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.:
402-950-5
CAS no.:
-
Index number:
Molecular formula:
C22H26O6
SMILES:
[H][C@]12COC(O[C@@]1([H])[C@]([H])(OC(O2)C1=CC=C(C)C=C1)[C@H](O)CO)C1=CC=C(C)C=C1
InChI:
InChI=1S/C22H26O6/c1-13-3-7-15(8-4-13)21-25-12-18-20(28-21)19(17(24)11-23)27-22(26-18)16-9-5-14(2)6-10-16/h3-10,17-24H,11-12H2,1-2H3/t17-,18+,19-,20-,21,22/m1/s1
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
6
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:
ELINCS (European LIst of Notified Chemical Substances) List

Hazard classification & labelling

According to the classification provided by companies to ECHA in REACH registrations this substance is toxic to aquatic life with long lasting effects.

According to the majority of notifications provided by companies to ECHA in CLP notifications no hazards have been classified.

Breakdown of all 145 C&L notifications submitted to ECHA

Not Classified
Aquatic Chronic 2 H411
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

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

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

Properties of concern

Regulatory activities

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

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 6 active registrations under REACH, 0 Joint Submission(s) and 5 Individual Submission(s).
Please see Registrants/Suppliers details.
Evaluation
Dossier Evaluation:
Registration dossiers submitted to ECHA for this substance have been evaluated under REACH.
Substance Evaluation:
Authorisation
Candidate List:
Annex XIV (Authorisation List):
Restriction
Annex XVII (Restriction List):

Classification Labelling & Packaging (CLP)

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

Biocidal Products Regulation (BPR)

Active Substance:
Biocidal Products:

Prior Informed Consent (PIC)

Annex I:
Annex V:

European Union Observatory for Nanomaterials (EUON)

EUON:

About this substance

This substance is manufactured and/or imported in the European Economic Area in 100+ tonnes per year.

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

This substance is used in the following products: polymers.

Other release to the environment of this substance is likely to occur from: indoor use and outdoor use resulting in inclusion into or onto a materials (e.g. binding agent in paints and coatings or adhesives).

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: plastic (e.g. food packaging and storage, toys, mobile phones).

This substance is used in the following products: polymers.

This substance is used for the manufacture of: plastic products.

This substance is used in the following activities or processes at workplace: transfer of substance into small containers and the low energy manipulation of substances bound in materials or articles.

Other release to the environment of this substance is likely to occur from: indoor use and outdoor use resulting in inclusion into or onto a materials (e.g. binding agent in paints and coatings or adhesives).

This substance is used in the following products: polymers.

This substance is used in the following activities or processes at workplace: transfer of chemicals, closed processes with no likelihood of exposure, closed, continuous processes with occasional controlled exposure, closed batch processing in synthesis or formulation, mixing in open batch processes, transfer of substance into small containers, batch processing in synthesis or formulation with opportunity for exposure, calendering operations, production of mixtures or articles by tabletting, compression, extrusion or pelletisation, laboratory work and the low energy manipulation of substances bound in materials or articles.

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

This substance is used in the following products: polymers.

This substance is used for the manufacture of: chemicals and plastic products.

This substance is used in the following activities or processes at workplace: mixing in open batch processes, transfer of chemicals, closed processes with no likelihood of exposure, closed, continuous processes with occasional controlled exposure, closed batch processing in synthesis or formulation, calendering operations, transfer of substance into small containers and production of mixtures or articles by tabletting, compression, extrusion or pelletisation.

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

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

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

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.

Response statements

In case of incident: 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

  • COVANCE CRS SA 098, Parque Empresarial Las Tablas, Edificio 1 Calle Federico Mompou, 5-5 Planta 28050 Madrid Spain
  • Envigo Research Limited 222, Shardlow Business Park London Road DE72 2GD Shardlow Derbyshire United Kingdom
  • Everspring Europe Sprl, Rue Rodenbach 125 1190 Brussels Belgium
  • Milliken Europe B.V.B.A., Ham 18-24 9000 Gent Belgium
  • RiKA International Limited, 3 Howarth Court, Gateway Crescent Broadway Business Park OL9 9XB Chadderton Oldham United Kingdom
  • TÜV SÜD Iberia, S.A.U. (068), Ronda Can Fatjó 13 08290 Cerdanyola del Vallès Barcelona Spain
  • LANXESS SOLUTIONS UK LTD, Tenax Road M17 1WT Manchester United Kingdom
  • ROQUETTE Frères, 1 rue de la haute loge 62136 LESTREM Cedex France

