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Please be aware that the REACH registration parts of this Brief Profile are no longer maintained; they remain frozen as of 19th May 2023.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.:
424-090-1
CAS no.:
10097-02-6
Index number:
607-420-00-9
Molecular formula:
C6H12O4
SMILES:
CCC(CO)(CO)C(O)=O
InChI:
InChI=1S/C6H12O4/c1-2-6(3-7,4-8)5(9)10/h7-8H,2-4H2,1H3,(H,9,10)
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
5
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:
ELINCS (European LIst of Notified Chemical Substances) List

Hazard classification & labelling

Danger! According to the harmonised classification and labelling (CLP00) approved by the European Union, this substance causes serious eye damage and is harmful to aquatic life with long lasting effects.

Breakdown of all 98 C&L notifications submitted to ECHA

Eye Dam. 1 H318 Harmonised Classification
Aquatic Chronic 3 H412 Harmonised Classification
Aquatic Acute 3 H402
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

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

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

Properties of concern

Regulatory context

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

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 11 active registrations under REACH, 2 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:
A European Union Harmonised Classification & Labelling has been assigned to this substance.
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:

About this substance

This substance is registered under the REACH Regulation and is manufactured in and / or imported to the European Economic Area, at ≥ 10 tonnes per annum.

This substance is used in formulation or re-packing, at industrial sites and in manufacturing.

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

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

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

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

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

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

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

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

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

This substance is used in the following products: polymers.

This substance is used in the following activities or processes at workplace: mixing in open batch processes, transfer of chemicals at dedicated facilities and transfer of substance into small containers.

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

This substance is used in the following products: coating products, inks and toners and polymers.

This substance is used in the following areas: printing and recorded media reproduction. This substance is used for the manufacture of: chemicals and electrical, electronic and optical equipment.

This substance is used in the following activities or processes at workplace: transfer of chemicals, closed, continuous processes with occasional controlled exposure, mixing in open batch processes, transfer of substance into small containers and laboratory work.

Release to the environment of this substance can occur from industrial use: in the production of articles, for thermoplastic manufacture and as processing aid.

This substance is used in the following activities or processes at workplace: 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 chemicals at dedicated facilities, transfer of substance into small containers, laboratory work and manual maintenance (cleaning and repair) of machinery.

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

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

Prevention statements

When handling this substance: avoid release to the environment; wear protective gloves and/or clothing, and eye and/or face protection as specified by manufacturer/supplier.

Response statements

In case of incident: Immediately call a poison center or doctor/physician. If in eyes: rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.

Disposal statements

The substance must be disposed in accordance with local/regional/national/international regulation.

Guidance on the safe use of the substance provided by manufacturers and importers of this substance.

Registrants/suppliers

  • Former NONS notifier unknown to ECHA - Contact the relevant German competent national authority., null
  • Former NONS notifier unknown to ECHA - Contact the relevant UK competent national authority., null
  • Lamberti France s.a.s., Elitec Bât C - 3 Avenue Edouard Herriot 69400 LIMAS France
  • Lamberti Iberia s.a.u., Calle Ceuta 1 - Poligon industrial El Colomer 12200 Onda Castellon Spain
  • Lamberti S.p.A., via Piave 18 21041 Albizzate Varese Italy
  • Lubrizol Advanced Materials Europe B.V.B.A, Nijverheidsstraat 30 2260 Westerlo-Oevel Belgium
  • Lubrizol Deutschland GmbH, Max-Planck-Strasse 6 27721 RITTERHUDE Germany
  • Lubrizol Europe Coordination Center BVBA 02 , Chaussee De Wavre 1945 Brussels Belgium
  • Stahl Europe B.V., Sluisweg 10 5145PE Waalwijk Noord Brabant Netherlands
  • VUP a.s., Nabrezna 4 97104 Prievidza Slovakia
  • Perstorp Specialty Chemicals AB, Perstorp Industripark SE-28480 Perstorp Sweden

