Brief Profile

The Brief Profile summarizes the non-confidential data on substances as it is held in the databases of the European Chemicals Agency (ECHA), including data provided by third parties. The Brief Profile is automatically generated; note that it does not currently distinguish between harmonised classification and minimum classification; information requirements under different legislative frameworks may therefore not be fully up to date or complete. For accuracy reasons, substance manufacturers and imports have the responsibility to consult official sources, e.g. the electronic edition of the Official Journal of the European Union.
This Brief Profile is covered by the ECHA Legal Notice.

Substance Description

Substance identity

EC / List no.:
810-161-6
CAS no.:
1229654-66-3
Index number:
Molecular formula:
SMILES:
InChI:
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
1
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:

Hazard classification & labelling

Warning! 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 and may cause an allergic skin reaction.

Breakdown of all 94 C&L notifications submitted to ECHA

Aquatic Acute 1 H400
Aquatic Chronic 1 H410
Skin Sens. 1B 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

  • Ss
There is broad agreement in that a majority of data submitters agree this substance is Skin sensitising (100% of REACH registrations).

Regulatory activities

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

Registration
Pre-registration:
Registration:
This substance has 1 active registrations under REACH, 0 Joint Submission(s) and 1 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 10 - 100 tonnes per year.

This substance is used in formulation or re-packing and in manufacturing.

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 routes by which this substance is most likely to be released to the environment.

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

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

ECHA has no public registered data indicating whether or into which articles the substance might have been processed.

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.

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.

This substance is used in the following products: plant protection products.

This substance is used in the following activities or processes at workplace: closed batch processing in synthesis or formulation, transfer of chemicals at dedicated facilities, transfer of substance into small containers and laboratory work.

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

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.

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.

This substance is used in the following activities or processes at workplace: closed batch processing in synthesis or formulation, transfer of chemicals at dedicated facilities and laboratory work.

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

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

Prevention statements

When handling this substance: contaminated work clothing should not be allowed out of the workplace; avoid release to the environment; wear protective gloves and/or clothing, and eye and/or face protection as specified by manufacturer/supplier; avoid breathing the dust, fume, gas, mist, vapours or spray.

Response statements

In case of incident: Wash contaminated clothing before reuse. If skin irritation or a rash occurs: get medical advice/attention. Collect spillage. If on skin: wash with soap and water. Follow specific treatment (see label).

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

  • Bayer AG, Kaiser-Wilhelm-Allee 51373 Leverkusen Germany

Substance names and other identifiers

1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide
C&L Inventory, Registration dossier
N-(Cyano-alkylcarboxamido-alkylaryl)-haloalkylheteroarylalkylcarboxamide
Registration dossier
1229654-66-3
CAS number
C&L Inventory, Registration dossier

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

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

Melting/freezing point

Study results
  • 2 studies submitted
  • 2 studies processed
R Melting / freezing point
226.9 - 230.1 °C @ 101.3 kPa [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Melting / freezing point at 101 325 Pa
228.4 °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
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Density

Study results
  • 2 studies submitted
  • 2 studies processed
R Relative density
1.47 - 1.52 @ 20 °C [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
Relative density at 20°C
1.47

Vapour pressure

Study results
  • 1 study submitted
  • 1 study processed
R Vapour pressure
0 - 0 Pa @ 20 - 25 °C [2]

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
1.9 - 2.6 @ 25 °C and pH 4 - 9 [3]

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

Water solubility

Study results
  • 1 study submitted
  • 1 study processed
R Water solubility (mass/vol.)
1 - 1.3 mg/L @ 20 °C and pH 4.01 - 9.01 [4]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Water solubility
1.2 mg/L @ 20 °C

Solubility in organic solvents / fat solubility

Study results
  • 1 study submitted
  • 1 study processed
R Acetone
21.8 g/L @ 20 °C [1]
R Ethyl acetate
6.4 g/L @ 20 °C [1]
R Methanol
2.9 g/L @ 20 °C [1]
R Toluene
170 mg/L @ 20 °C [1]

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

No automatically processable data submitted

Surface tension

Study results
  • 1 study submitted
  • 1 study processed
R Surface tension
72.1 mN/m @ 996.5 µg/L and 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
Surface tension at 20 °C
72.1 mN/m @ 0.997 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 1
Sci. unjustified
Exposure cons.
Other
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Auto flammability

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
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Flammability

Study results
  • 5 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 2
Supporting study 1
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
C Summaries
  • 1 summary submitted
  • 1 summary processed
Flammability
Not classified (100%)

Explosiveness

Study results
  • 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
C Summaries
  • 1 summary submitted
  • 1 summary processed
Explosiveness
Non-explosive (100%)

Oxidising

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
C Summaries
  • 1 summary submitted
  • 1 summary processed
Oxidising
Non oxidising (100%)

