Brief Profile

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

Substance Description

Substance identity

  • EC / List name: Sodium salicylate
  • IUPAC name: sodium 2-hydroxybenzoate
  • Other names
EC / List no.:
200-198-0
CAS no.:
54-21-7
Index number:
Molecular formula:
C7H5NaO3
SMILES:
[Na+].OC1=C(C=CC=C1)C([O-])=O
InChI:
InChI=1S/C7H6O3.Na/c8-6-4-2-1-3-5(6)7(9)10;/h1-4,8H,(H,9,10);/q;+1/p-1
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
6
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 classification provided by companies to ECHA in REACH registrations this substance is harmful if swallowed, causes serious eye irritation and is suspected of damaging fertility or the unborn child.

Breakdown of all 323 C&L notifications submitted to ECHA

Acute Tox. 4 H302
Eye Irrit. 2 H319
Repr. 2 H361
Acute Tox. 3 H301
STOT SE 3 H335
Skin Irrit. 2 H315
Not Classified
Acute Tox. 4 H312
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

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

Properties of concern

Regulatory activities

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

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 8 active registrations under REACH, 1 Joint Submission(s) and 0 Individual Submission(s).
Please see Registrants/Suppliers details.
Evaluation
Dossier Evaluation:
Substance Evaluation:
Authorisation
Candidate List:
Annex XIV (Authorisation List):
Restriction
Annex XVII (Restriction List):

Classification Labelling & Packaging (CLP)

Harmonised C&L:
Notification:
Classification & Labelling has been notified by industry to ECHA for this substance.

Biocidal Products Regulation (BPR)

Active Substance:
Biocidal Products:

Prior Informed Consent (PIC)

Annex I:
Annex V:

European Union Observatory for Nanomaterials (EUON)

EUON:

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, at industrial sites and in manufacturing.

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

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 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.

This substance is used in the following products: laboratory chemicals and cosmetics and personal care products.

ECHA has no public registered data on the types of manufacture using this substance.

This substance is used in the following activities or processes at workplace: laboratory work.

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

This substance is used in the following products: pharmaceuticals, cosmetics and personal care products and perfumes and fragrances. This substance has an industrial use resulting in manufacture of another substance (use of intermediates).

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, continuous processes with occasional controlled exposure, closed batch processing in synthesis or formulation and batch processing in synthesis or formulation with opportunity for exposure.

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

This substance is used in the following products: pharmaceuticals, laboratory chemicals and cosmetics and personal care products. This substance has an industrial use resulting in manufacture of another substance (use of intermediates).

This substance is used in the following areas: health services and formulation of mixtures and/or re-packaging. This substance is used for the manufacture of: chemicals.

This substance is used in the following activities or processes at workplace: transfer of chemicals, 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, transfer of substance into small containers, production of mixtures or articles by tabletting, compression, extrusion or pelletisation, closed processes with no likelihood of exposure and laboratory work.

Release to the environment of this substance can occur from industrial use: in the production of articles, as an intermediate step in further manufacturing of another substance (use of intermediates) and as processing aid.

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: 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

  • Biesterfeld Spezialchemie GmbH, Ferdinandstr. 41 20095 Hamburg Germany
  • Brenntag Nederland B.V., Donker Duyvisweg 44 3316 BM Dordrecht Netherlands
  • Chemreach GmbH, Akazienweg 30 48317 Drensteinfurt Germany
  • CHIMEX SAS, 16 rue Maurice Berteaux 95500 LE THILLAY France
  • Merck KGaA, Frankfurter Strasse 64293 Darmstadt Germany
  • NetSun EU B.V.(Yixing City Shenguang Medicine Chemicals Co., Ltd), Blaak 40, Fifth Floor 3011 TA Rotterdam Netherlands
  • Sustainability Support Services (Europe) AB, Markaskälsvägen 6 22647 Lund Sweden
  • Sustainability Support Services (Europe) AB, Markaskälsvägen 6, 22647 Lund Sweden

Other names

  • -
  • MEXORYL SCQ
  • Monosodium 2-hydroxybenzoate
  • Natrium salicylat
  • Nátrium-szalicilát
  • salicylic acid sodium
  • Sodium 2-hydroxybenzoate
  • SODIUM SALICYLATE
  • sodium salicylatesodium 2-hydroxybenzoate
  • Sodium salicylate
  • MEXORYL SCQ

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
  • 1 study processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [1]
C Form
Crystalline (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 2
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
  • 3 studies submitted
  • 2 studies processed
R Melting / freezing point
208.5 - 213.5 °C @ 96.73 kPa [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Melting / freezing point at 101 325 Pa
213 °C

Boiling point

Study results
  • 1 study submitted
  • 1 study processed
R Boiling point
237 °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
Boiling point at 101 325 Pa
237 °C

Density

Study results
  • 3 studies submitted
  • 2 studies processed
R Density
0.32 g/cm³ @ 25 °C [1]
R Pour density
0.556 g/cm³ @ 20 °C [1]
R Tap density
0.616 g/cm³ @ 20 °C [1]

Type of Study provided
Studies with data
Key study 2
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
0.616

Vapour pressure

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

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Vapour pressure
0 Pa @ 25 °C

Partition coefficient

Study results
  • 2 studies submitted
  • 1 study processed
R Log Pow
-1.259 @ 25 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Log Kow (Log Pow)
-1.259 @ 25 °C

Water solubility

Study results
  • 5 studies submitted
  • 2 studies processed
R Water solubility (mass/vol.)
575.708 - 1 000 g/L @ 20 - 25 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 3
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Water solubility
575.708 g/L @ 25 °C

