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.:
701-238-4
CAS no.:
-
Index number:
Molecular formula:
SMILES:
InChI:
Type of substance:
UVCB
Origin:
Organic
Registered compositions:
13
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:

Hazard classification & labelling

Warning! According to the classification provided by companies to ECHA in REACH registrations this substance is harmful if swallowed.

Breakdown of all 10 C&L notifications submitted to ECHA

Acute Tox. 4 H302
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

Properties of concern

Regulatory context

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

Registration
Pre-registration:
Registration:
This substance has 10 active registrations under REACH, 1 Joint Submission(s) and 0 Individual Submission(s).
Please see Registrants/Suppliers details.
Evaluation
Dossier Evaluation:
Substance Evaluation:
Authorisation
Candidate List:
Annex XIV (Authorisation List):
Restriction
Annex XVII (Restriction List):

Persistent Organic Pollutants Regulation (POPs)

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

Classification Labelling & Packaging (CLP)

Harmonised C&L:
Seveso Annex I:
Notified C&L:
Classification & Labelling has been notified by industry to ECHA for this substance.

Biocidal Products Regulation (BPR)

Active Substance:
Biocidal Products:

Prior Informed Consent (PIC)

Annex I:
Annex V:

European Union Observatory for Nanomaterials (EUON)

EUON:

About this substance

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

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

This substance is used in the following products: washing & cleaning products, coating products and fertilisers.

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.

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

This substance can be found in products with material based on: fabrics, textiles and apparel (e.g. clothing, mattress, curtains or carpets, textile toys).

This substance is used in the following products: water softeners, washing & cleaning products, air care products, coating products, fertilisers, polishes and waxes and cosmetics and personal care products.

This substance is used in the following areas: agriculture, forestry and fishing and building & construction work.

This substance is used in the following activities or processes at workplace: transfer of chemicals, non-industrial spraying, roller or brushing applications, closed, continuous processes with occasional controlled exposure, batch processing in synthesis or formulation with opportunity for exposure, mixing in open batch processes and hand mixing with intimate contact only with personal protective equipment available.

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.

This substance is used in the following products: washing & cleaning products, water softeners, pH regulators and water treatment products, textile treatment products and dyes and leather treatment products.

This substance is used in the following activities or processes at workplace: transfer of chemicals, mixing in open batch processes 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: water softeners, pH regulators and water treatment products, water treatment chemicals, washing & cleaning products, textile treatment products and dyes and leather treatment products.

This substance is used in the following areas: mining and municipal supply (e.g. electricity, steam, gas, water) and sewage treatment. This substance is used for the manufacture of: textile, leather or fur, pulp, paper and paper products, metals, fabricated metal products, machinery and vehicles and furniture.

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, mixing in open batch processes, treatment of articles by dipping and pouring and industrial spraying.

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

This substance is used in the following activities or processes at workplace: transfer of chemicals, closed batch processing in synthesis or formulation, 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, batch processing in synthesis or formulation with opportunity for exposure, laboratory work and production of mixtures or articles by tabletting, compression, extrusion or pelletisation.

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: do not eat, drink or smoke when using this product; wash parts of the body (as specified by manufacturer/supplier)in contact with substance thoroughly after handling.

Response statements

In case of incident: Rinse the mouth. If swallowed: call a poison center or doctor/physician if you feel unwell.

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

  • Archroma France, SAS, Rue du Flottage 60350 Trosly-Breuil France
  • BASF SE, Carl-Bosch-Str. 38 67056 Ludwigshafen am Rhein Rheinland-Pfalz Germany
  • Covance Clinical Development SA 016, Parque Empresarial Las Tablas, Edificio 1 Calle Federico Mompou, 5 – 5 Planta 28050 Madrid Spain
  • DyStar Colours Distribution GmbH, Am Prime-Parc 12 65479 Raunheim Germany
  • Eurodye-ctc, Chaussée de Charleroi 119 B-1370 Jodoigne Belgium
  • Giovanni Bozzetto SpA, Via Provinciale, 12 24040 Filago Lombardia Italy
  • Italmatch Chemicals SpA - OR 1, Via Magazzini del Cotone 17 – modulo 4 16128 genova Italy
  • Pulcra Chemicals GmbH, Isardamm 79-83 82538 Geretsried Germany
  • RIHASSAS-CONSULTING, Rotterdamer Str. 5 50735 Köln NRW Germany
  • ZSCHIMMER & SCHWARZ MOHSDORF GmbH & Co KG, Chemnitztalstraße 1 09217 BURGSTÄDT Germany

