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; 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: Bronopol
  • IUPAC name: 2-bromo-2-nitropropane-1,3-diol
  • Other names
EC / List no.:
200-143-0
CAS no.:
52-51-7
Index number:
603-085-00-8
Molecular formula:
C3H6BrNO4
SMILES:
OCC(Br)(CO)N(=O)=O
InChI:
InChI=1S/C3H6BrNO4/c4-3(1-6,2-7)5(8)9/h6-7H,1-2H2 AuxInfo=1/0/N:6,7,2,5,1,8,9,3,4/E:(1,2)(6,7)(8,9)/CRV:5.5/rA:9NCOOBrCCOO/rB:s1;d1;d1;s2;s2;s2;s6;s7;/rC:2.3031,-3.0845,0;2.3031,-1.5491,0;3.6269,-3.8476,0;.9882,-3.8476,0;2.3122,0,0;.7631,-1.5491,0;3.8476,-1.5491,0;0,-2.8732,0;4.5877,-.2162,0;
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:
EINECS (European INventory of Existing Commercial chemical Substances) List

Hazard classification & labelling

Danger! According to the harmonised classification and labelling (ATP01) approved by the European Union, this substance is very toxic to aquatic life, is harmful if swallowed, is harmful in contact with skin, causes serious eye damage, causes skin irritation and may cause respiratory irritation.

Additionally, the classification provided by companies to ECHA in REACH registrations identifies that this substance is toxic to aquatic life with long lasting effects.

Breakdown of all 1455 C&L notifications submitted to ECHA

Eye Dam. 1 H318 Harmonised Classification
Skin Irrit. 2 H315 Harmonised Classification
Aquatic Acute 1 H400 Harmonised Classification
Acute Tox. 4 H312 Harmonised Classification
STOT SE 3 H335 Harmonised Classification
Acute Tox. 4 H302 Harmonised Classification
Aquatic Chronic 2 H411
Acute Tox. 3 H301
Acute Tox. 3 H331
Flam. Sol. 2 H228
Self-react. C H242
Acute Tox. 2 H310
Acute Tox. 2 H330
Aquatic Chronic 1 H410
Aquatic Chronic 3 H412
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 1 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:
A European Union Harmonised Classification & Labelling has been assigned to this substance.
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, by professional workers (widespread uses), in formulation or re-packing and at industrial sites.

This substance is used in the following products: perfumes and fragrances and cosmetics and personal care products.

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

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.

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

This substance is used in the following activities or processes at workplace: transfer of chemicals, 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.

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 in which chemical products the substance might be used.

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, mixing in open batch processes and transfer of substance into small containers.

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

ECHA has no public registered data indicating whether or in which chemical products the substance might be used.

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

This substance is used in the following activities or processes at workplace: transfer of chemicals, 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.

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 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

  • BASF SE, Carl-Bosch-Str. 38 67056 Ludwigshafen am Rhein Rheinland-Pfalz Germany

Other names

  • -
  • 1,3-Propanediol, 2-bromo-2-nitro-
  • 14150_52-51-7
  • 2 bromo-2-nitropropane-1,3-diol
  • 2-Brom-2-nitropropan-1,3-diol
  • 2-Brom-2-Nitropropane-1,3-Diol
  • 2-Bromo-2-nitro-1,3-propanediol
  • 2-bromo-2-nitro-1,3-propanediolbronopol
  • 2-bromo-2-nitro-propane-1,3-diol
  • 2-bromo-2-nitropropane-
  • 2-Bromo-2-nitropropane-1,3-diol
  • 2-bromo-2-nitropropane-1,3-diol bronopol (INN)
  • 2-bromo-2nitropropane-1,3-diol
  • BRONOPOL
  • bronopol (INN)
  • bronopol (INN); 2-bromo-2-nitropropane-1,3-diol
  • Morpholin-4-yl morpholine-4-carbodithioate
  • 2-bromo-2-nitropropane-1,3-diol
  • Bronopol
  • bronopol (INN)
  • 2-Bromo-2-nitro-1,3-propanediol (IUPAC name)
  • 2-Bromo-2-nitropropane-1,3-diol (chemical name)
  • BNPD (abbreviated common name)
  • Bronopol (common name)
  • Myacide AS (trade name)
  • Myacide Pharma (trade name)

