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EC number: 700-235-5 | CAS number: 174899-82-2
- 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: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12. September 2017 - 04. January 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Guideline No. 439 adopted 28 July 2017
- Deviations:
- yes
- Remarks:
- this deviation is considered as without impact on the concluion of the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Test method B.46 of Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220) - ATP Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220) - ATP Council regulation No. 440/2008 of 30 May 2008 (EU Journal L142)
- Deviations:
- yes
- Remarks:
- this deviation is considerd as without impact on the conclusion of the study
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-ethyl-3-methyl-1H-imidazol-3-ium; trifluoro[(trifluoromethanesulfonylazanidyl)sulfonyl]methane
- EC Number:
- 700-235-5
- Cas Number:
- 174899-82-2
- Molecular formula:
- C8H11F6N3O4S2
- IUPAC Name:
- 1-ethyl-3-methyl-1H-imidazol-3-ium; trifluoro[(trifluoromethanesulfonylazanidyl)sulfonyl]methane
- Test material form:
- liquid
- Details on test material:
- clear liquid, colorless
Constituent 1
- Specific details on test material used for the study:
- Source and lot/batch No.of test material: 25PI208_12; PA204
- Expiration date of the lot/batch: May 2019
- Purity test date: 99,84 wt%
- Storage condition of test material: room temperature, dry place
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: 0,5 cm² reconstructed epidermis of normal human keratinocytes
- Cell source:
- foreskin from a single donor
- Details on test system:
- 0,50 cm² reconstructed epidermis (Episkin SA, RHE/S/17 Batch no. 17-RHE-104)
growth medium (Episkin SA, Batch No. 17 SGM 026)
maintenance medium (Episkin SA, Batch No. 17 SMM 016) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16µL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 16 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 16 µL
- Concentration (if solution): 5% SDS - Duration of treatment / exposure:
- 42 minutes at room temperature, recovered with a nylon mesh provided by Episkin SA
- Number of replicates:
- 3 living human skin models
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 109.1
- Negative controls validity:
- valid
- Remarks:
- Mean viability 100%
- Positive controls validity:
- valid
- Remarks:
- Mean viability 1,8%
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: yes
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
- Range of historical values if different from the ones specified in the test guideline: no
Any other information on results incl. tables
ASSESMENT OF THE SKIN IRRITATION
INDIVIDUAL AND AVERAGE VALUES OF OD AFTER 42 MINUTES EXPOSURE
TEST ITEM: 1 -Ethyl-3 -methylimidazolium bis(trifluoromethylsulfonyl)imide
Application: 16µL of the test item on 0.50 cm² human skin model
Application dates: 03.October 2017
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with the Regulation EC No. 1272/2008, the test item 1-Ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required. - Executive summary:
The aim was to evaluate the possible irritating effects of the test item 1-Ethyl-3 -methylimidazolium bis(trifluoromethylsulfonyl)imide after topical application on in vitro human reconstructed epidermis (SkinEthic RHE model)
The test item 1-Ethyl-3 -methylimidazolium bis(trifluoromethylsulfonyl)imide was applied as supplied, at the dose of 16 µL, to 3 living Reconstructed Human eoidermis (SkinEthic RHE model) during 42 minutes. The application was followed by rinse with 25 mL of DPBS and a 42 hours and 40 minutes post-incubation period at 37°C, 5% CO2.Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. The experimental protocol was established in accordance with OECD Test Guideline No. 439 adopted 28 July 2015 and the Test methode B.46 of Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220) - ATP Council regulation No. 440/2008 of 30 May 2008 (EU Journal L142)
The mean percent viability of the treated tissues was 109.1% (considered as 100 %), versus 1.8% in the positive control (5% Sodium Dodecyl Sulfate)
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