Substance names and other identifiers

(1-hydroxyethylidene)bisphosphonic acid, sodium salts
Registration dossier
HEDP (2-3Na)
Registration dossier
Sodium salts of (1-hydroxyethane-1,1-diyl)bisphosphonate (2-3 Na:1)
Registration dossier
Sodium salts of (1-hydroxyethylidene)bisphosphonic acid (2-3 Na1)
Registration dossier
Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)
Registration dossier
Sodium salts of (1-hydroxyethylidene)bisphosphonic acid (2-3:1)
Registration dossier
CUBLEN K 2012
Registration dossier
CUBLEN K 9012 GR
Registration dossier

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
Liquid (50%), Solid (50%) [2]
C Form
Liquid (50%), Solid (50%) [2]
C Substance type
Organic (100%) [2]

Type of Study provided
Studies with data
Key study 2 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Physical state at 20°C and 1013 hPa
Liquid (50%), Solid (50%)

Melting/freezing point

Study results
  • 3 studies submitted
  • 1 study processed
R Melting / freezing point
449.85 °C [1]

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

No automatically processable data submitted

Boiling point

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study 1
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

Density

Study results
  • 3 studies submitted
  • 1 study processed
R Relative density
1.92 @ 21 °C [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
Relative density at 20°C
1.92

Vapour pressure

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

Type of Study provided
Studies with data
Key study 1 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
-3.5 [1]

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
Log Kow (Log Pow)
-3.5

Water solubility

Study results
  • 9 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study 5 1 1
Weight of evidence 2
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Water solubility
200 g/L @ 25 °C

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Flash point

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Auto flammability

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
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

Flammability

Study results
  • 5 studies submitted
  • 2 studies processed
C Interpretation of results
Not classified based on GHS criteria (50%), GHS criteria not met (50%) [2]

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

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers

No summary exists for this scientific endpoint

Dissociation constant

Study results
  • 3 studies submitted
  • 1 study processed
C Dissociating properties
Yes (100%) [1]
R Dissociation constant
1.7 - 10.29 @ 25 °C [4]

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

No automatically processable data submitted

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
  • 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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Phototransformation in water

Study results
  • 9 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study 8 1
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Phototransformation in soil

Data not provided by the registrant

Biodegradation in water - screening tests

Study results
  • 9 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1 1
Supporting study 6
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
C Summaries
  • 1 summary submitted
  • 1 summary processed
Biodegradation in water
Under test conditions no biodegradation observed (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
10 days @ 12 °C
Half-life in freshwater sediment
10 days @ 12 °C

Biodegradation in soil

Study results
  • 6 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study 1 1
Supporting study 4
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Half-life in soil
10 days @ 12 °C

Bioaccumulation: aquatic / sediment

Study results
  • 3 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

No automatically processable data submitted

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 12 studies submitted
  • 1 study processed
R Koc
16 610 L/kg [1]
R log Koc
4.22 dimensionless [1]

Type of Study provided
Studies with data
Key study 1 1
Supporting study 10
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Koc at 20°C
40 000

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 68 µg/L (1)
Intermittent releases (freshwater) -
Marine water 6.8 µg/L (1)
Intermittent releases (marine water) -
Sewage treatment plant (STP) 40 mg/L (1)
Sediment (freshwater) 136 mg/kg sediment dw (1)
Sediment (marine water) 13.6 mg/kg sediment dw (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 10 mg/kg soil dw (1)
Hazard for Predators
Secondary poisoning 3.7 mg/kg food (1)

Short–term toxicity to fish

Study results
  • 7 studies submitted
  • 1 study processed
P/RResults
LC50 (14 days) 180 mg/L [1]
LC50 (4 days) 195 mg/L [1]
LC50 (72 h) 200 mg/L [1]
LC50 (48 h) 279 mg/L [1]
LC50 (24 h) 310 mg/L [1]

Type of Study provided
Studies with data
Key study 1 1
Supporting study 5
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Long–term toxicity to fish

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

No automatically processable data submitted

Short–term toxicity to aquatic invertebrates

Study results
  • 7 studies submitted
  • 2 studies processed
P/RResults
EC50 (48 h) 527 - 1 770 mg/L [2]
EC50 (24 h) 871 mg/L [1]
NOEC (48 h) 400 - 3 925 mg/L [2]

Type of Study provided
Studies with data
Key study 2 1
Supporting study 4
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Long–term toxicity to aquatic invertebrates

