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.:
217-699-5
CAS no.:
1934-21-0
Index number:
Molecular formula:
C16H9N4Na3O9S2
SMILES:
[Na+].[Na+].[Na+].[O-]C(=O)C1=NN(C(=O)C1\N=N\c1ccc(cc1)S([O-])(=O)=O)c1ccc(cc1)S([O-])(=O)=O
InChI:
InChI=1/C16H12N4O9S2.3Na/c21-15-13(18-17-9-1-5-11(6-2-9)30(24,25)26)14(16(22)23)19-20(15)10-3-7-12(8-4-10)31(27,28)29;;;/h1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);;;/q;3*+1/p-3/b18-17+;;
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
11
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

According to the notifications provided by companies to ECHA in REACH registrations no hazards have been classified.

Additionally, the classification provided by companies to ECHA in CLP notifications identifies that this substance may cause an allergic skin reaction and may cause allergy or asthma symptoms or breathing difficulties if inhaled.

Breakdown of all 3629 C&L notifications submitted to ECHA

Not Classified
Skin Sens. 1 H317
Resp. Sens. 1 H334
Aquatic Chronic 2 H411
Repr. 2 H361
Aquatic Chronic 3 H412
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

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

https://www.echa.europa.eu/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

Nanomaterial form

Substance is known to be on the EEA market in nanomaterial form, as listed in the EUON Nanomaterials in the EU market list.

Regulatory context

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

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 14 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):

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:
Seveso Annex I:
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:
Nanomaterials in the EU Market

About this substance

This substance is registered under the REACH Regulation and is manufactured in and / or imported to the European Economic Area, at ≥ 100 to < 1 000 tonnes per annum.

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

This substance is used in the following products: cosmetics and personal care products, washing & cleaning products, plant protection products and inks and toners.

Other release to the environment of this substance is likely to occur from: indoor use (e.g. machine wash liquids/detergents, automotive care products, paints and coating or adhesives, fragrances and air fresheners) and outdoor use.

This substance is used in the following activities or processes at workplace: the low energy manipulation of substances bound in materials or articles and high energy work-up of substances bound in materials or articles (e.g. hot rolling/forming, grinding, mechanical cutting, drilling or sanding).

Release to the environment of this substance can occur from industrial use: industrial abrasion processing with low release rate (e.g. cutting of textile, cutting, machining or grinding of metal). Other release to the environment of this substance is likely to occur from: indoor use in long-life materials with low release rate (e.g. flooring, furniture, toys, construction materials, curtains, foot-wear, leather products, paper and cardboard products, electronic equipment) and outdoor use in long-life materials with low release rate (e.g. metal, wooden and plastic construction and building materials).

This substance can be found in products with material based on: fabrics, textiles and apparel (e.g. clothing, mattress, curtains or carpets, textile toys), leather (e.g. gloves, shoes, purses, furniture) and paper (e.g. tissues, feminine hygiene products, nappies, books, magazines, wallpaper).

This substance is used in the following products: cosmetics and personal care products, textile treatment products and dyes and inks and toners.

This substance is used in the following areas: agriculture, forestry and fishing, printing and recorded media reproduction and building & construction work. This substance is used for the manufacture of: textile, leather or fur and wood and wood products.

This substance is used in the following activities or processes at workplace: non-industrial spraying, mixing in open batch processes, roller or brushing applications, manual maintenance (cleaning and repair) of machinery and treatment of articles by dipping and pouring.

Other release to the environment of this substance is likely to occur from: indoor use (e.g. machine wash liquids/detergents, automotive care products, paints and coating or adhesives, fragrances and air fresheners) and outdoor use.

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, mixing in open batch processes, transfer of substance into small containers, closed processes with no likelihood of exposure, closed batch processing in synthesis or formulation, production of mixtures or articles by tabletting, compression, extrusion or pelletisation, laboratory work and closed, continuous processes with occasional controlled exposure.

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

This substance is used in the following products: paper chemicals and dyes, inks and toners, textile treatment products and dyes, leather treatment products and polymers.

This substance is used in the following areas: printing and recorded media reproduction. This substance is used for the manufacture of: textile, leather or fur, pulp, paper and paper products, wood and wood products and plastic products.

