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EC number: 682-238-0 | CAS number: 1190931-27-1
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-03-19 until 2009-06-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM international validation study on in vitro tests for acute skin irritation: Report on the validity of the EPlSKlN and EpiDerm assays and on the Skin Integrity Function Test (Altern Lab Anim. 2007 Dec; 35 (6): 559-601).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission: Institute for Health an Consumer Protection and European Centre for the Validation of Alternative Methods (ECVAM): Statement on the validity of in-vitm tests for skin irritation (2007).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Human Skin Model Test, December 2007.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz
Test material
- Reference substance name:
- cC6O4 ammonium salt
- IUPAC Name:
- cC6O4 ammonium salt
- Reference substance name:
- Acetic acid, 2,2-difluoro-2-[[2,2,4,5- tetrafluoro-5-(trifluoromethoxy)-1,3- dioxolan-4-yl]oxy]-, ammonium salt (1:1)
- IUPAC Name:
- Acetic acid, 2,2-difluoro-2-[[2,2,4,5- tetrafluoro-5-(trifluoromethoxy)-1,3- dioxolan-4-yl]oxy]-, ammonium salt (1:1)
- Reference substance name:
- ammonium 2,2-difluoro-2-{[2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetate
- EC Number:
- 682-238-0
- Cas Number:
- 1190931-27-1
- Molecular formula:
- C6H4F9NO6
- IUPAC Name:
- ammonium 2,2-difluoro-2-{[2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetate
- Details on test material:
- - Name of test material (as cited in study report): cC6O4
- Substance type: pure substance
- Physical state: solid
- Analytical purity: 96.2%
- Impurities (identity and concentrations): NH4F=0.021% (w/w), NH4Cl=0.31% (w/w), H2O=0.328% (w/w), the organic impurities are dioxolan based and represent the 0.8% by mol on total mol of organic phase of sample
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: 150/31
- Expiration date of the lot/batch: 31 December 2020
- Stability under test conditions: Stable in water and saline at room temperature for days
- Storage condition of test material: at room temperature
Constituent 1
Constituent 2
Constituent 3
In vitro test system
- Test system:
- human skin model
- Remarks:
- EPISKIN kits
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- water
- Remarks:
- deionised water
- Details on test system:
- CELL CULTURE FOR IN VITRO TEST:
EPISKIN kits are purchased from Skinethic Laboratories (06000 Nice, France).
The EPISKIN tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EPISKIN tissues (surface 0.38 cm²) are cultured on specially prepared cell culture inserts.
EPISKIN tissues were shipped at ambient temperature on medium-supplemented agarose gels in a 12-well plate and reached Harlan CCR on April 08, 2009. On day of receipt EPISKIN tissues were transferred to 12-well plates with maintenance medium.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 15 mg of the test item were applied to each tissue and wetted with 15 μL deionised water
- Concentration (if solution): 1000 g/l
VEHICLE
- Amount(s) applied (volume or weight with unit): 15 μL deionised water
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1°C, 5 ± 0.5% CO2
- Temperature of post-treatment incubation (if applicable):
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps:
- Observable damage in the tissue due to washing:
- Modifications to validated SOP:
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Wavelength:
- Filter:
- Filter bandwidth:
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: triplicate tissues
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if [complete, e.g. if the mean TER value is less than or equal to 5 kΩ and the skin disk is obviously damaged, or if the mean TER value is less than or equal to 5 kΩ, and the skin disc is showing no obvious damage, but the mean disc dye content is greater than or equal to the mean disc dye content of the 10M HCl positive control obtained concurrently.]
- The test substance is considered to be non-corrosive to skin if [complete, e.g. if the mean TER value obtained for the test substance is greater than 5 kΩ, or if the mean TER value is less than or equal to 5 kΩ, and the skin disc is showing no obvious damage, and the mean disc dye content is well below the mean disc dye content of the 10M HCl positive control obtained concurrently.]
- Justification for the selection of the cut-off point(s) if different than recommended in TG 430: - Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
Test system
- Duration of treatment / exposure:
- 15 +/- 1 min direct exposure of the cell culture to the test item (after this 42 hours incubation)
- Observation period:
- not applicable, direct readings of the assay results
- Number of animals:
- No animals used. Three tissues were used, from each two replicate wells were tested per test substance concentration and controls.
- Details on study design:
- not applicable
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: Relative absorbance (% of negative control)
- Value:
- 49.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- (3% of control)
- Remarks on result:
- other:
- Remarks:
- Basis: mean tissue 1, 2, and 3. Time point: 15 min exposure. Max. score: 62.83. Reversibility: not assessed.
- Other effects / acceptance of results:
- The relative absorbance in % of negative control is used for quantifying the potential skin irritating effect of the tested substances. After treatment with the test item cC6O4 the relative absorbance values were decreased to 49.2%. This value is slightly below the threshold for irritancy of ≤ 50%
Any other information on results incl. tables
Table 1: Results after treatment with cC604
Dose group | Treatment Interval | Absorbance 570 nm Tissue 1* | Absorbance 570 nm Tissue 2* | Absorbance 570 nm Tissue 3* | Mean Absorbance of 3 Tissues | Rel. Absorbance [% of Negative Control]** |
Negative Control | 15 min | 0.8993 | 0.8653 | 0.7961 | 0.8536 | 100 |
Positive Control | 15 min | 0.0371 | 0.0247 | 0.0156 | 0.0258 | 3.0 |
cC6O4 | 15 min | 0.3922 | 0.3656 | 0.5016 | 0.4198 | 49.2 |
* Mean of two replicate wells after blank correction
** relative absorbance [rounded values]: (absorbance ) 100 x (absorbance test item) / (absorbance negative control)
Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- As a conclusion for this in-vitro study it can be stated that under the experimental conditions reported, the test item cC6O4 ammonium salt is irritant to skin. The in-vivo prediction would be an EU classification as Xi; R38, and a CLP classification as H315, Skin. irrit. 2.
- Executive summary:
This in vitro study was performed to assess the irritation potential of cC6O4 ammonium salt by means of the Human Skin Model Test.
Three tissues of the human skin model EPISKIN were treated with either the test item, the negative or the positive control for 15 minutes. 15 mg of the test item were applied to each tissue and wetted with 15 μL deionised water. 15 μL of either the negative control (deionised water) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue. After treatment with the negative control the absorbance values were well above the required acceptability criterion of mean OD ≥ 0.6 for the 15 minutes treatment interval thus showing the quality of the tissues.
Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 3.0% thus ensuring the validity of the test system. After treatment with the test item cC6O4 ammonium salt the relative absorbance values were decreased to 49.2%. This value is slightly below the threshold for irritancy of ≤ 50%. Therefore, the test item is considered to possess an irritant potential.
Note: For the current test, an irritation potential of a test item according to EU CLP classification, skin irrit. 2, H315 is predicted if the mean relative tissue viability of three individual tissues is reduced below 50% of the negative control.
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