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: Cetrimonium bromide
  • IUPAC name: hexadecyltrimethylazanium bromide
  • Other names
EC / List no.:
200-311-3
CAS no.:
57-09-0
Index number:
Molecular formula:
C19H42BrN
SMILES:
[Br-].CCCCCCCCCCCCCCCC[N+](C)(C)C
InChI:
InChI=1S/C19H42N.BrH/c1-5-6-7-8-9-10-11-12-13-14-15-16-17-18-19-20(2,3)4;/h5-19H2,1-4H3;1H/q+1;/p-1 AuxInfo=1/1/N:20,3,4,5,7,8,18,10,11,12,13,14,15,19,9,16,17,6,2,1;21/E:(2,3,4);/CRV:20+1;/rA:21N+CCCCCCCCCCCCCCCCCCCBr-/rB:s1;s1;s1;s1;s2;;s7;;;s10;s11;s12;s13;s14;s9;s6s16;s8s10;s9s15;s7;;/rC:-1.0333,-2.3946,0;-2.3429,-1.5748,0;.2879,-3.1505,0;-1.7892,-3.6722,0;-.2232,-1.0628,0;-3.6739,-2.3201,0;5.6651,-1.5533,0;5.6651,-.0407,0;-3.6311,.7046,0;4.3127,2.2805,0;3.0135,3.0578,0;1.6721,2.2911,0;.3304,3.0578,0;-1.0012,2.2911,0;-2.3003,3.0684,0;-4.9729,-.0513,0;-4.9729,-1.5641,0;4.3127,.7046,0;-3.6311,2.2805,0;4.3127,-2.3521,0;9.8451,0,0;
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 is very toxic to aquatic life, is very toxic to aquatic life with long lasting effects, is harmful if swallowed, causes serious eye damage, may cause damage to organs through prolonged or repeated exposure, causes skin irritation and may cause respiratory irritation.

Breakdown of all 485 C&L notifications submitted to ECHA

Acute Tox. 4 H302
Aquatic Acute 1 H400
Eye Dam. 1 H318
Skin Irrit. 2 H315
STOT SE 3 H335
STOT RE 2 H373
Eye Irrit. 2 H319
Aquatic Chronic 1 H410
Skin Corr. 1A H314
Aquatic Chronic 3 H411
Acute Tox. 4 H312
STOT SE 3 H336
STOT SE 1 H370
Repr. 2 H361
Not Classified
https://echa.europa.eu/diss-blank-theme/images/cnl/graph/more.png 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 5 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:

About this substance

This substance is manufactured and/or imported in the European Economic Area in 10 - 100 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: cosmetics and personal care products, perfumes and fragrances and pharmaceuticals.

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

ECHA has no public registered data on the use of this substance in activities or processes at the workplace.

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).

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: laboratory chemicals, cosmetics and personal care products and pH regulators and water treatment products.

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: laboratory work, hand mixing with intimate contact only with personal protective equipment available, 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 and transfer of substance into small containers.

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: perfumes and fragrances, pharmaceuticals, cosmetics and personal care products, laboratory chemicals and water treatment chemicals.

This substance is used in the following activities or processes at workplace: closed, continuous processes with occasional controlled exposure, mixing in open batch processes, transfer of chemicals, transfer of substance into small containers, closed processes with no likelihood of exposure, closed batch processing in synthesis or formulation 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: laboratory chemicals, pH regulators and water treatment products, polymers and cosmetics and personal care products.

This substance is used in the following areas: scientific research and development and health services. 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, transfer of substance into small containers and mixing in open batch processes.