This substance is used in the following activities or processes at workplace: transfer of chemicals, transfer of substance into small containers, mixing in open batch processes, industrial spraying, treatment of articles by dipping and pouring, roller or brushing applications, laboratory work and manual maintenance (cleaning and repair) of machinery.

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

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

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

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

  • AromataGroup, Via Carolina Romani n. 35 20091 Bresso (MI) Italy
  • Colorants Solutions Deutschland GmbH, Brüningstrasse 50 65929 Frankfurt am Main Germany
  • CSI-OR028, Pentlands Science Park Penicuik EH26 0PZ Edinburgh United Kingdom
  • DyStar Colours Distribution GmbH, Am Prime-Parc 12 65479 Raunheim Germany
  • Fredcolor, SL, Carrer de l'Empordà 13-15 08211 Castellardel Vallès Spain
  • Global Product Compliance (Europe) AB, IDEON, Beta 5, Scheelevägen 17 22363 Lund Sweden
  • Milliken Europe B.V., Ham 18-24 9000 Gent Belgium
  • Orzeszyna Int. sp. z o.o. sp. k., ul. Cmentarna 47 43-300 Bielsko-Biala Poland
  • Reach & Colours s.r.o, Thunovská 196/19 Malá Strana 118 00 Prague Czech Republic
  • Reach & Colours Trade Kft, Levente u. 14/a 2161 Csomád Hungary
  • REACH&Colours Kft, Petofi Sandor utca 11 I Em. 4 1052 Budapest Hungary
  • Roha Polska sp. z o.o, ul. Połczyńska 31A , 01-377 Warszawa Warszawa Poland
  • Symrise AG, Mühlenfeldstraße 1 37603 Holzminden Germany
  • Triade B.V., Dijkweg 159 2675 AD Honselersdijk Netherlands
  • Reach & Colours Holding Limited, BIRCHIN COURT, 20 BIRCHIN LANE EC3V 9DJ LONDON United Kingdom
  • Unicolour Limited, Tandem Works Wakefield Road HD5 0AN Huddersfield West Yorkshire United Kingdom

Substance names and other identifiers

CI 19140
Cosmetic Products Regulation, Annex III - Restricted Substances
Tartrazine
Other
Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-((4-sulphophenyl)azo)pyrazole-3-carboxylate
Cosmetic Products Regulation, Annex IV - Allowed Colorants
Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
EC Inventory, REACH pre-registration
Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate and aluminium lake
Cosmetic Products Regulation, Annex III - Restricted Substances
1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[2-(4-sulfophenyl)diazenyl]-, sodium salt (1:3)
Other
: trisodium 5-oxo-1-(4-sulfonatophenyl)-4-[(E)-2-(4-sulfonatophenyl)diazen-1-yl]-4,5-dihydro-1H-pyrazole-3-carboxylate
Registration dossier
Acid Yellow 23
C&L Inventory
CI Acid Yellow 23
C&L Inventory
Neelicol TartrazineNeelicert FD&C Yellow 5Neelicol Acid Yellow 4YNeelink Yellow TNeeligran Tatrazine Granules Neeligran FD&C Yellow 5 Granules / NeelicleanTartrazine/Neeliclean FD&C Yellow 5 / NeelisolTartrazine / Neelisol FD&C Yellow 5
Registration dossier
Tartrazine E102, FD&C Yellow 5
Registration dossier
Tartrazine, FD&C Yellow 5
Registration dossier
Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate (CI 19140)
C&L Inventory
trisodium 5-oxo-1-(4-sulfonatophenyl)-4-(4-sulfonatophenyl)diazenyl- 4H-pyrazole-3-carboxylate
C&L Inventory
trisodium 5-oxo-1-(4-sulfonatophenyl)-4-(4-sulfonatophenyl)diazenyl-4H-pyrazole-3-carboxylate
C&L Inventory
trisodium 5-oxo-1-(4-sulfonatophenyl)-4-[(E)-(4-sulfonatophenyl)diazenyl]-4,5-dihydro-1H-pyrazole-3-carboxylate
Registration dossier
trisodium 5-oxo-1-(4-sulfonatophenyl)-4-[(E)-2-(4-sulfonatophenyl)diazen-1-yl]-4,5-dihydro-1H-pyrazole-3-carboxylate
Registration dossier, Other
trisodium;5-oxo-1-(4-sulfonatophenyl)-4-[(4-sulfonatophenyl)diazenyl]-4H-pyrazole-3-carboxylate
Other
Amarillo Tartracina E-102
Registration dossier
117209-34-4
CAS number
Other
12000-64-5
CAS number
Other
1342-47-8
CAS number
Other
1342-53-6
CAS number
Other
134240-82-7
CAS number
Other
139601-06-2
CAS number
Other
154881-98-8
CAS number
Other
183808-13-1
CAS number
Other
191807-79-1
CAS number
Other
1934-21-0
CAS number
EC Inventory, C&L Inventory, Registration dossier, REACH pre-registration, Other, Cosmetic Products Regulation, Annex III - Restricted Substances, Cosmetic Products Regulation, Annex IV - Allowed Colorants
389057-90-3
CAS number
Other
469888-21-9
CAS number
Other
50809-64-8
CAS number
Other
642-62-6
CAS number
Other
84842-94-4
CAS number
Other