Substance names and other identifiers

1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol
EC Inventory, REACH pre-registration
D-Glucitol, 1,3:2,4-bis-O-[(methylphenyl)methylene]-
Other
(1R)-1-((4R,4aR,8aS)-2,6-bis(4-methylphenyl)tetrahydro-[1,3]dioxino[5,4-d][1,3]dioxino-4-yl) ethane-1,2-diol
Registration dossier
(1R)-1-[(1R,2S,4R,6R,9S)-4,9-bis(4-methylphenyl)-3,5,8,10-tetraoxabicyclo[4.4.0]dec-2-yl]ethane-1,2-diol
Registration dossier
(1R)-1-[(4R,4aR,8aS)-2,6-bis(4-methylphenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
Other
bis(4-methylbenzylidene)sorbitol
Registration dossier
Geniset MD
Registration dossier
CLEARLITE NU 005
Registration dossier
DISORBENE M
Registration dossier
Everclear 3940
Registration dossier
Everstab 3940
Registration dossier
GLC NU 005
Registration dossier
K-Clear-40
Registration dossier
MILLAD 3940
Registration dossier
NU 005
Registration dossier
TOWREX NU 500
Registration dossier
87826-41-3
CAS number
Other

Scientific properties

Physical and chemical properties

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

Appearance/physical state / colour

Study results
  • 8 studies submitted
  • 3 studies processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [3]
C Form
Powder (100%) [3]
C Odour
Faint (50%), Odourless (50%) [2]
C Substance type
Organic (100%) [2]

Type of Study provided
Studies with data
Key study 6
Supporting study
Weight of evidence
Other 2
Data waiving
no waivers
C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Physical state at 20°C and 1013 hPa
Solid (100%)

Melting/freezing point

Study results
  • 13 studies submitted
  • 7 studies processed
R Melting / freezing point
235 - 251.8 °C [7]

Type of Study provided
Studies with data
Key study 4
Supporting study 3
Weight of evidence 5
Other 1
Data waiving
no waivers
R Summaries
  • 3 summaries submitted
  • 3 summaries processed
Melting / freezing point at 101 325 Pa
235.45 - 250 °C

Boiling point

Study results
  • 8 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 1
Other 3
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other 1
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Density

Study results
  • 13 studies submitted
  • 9 studies processed
R Bulk density
0.187 - 0.258 g/cm³ @ 20 °C [2]
R Relative density
0.45 - 1.3 @ 20 °C [7]

Type of Study provided
Studies with data
Key study 3
Supporting study 1
Weight of evidence 8
Other 1
Data waiving
no waivers
R Summaries
  • 4 summaries submitted
  • 4 summaries processed
Relative density at 20°C
0.186 - 1.3

Vapour pressure

Study results
  • 11 studies submitted
  • 4 studies processed
R Vapour pressure
0 - 0.03 Pa @ 25 - 95 °C [7]

Type of Study provided
Studies with data
Key study 6
Supporting study 4
Weight of evidence
Other 1
Data waiving
no waivers
R Summaries
  • 3 summaries submitted
  • 3 summaries processed
Vapour pressure
0 - 0 Pa @ 25 °C

Partition coefficient

Study results
  • 12 studies submitted
  • 6 studies processed
R Log Pow
2.5 - 2.7 @ 20 - 25 °C and pH 5.8 - 5.9 [6]

Type of Study provided
Studies with data
Key study 5
Supporting study 3
Weight of evidence 3
Other 1
Data waiving
no waivers
R Summaries
  • 4 summaries submitted
  • 4 summaries processed
Log Kow (Log Pow)
2.5 - 2.7 @ 23 - 25 °C

Water solubility

Study results
  • 12 studies submitted
  • 6 studies processed
R Water solubility (mass/vol.)
200 - 2 200 µg/L @ 20 - 40 °C and pH 1 - 14 [9]

Type of Study provided
Studies with data
Key study 5
Supporting study 3
Weight of evidence 3
Other 1
Data waiving
no waivers
R Summaries
  • 4 summaries submitted
  • 4 summaries processed
Water solubility
800 - 1 500 µg/L @ 20 - 25 °C

Solubility in organic solvents / fat solubility

Study results
  • 4 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 3
Supporting study
Weight of evidence
Other 1
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Solubility in mg/100g standard fat at 20 °C
1

Surface tension

Study results
  • 10 studies submitted
  • 4 studies processed
R Surface tension
66.3 - 72.7 mN/m @ 500 - 900 µg/L and 20 °C [5]