Substance names and other identifiers

2,2-bis(hydroxymethyl)butanoic acid
EC Inventory, C&L Inventory, 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
2,2-Bis(hydroxymethyl)butanoic acid
DMBA
C&L Inventory, 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, 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
Butanoic acid, 2,2-bis(hydroxymethyl)-
DMBA
Other
2,2-bis(hidroksimetil)butano rūgštis (lt)
C&L Inventory
2,2-bis(hidroksimetil)butanojska kislina (sl)
C&L Inventory
2,2-bis(hidroksimetil)butanska kiselina (hr)
C&L Inventory
2,2-bis(hydroksimetyyli)butaanihappo (fi)
C&L Inventory
2,2-bis(hydroksymetyl)butansyre (no)
C&L Inventory
2,2-bis(hydroximetyl)butankarboxylsyra (sv)
C&L Inventory
2,2-bis(hydroxymethyl)butaanzuur (nl)
C&L Inventory
2,2-bis(hydroxymethyl)butanová kyselina (cs)
C&L Inventory
2,2-bis(hydroxymethyl)butansyre (da)
C&L Inventory
2,2-Bis(hydroxymethyl)butansäure (de)
C&L Inventory
2,2-bis(hüdroksümetüül)võihape (et)
C&L Inventory
2,2-bisz(hidroximetil)vajsav (hu)
C&L Inventory
2,2-δις(υδρoξυμεθυλo)βoυτανoϊκό oξύ (el)
C&L Inventory
2,2-бис(хидроксиметил)бутанова киселина (bg)
C&L Inventory
acid 2,2-bis(hidroximetil)butanoic (ro)
C&L Inventory
acide 2,2-bis(hydroxyméthyl)butanoïque (fr)
C&L Inventory
acido 2,2-bis(idrossimetil)butanoico (it)
C&L Inventory
kwas 2,2-bis(hydroksymetylo)butanowy (pl)
C&L Inventory
kyselina 2,2-bis(hydroxymetyl)butánová (sk)
C&L Inventory
ácido 2,2-bis(hidroximetil)butanoico (es)
C&L Inventory
ácido 2,2-bis(hidroximetil)butanóico (pt)
C&L Inventory
2,2-Bis(hydroxymethyl)butanoic acid
C&L Inventory, Registration dossier, Other
2,2-Bis(hydroxymethyl)butanoic acid
C&L Inventory, Registration dossier, Other
2,2-bis(hydroxymethyl)butanoic acid
Registration dossier
2-Ethyl-2-(hydroxymethyl)-1,3-propanediol
C&L Inventory
DMBA
Registration dossier
10097-02-6
CAS number
C&L Inventory, Registration dossier, 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, 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
1403353-18-3
CAS number
Other
225519-86-8
CAS number
Other
56743-27-2
CAS number
Other
607-420-00-9
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
  • 5 studies submitted
  • 1 study processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [1]
C Form
Powder (100%) [1]
C Odour
Other (100%) [1]
C Substance type
Organic (100%) [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other 4
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
  • 5 studies submitted
  • 1 study processed
R Melting / freezing point
111.85 - 113.85 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other 4
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Melting / freezing point at 101 325 Pa
112 °C

Boiling point

Study results
  • 5 studies submitted
  • 1 study processed
R Boiling point
284.85 °C @ 96.792 kPa [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other 4
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Boiling point at 101 325 Pa
285 °C

Density

Study results
  • 5 studies submitted
  • 1 study processed
R Relative density
1.26 @ 23 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other 4
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
1.26

Vapour pressure

Study results
  • 5 studies 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 4
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Vapour pressure
0 Pa @ 25 °C

Partition coefficient

Study results
  • 5 studies submitted
  • 1 study processed
R Pow
0.21 @ 20 °C and pH 4 [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other 4
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Log Kow (Log Pow)
-0.68 @ 20 °C

Water solubility

Study results
  • 5 studies submitted
  • 1 study processed
R Water solubility (mass/vol.)
487 g/L @ 20 °C and pH 1.79 - 1.85 [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other 4
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Water solubility
487 g/L @ 20 °C

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

Study results
  • 5 studies submitted
  • 1 study processed
R Surface tension
71 mN/m @ 1 g/L and 21 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other 4
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Surface tension at 20 °C
71 mN/m @ 1 000 mg/L

Flash point

Study results
  • 5 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 4
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
  • 5 studies 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 4
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Flammability

Study results
  • 5 studies 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 4
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Flammability
Non flammable (100%)

