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: Denatonium benzoate
  • IUPAC name: benzyl({[(2,6-dimethylphenyl)carbamoyl]methyl})diethylazanium benzoate hydrate
  • Other names
EC / List no.:
223-095-2
CAS no.:
3734-33-6
Index number:
Molecular formula:
C28H36N2O4
SMILES:
O.[O-]C(=O)C1=CC=CC=C1.CC[N+](CC)(CC(=O)NC1=C(C)C=CC=C1C)CC1=CC=CC=C1
InChI:
InChI=1S/C21H28N2O.C7H6O2.H2O/c1-5-23(6-2,15-19-13-8-7-9-14-19)16-20(24)22-21-17(3)11-10-12-18(21)4;8-7(9)6-4-2-1-3-5-6;/h7-14H,5-6,15-16H2,1-4H3;1-5H,(H,8,9);1H2
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 fatal if inhaled, is harmful if swallowed and causes serious eye damage.

Additionally, the classification provided by companies to ECHA in CLP notifications identifies that this substance is harmful to aquatic life with long lasting effects, is harmful if inhaled and causes skin irritation.

Breakdown of all 1586 C&L notifications submitted to ECHA

Acute Tox. 4 H302
Aquatic Chronic 3 H412
Acute Tox. 4 H332
Eye Dam. 1 H318
Skin Irrit. 2 H315
Not Classified
Eye Irrit. 2 H319
STOT SE 3 H335
Acute Tox. 2 H330
Acute Tox. 4 H312
Skin Sens. 1 H317
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 6 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 100 - 1 000 tonnes per year.

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

This substance is used in the following products: washing & cleaning products, biocides (e.g. disinfectants, pest control products), polishes and waxes, fertilisers, air care products, anti-freeze products, coating products, fillers, putties, plasters, modelling clay, finger paints, plant protection products, polymers, water softeners and cosmetics and personal care 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) and outdoor use.

This substance is used in the following activities or processes at workplace: 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: outdoor use in long-life materials with low release rate (e.g. metal, wooden and plastic construction and building materials) and 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).

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).

This substance is used in the following products: washing & cleaning products, biocides (e.g. disinfectants, pest control products), plant protection products, polishes and waxes, anti-freeze products, air care products, coating products, fillers, putties, plasters, modelling clay, finger paints, polymers, water softeners and cosmetics and personal care products.

This substance is used in the following areas: agriculture, forestry and fishing and health services. This substance is used for the manufacture of: chemicals, plastic products, mineral products (e.g. plasters, cement), electrical, electronic and optical equipment, machinery and vehicles and furniture.

This substance is used in the following activities or processes at workplace: transfer of chemicals, hand mixing with intimate contact only with personal protective equipment available, non-industrial spraying, mixing in open batch processes, treatment of articles by dipping and pouring and roller or brushing applications.

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: washing & cleaning products, polymers, biocides (e.g. disinfectants, pest control products), polishes and waxes, fertilisers, anti-freeze products and plant protection products.

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

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, polymers, biocides (e.g. disinfectants, pest control products), plant protection products, anti-freeze products and polishes and waxes.

This substance is used in the following areas: agriculture, forestry and fishing and health services. This substance is used for the manufacture of: plastic products, electrical, electronic and optical equipment and machinery and vehicles.

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

Release to the environment of this substance can occur from industrial use: in processing aids at industrial sites, in the production of articles and for thermoplastic manufacture.

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

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

ECHA has no 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

  • CHEMICAL INSPECTION & REGULATION SERVICE LIMITED, Room 002, Regus Harcourt Centre D02 HW77 Dublin Ireland
  • Macfarlan Smith Limited, Wheatfield Road EH11 2QA Edinburgh United Kingdom
  • SENTINALCO SA, Rue de la forêt 2 7522 BLANDAIN Belgium
  • Sustainability Support Services (Europe) AB, Markaskälsvägen 6 22647 Lund Sweden