Type of Study provided
Studies with data
Key study 5
Supporting study 2
Weight of evidence 2
Other 1
Data waiving
no waivers
R Summaries
  • 4 summaries submitted
  • 4 summaries processed
Surface tension at 20 °C
66.3 - 72.7 mN/m @ 0.8 - 0.9 mg/L

Flash point

Study results
  • 7 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 3
Data waiving
Not feasible 2
Sci. unjustified 2
Exposure cons.
Other
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Auto flammability

Study results
  • 14 studies submitted
  • 4 studies processed
R Autoflammability / self-ignition
238 - 270 °C @ 100 kPa [4]

Type of Study provided
Studies with data
Key study 3
Supporting study 2
Weight of evidence 8
Other 1
Data waiving
no waivers
R Summaries
  • 4 summaries submitted
  • 1 summary processed
Autoflammability / self-ignition at 101 325 Pa
250 °C

Flammability

Study results
  • 14 studies submitted
  • 6 studies processed
C Interpretation of results
Non flammable (100%) [6]

Type of Study provided
Studies with data
Key study 6
Supporting study 3
Weight of evidence 3
Other 2
Data waiving
no waivers
C Summaries
  • 4 summaries submitted
  • 4 summaries processed
Flammability
Non flammable (100%)

Explosiveness

Study results
  • 9 studies submitted
  • 4 studies processed
C Interpretation of results
Non-explosive (100%) [4]

Type of Study provided
Studies with data
Key study 4
Supporting study
Weight of evidence 2
Other 2
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
C Summaries
  • 3 summaries submitted
  • 3 summaries processed
Explosiveness
Non-explosive (100%)

Oxidising

Study results
  • 10 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1 1
Supporting study 1
Weight of evidence 1
Other 1 3
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
C Summaries
  • 4 summaries submitted
  • 4 summaries processed
Oxidising
No (100%)

Oxidation reduction potential

Data not provided by the registrant

pH

Data not provided by the registrant

Dissociation constant

Study results
  • 2 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
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Viscosity

Study results
  • 2 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
Sci. unjustified 1
Exposure cons.
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

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
  • 4 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study 3
Supporting study
Weight of evidence
Other 1
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Phototransformation in water

Data not provided by the registrant

Phototransformation in soil

Data not provided by the registrant

Biodegradation in water - screening tests

Study results
  • 16 studies submitted
  • 5 studies processed
R BOD5
0 mg O2/g test material [4]
R COD
1.55 - 1.71 g O2/g test material [4]
R BOD5*100/COD
60 mg O2/g test material [1]
C Interpretation of results
Under test conditions no biodegradation observed (100%) [4]

Type of Study provided
Studies with data
Key study 4
Supporting study 2
Weight of evidence 8
Other 2
Data waiving
no waivers
C Summaries
  • 3 summaries submitted
  • 3 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

Study results
  • 2 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 1
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Bioaccumulation: aquatic / sediment

Study results
  • 2 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 1
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 5 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 3
Supporting study
Weight of evidence
Other 2
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Koc at 20°C
296

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
  • 2 summaries submitted
  • 2 summaries 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 2 - 2.6 µg/L (2)
Intermittent releases (freshwater) 1 µg/L (2)
Marine water 200 - 260 ng/L (2)
Intermittent releases (marine water) -
Sewage treatment plant (STP) 10 - 100 mg/L (2)
Sediment (freshwater) No hazard identified (1)
Sediment (marine water) No hazard identified (1)
Hazard for Air
Air No hazard identified (1)
Hazard for Terrestrial Organism
Soil 1 mg/kg soil dw (2)
Hazard for Predators
Secondary poisoning No potential for bioaccumulation (1)

Short–term toxicity to fish

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

Type of Study provided
Studies with data
Key study 3
Supporting study
Weight of evidence
Other 1
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
LC50 for freshwater fish
100 µg/L

Long–term toxicity to fish

Study results
  • 2 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
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Short–term toxicity to aquatic invertebrates

Study results
  • 11 studies submitted
  • 8 studies processed
P/RResults
EC50 (48 h) 100 - 200 µg/L [6]
EC50 (24 h) 100 - 700 µg/L [8]
EC100 (48 h) 200 µg/L [2]
NOEC (48 h) 100 - 200 µg/L [6]

Type of Study provided
Studies with data
Key study 4
Supporting study
Weight of evidence 6
Other 1
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
EC50 / LC50 for freshwater invertebrates
100 - 700 µg/L

