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Diss Factsheets
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EC number: 207-055-1 | CAS number: 429-06-1
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 October - 14 November 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- 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:
- adopted 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Official Journal of the European Union No. L142; Amended by EC No. 640/2012 OJ No. L193, 20 July 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- tetraethylammonium tetrafluoroborate
- Cas Number:
- 429-06-1
- Molecular formula:
- C8H20BF4N
- IUPAC Name:
- tetraethylammonium tetrafluoroborate
- Test material form:
- solid: crystalline
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: adult humanderived epidermal keratinocytes
- Cell source:
- other: the keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum
- Justification for test system used:
- The test item has been tested previously in the Skin corrosion test using EpiDerm as a skin model and was found not corrosive (Study No. 20162875). In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimize the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).
- Vehicle:
- not specified
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: three dimensional epidermal model (EPISKIN Small model (EPISKIN-SMTM)
- Tissue batch number(s): 18-EKIN-040
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: in the dark at 37.0 ± 1.0°C (actual range 36.8 - 37.3°C)
NUMBER OF REPLICATE TISSUES: 3 tissues per test item
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 h
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
PREDICTION MODEL / DECISION CRITERIA
- A test item is considered irritant in the skin irritation test if the relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is ≤ 50% of the mean viability of the negative controls.
- A test item is considered non-irritant in the in vitro skin irritation test if the relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is > 50% of the mean viability of the negative controls. - Amount/concentration applied:
- NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL (Phosphate buffered saline)
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL (Sodium dodecyl sulfate)
- Concentration (if solution):5%
MTT-solution
- Amount(s) applied (volume or weight with unit): 2 mL
- Concentration (if solution): 0.3 mg/mL in PBS - Duration of treatment / exposure:
- 15 ± 0.5 minutes
Test animals
- Details on test animals or test system and environmental conditions:
- ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37.0 ± 1.0°C (actual range 36.8 - 37.3°C)
- Humidity (%): a humid atmosphere of 80 - 100% (actual range 71 - 86%)
- Air changes (per hr): containing 5.0 ± 0.5% CO2 in air
- Photoperiod (hrs dark / hrs light): in the dark
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- negative control
- Run / experiment:
- 15 ± 0.5 minutes treatment
- Value:
- 89
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 89%. The mean relative tissue viability for the test item was above 50% after 15 ± 0.5 minutes treatment.
- The positive control had a mean cell viability of 17% after 15 ± 0.5 minutes exposure.
- The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range.
- The standard deviation value of the percentage viability of three tissues treated identically was ≤ 12% for the negative and positive control, indicating that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tetraethylammonium tetrafluoroborate is non-irritant in the in vitro skin irritation test and should not be classified.
- Executive summary:
The objective of this study was to evaluate Tetraethylammonium tetrafluoroborate for its ability to induce skin irritation on a human three dimensional epidermal model (EPISKIN Small model (EPISKIN-SMTM)). The possible skin irritation potential of the test item was tested through topical application for 15 minutes.
Skin tissue was moistened with 5 µL of Milli-Q water and an excessive amount of the test item was applied directly on top of the skin tissue for 15 ± 0.5 minutes. After a 42 hour postincubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 89%. Since the mean relative tissue viability for the test item was above 50% after 15 ± 0.5 minutes treatment the test item is considered to be non-irritant.
The positive control had a mean cell viability of 17% after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was ≤ 12% for the negative and positive control, indicating that the test system functioned properly.
In conclusion, Tetraethylammonium tetrafluoroborate is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report and should not be classified.
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