Brief Profile

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Please be aware that the REACH registration parts of this Brief Profile are no longer maintained; they remain frozen as of 19th May 2023. All other data parts (substance identity, C&L, key regulatory lists etc. are up to date).

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss 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.:
200-237-1
CAS no.:
55-55-0
Index number:
650-031-00-4
Molecular formula:
C14H20N2O6S
SMILES:
[O-]S([O-])(=O)=O.C[NH2+]C1=CC=C(O)C=C1.C[NH2+]C1=CC=C(O)C=C1
InChI:
InChI=1S/2C7H9NO.H2O4S/c2*1-8-6-2-4-7(9)5-3-6;1-5(2,3)4/h2*2-5,8-9H,1H3;(H2,1,2,3,4)
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
2
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

Warning! According to the harmonised classification and labelling (CLP00) approved by the European Union, this substance is very toxic to aquatic life, is very toxic to aquatic life with long lasting effects, is harmful if swallowed, may cause damage to organs through prolonged or repeated exposure and may cause an allergic skin reaction.

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

Breakdown of all 258 C&L notifications submitted to ECHA

Aquatic Chronic 1 H410 Harmonised Classification
Acute Tox. 4 H302 Harmonised Classification
STOT RE 2 H373 Harmonised Classification
Skin Sens. 1 H317 Harmonised Classification
Aquatic Acute 1 H400 Harmonised Classification
Eye Irrit. 2 H319
Acute Tox. 3 H301
Skin Sens. 1B H317
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

https://echa.europa.eu/o/diss-blank-theme/images/cnl/graph/tick.png Harmonised Classification

https://echa.europa.eu/o/diss-blank-theme/images/cnl/graph/Reach.png REACH registration dossiers notifications

https://echa.europa.eu/o/diss-blank-theme/images/cnl/graph/CLP.png CLP notifications

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

Properties of concern

  • Ss
Officially recognised in the EU as Skin sensitising ( Harmonised C&L).
  • Ss
There is broad agreement in that a majority of data submitters agree this substance is Skin sensitising (100% of CLP notifications).

Regulatory context

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

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 0 active registrations under REACH, 1 Joint Submission(s) and 0 Individual Submission(s).
Please see Registrants/Suppliers details.
Evaluation
Dossier Evaluation:
Substance Evaluation:
Substance included in the Community Rolling Action Plan (CoRAP).
Authorisation
Candidate List:
Annex XIV (Authorisation List):
Restriction
Annex XVII (Restriction List):

Persistent Organic Pollutants Regulation (POPs)

List of substances subject to the POPs Regulation:
List of substances proposed as POPs:

Classification Labelling & Packaging (CLP)

Harmonised C&L:
A European Union Harmonised Classification & Labelling has been assigned to this substance.
Seveso Annex I:
Industrial accident prevention and reporting requirements have been established for this substance.
Notified C&L:
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 registered under the REACH Regulation but is not currently being manufactured in and / or imported to the European Economic Area.

This substance is used by professional workers (widespread uses) and at industrial sites.

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.

This substance is used in the following products: photo-chemicals.

This substance is used in the following areas: printing and recorded media reproduction.

This substance is used in the following activities or processes at workplace: transfer of chemicals, batch processing in synthesis or formulation with opportunity for exposure, mixing in open batch processes, transfer of substance into small containers and treatment of articles by dipping and pouring.

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

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 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: photo-chemicals.

This substance is used in the following areas: printing and recorded media reproduction.

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

Release to the environment of this substance can occur from industrial use: in the production of articles.

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

  • Global Product Compliance (Europe) AB, IDEON, Beta 5, Scheelevägen 17 22363 Lund Sweden
  • Sustainability Support Services (Europe) AB, Markaskälsvägen 6 22647 Lund Sweden