Long–term toxicity to aquatic invertebrates

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
NOEC (21 days) 130 µg/L [1]
EC50 (21 days) 400 µg/L [2]
EC50 (14 days) 400 µg/L [1]

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
EC10 / LC10 or NOEC for freshwater invertebrates
130 µg/L

Toxicity to aquatic algae and cyanobacteria

Study results
  • 8 studies submitted
  • 4 studies processed
P/RResults
EC50 (72 h) 41 - 400 µg/L [7]
NOEC (72 h) 200 - 410 µg/L [6]

Type of Study provided
Studies with data
Key study 4 2
Supporting study
Weight of evidence
Other 2
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
EC50 for freshwater algae
200 - 400 µg/L
EC10 or NOEC for freshwater algae
200 - 400 µg/L

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

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

Type of Study provided
Studies with data
Key study 2 1
Supporting study
Weight of evidence
Other 1
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 for microorganisms
1 g/L
EC10 or NOEC for microorganisms
1 g/L

Sediment toxicity

Data not provided by the registrant

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

Study results
  • 2 studies submitted
  • 1 study processed
P/RResults
LC50 (14 days) 1 g/kg soil dw [1]
LC50 (7 days) 1 g/kg soil dw [1]

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
Short-term EC50 / LC50
1 g/kg soil dw

Toxicity to terrestrial arthropods

Study results
  • 2 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
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Toxicity to terrestrial plants

Study results
  • 2 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
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Toxicity to soil microorganisms

Study results
  • 2 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
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

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
  • 2 summaries submitted
  • 2 summaries 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) 8.46 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) 2.4 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: No hazard identified
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: No hazard identified
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) 1.17 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
  • 3 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 2
Supporting study
Weight of evidence
Other 1
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
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Bioaccumulation potential:
Low bioaccumulation potential

Acute toxicity

Study results
oral
  • 11 studies submitted
  • 6 studies processed
P/RResults
LD50 2 000 - 5 000 mg/kg bw (rat) [5]
M/CInterpretations of results
Practically nontoxic [1]

Type of Study provided
oral
Studies with data
Key study 5
Supporting study 2
Weight of evidence 3
Other 1
Data waiving
no waivers
inhalation
  • 3 studies submitted
  • 1 study processed
P/RResults
LC50 (4 h) 670 - 12 600 mg/m³ air (rat) [2]
M/CInterpretations of results
Not classified [1]

inhalation
Studies with data
Key study 2
Supporting study
Weight of evidence
Other 1
Data waiving
no waivers
dermal
  • 4 studies submitted
  • 1 study processed
P/RResults
LD50 2 100 mg/kg bw (rat) [1]
M/CInterpretations of results
Not classified [1]

dermal
Studies with data
Key study 3
Supporting study
Weight of evidence
Other 1
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
  • 3 summaries submitted
  • 3 summaries processed
Oral route:
No adverse effect observed LD50 2 000 mg/kg bw
Inhalation route:
No adverse effect observed LC50 670 mg/m³
Dermal route:
No adverse effect observed LD50 2 100 mg/kg bw

Irritation / corrosion

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

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 6
Supporting study 1
Weight of evidence 3
Other 1
Data waiving
no waivers
Study data: eye
  • 11 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 5
Supporting study 2
Weight of evidence 3
Other 1
Data waiving
no waivers
M/C Summaries
  • 3 summaries submitted
  • 3 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
  • 11 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 5
Supporting study 2
Weight of evidence 3
Other 1
Data waiving
no waivers
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
  • 3 summaries submitted
  • 3 summaries processed
Skin sensitisation
No adverse effect observed (not sensitising)
Respiratory sensitisation
No study available

Repeated dose toxicity

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

No automatically processable data submitted

Type of Study provided
Study data: oral
Studies with data
Key study 3
Supporting study 3
Weight of evidence
Other 1
Data waiving
no waivers
Study data: inhalation
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Study data: dermal
Studies with data
Key study
Supporting study
Weight of evidence
Other 1
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route - systemic effects:
No adverse effect observed LOAEL 720 mg/kg bw/day (subchronic, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 18 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 9
Supporting study 4
Weight of evidence 3
Other 2
Data waiving
no waivers
Study data: in vivo
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: in vivo
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 3 summaries 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
  • 2 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
Data waiving
no waivers
Study data: developmental
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 2
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:
No adverse effect observed NOAEL 1 000 mg/kg bw/day (subchronic, rat)
Effect on developmental toxicity
Oral route:
No adverse effect observed NOAEL 1 000 mg/kg bw/day (subchronic, 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