Oxidation reduction potential

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

pH

Data not provided by the registrant

Dissociation constant

Study results
  • 1 study submitted
  • 1 study processed
C Dissociating properties
Yes (100%) [1]
R Dissociation constant
9.1 @ 23 °C [1]

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

No automatically processable data submitted

Viscosity

Data not provided by the registrant

Environmental fate and pathways

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

Phototransformation in air

Data not provided by the registrant

Hydrolysis

Study results
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

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

No automatically processable data submitted

Phototransformation in water

Study results
  • 0 studies submitted
  • 0 studies processed

No data available

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Half-life in water
16.8 h

Phototransformation in soil

Study results
  • 0 studies submitted
  • 0 studies processed

No data available

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

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

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
  • 1 summary submitted
  • 1 summary processed
Half-life in water
6.3 days @ 20.3 °C
Half-life in sediment
4.067 months @ 20.3 °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
  • 2 summaries submitted
  • 2 summaries processed
Half-life in soil
6.1 months @ 20 °C

Bioaccumulation: aquatic / sediment

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
R Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation Factor (BCF) - dimensionless
2

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 1 study submitted
  • 1 study processed
R Koc
195.3 - 252.3 L/kg @ 20 °C and 1.8 - 5.1 % organic carbon [4]

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
Koc at 20°C
214.75

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
  • 2 summaries submitted
  • 2 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 71 - 1 300 ng/L (2)
Intermittent releases (freshwater) 1.73 µg/L (2)
Marine water 1.5 µg/L (2)
Intermittent releases (marine water) 14.9 µg/L (2)
Sewage treatment plant (STP) 10 mg/L (1)
Sediment (freshwater) 59.6 - 119.2 ng/kg sediment dw (2)
Sediment (marine water) 5.96 - 11.92 ng/kg sediment dw (2)
Hazard for Air
Air No hazard identified (2)
Hazard for Terrestrial Organism
Soil 2.69 µg/kg soil dw (2)
Hazard for Predators
Secondary poisoning No potential for bioaccumulation (2)

Short–term toxicity to fish

Study results
  • 3 studies submitted
  • 2 studies processed
P/RResults
LC50 (4 days) 9.09 - 11.2 mg/L [3]

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
LC50 for freshwater fish
10 mg/L
LC50 for marine water fish
9.09 mg/L

Long–term toxicity to fish

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
NOEC (35 days) 4.21 mg/L [6]
NOEC (33 days) 2.5 - 5 mg/L [5]
NOEC (8 days) 4.21 mg/L [1]
NOEC (4 days) 5 mg/L [1]
LOEC (35 days) 4.21 mg/L [6]

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
EC10 / LC10 or NOEC for freshwater fish
2.5 mg/L
EC10 / LC10 or NOEC for marine water fish
4.21 mg/L

Short–term toxicity to aquatic invertebrates

Study results
  • 5 studies submitted
  • 2 studies processed
P/RResults
EC50 (4 days) 2.2 mg/L [1]
EC50 (48 h) 173.3 µg/L [1]
NOEC (4 days) 1.3 mg/L [1]

Type of Study provided
Studies with data
Key study 2
Supporting study 3
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 / LC50 for freshwater invertebrates
173.3 µg/L
EC50 / LC50 for marine invertebrates
2.2 mg/L

Long–term toxicity to aquatic invertebrates

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
NOEC (30 days) 150 µg/L [1]
NOEC (21 days) 13.3 - 140 µg/L [5]
LOEC (30 days) 280 µg/L [1]
LOEC (21 days) 24 - 140 µg/L [5]
EC10 (21 days) 28 µg/L [1]

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
EC10 / LC10 or NOEC for freshwater invertebrates
13.3 µg/L
EC10 / LC10 or NOEC for marine invertebrates
150 µg/L

Toxicity to aquatic algae and cyanobacteria

Study results
  • 3 studies submitted
  • 2 studies processed
P/RResults
EC50 (4 days) 1.36 - 2.6 mg/L [2]
EC50 (72 h) 1.49 - 3.19 mg/L [2]
NOEC (4 days) 154 - 266 µg/L [2]
NOEC (72 h) 285 - 429 µg/L [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
EC50 for freshwater algae
3.19 mg/L
EC50 for marine water algae
1.49 mg/L
EC10 or NOEC for freshwater algae
285 µg/L
EC10 or NOEC for marine water algae
429 µg/L

Toxicity to aquatic plants other than algae

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
EC50 (7 days) 6.64 mg/L [2]
NOEC (7 days) 2.05 mg/L [1]
LOEC (7 days) 6.64 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 freshwater plants
6.64 mg/L
EC10 or NOEC for freshwater plants
2.05 mg/L