Substance names and other identifiers

Bis(4-hydroxy-N-methylanilinium) sulphate
EC Inventory, CAD - Chemical Agents Directive, Art. 2(b)(i) - Hazardous Agents, Construction Product Regulation - Annex I (3) - Hazardous Substances, Construction Product Regulation - Art. 6(5) - SDS and Declaration, EU Ecolabels - Restrictions for Hazardous Substances/Mixtures, End-of-Life Vehicles Directive - Hazardous Substances, Active Implantable Medical Devices Directive - Hazardous Substances, In Vitro Diagnostic Medical Devices Directive - Hazardous Substances, In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances, Marine Environmental Policy Framework Directive - Hazardous Substances, Medical Devices Directive - Hazardous Substances, Medical Devices Regulation - Hazardous Substances, General Product Safety Directive - Hazardous Substances, Workplace Signs - minimum requirements & signs on containers and pipes, Safety and Health of Workers at Work Directive - Hazardous Substances, Waste Framework Directive, Annex III - Waste - Hazardous Properties, Physical, Biological and Chemical Agents & Processes and Work
bis(4-hydroxy-N-methylanilinium) sulphate
REACH pre-registration, CAD - Chemical Agents Directive, Art. 2(b)(i) - Hazardous Agents, Construction Product Regulation - Annex I (3) - Hazardous Substances, Construction Product Regulation - Art. 6(5) - SDS and Declaration, EU Ecolabels - Restrictions for Hazardous Substances/Mixtures, End-of-Life Vehicles Directive - Hazardous Substances, Active Implantable Medical Devices Directive - Hazardous Substances, In Vitro Diagnostic Medical Devices Directive - Hazardous Substances, In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances, Marine Environmental Policy Framework Directive - Hazardous Substances, Medical Devices Directive - Hazardous Substances, Medical Devices Regulation - Hazardous Substances, General Product Safety Directive - Hazardous Substances, Workplace Signs - minimum requirements & signs on containers and pipes, Safety and Health of Workers at Work Directive - Hazardous Substances, Waste Framework Directive, Annex III - Waste - Hazardous Properties, Physical, Biological and Chemical Agents & Processes and Work
p-Methylaminophenol sulfate
Other
p-Methylaminophenol sulphate
Cosmetic Products Regulation, Annex III - Restricted Substances
bi(4-hidroksi-N-metilanilinio) sulfatas (lt)
C&L Inventory
bis(4-hidroksi-N-metilanilin) sulfat (hr)
C&L Inventory
bis(4-hüdroksü-N-metüülaniliinium)sulfaat (et)
C&L Inventory
bisz(4-hidroxi-N-metilanilínium)-szulfát (hu)
C&L Inventory
siarczan(VI) bis(4-hydroksy-N-metyloanilinium) (pl)
C&L Inventory
Sulfate de bis(4-hydroxy-N-méthylanilinium) (fr)
C&L Inventory
4-(Methylamino)phenol Sulfate
C&L Inventory
4-(methylamino)phenol; sulfuric acid
C&L Inventory
4-(methylamino)phenol;sulfuric acid
C&L Inventory
4-(Methylamino)phenolsulfat
C&L Inventory
4-Methylaminophenol sulfate
C&L Inventory
bis(4-(methylamino)phenol); sulfuric acid
C&L Inventory
bis(4-hydroxy-N-methylanilinium) sulfate
C&L Inventory, Other
Bis(4-hydroxy-N-methylanilinium) sulphate
C&L Inventory, Registration dossier
p-METHYL AMINOPHENOL SULPHATE (METOL / ELON)
C&L Inventory
Phenol, 4-(methylamino)-, sulfate (2:1)
C&L Inventory
Metol
C&L Inventory
160976-13-6
CAS number
Other
55-55-0
CAS number
EC Inventory, C&L Inventory, Registration dossier, REACH pre-registration, Other, CAD - Chemical Agents Directive, Art. 2(b)(i) - Hazardous Agents, Construction Product Regulation - Annex I (3) - Hazardous Substances, Construction Product Regulation - Art. 6(5) - SDS and Declaration, Cosmetic Products Regulation, Annex III - Restricted Substances, EU Ecolabels - Restrictions for Hazardous Substances/Mixtures, End-of-Life Vehicles Directive - Hazardous Substances, Active Implantable Medical Devices Directive - Hazardous Substances, In Vitro Diagnostic Medical Devices Directive - Hazardous Substances, In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances, Marine Environmental Policy Framework Directive - Hazardous Substances, Medical Devices Directive - Hazardous Substances, Medical Devices Regulation - Hazardous Substances, General Product Safety Directive - Hazardous Substances, Workplace Signs - minimum requirements & signs on containers and pipes, Safety and Health of Workers at Work Directive - Hazardous Substances, Waste Framework Directive, Annex III - Waste - Hazardous Properties, Physical, Biological and Chemical Agents & Processes and Work
650-031-00-4
Index number
C&L Inventory