Scientific properties

Physical and chemical properties

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

Appearance/physical state / colour

Study results
  • 1 study submitted
  • 1 study processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [1]
C Form
Powder (100%) [1]
C Odour
Odourless (100%) [1]
C Substance type
Organic (100%) [1]

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

Melting/freezing point

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Melting / freezing point at 101 325 Pa
347.1 °C

Boiling point

Study results
  • 2 studies submitted
  • 1 study processed
R Boiling point
909.54 °C @ 101.325 kPa [1]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 1
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
R Summaries
  • 1 summary submitted
  • 1 summary processed
Boiling point at 101 325 Pa
909.54 °C

Density

Study results
  • 1 study submitted
  • 1 study processed
R Relative density
2.121 @ 20 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
2.121

Vapour pressure

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

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 1
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
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
-1.572 @ 20 °C and pH 6.13 [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Log Kow (Log Pow)
-1.572 @ 20 °C

Water solubility

Study results
  • 1 study submitted
  • 1 study processed
R Water solubility (mass/vol.)
167.05 g/L @ 20 °C and pH 7 [1]

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

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Flash point

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Auto flammability

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Autoflammability / self-ignition at 101 325 Pa
400 °C

Flammability

Study results
  • 1 study submitted
  • 1 study processed
C Interpretation of results
GHS criteria not met (100%) [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Flammability
Non flammable (100%)

Explosiveness

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

Oxidising

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

Oxidation reduction potential

Data not provided by the registrant

pH

Data not provided by the registrant

Dissociation constant

Data not provided by the registrant

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

No automatically processable data submitted

Environmental fate and pathways

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

Phototransformation in air

Data not provided by the registrant

Hydrolysis

Study results
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

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

No automatically processable data submitted

Phototransformation in water

Data not provided by the registrant

Phototransformation in soil

Data not provided by the registrant

Biodegradation in water - screening tests

Study results
  • 2 studies submitted
  • 1 study processed
C Interpretation of results
Not 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
C Summaries
  • 1 summary submitted
  • 1 summary processed
Biodegradation in water
Under test conditions no biodegradation observed (100%)

Biodegradation in water & sediment - simulation tests

Data not provided by the registrant

Biodegradation in soil

Data not provided by the registrant

Bioaccumulation: aquatic / sediment

Data not provided by the registrant

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 1 study submitted
  • 1 study processed
R log Koc
-4.228 dimensionless @ 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
Koc at 20°C
0

Henrys law constant (H)

Data not provided by the registrant

Distribution modelling

Data not provided by the registrant

Ecotoxicological information

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

Predicted No-Effect Concentration (PNEC)

R Summaries
  • 1 summary submitted
  • 1 summary processed

The Predicted No-Effect Concentration (PNEC) value is the concentration of a substance below which adverse effects in the environment are not expected to occur. Please note that when more than one summary is provided, PNEC values may refer to constituents of the substance and not to the substance as a whole. More detailed information is available in the dossiers.

