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EC number: 680-002-1 | CAS number: 145022-44-2
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- 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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 761/2009
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-ethyl-3-methyl-1H-imidazol-3-ium trifluoromethanesulfonate
- EC Number:
- 680-002-1
- Cas Number:
- 145022-44-2
- Molecular formula:
- C6 H11 N2. C F3 O3 S
- IUPAC Name:
- 1-ethyl-3-methyl-1H-imidazol-3-ium trifluoromethanesulfonate
- Details on test material:
- - Name of the test substance used in the study report: EMIM Triflat
- Test-substance No.: 09/0070-2
- pH-value: ca. 5 (undiluted test substance)
- Physical state: Liquid
- Analytical purity: The test substance has been characterized by analyses
- Lot/batch No.: Los-Nr. 0000000001
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this
responsibility
Constituent 1
Test animals
- Species:
- other: three dimensional human epidermis model
- Strain:
- other: in vitro testing
Test system
- Type of coverage:
- other: in vitro testing
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Single topical application of 50 uL (corrosion test) or 30 uL (irritation test)
- Duration of treatment / exposure:
- Corrosion Test:3 minutes
Irritation test: 1 hour - Number of animals:
- Two EpiDerm tissue samples per application time (corrosion test)
Three EpiDerm tissue samples (irritation test) - Details on study design:
- The present test is based on the experience that corrosive and irritant chemicals produce cytotoxicity in human reconstructed epidermis after a short term topical exposure. The test is designed to predict a skin corrosion or irritation potential of a chemical by using the three dimensional human epidermis model EpiDerm. After application of the test material to the stratum corneum surface of the EpiDerm tissue the induced cytotoxicity (= loss of viability) is measured by a colorimetric assay. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity. The mitochondrial dehydrogenase reduces the yellow colored water-soluble 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) to the insoluble blue colored formazan. After isopropanol-extraction of the formazan from the tissues, the optical density of the extract is determined spectrophotometrically. Optical density of the extracts of test-substance treated tissues is compared to negative control values from tissues and expressed as relative tissue viability.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: viability compared to control
- Basis:
- mean
- Remarks:
- (of corrossion test)
- Time point:
- other: 3 min
- Score:
- 77
- Remarks on result:
- other: Negative control set to 100%
- Irritation parameter:
- other: viability compared to control
- Basis:
- mean
- Remarks:
- (of corrosion test)
- Time point:
- other: 1 hour
- Score:
- 94
- Remarks on result:
- other: Negative control set to 100%
- Irritation parameter:
- other: viability compared to control
- Basis:
- mean
- Remarks:
- (of irritation tes)
- Score:
- 101
- Remarks on result:
- other: Negative control set to 100 %
- Irritant / corrosive response data:
- The test substance is not able to reduce MTT directly.
Corrosion test: The mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 77%, and it was 94% after an exposure period of 1 hour.
Irritation test: The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 101%.
Any other information on results incl. tables
Corrosion test
|
Exposure: 3 min |
Exposure: 1hour |
|||||
Test substance |
|
Tissue 1 |
Tissue 2 |
mean |
Tissue 1 |
Tissue 2 |
mean |
NC |
mean OD570 |
1.989 |
2.035 |
2.012 |
2.124 |
2.041 |
2.082 |
Viability [% of NC] |
96.8 |
101.2 |
100 |
102.0 |
98.0 |
100 |
|
09/0070 -2 |
mean OD570 |
1.520 |
1.587 |
1.553 |
2.013 |
1.898 |
1.955 |
Viability [% of NC] |
75.5 |
78.9 |
77 |
96.7 |
91.2 |
94 |
|
PC |
mean OD570 |
0.358 |
0.249 |
0.303 |
0.072 |
0.099 |
0.085 |
Viability [% of NC] |
17.8 |
12.4 |
15 |
3.4 |
4.7 |
4 |
Irritation test
Test substance |
|
Tissue 1 |
Tissue 2 |
Tissue 3 |
Mean |
SD |
NC |
mean OD570 |
1.831 |
2.369 |
2.220 |
2.140 |
|
Viability [% of NC] |
85.6 |
110.7 |
103.7 |
100 |
12.97 |
|
09/0070 -2 |
mean OD570 |
1.985 |
2.301 |
2.181 |
2.156 |
|
Viability [% of NC] |
92.8 |
107.5 |
101.9 |
101 |
7.45 |
|
PC |
mean OD570 |
0.064 |
0.067 |
0.059 |
0.064 |
|
Viability [% of NC] |
3.0 |
3.1 |
2.8 |
3 |
0.18 |
Applicant's summary and conclusion
- Conclusions:
- Based on the observed results it was concluded, that EMIM Triflat does not show a skin irritation potential in the EpiDerm skin corrosion/irritation test under the test conditions chosen.
- Executive summary:
The potential of EMIM Triflat to cause dermal corrosion/irritation was assessed by a single topical application of 50 μL (corrosion test) or 30 μL (irritation test) of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™).
For the corrosion test two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was performed with three EpiDerm™ tissue samples, which were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The EpiDerm™ skin corrosion/irritation test showed the following results:
The test substance is not able to reduce MTT directly.
Corrosion test:
The mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 77%, and it was 94% after an exposure period of 1 hour.
Irritation test:
The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 101%.
Based on the observed results and applying the evaluation criteria it was concluded, that EMIM Triflat does not show a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.
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