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
  • 1 study processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [1]
C Form
Pellets (100%) [1]
C Substance type
Organic (100%) [1]

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

No data available

Melting/freezing point

Study results
  • 5 studies submitted
  • 1 study processed
R Melting / freezing point
129 °C [1]

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

No data available

Boiling point

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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Density

Study results
  • 1 study submitted
  • 1 study processed
R Relative density
1.9 @ 20 °C [1]

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

No data available

Vapour pressure

Study results
  • 1 study submitted
  • 1 study processed
R Vapour pressure
0.005 - 0.22 Pa @ 20 - 50 °C [3]

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

No data available

Partition coefficient

Study results
  • 3 studies submitted
  • 1 study processed
R Log Pow
-0.34 - 0.22 @ 24 °C and pH 5 - 9 [3]

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

No data available

Water solubility

Study results
  • 2 studies submitted
  • 1 study processed
R Water solubility (mass/vol.)
180 - 449 g/L @ 10.1 - 30.1 °C and pH 5 - 9 [9]

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

No data available

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

Study results
  • 1 study submitted
  • 1 study processed
R Surface tension
72 mN/m @ 1 g/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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Auto flammability

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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Flammability

Study results
  • 7 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 2
Supporting study 1 1
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 3
Exposure cons.
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Oxidation reduction potential

Data not provided by the registrant

pH

Data not provided by the registrant

Dissociation constant

Study results
  • 1 study submitted
  • 1 study processed
C Dissociating properties
No (100%) [1]
R Dissociation constant
9.56 @ 21 °C [1]

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

No data available

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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Environmental fate and pathways

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

Phototransformation in air

Study results
  • 1 study submitted
  • 1 study processed
R Dissipation half life (DT50)
12.1 days [1]

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

No data available

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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Phototransformation in water

Study results
  • 1 study submitted
  • 1 study processed
R Dissipation Half-life (DT50)
24 h [1]

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

No data available

Phototransformation in soil

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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Biodegradation in water - screening tests

Study results
  • 2 studies submitted
  • 1 study processed
C Interpretation of results
Readily biodegradable (100%) [1]

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

No data available

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
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Bioaccumulation: aquatic / sediment

Study results
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

No data available

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Henrys law constant (H)

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

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

No data available

Distribution modelling

Study results
  • 1 study submitted
  • 1 study processed
% Distribution in Media:
R Air 0 % [1]
R Water 99.97 % [1]
R Soil 0.01 % [1]
R Sediment 0.01 % [1]
R Suspended sediment 0 % [1]
R Biota 0 % [1]
R Aerosol 0 % [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers

No summary exists for this scientific endpoint

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 10 µg/L (1)
Intermittent releases (freshwater) 2.5 µg/L (1)
Marine water 800 ng/L (1)
Intermittent releases (marine water) -
Sewage treatment plant (STP) 430 µg/L (1)
Sediment (freshwater) 41 µg/kg sediment dw (1)
Sediment (marine water) 3.28 µg/kg sediment dw (1)
Hazard for Air
Air -
Hazard for Terrestrial Organism
Soil 500 µg/kg soil dw (1)
Hazard for Predators
Secondary poisoning -

Short–term toxicity to fish

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
LC50 (3.2 months) 35.7 mg/L [1]
NOEC (4 days) 20 mg/L [1]

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

No data available

Long–term toxicity to fish

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
NOEC (49 days) 21.5 mg/L [1]
LOEC (49 days) 40 mg/L [1]
LC50 (49 days) 39.1 mg/L [1]

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

No data available

Short–term toxicity to aquatic invertebrates

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
EC50 (48 h) 1.4 mg/L [1]
EC0 (48 h) 560 µg/L [1]
EC100 (48 h) 3.2 mg/L [1]