Study results
  • 4 studies submitted
  • 1 study processed
P/RResults
NOEC (28 days) 6.75 mg/L [1]

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

No automatically processable data submitted

Toxicity to aquatic algae and cyanobacteria

Study results
  • 12 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study 9 1 1
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

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 6 studies submitted
  • 3 studies processed
P/RResults
NOEC (53 days) 300 mg/L [1]
NOEC (30 days) 200 mg/L [1]
LOEC (54 days) 400 mg/L [1]
LOEC (30 days) 500 mg/L [1]
IC0 (30 min) 250 mg/L [1]

Type of Study provided
Studies with data
Key study
Supporting study 2
Weight of evidence 2 1 1
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC10 or NOEC for microorganisms
200 mg/L

Sediment toxicity

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

No automatically processable data submitted

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
NOEC (28 days) 500 mg/kg soil dw [1]
EC50 (28 days) 1 g/kg soil dw [1]

Type of Study provided
Studies with data
Key study 1 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Long-term EC10 / LC10 / NOEC
500 mg/kg soil dw

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

No data available

Toxicity to terrestrial plants

Study results
  • 4 studies submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Toxicity to birds

Study results
  • 4 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study 2 1
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
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) 12 mg/m³ repeated dose toxicity
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) 34 mg/kg bw/day repeated dose toxicity
Acute /short term: (No hazard identified) -
Local Effects
Long-term: (No hazard identified) -
Acute /short term: (No hazard identified) -
EYE Exposure
No hazard identified
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 2.95 mg/m³ repeated dose toxicity
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) 17 mg/kg bw/day repeated dose toxicity
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) 1.7 mg/kg bw/day repeated dose toxicity
Acute /short term: (No hazard identified) -
EYE Exposure
No hazard identified

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 18 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 10 6
Weight of evidence 1
Other
Data waiving
no waivers
Study data: dermal absorption
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: dermal absorption
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

Acute toxicity

Study results
oral
  • 14 studies submitted
  • 1 study processed
P/RResults
LD50 2 850 mg/kg bw (rat) [1]
M/CInterpretations of results
GHS criteria not met [1]

Type of Study provided
oral
Studies with data
Key study 1
Supporting study 12
Weight of evidence 1
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 1
Exposure cons.
Other
dermal
  • 4 studies submitted
  • 1 study processed
P/RResults
LD50 5 000 mg/kg bw (rabbit) [1]
M/CInterpretations of results
GHS criteria not met [1]

dermal
Studies with data
Key study 1
Supporting study 2
Weight of evidence 1
Other
Data waiving
no waivers
other routes
  • 0 studies submitted
  • 0 studies processed

No data available

other routes
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route:
No adverse effect observed LD50 940 mg/kg bw
Dermal route:
No adverse effect observed LD50 3 500 mg/kg bw

Irritation / corrosion

Study results
Study data: skin
  • 9 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 6
Weight of evidence 1
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
Study data: eye
  • 12 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 1
Supporting study 9
Weight of evidence 1
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin
No adverse effect observed (not irritating)
Eye
No adverse effect observed (not irritating)
Respiratory
No study available

Sensitisation

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

Study data not processed for brief profile

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

Repeated dose toxicity

Study results
Study data: oral
  • 8 studies submitted
  • 2 studies processed
P/RResults
NOAEL (rat): 41 - 78 mg/kg bw/day [2]
LOAEL (rat): 169 mg/kg bw/day [1]

Type of Study provided
Study data: oral
Studies with data
Key study 2
Supporting study 5
Weight of evidence 1
Other
Data waiving
no waivers
Study data: inhalation
  • 6 studies submitted
  • 0 studies processed

No automatically processable data submitted

Study data: inhalation
Studies with data
Key study
Supporting study 5 1
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:
Adverse effect observed NOAEL 34 mg/kg bw/day (subchronic, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 8 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 5
Supporting study 2
Weight of evidence 1
Other
Data waiving
no waivers
Study data: in vivo
  • 3 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: in vivo
Studies with data
Key study 2
Supporting study
Weight of evidence 1
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Toxicity - InVitro
No adverse effect observed (negative)
Toxicity - InVivo
No adverse effect observed (negative)

Carcinogenicity

Study results
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

No automatically processable data submitted

Toxicity to reproduction

Study results
Study data: reproduction
  • 11 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 4
Weight of evidence 3 1
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
Study data: developmental
  • 15 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 3
Supporting study 1
Weight of evidence 10 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
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

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