Explosiveness

Study results
  • 5 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 4
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
  • 5 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 4
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
C Summaries
  • 1 summary submitted
  • 1 summary processed
Oxidising
No (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

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
  • 5 studies 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 4
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Half-life for hydrolysis
1 years @ 50 °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
  • 5 studies 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 4
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
  • 4 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other 2
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Koc at 20°C
10

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 105 µg/L (1)
Intermittent releases (freshwater) 1.05 mg/L (1)
Marine water 10.5 µg/L (1)
Intermittent releases (marine water) 1.05 mg/L (1)
Sewage treatment plant (STP) 10 mg/L (1)
Sediment (freshwater) 483 µg/kg sediment dw (1)
Sediment (marine water) 48.3 µg/kg sediment dw (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 35 µg/kg soil dw (1)
Hazard for Predators
Secondary poisoning 26.67 mg/kg bw (1)

Short–term toxicity to fish

Study results
  • 6 studies submitted
  • 1 study processed
P/RResults
LC50 (4 days) 100 mg/L [1]
LC50 (72 h) 100 mg/L [1]
LC50 (48 h) 100 mg/L [1]
LC50 (24 h) 100 mg/L [1]
NOEC (4 days) 100 mg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other 4
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
  • 5 studies submitted
  • 1 study processed
P/RResults
EC50 (48 h) 98 - 100 mg/L [2]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other 4
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
  • 5 studies 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 4
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 for freshwater algae
105 mg/L
EC10 or NOEC for freshwater algae
48 mg/L

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 6 studies submitted
  • 1 study processed
P/RResults
IC50 (3 h) 100 mg/L [1]
NOEC (3 h) 100 mg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other 4
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 for microorganisms
100 mg/L
EC10 or NOEC for microorganisms
100 mg/L

Sediment toxicity

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) 3.53 mg/m³ effect on fertility
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) 1 mg/kg bw/day effect on fertility
Acute /short term: No hazard identified
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
EYE Exposure
Medium hazard (no threshold derived)
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 870 µg/m³ effect on fertility
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) 500 µg/kg bw/day effect on fertility
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) 500 µg/kg bw/day effect on fertility
Acute /short term: No hazard identified
EYE Exposure
Medium hazard (no threshold derived)

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 5 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

Study data not processed for brief profile

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

No automatically processable data submitted

Acute toxicity

Study results
oral
  • 5 studies submitted
  • 1 study processed
P/RResults
LD50 2 000 mg/kg bw (rat) [1]
M/CInterpretations of results
Other [1]

Type of Study provided
oral
Studies with data
Key study 1
Supporting study
Weight of evidence
Other 4
Data waiving
no waivers
inhalation
  • 2 studies submitted
  • 2 studies processed
P/RResults
LC50 (4 h) 5 mg/L air (rat) [1]
M/CInterpretations of results
Other [2]

inhalation
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
dermal
  • 5 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
Weight of evidence
Other 4
Data waiving
no waivers
other routes
  • 0 studies submitted
  • 0 studies processed

No data available

other routes
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route:
No adverse effect observed LD50 2 000 mg/kg bw
Inhalation route:
No adverse effect observed LC50 5 mg/L air
Dermal route:
No adverse effect observed LD50 2 000 mg/kg bw

Irritation / corrosion

Study results
Study data: skin
  • 7 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 4
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Study data: eye
  • 7 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other 4
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)

Sensitisation

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

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 1
Supporting study
Weight of evidence
Other 4
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
  • 6 studies submitted
  • 1 study processed
P/RResults
NOAEL (rat): 1 000 mg/kg bw/day [1]
NOEL (rat): 200 mg/kg bw/day [1]

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

No data available

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

No data available

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

Genetic toxicity

Study results
Study data: in vitro
  • 14 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: in vitro
Studies with data
Key study 3
Supporting study 1
Weight of evidence
Other 10
Data waiving
no waivers
Study data: in vivo
  • 0 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
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Toxicity - InVitro
No adverse effect observed (negative)

Carcinogenicity

Data not provided by the registrant

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
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: other studies
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: other studies
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Effect on fertility
Oral route:
Adverse effect observed NOAEL 200 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