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

No data available

Long–term toxicity to aquatic invertebrates

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
NOEC (21 days) 270 µg/L [1]
LOEC (21 days) 880 µg/L [1]
EC50 (21 days) 270 - 880 µg/L [2]

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

No data available

Toxicity to aquatic algae and cyanobacteria

Study results
  • 5 studies submitted
  • 2 studies processed
P/RResults
EC50 (72 h) 250 - 370 µg/L [2]
NOEC (72 h) 80 - 100 µg/L [2]

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

No data available

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Sediment toxicity

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No data available

Toxicity to terrestrial macroorganisms except arthropods

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
NOEC (14 days) 12.8 mg/kg soil dw [1]
EC50 (14 days) 500 mg/kg soil dw [1]
LC50 (14 days) 500 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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Toxicity to terrestrial arthropods

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No data available

Toxicity to terrestrial plants

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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Toxicity to soil microorganisms

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
EC10 (28 days) 25 mg/kg soil dw [1]
EC50 (28 days) 679 mg/kg soil dw [1]

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

No data available

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) 4.1 mg/m³ repeated dose toxicity
Acute /short term: (DNEL) 12.3 mg/m³ acute toxicity
Local Effects
Long-term: (DNEL) 4.2 mg/m³ skin irritation/corrosion
Acute /short term: (DNEL) 4.2 mg/m³ acute toxicity
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 2.3 mg/kg bw/day repeated dose toxicity
Acute /short term: (DNEL) 7 mg/kg bw/day repeated dose toxicity
Local Effects
Long-term: (DNEL) 13 µg/cm² repeated dose toxicity
Acute /short term: (DNEL) 13 µg/cm² repeated dose toxicity
EYE Exposure
Medium hazard (no threshold derived)
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 1.2 mg/m³ repeated dose toxicity
Acute /short term: - -
Local Effects
Long-term: (DNEL) 1.3 mg/m³ acute toxicity
Acute /short term: (DNEL) 1.3 mg/m³ acute toxicity
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 1.4 mg/kg bw/day repeated dose toxicity
Acute /short term: - -
Local Effects
Long-term: (DNEL) 8 µg/cm² repeated dose toxicity
Acute /short term: (DNEL) 8 µg/cm² skin irritation/corrosion
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 350 µg/kg bw/day repeated dose toxicity
Acute /short term: (DNEL) 1.1 mg/kg bw/day repeated dose toxicity
EYE Exposure
Low hazard (no threshold derived)

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 13 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 13
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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Acute toxicity

Study results
oral
  • 6 studies submitted
  • 4 studies processed
P/RResults
LD50 254 - 354 mg/kg bw (rat) [7]

Type of Study provided
oral
Studies with data
Key study 4
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
inhalation
  • 3 studies submitted
  • 1 study processed
P/RResults
LC50 (4 h) 588 mg/m³ air (rat) [1]

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

dermal
Studies with data
Key study 1
Supporting study 2
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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

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 1
Weight of evidence
Other
Data waiving
no waivers
Study data: eye
  • 1 study 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
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Sensitisation

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: 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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Repeated dose toxicity

Study results
Study data: oral
  • 3 studies submitted
  • 3 studies processed
P/RResults
NOAEL (rat): 7 - 20 mg/kg bw/day [2]
NOAEL (dog): 8 mg/kg bw/day [1]
LOAEL (rat): 20 - 32 mg/kg bw/day [2]
LOAEL (dog): 20 mg/kg bw/day [1]

Type of Study provided
Study data: oral
Studies with data
Key study 3
Supporting study
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
  • 0 studies processed

No automatically processable data submitted

Study data: dermal
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Genetic toxicity

Study results
Study data: in vitro
  • 4 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 4
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: in vivo
  • 3 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

No data available

Carcinogenicity

Study results
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

No data available

Toxicity to reproduction

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

Study data not processed for brief profile

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

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 5
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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Neurotoxicity

Data not provided by the registrant

Immunotoxicity

Data not provided by the registrant