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EC number: 247-832-2 | CAS number: 26591-72-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-methyl-1-vinyl-1H-imidazolium methyl sulphate
- EC Number:
- 247-832-2
- EC Name:
- 3-methyl-1-vinyl-1H-imidazolium methyl sulphate
- Cas Number:
- 26591-72-0
- Molecular formula:
- C6H9N2.CH3O4S
- IUPAC Name:
- 1-ethenyl-3-methyl-1H-imidazol-3-ium methyl sulfate
- Details on test material:
- - Name of test item: 3-Methyl-1-vinyl-1H-imidazolium methyl sulfate
- Test-item No.: 11/0584-1
- Batch identification: 77761968E0
- Purity: Main component: 96.2 g/100g; w (C6H9N2, cation in the main component): 47.3 g/100 g; w (CH3O4S, anion in the main component): 48.9 g/100 g; water: 1.9 g/100 g. Determined by 1H-NMR-spectroscopy
- Homogeneity: The test item was homogeneous by visual inspection.
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Expiry date: August 19, 2013
- Storage conditions: Room temperature
- Physical state/ color: Solid / yellowish
- pH-value: approx. 5 (undiluted test item, determined by Bioassay)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 3 months
- Weight at study initiation: 2.36 kg – 2.60 kg
- Housing: single housing in stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm²
- Enrichment: Wooden gnawing blocks (Typ KNH E-041); Abedd ® Lab. and Vet. Service GmbH Vienna, Austria
- Diet (e.g. ad libitum): STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: negative control: untreated left eye
- Amount / concentration applied:
- Test item preparation: For better handling the test item was ground with mortar and pestle until the test item was liquid.
Application volume: 0.1 mL (undiluted) - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- EXPERIMENTAL PROCEDURE
- Body weight determination: Just before application of the test item and after the last reading.
- Route of application: The test item was applied in a single dose to the conjunctival sac of the right eyelid.
- Rinsing of the eye: About 24 hours after application of the test item the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Readings: Approx. 1, 24, 48 and 72 h after application and after seven days.
- Examination of the eye(s): An additional eye examination was performed 24 h after application with the instillation of a fluorescein solution.
- Illumination used for reading: At the 24 hours reading reactions on cornea or iris were observed using a slit lamp and otoscope lamp.
- Mortality: A check for any dead or moribund animal was made at least once each workday.
SCORING SYSTEM:
The evaluation of eye irritation was performed according to the quoted guidelines. In addition to specific observations recommended by the regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.
Cornea opacity (op): Degree of density (the most dense area is taken for reading)
Grading:
0 No ulceration or opacity
1 slight: Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 moderate: easily discernible translucent area, details of iris slightly obscured
3 marked: nacreous area, no details of iris visible, size of pupil barely discernible
4 severe: opaque cornea, iris not discernible through the opacity
Area of cornea involved (ar) (The assessment of these ocular reactions is performed independent of the quoted guidelines):
Grading
1 > 0 ≤ ¼
2 > ¼ < ½
3 > ½ < ¾
4 > ¾
Area with fluorescein:
Grading
1 > 0 ≤ ¼
2 > ¼ < ½
3 > ½ < ¾
4 > ¾
Iris:
Grading
0 Normal
1 moderate: markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these observations or combination of
any thereof, iris still reacting to light (sluggish reaction is positive)
2 severe: no reaction to light, haemorrhage, gross destruction (any or all of these)
Conjunctivae redness (red) (Refers to palpebral and bulbar conjunctivae, not to cornea and iris):
Grading
0 Blood vessels normal
1 slight: some blood vessels definitely hyperemic (injected)
2 obvious: diffuse, crimson color, individual vessels not easily discernible
3 severe: diffuse beefy red
Chemosis (sw) (Lids and/or nictitating membrane):
Grading
0 No swelling
1 slight: any swelling above normal (includes nictitating membranes)
2 moderate: obvious swelling with partial eversion of lids
3 marked: swelling with lids about half closed
4 severe: swelling with lids more than half closed
Discharge (di)(The assessment of these ocular reactions is performed independent of the quoted guidelines):
Grading
0 No discharge
1 slight: any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 obvious: discharge with moistening of the lids and hairs just adjacent to lids
3 severe: discharge with moistening of the lids and hairs, and considerable area around the eye
Descriptions of any ocular findings not covered by this scale were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and 7 days
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h and 7 days
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 - 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48, 72 h and 7 days
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No corneal opacity was observed in any animal at any examination time point.
Moderate iritis was observed in all animals 1 hour after application only.
Slight conjunctival redness (grade 1) was noted in all animals from 1 hour up to 72 hours after application.
Slight conjunctival chemosis (grade 1) was noted in two animals 1 hour after application, and persisted in one animal until hour 24. In one animal moderate
conjunctival chemosis (grade 2) was noted 1 hour after administration. Furthermore slight or obvious discharge (grade 1 or 2) was observed in all animals 1
hour after application.
Additional findings like injected scleral vessels in a circumscribed or circular area were noted in all animals from hour 1 up to hour 72 at the latest.
The ocular reactions were reversible in all animals within 7 days after application.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 1.0, 1.0 and 1.0 for redness of the conjunctiva and 0.3, 0.0 and 0.0 for chemosis.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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