Solubility in organic solvents / fat solubility

Study results
  • 1 study submitted
  • 1 study processed
R Methanol
206 g/L @ 25 °C [1]

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

Surface tension

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Flash point

Study results
  • 2 studies submitted
  • 2 studies processed
R Flash point
97.24 - 98.3 °C @ 96.7 kPa [2]

Type of Study provided
Studies with data
Key study 1 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Flash point at 101 325 Pa
98.3 °C

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
250 °C

Flammability

Study results
  • 1 study submitted
  • 1 study processed
C Interpretation of results
Non flammable (100%) [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Flammability
Not classified (100%)

Explosiveness

Study results
  • 1 study submitted
  • 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

Study results
  • 3 studies submitted
  • 1 study processed
R pH
6.5 @ 20 °C and 100 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

Study results
  • 1 study submitted
  • 1 study processed
C Dissociating properties
Yes (100%) [1]
R Dissociation constant
0 @ 25 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
pKa at 20 °C
0

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
  • 4 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 3
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Biodegradation in water
Readily 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
15 days @ 25 °C
Half-life in freshwater sediment
4.5 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
30 days @ 25 °C

Bioaccumulation: aquatic / sediment

Study results
  • 5 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 3 2
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation Factor (BCF) - L/kg ww
3.162 L/kg ww

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 1 study submitted
  • 1 study processed
R log Koc
0.651 dimensionless @ 25 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Koc at 20°C
4.48

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 63.1 µg/L (1)
Intermittent releases (freshwater) 631 µg/L (1)
Marine water 6.31 µg/L (1)
Intermittent releases (marine water) 63.1 µg/L (1)
Sewage treatment plant (STP) No hazard identified (1)
Sediment (freshwater) 364 µg/kg sediment dw (1)
Sediment (marine water) 36.4 µg/kg sediment dw (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 35.8 µg/kg soil dw (1)
Hazard for Predators
Secondary poisoning No potential for bioaccumulation (1)

Short–term toxicity to fish

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
LC50 (4 days) 100 mg/L [1]

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

Long–term toxicity to fish

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
NOEC (28 days) 6.867 mg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC10 / LC10 or NOEC for freshwater fish
6.867 mg/L

Short–term toxicity to aquatic invertebrates

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
EC50 (48 h) 100 mg/L [1]

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

Long–term toxicity to aquatic invertebrates

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
NOEC (21 days) 4.126 mg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC10 / LC10 or NOEC for freshwater invertebrates
4.126 mg/L

Toxicity to aquatic algae and cyanobacteria

Study results
  • 1 study submitted
  • 1 study processed
P/RResults
EC50 (72 h) 48.29 mg/L [1]

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

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 3 studies submitted
  • 2 studies processed
P/RResults
EC50 (3 h) 1 g/L [2]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 2 1
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 for microorganisms
200 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

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

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

No automatically processable data submitted

Toxicity to terrestrial plants

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

Toxicity to soil microorganisms

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

Toxicity to birds

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

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) 1.32 mg/m³ effect on fertility
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: Low hazard (no threshold derived)
Acute /short term: Low hazard (no threshold derived)
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 373 µg/kg bw/day effect on fertility
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: Low hazard (no threshold derived)
Acute /short term: Low hazard (no threshold derived)
EYE Exposure
Low hazard (no threshold derived)
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 197 µg/m³ effect on fertility
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: Low hazard (no threshold derived)
Acute /short term: Low hazard (no threshold derived)
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 133 µg/kg bw/day effect on fertility
Acute /short term: Low hazard (no threshold derived)
Local Effects
Long-term: Low hazard (no threshold derived)
Acute /short term: Low hazard (no threshold derived)
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 133 µg/kg bw/day effect on fertility
Acute /short term: Low hazard (no threshold derived)
EYE Exposure
Low hazard (no threshold derived)

Toxicokinetics, metabolism, and distribution

Data not provided by the registrant

Acute toxicity

Study results
oral
  • 10 studies submitted
  • 1 study processed
M/CInterpretations of results
Toxicity Category IV [1]

Type of Study provided
oral
Studies with data
Key study 1
Supporting study 9
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
  • 3 studies submitted
  • 1 study processed
P/RResults
LD50 2 000 mg/kg bw (rat) [1]
M/CInterpretations of results
Other [1]

dermal
Studies with data
Key study 1
Supporting study 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
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route:
Adverse effect observed LD50 2 000 mg/kg bw
Dermal route:
No adverse effect observed LD50 2 000 mg/kg bw

Irritation / corrosion

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
Exposure cons.
Other 1
Study data: eye
  • 10 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 2
Supporting study 7
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin
No adverse effect observed (not irritating)
Eye
Adverse effect observed (irritating)
Respiratory
No study available

Sensitisation

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

Study data not processed for brief profile

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

Study data not processed for brief profile

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

Repeated dose toxicity

Study results
Study data: oral
  • 4 studies submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Study data: inhalation
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons. 1
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 300 mg/kg bw/day (subacute, 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 3 1
Weight of evidence
Other
Data waiving
no waivers
Study data: in vivo
  • 4 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: in vivo
Studies with data
Key study 1
Supporting study 3
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

Data not provided by the registrant

Toxicity to reproduction

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

Study data not processed for brief profile

Type of Study provided
Study data: reproduction
Studies with data
Key study 1
Supporting study 5
Weight of evidence
Other
Data waiving
no waivers
Study data: developmental
  • 10 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 1
Supporting study 8
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
  • 1 summary submitted
  • 1 summary processed
Effect on fertility
Oral route:
No adverse effect observed NOAEL 80 mg/kg bw/day (subacute, rat)
Effect on developmental toxicity
Oral route:
No adverse effect observed NOAEL 80 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