Brief Profile

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.:
418-570-8
CAS no.:
25383-07-7
Index number:
015-178-00-5
Molecular formula:
SMILES:
InChI:
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
9
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

Warning! According to the harmonised classification and labelling (CLP00) approved by the European Union, this substance is toxic to aquatic life with long lasting effects and is suspected of damaging fertility.

Additionally, the classification provided by companies to ECHA in REACH registrations identifies that this substance is suspected of damaging fertility or the unborn child.

Breakdown of all 9 C&L notifications submitted to ECHA

Aquatic Chronic 2 H411 Harmonised Classification
Repr. 2 H361f Harmonised Classification
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

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

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

Properties of concern

  • R
Suspected to be Toxic to Reproduction (Harmonised C&L).

Regulatory context

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 2 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:
Industrial accident prevention and reporting requirements have been established for this substance.
Notified C&L:
Classification & Labelling has been notified by industry to ECHA for this substance.

Biocidal Products Regulation (BPR)

Active Substance:
Biocidal Products:

Prior Informed Consent (PIC)

Annex I:
Annex V:

European Union Observatory for Nanomaterials (EUON)

EUON:

About this substance

This substance is registered under the REACH Regulation 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 and at industrial sites.

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

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

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

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

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

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: pharmaceuticals.

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

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

This substance has an industrial use resulting in manufacture of another substance (use of intermediates).

This substance is used for the manufacture of: chemicals.

This substance is used in the following activities or processes at workplace: closed batch processing in synthesis or formulation, transfer of chemicals at dedicated facilities, closed processes with no likelihood of exposure, closed, continuous processes with occasional controlled exposure and laboratory work.

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

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.

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

Prevention statements

When handling this substance: obtain special instructions before use; 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: If exposed or concerned: get medical advice/attention. Collect spillage.

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

  • Clarochem Ireland Ltd, damastown mulhuddart dn 15 dublin Ireland
  • Ercros SA, Avenida Diagonal 593-595 08014 Barcelona Spain
  • F.I.S. Fabbrica Italiana Sintetici S.p.a., Viale Milano, 26 36075 Montecchio Maggiore (VI) Veneto Italy
  • Former NONS notifier unknown to ECHA - Contact the relevant Italian competent national authority., null
  • LABIANA PHARMACEUTICALS S.L., Carrer Casanova, 27-31 08757 Corbera de Llobregat Spain
  • QUIMICA SINTETICA, S.A., C/ Dulcinea, s/n 28805 Alcalá de Henares Madrid Spain
  • Siemsgluss Ibérica, S.A., Pol. Ind. Sant Antoni, parcela 6, nave 2 08620 Sant Vicenç dels Horts Barcelona Spain
  • ZaCh System, ZI La Croix Cadeaux 49242 Avrillè France