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
  • 3 studies submitted
  • 2 studies processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [2]
C Form
Solid: crystalline (50%), Other (50%) [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 1
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Physical state at 20°C and 1013 hPa
Solid (100%)

Melting/freezing point

Study results
  • 7 studies submitted
  • 2 studies processed
R Melting / freezing point
260 - 275.1 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 5
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Melting / freezing point at 101 325 Pa
260 - 271.6 °C

Boiling point

Study results
  • 2 studies submitted
  • 1 study processed
R Boiling point
300 °C @ 97.12 kPa [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
R Summaries
  • 2 summaries submitted
  • 1 summary processed
Boiling point at 101 325 Pa
300 °C

Density

Study results
  • 2 studies submitted
  • 2 studies processed
R Density
1.147 g/cm³ [1]
R Pour density
0.598 g/cm³ @ 20 °C [1]
R Tap density
0.69 g/cm³ @ 20 °C [1]

Type of Study provided
Studies with data
Key study 1 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Relative density at 20°C
0.69 - 1.147

Vapour pressure

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

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Vapour pressure
0 - 0 Pa @ 25 °C

Partition coefficient

Study results
  • 2 studies submitted
  • 2 studies processed
R Log Pow
0.79 @ 25 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Log Kow (Log Pow)
0.79 @ 25 °C

Water solubility

Study results
  • 7 studies submitted
  • 2 studies processed
R Water solubility (mass/vol.)
50 - 81.652 g/L @ 20 - 25 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 5
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Water solubility
50 - 81.652 g/L @ 20 - 25 °C

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

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
  • 2 summaries submitted
  • 2 summaries processed
Surface tension at 20 °C
47.1 mN/m

Flash point

Study results
  • 2 studies submitted
  • 1 study processed
R Flash point
257 °C @ 97.12 kPa [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
R Summaries
  • 2 summaries submitted
  • 1 summary processed
Flash point at 101 325 Pa
257 °C

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
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Autoflammability / self-ignition at 101 325 Pa
531 °C

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
C Summaries
  • 2 summaries submitted
  • 2 summaries 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
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
C Summaries
  • 2 summaries submitted
  • 2 summaries 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
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Oxidising
Non oxidising (100%)

Oxidation reduction potential

Data not provided by the registrant

pH

Study results
  • 3 studies submitted
  • 1 study processed
R pH
3.5 - 4.5 @ 20 °C and 50 g/L [1]

Type of Study provided
Studies with data
Key study 2
Supporting study 1
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
  • 4 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 1 1
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Half-life for hydrolysis
5.1 months @ 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
  • 2 studies submitted
  • 2 studies processed
C Interpretation of results
Inherently biodegradable (100%) [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Biodegradation in water
Inherently biodegradable (100%)

Biodegradation in water & sediment - simulation tests

Study results
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

Biodegradation in soil

Study results
  • 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
Half-life in soil
75 days @ 25 °C

Bioaccumulation: aquatic / sediment

Study results
  • 6 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 4 2
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Bioaccumulation Factor (BCF) - L/kg ww
16.26 L/kg ww

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Data not provided by the registrant

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)

Data not provided by the registrant

Short–term toxicity to fish

Study results
  • 6 studies submitted
  • 2 studies processed
P/RResults
LC50 (4 days) 925 µg/L [2]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 6
Other
Data waiving
no waivers
Summaries
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Long–term toxicity to fish

Data not provided by the registrant

Short–term toxicity to aquatic invertebrates

Study results
  • 6 studies submitted
  • 6 studies processed
P/RResults
EC50 (48 h) 315 - 724 µg/L [4]
LC50 (48 h) 240 µg/L [2]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 4 2
Other
Data waiving
no waivers
Summaries
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Long–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 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 2 summaries submitted
  • 0 summaries processed

