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EC number: 604-439-4 | CAS number: 144728-59-6
- 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:
- From 25-August-2016 to 18-January-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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:
- Amended by Commission Regulation (EU) No 640/2012 of 06 July 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspection dates: 02-04 June 2015 / Date of the certificate: 22 September 2015
Test material
- Reference substance name:
- 2-(1,2-dichloro-1,2,2-trifluoroethoxy)-1,1,2,2-tetrafluoroethane-1-sulfonyl fluoride
- EC Number:
- 604-439-4
- Cas Number:
- 144728-59-6
- Molecular formula:
- C4Cl2F8O3S
- IUPAC Name:
- 2-(1,2-dichloro-1,2,2-trifluoroethoxy)-1,1,2,2-tetrafluoroethane-1-sulfonyl fluoride
- Test material form:
- liquid
- Details on test material:
- See confidential details on test material
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL:
- Purity: 99.1%
- Appearance: Colourless liquid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL:
- Controlled room temperature (15-25°C, below 70 RH%)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The EPISKIN (SM) model has been validated for irritation testing in an international validation study and its use is recommended by the relevant OECD guideline for irritation testing (OECD No. 439); therefore, it was considered to be suitable for this study.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2)
- Tissue batch number(s): 16-EKIN-035
- Source: SkinEthic Laboratories, Lyon, France
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: All incubations, with the exception of the test item incubation of 15 minutes at room temperature, were carried out at 37.0 °C
- Temperature of post-treatment incubation: 37.0 °C
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 hours (± 5 min) at 37°C in an incubator with 5% CO2, in a >95% humidified atmosphere, protected from light
- Spectrophotometer: Not specified
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: IC50 = 1.8 mg/mL [1.5 mg/mL =< IC50 =< 3 mg/mL]
- Barrier function: Histology scoring: 22.5 +/- 0.4 (CV= 2.0%) [>= 19.5]
- Morphology: Well-differentiated epidermis consisting of a basal layer, several spinous and granular layers and a thick stratum corneum = satisfactory
- Contamination: EPISKINTM (SM) kits are manufactured according to defined quality assurance procedures (certified ISO 9001). All biological components of the epidermis and the kit culture medium have been tested for the presence of viruses, bacteria and mycoplasma.
- Reproducibility:
- Histology: probability 0.95 that 100% of the batch > 20
- IC50: probability 0.95 that IC50 >= 1.8 mg/mL (threshold value)
NUMBER OF REPLICATE TISSUES: 3 tissues per test item together with negative and positive controls
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the relative mean tissue viability of three individual tissues after 15 minutes of exposure and 42 hours post incubation is less than or equal to 50% of the mean viability of the negative controls.
- The test substance is considered to be non-irritant to skin if the relative mean tissue viability of three individual tissues after 15 minutes of exposure and 42 hours post incubation is greater than 50% of the mean viability of the negative controls. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL
- Concentration: Undiluted test item.
VEHICLE CONTROL
Not relevant.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 5% (w/v) - Duration of treatment / exposure:
- 15 minutes (± 0.5 min) at room temperature (26.3-27.5°C)
- Duration of post-treatment incubation (if applicable):
- 42 hours (± 1h) at 37°C in an incubator with 5% CO2, in a >95% humidified atmosphere
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Mean of the 3 replicates
- Value:
- 94.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100.0%
- Positive controls validity:
- valid
- Remarks:
- 4.0%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- The mean OD value of the three negative control tissues should be between 0.6 and 1.5, and the standard deviation value (SD) of the % viability values should be ≤ 18.
- The acceptable mean percentage viability range for positive controls is 0-40% and the standard deviation value (SD) of the % viability values should be ≤ 18.
- The SD calculated from individual % tissue viability values of the three test item treated replicates should be <18.
- The mean OD value of the blank samples (acidified isopropanol) should be <0.1.
Any other information on results incl. tables
Optical Density(OD) and the calculated relative viability % of the samples
Substance | Optical Density (OD) | Viability (% RV) | ||
Measured | Blank corrected | |||
Negative control: Phosphate Buffered Saline |
1 2 3 |
0.842 0.779 0.787 |
0.795 0.732 0.740 |
105.2 96.9 97.9 |
mean | -- | 0.756 | 100.0 | |
Positive control: 5% (w/v) SDS solution |
1 2 3 |
0.075 0.084 0.070 |
0.029 0.038 0.023 |
3.8 5.0 3.1 |
mean | -- | 0.030 | 4.0 | |
Test item: Fluorosulfonic Adduct |
1 2 3 |
0.761 0.766 0.763 |
0.714 0.719 0.716 |
94.5 95.1 94.8 |
mean | -- | 0.717 | 94.8 |
1. Mean blank value was 0.046.
2. Optical density means the mean value of the duplicate wells for each sample (rounded to three decimal places).
Validity of the test
After receipt, the two indicators of the delivered kit were checked. Based on the observed colours, the epidermis units were in proper conditions.
The mean OD value of the three negative control tissues was in the recommended range (0.756). Standard deviation of the viability results for negative control samples was 4.5.
The positive control treated tissues showed 4.0% viability demonstrating the proper performance of the assay. The standard deviation of the viability results for positive control samples was 1.0.
The standard deviation of viability values of the three test item-treated tissue samples in the MTT assay was 0.3.
The mean OD value of the blank samples (acidified isopropanol) was 0.046.
All these parameters met the acceptability criteria, therefore the study was considered to be valid.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Fluorosulfonic adduct is not irritant in the in vitro skin irritation test (OECD Guideline No. 439, adopted 28 July 2015 and, EU Method B.46, amended 06 July 2012) under the experimental conditions described in this report.
The substance is not classified as irritant to skin according to GHS criteria. - Executive summary:
The assessment of the irritant potential to skin of Fluorosulfonic adduct was carried out, under GLP compliance, using an in vitro skin irritation test based on the guidelines described in: OECD No. 439 (adopted 28 July 2015) and EU Method B.46 (Amended by Commission Regulation (EU) No 640/2012 of 06 July 2012).
Disks of reconstructed human epidermis model. EPISKINTM (SM) (three units) were treated with the test item (10 µL) and incubated for 15 minutes at room temperature. Exposure of the undiluted test item was terminated by rinsing with Phosphate Buffered Saline (PBS). The epidermis units were then incubated at 37°C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in an incubator with 5% CO2 protected from light. The precipitated formazan crystals were then extracted using acidified isopropanol and quantified spectrophotometrically.
Following exposure with Fluorosulfoni Adduct, the mean cell viability was 94.8% compared to the negative control. This is above the threshold of 50%, therefore the test item was considered as being non-irritant to skin. The experiment met the validity criteria, therefore the study was considered to be valid. In conclusion, Fluorosulfonic Adduct is considered to be non-irritant. The substance is not classified as irritant to skin according to GHS criteria.
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