Substance names and other identifiers

(R)-a-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
Other
(R)-alpha-Phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
Other
(R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
EC Inventory
(R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
REACH pre-registration
(R)-α-Phenylethylammonium (-)-(1R,2S)-(1,2-epoxypropyl)phosphonate monohydrate
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
Cosmetic Products Regulation, Annex II - Prohibited Substances
(R)-α-phenylethylammonium(-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
FCM Active and Intelligent Materials - CMRs not allowed for use, 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, Protection of Pregnant and Breastfeeding Workers Directive, Annex I+II, 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
Fosfomycin (R)-1-phenethylamine salt
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
Other
Fosfomycin (R)-1-phenethylamine
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
Other
Levo-phosphonomycin (R)-1-phenethylamine salt
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
Other
Phosphonic acid, (1,2-epoxypropyl)-, cis-(-)-, compd. with (+)-alpha-methylbenzylamine (1:1)
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
Other
Phosphonic acid, P-((2R,3S)-3-methyl-2-oxiranyl)-, compd. with (alphaR)-alpha-methylbenzenemethanamine (1:1)
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
Other
Phosphonomycin (R)-1-phenethylamine salt
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
Other
R)-alpha-Methylbenzenemethanamine (2R-cis)-(3-methyloxiranyl)phosphonate (1:1)
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
Other
(R)-alfa-feniletilamonio(-)-(1R, 2S)-(1,2-epoksipropil)fosfonato monohidratas (lt)
C&L Inventory
(R)-α-feniletilammónium(-)-(1R,2S)-(1,2-epoxipropil)foszfonát-monohidrát (hu)
C&L Inventory
(R)-alpha-Phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
Registration dossier
(R)-alpha-phenylethylammonium(-)-(1R,2S)-(1,2- epoxipropyl)phosphonate monohydrate
Registration dossier
(R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
C&L Inventory, Registration dossier
(R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
Registration dossier
1-phenylethan-1-aminium hydrate hydrogen [(2R,3S)-3-methyloxiran-2-yl]phosphonate
Other
[(2R,3S)-3-methyloxiran-2-yl]phosphonic acid;(1R)-1-phenylethanamine
Other
Fosfomycin PEA salt
Registration dossier
FOSFOMYCIN PHENETHYLAMINE
Registration dossier
Phenethylammonium salt of fosfomycin
Registration dossier
Reaction mass of D-α-methylbenzylamine and fosfomycin
C&L Inventory
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
Registration dossier
015-178-00-5
Index number
C&L Inventory
25383-07-7
CAS number
C&L Inventory, Other, FCM Active and Intelligent Materials - CMRs not allowed for use, CAD - Chemical Agents Directive, Art. 2(b)(i) - Hazardous Agents, Construction Product Regulation - Annex I (3) - Hazardous Substances, Construction Product Regulation - Art. 6(5) - SDS and Declaration, Cosmetic Products Regulation, Annex II - Prohibited Substances, EU Ecolabels - Restrictions for Hazardous Substances/Mixtures, End-of-Life Vehicles Directive - Hazardous Substances, Active Implantable Medical Devices Directive - Hazardous Substances, In Vitro Diagnostic Medical Devices Directive - Hazardous Substances, In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances, Marine Environmental Policy Framework Directive - Hazardous Substances, Medical Devices Directive - Hazardous Substances, Medical Devices Regulation - Hazardous Substances, Protection of Pregnant and Breastfeeding Workers Directive, Annex I+II, 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

Scientific properties

Physical and chemical properties

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

Appearance/physical state / colour

Study results
  • 3 studies submitted
  • 2 studies processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [2]
C Form
Crystalline (100%) [2]
C Substance type
Organic (100%) [2]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence 1
Other 1
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
  • 2 studies submitted
  • 2 studies processed
R Melting / freezing point
135.7 - 144.3 °C [2]

Type of Study provided
Studies with data
Key study 2
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
135.7 °C

Boiling point

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No data available

Density

Study results
  • 2 studies submitted
  • 2 studies processed
R Relative density
1.298 - 1.3 @ 20 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
1.298

Vapour pressure

Study results
  • 2 studies submitted
  • 2 studies processed
R Vapour pressure
0.003 - 0.003 Pa @ 30 - 40 °C [4]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Vapour pressure
0.003 Pa @ 30 °C

Partition coefficient

Study results
  • 2 studies submitted
  • 2 studies processed
R Log Pow
-3 @ 20 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Log Kow (Log Pow)
-3 @ 20 °C

Water solubility

Study results
  • 2 studies submitted
  • 2 studies processed
R Water solubility (mass/vol.)
70.59 g/L @ 20 °C and pH 3.9 [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Water solubility
70.59 g/L @ 20 °C

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

Study results
  • 2 studies submitted
  • 2 studies processed
R Surface tension
71.05 mN/m @ 1 g/L and 20 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Surface tension at 20 °C
71.05 mN/m @ 1 000 mg/L

Flash point

Study results
  • 3 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 1
Data waiving
Not feasible 1
Sci. unjustified 1
Exposure cons.
Other
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Auto flammability

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Flammability

Study results
  • 4 studies submitted
  • 3 studies processed
C Interpretation of results
Not classified based on GHS criteria (33%), GHS criteria not met (33%), Non flammable (33%) [3]

Type of Study provided
Studies with data
Key study 3
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
C Summaries
  • 1 summary submitted
  • 1 summary processed
Flammability
Not classified (100%)

Explosiveness

Study results
  • 4 studies submitted
  • 4 studies processed
C Interpretation of results
GHS criteria not met (75%), Non-explosive (25%) [4]

Type of Study provided
Studies with data
Key study 4
Supporting study
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Explosiveness
Non-explosive (100%)

Oxidising

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

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
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 1
Sci. unjustified
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
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 1 summary processed
Half-life for hydrolysis
1.784 years @ 25 °C

