mg/L [2]
NOELR (72 h) 160 - 1 081 mg/L [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 1
Weight of evidence 13 1
Other
Data waiving
no waivers
R Summaries
  • 5 summaries submitted
  • 4 summaries processed
EC50 for freshwater algae
100 - 344.48 mg/L

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 14 studies submitted
  • 7 studies processed
P/RResults
EC50 (15 min) 75.387 mg/L [7]

Type of Study provided
Studies with data
Key study
Supporting study 1
Weight of evidence 8 3 1
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
R Summaries
  • 5 summaries submitted
  • 3 summaries processed
EC50 for microorganisms
1 g/L

Sediment toxicity

Data not provided by the registrant

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

Study results
  • 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
Exposure cons.
Other 3
Summaries
  • 3 summaries 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
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 3
Summaries
  • 3 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

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
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 3
Summaries
  • 3 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Toxicity to soil microorganisms

Study results
  • 3 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 3
Summaries
  • 3 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Toxicity to birds

Data not provided by the registrant

Toxicity to mammals

Data not provided by the registrant

Toxicological information

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

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

M/C Summaries
  • 5 summaries submitted
  • 5 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) 32.9 mg/m³ repeated dose toxicity
Acute /short term: No hazard identified
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 9.33 mg/kg bw/day repeated dose toxicity
Acute /short term: No hazard identified
Local Effects
Long-term: (DNEL) 172 µg/cm² skin irritation/corrosion
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: (DNEL) 5.8 mg/m³ repeated dose toxicity
Acute /short term: No hazard identified
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 3.33 mg/kg bw/day repeated dose toxicity
Acute /short term: No hazard identified
Local Effects
Long-term: (DNEL) 86 µg/cm² skin irritation/corrosion
Acute /short term: No hazard identified
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 3.33 mg/kg bw/day repeated dose toxicity
Acute /short term: No hazard identified
EYE Exposure
No hazard identified

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 7 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 1
Supporting study 3 3
Weight of evidence
Other
Data waiving
no waivers
Study data: dermal absorption
  • 8 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: dermal absorption
Studies with data
Key study
Supporting study 4 4
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 1 summary processed
Bioaccumulation potential:
No bioaccumulation potential

Acute toxicity

Study results
oral
  • 41 studies submitted
  • 10 studies processed
P/RResults
LD50 2 000 - 10 000 mg/kg bw (rat) [10]
M/CInterpretations of results
Category 5 based on GHS criteria [1]

Type of Study provided
oral
Studies with data
Key study 6 3
Supporting study 20 5
Weight of evidence 7
Other
Data waiving
no waivers
inhalation
  • 6 studies submitted
  • 1 study processed
M/CInterpretations of results
GHS criteria not met [1]

inhalation
Studies with data
Key study
Supporting study
Weight of evidence 2
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other 3
dermal
  • 11 studies submitted
  • 6 studies processed
P/RResults
LD50 2 000 mg/kg bw (rat) [4]
LD50 2 000 - 3 072 mg/kg bw (rabbit) [2]
M/CInterpretations of results
GHS criteria not met [2]

dermal
Studies with data
Key study 4 1
Supporting study 2 2
Weight of evidence 1 1
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
  • 5 summaries submitted
  • 5 summaries processed
Oral route:
No adverse effect observed LD50 2 000 mg/kg bw
Inhalation route:
No adverse effect observed LC50 1 241 mg/m³
Dermal route:
No adverse effect observed LD50 2 000 mg/kg bw

Irritation / corrosion

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

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 8 3
Supporting study 11 4
Weight of evidence 6 1
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 2
Study data: eye
  • 34 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 3 1
Supporting study 17 6
Weight of evidence 4 1 1
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
M/C Summaries
  • 5 summaries submitted
  • 5 summaries 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
  • 29 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 4 6
Weight of evidence 8 3 1
Other
Data waiving
Not feasible
Sci. unjustified 3
Exposure cons.
Other 2
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
  • 5 summaries submitted
  • 5 summaries processed
Skin sensitisation
No adverse effect observed (not sensitising)
Respiratory sensitisation
No study available

Repeated dose toxicity

Study results
Study data: oral
  • 20 studies submitted
  • 11 studies processed
P/RResults
NOAEL (rat): 1 000 - 5 000 mg/kg bw/day [7]
NOAEL (rat): 2 500 mg/kg diet [2]
LOAEL (rat): 10 000 mg/kg bw/day [2]
NOEL (rat): 1 000 mg/kg bw/day [4]

Type of Study provided
Study data: oral
Studies with data
Key study
Supporting study
Weight of evidence 14 5 1
Other
Data waiving
no waivers
Study data: inhalation
  • 5 studies 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. 3
Other 1
Study data: dermal
  • 17 studies submitted
  • 1 study processed
P/RResults
NOAEL (rat): 111.25 - 1 089.75 mg/kg bw/day [2]

Study data: dermal
Studies with data
Key study 1 1
Supporting study 5 6
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 4
M/C Summaries
  • 5 summaries submitted
  • 5 summaries processed
Oral route - systemic effects:
No adverse effect observed NOAEL 1 530 mg/kg bw/day (subacute, rat)
Dermal route - systemic effects:
No adverse effect observed NOAEL 1 089.75 mg/kg bw/day (subacute, rat)
Dermal route - local effects:
Adverse effect observed NOAEL 860 µg/cm² (subacute, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 37 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 6 6
Supporting study 1 1
Weight of evidence 21 2
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
  • 5 summaries submitted
  • 5 summaries processed
Toxicity - InVitro
No adverse effect observed (negative)
Toxicity - InVivo
No study available

Carcinogenicity

Study results
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study
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
  • 16 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: reproduction
Studies with data
Key study 1 1
Supporting study
Weight of evidence 11 1
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 2
Study data: developmental
  • 10 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 4 1
Supporting study 4 1
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
  • 5 summaries submitted
  • 5 summaries processed
Effect on fertility
Oral route:
Adverse effect observed NOAEL 603.33 mg/kg bw/day (subacute, rat)
Dermal route:
No adverse effect observed NOAEL 1 089.75 mg/kg bw/day (subacute, rat)
Effect on developmental toxicity
Oral route:
No adverse effect observed NOAEL 1 000 mg/kg bw/day (subchronic, rat)
Dermal route:
No adverse effect observed NOAEL 1 089.75 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