Other names

  • -
  • 223-095-2
  • benzyl({[(2,6-dimethylphenyl)carbamoyl]methyl})diethylazanium benzoate hydrate
  • benzyl-[2-(2,6-dimethylanilino)-2-oxoethyl]-diethylazanium benzoate
  • Benzyldiethyl [(2,6 xylylcarbamoyl) methyl] ammonium benzoate
  • BENZYLDIETHYL((2,6-XYLYLCARBAMOYL)METHYL)AMMONIUM-BENZOATE
  • Benzyldiethyl(2,6-xylylcarbamoyl)- methylammoniumbenzoat
  • DENATONIUM BENZOATE
  • N-benzyl-2-[(2,6-dimethylphenyl)amino]-N,N-diethyl-2-oxoethanaminium benzoate hydrate
  • N-[2-[(2,6-Dimethylphenyl)amino]-2-oxoethyl]-N,N-diethylbenzenemethanaminium benzoate
  • phenylmethyl-[2- [(2,6-dimethylphenyl)amino]- 2-oxoethyl]-diethylammonium benzoate
  • phenylmethyl-[2-[(2,6-dimethylphenyl)amino]-2-oxoethyl]-diethylammonium benzoate
  • [2-(2,6-dimethylanilino)-2-oxoethyl]-diethyl-(phenylmethyl)azanium benzoate
  • Denathonium benzoate
  • Denatonium benzoate
  • DENATONIUM BENZOATE

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
  • 5 studies submitted
  • 2 studies processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [2]
C Form
Solid: granular (50%), Solid: particulate/powder (50%) [2]
C Odour
Other (100%) [2]
C Substance type
Organic (100%) [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 3
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
  • 6 studies submitted
  • 2 studies processed
R Melting / freezing point
160 - 171 °C @ 96 - 96.93 kPa [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 4
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Melting / freezing point at 101 325 Pa
163 °C

Boiling point

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Boiling point at 101 325 Pa
180 °C

Density

Study results
  • 3 studies submitted
  • 2 studies processed
R Pour density
0.333 - 0.385 g/cm³ @ 26 °C [2]
R Tap density
0.4 - 0.455 g/cm³ @ 26 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
0.385

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
  • 2 studies submitted
  • 1 study processed
R Log Pow
2.2 @ 25 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Log Kow (Log Pow)
2.2 @ 25 °C

Water solubility

Study results
  • 2 studies submitted
  • 1 study processed
R Water solubility (mass/vol.)
42.555 g/L @ 25 °C [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
Water solubility
42.555 g/L @ 25 °C

Solubility in organic solvents / fat solubility

Study results
  • 3 studies submitted
  • 2 studies processed
R Acetone
1 - 50 g/L @ 33.8 °C [2]
R Acetonitrile
50 - 100 g/L @ 33.8 °C [1]
R Dimethylformamide
100 - 200 g/L @ 33.8 °C [1]
R Ethanol
200 - 1 000 g/L @ 33.8 °C [1]
R Methanol
1 000 g/L @ 33.8 °C [1]
R Toluene
1 g/L @ 33.8 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Solubility in organic solvents at 20 °C
1 000 g/L

Surface tension

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Flash point

Study results
  • 2 studies submitted
  • 2 studies processed
R Flash point
100 °C @ 96.89 kPa [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Flash point at 101 325 Pa
100 °C

Auto flammability

Study results
  • 1 study submitted
  • 1 study processed
R Autoflammability / self-ignition
164.5 °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
Autoflammability / self-ignition at 101 325 Pa
164.5 °C

Flammability

Study results
  • 1 study submitted
  • 1 study processed
C Interpretation of results
Not classified based on GHS criteria (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
Flammability
Not classified (100%)

Explosiveness

Study results
  • 1 study submitted
  • 1 study processed
C Interpretation of results
Other: (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
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 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Oxidising
Oxidising (100%)

Oxidation reduction potential

Data not provided by the registrant

pH

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers

No summary exists for this scientific endpoint

Dissociation constant

Data not provided by the registrant

Viscosity

Data not provided by the registrant

Environmental fate and pathways

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

Phototransformation in air

Data not provided by the registrant

Hydrolysis

Study results
  • 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 for hydrolysis
1 years @ 25 °C

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
  • 1 study submitted
  • 1 study processed
C Interpretation of results
Under test conditions no biodegradation observed (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
Biodegradation in water
Under test conditions no biodegradation observed (100%)

Biodegradation in water & sediment - simulation tests

Data not provided by the registrant

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 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Bioaccumulation: aquatic / sediment

Data not provided by the registrant

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 2
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Koc at 20°C
2 466.04

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 100 µg/L (1)
Intermittent releases (freshwater) 1 mg/L (1)
Marine water 10 µg/L (1)
Intermittent releases (marine water) 100 µg/L (1)
Sewage treatment plant (STP) No hazard identified (1)
Sediment (freshwater) 25 mg/kg sediment dw (1)
Sediment (marine water) 2.5 mg/kg sediment dw (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 4.95 mg/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) 100 mg/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
100 mg/L