Hazard for Aquatic Organisms
Freshwater 120 µg/L (1)
Intermittent releases (freshwater) 1.2 mg/L (1)
Marine water 12 µg/L (1)
Intermittent releases (marine water) -
Sewage treatment plant (STP) 10 mg/L (1)
Sediment (freshwater) 469.92 µg/kg sediment dw (1)
Sediment (marine water) 46.992 µg/kg sediment dw (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 23.53 µg/kg soil dw (1)
Hazard for Predators
Secondary poisoning No potential for bioaccumulation (1)

Short–term toxicity to fish

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
LC50 (4 days) 120 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
  • 1 summary 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
  • 2 studies submitted
  • 1 study processed
P/RResults
EC50 (48 h) 125 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
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Long–term toxicity to aquatic invertebrates

Data not provided by the registrant

Toxicity to aquatic algae and cyanobacteria

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
EC50 (72 h) 125 mg/L [2]

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

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
EC50 (3 h) 1 g/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
1 g/L

Sediment toxicity

Data not provided by the registrant

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

Data not provided by the registrant

Toxicity to terrestrial arthropods

Data not provided by the registrant

Toxicity to terrestrial plants

Data not provided by the registrant

Toxicity to soil microorganisms

Data not provided by the registrant

Toxicity to birds

Data not provided by the registrant

Toxicity to mammals

Data not provided by the registrant

Toxicological information

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

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

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

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

Data for WORKERS
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 372.52 mg/m³ developmental toxicity / teratogenicity
Acute /short term: No hazard identified
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 52.82 mg/kg bw/day developmental toxicity / teratogenicity
Acute /short term: (No hazard identified) -
Local Effects
Long-term: (No hazard identified) -
Acute /short term: (No hazard identified) -
EYE Exposure
No hazard identified
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 91.86 mg/m³ developmental toxicity / teratogenicity
Acute /short term: No hazard identified
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 26.41 mg/kg bw/day developmental toxicity / teratogenicity
Acute /short term: (No hazard identified) -
Local Effects
Long-term: (No hazard identified) -
Acute /short term: (No hazard identified) -
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 26.41 mg/kg bw/day developmental toxicity / teratogenicity
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
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

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

No data available

Acute toxicity

Study results
oral
  • 3 studies submitted
  • 1 study processed
P/RResults
LD50 1 000 mg/kg bw (mouse) [1]
M/CInterpretations of results
GHS criteria not met [1]

Type of Study provided
oral
Studies with data
Key study 1
Supporting study 1 1
Weight of evidence
Other
Data waiving
no waivers
inhalation
  • 1 study 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 1
dermal
  • 1 study submitted
  • 1 study processed
M/CInterpretations of results
GHS criteria not met [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

Irritation / corrosion

Study results
Study data: skin
  • 1 study 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
no waivers
Study data: eye
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 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
  • 3 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

Study data not processed for brief profile

Study data: respiratory
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin sensitisation
No adverse effect observed (not sensitising)
Respiratory sensitisation
No study available

Repeated dose toxicity

Study results
Study data: oral
  • 2 studies submitted
  • 1 study processed
P/RResults
NOAEL (rat): 8 103 - 9 735 mg/kg bw/day [2]

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

No automatically processable data submitted

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

No automatically processable data submitted

Study data: dermal
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route - systemic effects:
No adverse effect observed NOAEL 8 103 mg/kg bw/day (chronic, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 10 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 7
Supporting study 3
Weight of evidence
Other
Data waiving
no waivers
Study data: in vivo
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: in vivo
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
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:
No adverse effect observed NOAEL 2 641 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 1
Supporting study 1
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 2 641 mg/kg bw/day (chronic, rat)
Effect on developmental toxicity
Oral route:
No adverse effect observed NOAEL 1 000 mg/kg bw/day (chronic, rat)

Neurotoxicity

Data not provided by the registrant

Immunotoxicity

Data not provided by the registrant

Endocrine disrupter mammalian screening - in vivo

Data not provided by the registrant