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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was already available and conducted before LLNA was chosen as prefered test system.
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 the test substance used in the study report: 3-Methyl-l-vinylimidazolium methosulfat
Degree of purity / content: 46.4 g/100 g in water, regarded as 100 % substance preparation
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH
- Age at study initiation: young adult animals
- Weight at study initiation: 326 - 378 g
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- epicutaneous induction: not further diluted => 46.4 %
intradermal induction: 5 % => 2.32 %
epicutaneous challenge: 75% => 34.8 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- epicutaneous induction: not further diluted => 46.4 %
intradermal induction: 5 % => 2.32 %
epicutaneous challenge: 75% => 34.8 %
- No. of animals per dose:
- 10 (test group)
5 (control group 1) + 5 (control group 2) - Details on study design:
- RANGE FINDING TESTS:
The concentrations of the test substance suitable for use in the main experiment were determined in a pretest.
Two 24-hour percutaneous occlusive applications were performed within 96 hours. The minimum irritant
concentration was found to be the undiluted test substance (=> 46.4 % in water). The maximum non-irritant concentration was
found to be a 75 % test substance preparation in aqua bidest (=> 34.8 % in water).
Applicability: it was possible to inject a 5 % test substance preparation in 0 .9 % aqueous NaCl-solution resp . in Freund's adjuvant / 0 .9 % aqueous NaClsolution (1 : 1) with a syringe (=> 2.32 %).
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal induction :
- 6 intradermal injections in groups of two per animal
Injections for the test group:
A) front row : 2 injections each of 0 .1 ml Freund's adjuvant without test substance emulsified with 0 .9 % aqueous NaCl-solution in a ratio of 1 : 1
B) middle row : 2 injections each of 0 .1 ml of the test substance formulation
C) back row : 2 injections each of 0 .1 ml Freund's adjuvant/ 0 .9 % aqueous NaCl-solution (1 : 1) with test substance
Injections for control groups 1 and 2:
- The animals were given the same injections (A, B,C) but without test substance, only with the formulating agent.
Site of application :
- shoulder
Readings :
- 24 h after the beginning of application
Assessment of the skin findings :
- analogous to the pretest
Percutaneous induction :
- Percutaneous induction was carried out one week after intradermal induction.
Amount applied :
2 x 4 cm filter paper strips containing the test substance were applied to the skin of the shoulder under an occlusive dressing . The filter paper strip was soaked in the test substance. The dressing consisted of rubberized linen patches (4 x 6 cm from Russka) and Fixomull Stretch (adhesive fleece) from Beiersdorf AG.
The control groups were not treated, since the test substance was applied undiluted and thus no solvent was used.
Duration of exposure :
- 48 hours
Site of application :
- shoulder, same area as in the case of the previous intradermal application
Readings:
- 48 h after the beginning of application
Assessment of skin findings:
- analogous to the pretest
B. CHALLENGE EXPOSURE
The challenge was performed 14 days after the percutaneous induction.
Amount applied :
2 x 2 cm filter paper strips containing the test substance formulation were applied to the skin of the
flank under an occlusive dressing. The filter paper strip was soaked in the test substance formulation.
The dressing consisted of rubberized linen patches
(4 x 4 cm from Russka), patches of Idealbinde (5 x 5 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull Stretch (adhesive fleece) from Beiersdorf
A.G .
- The test group and control group 1 were treated with the test substance formulation (control group 2 remained untreated) .
Duration of exposure :
- 24 hours
Site of application :
- intact flank
Readings :
- 24 and 48 h after the removal of the patch
Assessment of skin findings :
- analogous to the pretest - Positive control substance(s):
- yes
- Remarks:
- Alpha-Hexylcinnamaldehyde techn . 85%
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% => 34.8 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75% => 34.8 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group 1
- Dose level:
- control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- one animal died due to pneumonia
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group 1. Dose level: control. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: one animal died due to pneumonia.
Any other information on results incl. tables
Induction
After the intradermal induction well-defined erythema and slight edema were observed at the injection sites
of all control group animals and all test group animals, at which only Freund's adjuvant / 0 .9% aqueous
NaCl-solution (1 : 1) was applied . Injections of 5% test substance preparations in 0 .9% aqueous NaClsolution
or in Freund's adjuvant / 0 .9% aqueous NaClsolution (1 : 1) caused well-defined erythema and slight edema in all test group animals. The injection sites of all control group animals, at which 0 .9% aqueous NaCl-solution was applied, did not show any
skin reactions.
After the percutaneous induction with the undiluted test substance (=> 46.4 %) incrustation, partially open (caused
by the intradermal induction) could be observed in addition to well-defined .erythema and slight edema in
all test group animals.
Challenge
The challenge with a 75% (=> 34.8 %) test substance preparation did not cause any skin reactions, neither in control
group 1 nor in the test group 24 and 48 hours after removal of the patches.
Since no borderline results were observed, a 2nd challenge was not performed.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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