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

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

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

Response statements

In case of incident: Collect spillage. 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

  • Aceto France, 3-5 rue Scheffer 75016 Paris France
  • Dishman Europe Ltd, Suite 4, De Walden Court, 85, New Cavendish Street, W1W 6XD London United Kingdom
  • Novo Nordisk Pharmatech A/S, Koebenhavnsvej 216 4600 Koege Denmark
  • SIGMA-ALDRICH CHEMIE GMBH, Riedstrasse 2 89555 Steinheim Germany
  • Zeon Europe GmbH, Hansaallee 249 40549 Düsseldorf NRW Germany

Other names

  • -
  • Cetrimonium bromide
  • Cetyl Trimethyl Ammonium Bromide
  • Cetyl trimethylammonium bromide
  • cetyltrimethyl ammonium bromide
  • CTAB
  • CTAB, Cetyltrimethylammonium bromide, Palmityltrimethylammonium bromide, Hexadecyltrimethylammonium bromide, Cetrimide
  • hexadecyl(trimethyl)azanium bromide
  • Hexadecyl-trimethyl-ammonium bromide
  • Hexadecyltrimethylammonium Bromide
  • hexadecyltrimethylazanium bromide
  • N,N,N-trimethylhexadecan-1-aminium bromide
  • Cetrimonium bromide
  • CETRIMONIUM BROMIDE
  • CTAB

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
Crystalline (50%), Powder (50%) [2]
C Odour
Odourless (100%) [1]
C Substance type
Organic (100%) [1]

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

Melting/freezing point

Study results
  • 1 study submitted
  • 1 study processed
R Melting / freezing point
237 - 243 °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
Melting / freezing point at 101 325 Pa
237 °C

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

No automatically processable data submitted

Density

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

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
0.5

Vapour pressure

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

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Vapour pressure
0 Pa @ 25 °C

Partition coefficient

Study results
  • 1 study submitted
  • 1 study processed
R Log Pow
3.18 @ 25 °C and pH 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
Log Kow (Log Pow)
3.18 @ 20 °C

Water solubility

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Water solubility
55 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 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Surface tension at 20 °C
39 mN/m @ 291 mg/L

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

No automatically processable data submitted

Auto flammability

Study results
  • 1 study submitted
  • 1 study processed
R Autoflammability / self-ignition
210 °C @ 30 kPa [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
Autoflammability / self-ignition at 101 325 Pa
210 °C

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

No automatically processable data submitted

Explosiveness

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Oxidising

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Oxidation reduction potential

Data not provided by the registrant

pH

Data not provided by the registrant

Dissociation constant

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Viscosity

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Environmental fate and pathways

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

Phototransformation in air

Data not provided by the registrant

Hydrolysis

Study results
  • 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
  • 8 studies submitted
  • 2 studies processed
C Interpretation of results
Readily biodegradable (50%), Inherently biodegradable (50%) [2]

Type of Study provided
Studies with data
Key study
Supporting study 2
Weight of evidence 1 5
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
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Half-life in soil
58 days @ 22 °C

Bioaccumulation: aquatic / sediment

Study results
  • 6 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 5
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation Factor (BCF) - dimensionless
750

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 1
Supporting study 1 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Koc at 20°C
31 000

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 22 ng/L (1)
Intermittent releases (freshwater) 400 ng/L (1)
Marine water 2.2 ng/L (1)
Intermittent releases (marine water) -
Sewage treatment plant (STP) 190 µg/L (1)
Sediment (freshwater) Insufficient data available (further information necessary) (1)
Sediment (marine water) Insufficient data available (further information necessary) (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 210 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
  • 1 study processed
P/RResults
LC50 (4 days) 200 µg/L [1]
LC10 (4 days) 170 µg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 2 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
LC50 for freshwater fish
200 µg/L

Long–term toxicity to fish

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
NOEC (35 days) 53 - 230 µg/L [2]

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

No automatically processable data submitted

Short–term toxicity to aquatic invertebrates

Study results
  • 4 studies submitted
  • 1 study processed
P/RResults
EC50 (48 h) 26 µg/L [1]
EC10 (48 h) 21 µg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 3
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 / LC50 for freshwater invertebrates
26 µg/L

Long–term toxicity to aquatic invertebrates

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
NOEC (21 days) 23 µg/L [1]
EC50 (21 days) 23 - 40 µg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC10 / LC10 or NOEC for freshwater invertebrates
23 µg/L

Toxicity to aquatic algae and cyanobacteria

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
EC50 (72 h) 4.11 µg/L [1]
NOEC (72 h) 1.1 µg/L [1]
EC10 (72 h) 2.27 µg/L [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
EC50 / LC50 for freshwater algae
4.11 µg/L
EC10 / LC10 or NOEC for freshwater algae
1.1 µg/L