No automatically processable data submitted

Toxicity to aquatic algae and cyanobacteria

Study results
  • 6 studies submitted
  • 6 studies processed
P/RResults
EC50 (72 h) 506 - 670 µg/L [4]
LOEC (72 h) 300 µg/L [2]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 4 2
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
EC50 for freshwater algae
506 µg/L

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 4 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 2 2
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
EC50 for microorganisms
59.84 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)

Data not provided by the registrant

Toxicokinetics, metabolism, and distribution

Data not provided by the registrant

Acute toxicity

Study results
oral
  • 10 studies submitted
  • 10 studies processed
P/RResults
LD50 375 - 1 578.59 mg/kg bw (rat) [6]
LD50 380 - 565 mg/kg bw (mouse) [4]
M/CInterpretations of results
Category 4 based on GHS criteria [6]

Type of Study provided
oral
Studies with data
Key study
Supporting study
Weight of evidence 6 4
Other
Data waiving
no waivers
inhalation
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

inhalation
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 2
dermal
  • 8 studies submitted
  • 8 studies processed
P/RResults
LD50 2 000 mg/kg bw (rat) [2]
LD50 1 000 mg/kg bw (guinea pig) [2]
LD50 7 187.2 - 10 000 mg/kg bw (rabbit) [4]
M/CInterpretations of results
Other [8]

dermal
Studies with data
Key study
Supporting study
Weight of evidence 6 2
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
  • 2 summaries submitted
  • 2 summaries processed
Oral route:
Adverse effect observed LD50 1 578.59 mg/kg bw
Dermal route:
No adverse effect observed LD50 7 087.2 mg/kg bw

Irritation / corrosion

Study results
Study data: skin
  • 8 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 4
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 2
Study data: eye
  • 8 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 2
Supporting study 4
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 2
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Skin
No adverse effect observed (not irritating)
Eye
No adverse effect observed (not irritating)
Respiratory
No study available

Sensitisation

Study results
Study data: skin
  • 12 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 8
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 2
Study data: respiratory
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: respiratory
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Skin sensitisation
Adverse effect observed (sensitising)
Respiratory sensitisation
No study available

Repeated dose toxicity

Study results
Study data: oral
  • 6 studies submitted
  • 2 studies processed
P/RResults
NOAEL (rat): 56.917 mg/kg bw/day [2]

Type of Study provided
Study data: oral
Studies with data
Key study
Supporting study
Weight of evidence 4 2
Other
Data waiving
no waivers
Study data: inhalation
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Study data: inhalation
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 2
Study data: dermal
  • 6 studies submitted
  • 0 studies processed

No automatically processable data submitted

Study data: dermal
Studies with data
Key study 2
Supporting study 2
Weight of evidence 2
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Oral route - systemic effects:
No adverse effect observed NOAEL 56.917 mg/kg bw/day (subchronic, rat)
Dermal route - systemic effects:
No adverse effect observed NOAEL 11.47 mg/kg bw/day (chronic, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 6 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 4
Weight of evidence
Other
Data waiving
no waivers
Study data: in vivo
  • 6 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: in vivo
Studies with data
Key study
Supporting study
Weight of evidence 4 2
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Toxicity - InVitro
No adverse effect observed (negative)
Toxicity - InVivo
No adverse effect observed (negative)

Carcinogenicity

Study results
  • 3 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 2 1
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Dermal route:
No adverse effect observed NOAEL 286.75 µg/kg bw/day (chronic, mouse)

Toxicity to reproduction

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

Study data not processed for brief profile

Type of Study provided
Study data: reproduction
Studies with data
Key study
Supporting study
Weight of evidence 3 2
Other
Data waiving
no waivers
Study data: developmental
  • 3 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 1
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
  • 2 summaries submitted
  • 2 summaries processed
Effect on fertility
Oral route:
No adverse effect observed NOAEL 740 mg/kg bw/day (subchronic, rat)
Dermal route:
No adverse effect observed NOAEL 11.47 mg/kg bw/day (subacute, rat)
Effect on developmental toxicity
Oral route:
No adverse effect observed NOAEL 125 mg/kg bw/day (subacute, rat)
Dermal route:
No adverse effect observed NOAEL 11.47 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