Toxicity to microorganisms

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
EC50 (3 h) 100 mg/L [1]
NOEC (3 h) 100 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
100 mg/L
EC10 or NOEC for microorganisms
100 mg/L

Sediment toxicity

Study results
  • 7 studies submitted
  • 4 studies processed
P/RResults
NOEC (28 days) 6.76 µg/kg sediment dw [2]
NOEC (28 days) 800 ng/L [2]
NOEC (10 days) 728 µg/kg sediment dw [1]
NOEC (48 h) 32 µg/L [1]
LOEC (28 days) 12.7 µg/kg sediment dw [2]

Type of Study provided
Studies with data
Key study 4
Supporting study 3
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 / LC50 for marine water sediment
728 µg/kg sediment dw
EC10 / LC10 or NOEC for freshwater sediment
5.96 µg/kg sediment dw

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 (14 days) 869 mg/kg soil dw [1]
LC50 (14 days) 869 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
Short-term EC50 / LC50
869 mg/kg soil dw
Long-term EC10 / LC10 / NOEC
869 mg/kg soil dw

Toxicity to terrestrial arthropods

Study results
  • 0 studies submitted
  • 0 studies processed

No data available

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

No automatically processable data submitted

Toxicity to terrestrial plants

Data not provided by the registrant

Toxicity to soil microorganisms

Study results
  • 4 studies submitted
  • 2 studies processed
P/RResults
NOEC (28 days) 265 - 1 310 µg/kg soil dw [2]
EC10 (28 days) 1.31 mg/kg soil dw [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Long-term EC10 / NOEC
265 µg/kg soil dw

Toxicity to birds

Study results
  • 0 studies submitted
  • 0 studies processed

No data available

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Long-term EC10 / LC10 / NOEC
42.9 mg/kg food

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) 11.2 mg/m³ repeated dose toxicity
Acute /short term: Hazard unknown (no further information necessary as no exposure expected)
Local Effects
Long-term: Hazard unknown (no further information necessary as no exposure expected)
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 3.3 mg/kg bw/day repeated dose toxicity
Acute /short term: No hazard identified
Local Effects
Long-term: Medium hazard (no threshold derived)
Acute /short term: Medium hazard (no threshold derived)
EYE Exposure
No hazard identified
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 2.8 mg/m³ repeated dose toxicity
Acute /short term: Hazard unknown (no further information necessary as no exposure expected)
Local Effects
Long-term: Hazard unknown (no further information necessary as no exposure expected)
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 1.7 mg/kg bw/day repeated dose toxicity
Acute /short term: No hazard identified
Local Effects
Long-term: Medium hazard (no threshold derived)
Acute /short term: Medium hazard (no threshold derived)
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 1.6 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
  • 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 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: dermal absorption
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: dermal absorption
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation potential:
No bioaccumulation potential
Absorption values
Oral: 41.2 %

Acute toxicity

Study results
oral
  • 2 studies submitted
  • 2 studies processed
P/RResults
LD50 2 000 mg/kg bw (rat) [2]
M/CInterpretations of results
Other [2]

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 2 000 mg/kg bw (rat) [1]
M/CInterpretations of results
Other [1]

dermal
Studies with data
Key study 1
Supporting study
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:
No adverse effect observed LD50 2 000 mg/kg bw
Inhalation route:
Adverse effect observed LC50 5.01 mg/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 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
Study data: eye
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 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
No adverse effect observed (not irritating)
Eye
No adverse effect observed (not irritating)
Respiratory
No study available

Sensitisation

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 2
Supporting study 2
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
Adverse effect observed (sensitising)
Respiratory sensitisation
No study available

Repeated dose toxicity

Study results
Study data: oral
  • 8 studies submitted
  • 3 studies processed
P/RResults
NOAEL (rat): 4 000 - 10 000 ppm [3]
NOAEL (dog): 3 200 ppm [1]

Type of Study provided
Study data: oral
Studies with data
Key study 3
Supporting study 5
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
  • 2 studies submitted
  • 1 study processed
P/RResults
NOAEL (rat): 1 000 mg/kg bw/day [1]

Study data: dermal
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 - systemic effects:
Adverse effect observed NOAEL 159 mg/kg bw/day (chronic, rat)
Dermal route - systemic effects:
No adverse effect observed NOAEL 1 000 mg/kg bw/day (subacute, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 3 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
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 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Toxicity - InVitro
No adverse effect observed (negative)
Toxicity - InVivo
No adverse effect observed (negative)

Carcinogenicity

Study results
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study 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 NOAEL 221 mg/kg bw/day (chronic, rat)

Toxicity to reproduction

Study results
Study data: reproduction
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

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

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 2
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 896 mg/kg bw/day (subchronic, rat)
Effect on developmental toxicity
Oral route:
No adverse effect observed NOAEL 1 000 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