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

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

Sediment toxicity

Data not provided by the registrant

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
NOEC (21 days) 620 mg/kg soil dw [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
Long-term EC10 / LC10 / NOEC
620 mg/kg soil dw

Toxicity to terrestrial arthropods

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
NOEC (24 days) 3.084 g/kg soil dw [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
Long-term EC10 / LC10 / NOEC
308 mg/kg soil dw

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 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 soil microorganisms

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
NOEC (14 days) 250 mg/kg soil dw [1]
EC50 (14 days) 2.4 - 7.18 g/kg soil dw [6]

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
Short-term EC50 / LC50
2 g/kg soil dw
Long-term EC10 / LC10 / NOEC
21 mg/kg soil dw

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: Hazard unknown (no further information necessary)
Acute /short term: Hazard unknown (no further information necessary)
Local Effects
Long-term: Other toxicological threshold
Acute /short term: (DNEL) 50 µg/m³ irritation (respiratory tract)
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 400 µg/kg bw/day repeated dose toxicity
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: Other toxicological threshold
Acute /short term: Other toxicological threshold
EYE Exposure
High hazard (no threshold derived)
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: Hazard unknown (no further information necessary)
Acute /short term: Hazard unknown (no further information necessary)
Local Effects
Long-term: Hazard unknown (no further information necessary)
Acute /short term: Hazard unknown (no further information necessary)
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: Hazard unknown (no further information necessary)
Acute /short term: Hazard unknown (no further information necessary)
Local Effects
Long-term: Hazard unknown (no further information necessary)
Acute /short term: Hazard unknown (no further information necessary)
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: Hazard unknown (no further information necessary)
Acute /short term: Hazard unknown (no further information necessary)
EYE Exposure
Hazard unknown (no further information necessary)

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 2 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 1
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 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation potential:
No bioaccumulation potential
Absorption values
Oral: 6 %
Dermal: 3 %

Acute toxicity

Study results
oral
  • 2 studies submitted
  • 2 studies processed
P/RResults
LD50 1 550 - 2 970 mg/kg bw (rat) [3]
M/CInterpretations of results
Toxicity Category IV [1]

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

inhalation
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
dermal
  • 1 study submitted
  • 1 study processed
P/RResults
LD50 4.3 mL/kg bw (rabbit) [1]
M/CInterpretations of results
Not classified [1]

dermal
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
other routes
  • 2 studies submitted
  • 1 study processed
P/RResults
LD50 85 - 127 mg/kg bw (mouse) [1]

other routes
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route:
Adverse effect observed LD50 465 mg/kg bw
Inhalation route:
Adverse effect observed Discriminating conc. 1.8 mg/m³

Irritation / corrosion

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

Study data not processed for brief profile

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

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 2 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin
Adverse effect observed (irritating)
Eye
Adverse effect observed (irritating)
Respiratory
Adverse effect observed (irritating)

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
Supporting study 1 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)

Repeated dose toxicity

Study results
Study data: oral
  • 2 studies submitted
  • 1 study processed
P/RResults
NOAEL (rat): 10 mg/kg bw/day [1]

Type of Study provided
Study data: oral
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
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
  • 1 study submitted
  • 1 study processed
P/RResults
LOAEL (rabbit): 10 mg/kg bw/day [1]

Study data: dermal
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route - systemic effects:
Adverse effect observed NOAEL 10 mg/kg bw/day (chronic, rat)
Dermal route - systemic effects:
No adverse effect observed NOAEL 10 mg/kg bw/day (subacute, rabbit)
Dermal route - local effects:
Adverse effect observed LOAEL 50 µg/cm² (subacute, rabbit)

Genetic toxicity

Study results
Study data: in vitro
  • 7 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 2 2
Weight of evidence
Other
Data waiving
no waivers
Study data: in vivo
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: in vivo
Studies with data
Key study
Supporting study 1
Weight of evidence
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
  • 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
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study
Supporting study 2
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
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