Long–term toxicity to fish

Data not provided by the registrant

Short–term toxicity to aquatic invertebrates

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 2
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 / LC50 for freshwater invertebrates
500 mg/L

Long–term toxicity to aquatic invertebrates

Data not provided by the registrant

Toxicity to aquatic algae and cyanobacteria

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
EC50 (72 h) 281.556 mg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 for freshwater algae
281.556 mg/L

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
EC50 (15 min) 511.587 mg/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
EC50 for microorganisms
511.58 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

Data not provided by the registrant

Toxicity to terrestrial arthropods

Data not provided by the registrant

Toxicity to terrestrial plants

Data not provided by the registrant

Toxicity to soil microorganisms

Data not provided by the registrant

Toxicity to birds

Data not provided by the registrant

Toxicity to mammals

Data not provided by the registrant

Toxicological information

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

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

M/C Summaries
  • 1 summary submitted
  • 1 summary processed

The derived no- or minimum effect level (DN(M)EL) is the level of exposure above which a human should not be exposed to a substance. Please note that when more than one summary is provided, DN(M)EL values may refer to constituents of the substance and not to the substance as a whole. More detailed information is available in the dossiers.

Data for WORKERS
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 4.99 mg/m³ repeated dose toxicity
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: Low hazard (no threshold derived)
Acute /short term: Low hazard (no threshold derived)
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 1.43 mg/kg bw/day repeated dose toxicity
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: Low hazard (no threshold derived)
Acute /short term: Low hazard (no threshold derived)
EYE Exposure
Low hazard (no threshold derived)
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 768 µg/m³ repeated dose toxicity
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: Low hazard (no threshold derived)
Acute /short term: Low hazard (no threshold derived)
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 510 µg/kg bw/day repeated dose toxicity
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: Low hazard (no threshold derived)
Acute /short term: Low hazard (no threshold derived)
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 510 µg/kg bw/day repeated dose toxicity
Acute /short term: Low hazard (no threshold derived)
EYE Exposure
Low hazard (no threshold derived)

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 1 study 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
Not feasible
Sci. unjustified 1
Exposure cons.
Other
Study data: dermal absorption
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

Acute toxicity

Study results
oral
  • 5 studies submitted
  • 1 study processed
P/RResults
LD50 648 - 841 mg/kg bw (rat) [3]
M/CInterpretations of results
Category 4 based on GHS criteria [1]

Type of Study provided
oral
Studies with data
Key study 1
Supporting study 4
Weight of evidence
Other
Data waiving
no waivers
inhalation
  • 2 studies submitted
  • 1 study processed
P/RResults
LC50 (4 h) 200 mg/m³ air (rat) [1]
M/CInterpretations of results
Category 2 based on GHS criteria [1]

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

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

No data available

other routes
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route:
Adverse effect observed LD50 749 mg/kg bw
Inhalation route:
Adverse effect observed LC50 200 µg/m³
Dermal route:
No adverse effect observed LD50 2 000 mg/kg bw

Irritation / corrosion

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

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: eye
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin
Adverse effect observed (irritating)
Eye
Adverse effect observed (irreversible damage)
Respiratory
No study available

Sensitisation

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

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 1
Supporting study
Weight of evidence 1
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
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
  • 4 studies submitted
  • 1 study processed
P/RResults
LOAEL (monkey): 8 mg/kg bw/day [1]

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

No automatically processable data submitted

Study data: inhalation
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Study data: dermal
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Study data: dermal
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons. 1
Other
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route - systemic effects:
No adverse effect observed NOAEL 535.896 mg/kg bw/day (subacute, mouse)

Genetic toxicity

Study results
Study data: in vitro
  • 2 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
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
Weight of evidence 1
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Toxicity - InVitro
No adverse effect observed (negative)
Toxicity - InVivo
No adverse effect observed (negative)

Carcinogenicity

Study results
  • 1 study 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
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route:
No adverse effect observed NOAEL 16 mg/kg bw/day (chronic, rat)

Toxicity to reproduction

Study results
Study data: reproduction
  • 4 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
Supporting study
Weight of evidence 1 2
Other
Data waiving
no waivers
Study data: developmental
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: other studies
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: other studies
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Effect on fertility
Oral route:
No adverse effect observed NOAEL 60 mg/kg bw/day (chronic, rat)
Effect on developmental toxicity
Oral route:
No adverse effect observed NOAEL 60 mg/kg bw/day (chronic, 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