Phototransformation in water

Data not provided by the registrant

Phototransformation in soil

Data not provided by the registrant

Biodegradation in water - screening tests

Study results
  • 3 studies submitted
  • 2 studies processed
R COD
1.638 mg O2/g test material [1]
C Interpretation of results
Under test conditions no biodegradation observed (100%) [2]

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

No automatically processable data submitted

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

No automatically processable data submitted

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 4.6 µg/L (1)
Intermittent releases (freshwater) 46 µg/L (1)
Marine water 460 ng/L (1)
Intermittent releases (marine water) -
Sewage treatment plant (STP) 10 mg/L (1)
Sediment (freshwater) 18 µg/kg sediment dw (1)
Sediment (marine water) 1.8 µg/kg sediment dw (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 904 ng/kg soil dw (1)
Hazard for Predators
Secondary poisoning 33.3 mg/kg food (1)

Short–term toxicity to fish

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
LC50 (4 days) 100 mg/L [2]
LC50 (72 h) 100 mg/L [1]
LC50 (48 h) 100 mg/L [1]
LC50 (24 h) 100 mg/L [1]
LC100 (4 days) 100 mg/L [1]

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

No automatically processable data submitted

Long–term toxicity to fish

Data not provided by the registrant

Short–term toxicity to aquatic invertebrates

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
EC50 (48 h) 86 mg/L [2]
EC50 (24 h) 91.8 mg/L [2]
EC100 (48 h) 100 mg/L [1]
NOEC (48 h) 59 mg/L [1]

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

No automatically processable data submitted

Long–term toxicity to aquatic invertebrates

Data not provided by the registrant

Toxicity to aquatic algae and cyanobacteria

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
EC50 (72 h) 4.6 - 17.7 mg/L [4]
EC50 (48 h) 31.7 - 100 mg/L [2]
EC50 (24 h) 100 mg/L [2]
NOEC (72 h) 1 mg/L [4]
NOEC (48 h) 1 - 5.6 mg/L [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
EC50 for freshwater algae
4.6 - 17.7 mg/L
EC10 or NOEC for freshwater algae
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) 100 - 6 200 mg/L [2]
NOEC (3 h) 100 mg/L [1]
EC10 (3 h) 90 mg/L [1]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other 1
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
EC50 for microorganisms
100 - 6 200 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) 5.3 mg/m³ developmental toxicity / teratogenicity
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) 1 mg/kg bw/day developmental toxicity / teratogenicity
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
No hazard identified
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: - -
Acute /short term: - -
Local Effects
Long-term: - -
Acute /short term: - -
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: - -
Acute /short term: - -
Local Effects
Long-term: - -
Acute /short term: - -
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: - -
Acute /short term: - -
EYE Exposure
-

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
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
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
  • 2 studies submitted
  • 2 studies processed
P/RResults
LD50 2 000 mg/kg bw (rat) [2]
M/CInterpretations of results
GHS criteria not met [1]

Type of Study provided
oral
Studies with data
Key study 2
Supporting study
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
  • 2 studies submitted
  • 2 studies processed
P/RResults
LD50 2 000 mg/kg bw (rat) [2]
M/CInterpretations of results
GHS criteria not met [1]

dermal
Studies with data
Key study 2
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
  • 2 summaries submitted
  • 2 summaries processed
Oral route:
No 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 2
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
Study data: eye
  • 3 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

Sensitisation

Study results
Study data: skin
  • 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 2
Supporting study
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
  • 2 summaries submitted
  • 2 summaries 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): 150 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
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.
Other 1
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
Exposure cons.
Other 1
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Oral route - systemic effects:
Adverse effect observed NOAEL 150 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 4
Supporting study
Weight of evidence
Other 2
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
  • 2 summaries submitted
  • 1 summary processed
Toxicity - InVitro
No adverse effect observed (negative)
Toxicity - InVivo
No study available

Carcinogenicity

Data not provided by the registrant

Toxicity to reproduction

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

Study data not processed for brief profile

Type of Study provided
Study data: reproduction
Studies with data
Key study 2
Supporting study
Weight of evidence
Other 1
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
  • 2 summaries submitted
  • 2 summaries processed
Effect on fertility
Oral route:
Adverse effect observed NOAEL 100 mg/kg bw/day (chronic, rat)
Effect on developmental toxicity
Oral route:
Adverse effect observed NOAEL 100 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