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EC number: 206-585-0 | CAS number: 355-42-0
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tetradecafluorohexane
- EC Number:
- 206-585-0
- EC Name:
- Tetradecafluorohexane
- Cas Number:
- 355-42-0
- Molecular formula:
- C6F14
- IUPAC Name:
- tetradecafluorohexane
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Test system
EpiDerm Skin Model (EPI-200, Lot no.: 28356, kit A, Appendix 4).
The model 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 EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.
Rationale
Recommended test system in international guidelines (OECD and EC). Source
MatTek Corporation, Ashland MA, U.S.A. - Amount/concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 3 minutes & 1 hour
- Number of replicates:
- 2 x 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 minutes
- Value:
- ca. 97
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100
- Positive controls validity:
- valid
- Remarks:
- 11
- Remarks on result:
- other: No indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 95
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100
- Positive controls validity:
- valid
- Remarks:
- 5.6
- Remarks on result:
- other: No indication of corrosion
- Other effects / acceptance of results:
- Tétradécafluorohexane was checked for color interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Because the solutions did not turn blue / purple nor a blue / purple precipitate was observed it was concluded that the test item did not interfere with the MTT endpoint.
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit <2.8) and the laboratory historical control data range (See Appendix 3). The mean relative tissue viability following the 1-hour exposure to the positive control was 5.6%.
In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was
< 17%, indicating that the test system functioned properly (Appendix 1, Table 3).
Any other information on results incl. tables
Table 1
Mean Absorption in the in vitro Skin Corrosion Test with Tétradécafluorohexane
|
A(OD570) |
3-minute application B(OD570) Mean (OD570) |
SD |
1-hour application A (OD570) B(OD570) Mean (OD570) |
SD |
|||||
Negative control |
1.609 |
1.929 |
1.769 |
± |
0.227 |
1.838 |
1.843 |
1.841 |
± |
0.003 |
Tétradécafluorohexane |
1.774 |
1.656 |
1.715 |
± |
0.084 |
1.831 |
1.650 |
1.741 |
± |
0.129 |
Positive control |
0.247 |
0.131 |
0.189 |
± |
0.082 |
0.089 |
0.115 |
0.102 |
± |
0.018 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
In this table the values are corrected for background absorption (0.0423). Isopropanol was used to measure the background absorption.
Table 2
Mean Tissue Viability in the in vitro Skin Corrosion Test with Tétradécafluorohexane
|
3-minute application viability (percentage of control) |
1-hour application viability (percentage of control) |
Negative control |
100 |
100 |
Tétradécafluorohexane |
97 |
95 |
Positive control |
11 |
5.6 |
Table 3
Coefficient of Variation between Tissue Replicates
|
3 minute |
1 hour |
Negative control |
17 |
0.3 |
Tétradécafluorohexane |
6.7 |
9.9 |
Positive control |
47 |
22 |
CV (%) = 100 - [(lowest OD570/highest OD570) x 100%]
Individual OD Measurements at 570 nm
|
3-minute application(OD570) A B |
1-hour application(OD570) A B |
||
Negative control OD570 measurement 1 |
1.6578 |
1.9712 |
1.8766 |
1.9152 |
OD570 measurement 2 |
1.6490 |
1.9674 |
1.8973 |
1.8840 |
OD570 measurement 3 |
1.6464 |
1.9758 |
1.8675 |
1.8570 |
Test itemOD570 measurement1 |
1.8177 |
1.6722 |
1.9150 |
1.7002 |
OD570 measurement 2 |
1.8213 |
1.6912 |
1.8495 |
1.6773 |
OD570 measurement 3 |
1.8107 |
1.7306 |
1.8568 |
1.6985 |
Positive control OD570 measurement 1 |
0.2894 |
0.1751 |
0.1334 |
0.1601 |
OD570 measurement 2 |
0.2863 |
0.1716 |
0.1327 |
0.1559 |
OD570 measurement 3 |
0.2915 |
0.1722 |
0.1288 |
0.1567 |
OD = Optical density
Duplicate exposures are indicated by A and B.
Historical Control Data for in vitro Skin Corrosion Studies
|
Negative control |
Positive control |
||
3-minutetreatment (OD570) |
1-hourtreatment (OD570) |
3-minutetreatment (OD570) |
1-hourtreatment (OD570) |
|
Range |
1.258 – 2.615 |
1.371 – 2.371 |
0.0172 – 0.56 |
0.046 – 0.339 |
Mean |
1.80 |
1.82 |
0.19 |
0.14 |
SD |
0.26 |
0.22 |
0.09 |
0.05 |
n |
111 |
110 |
106 |
103 |
SD = Standard deviation
n = Number of observations
The above mentioned historical control data range of the controls were obtained by collecting all data over the period of November 2014 to November 2017.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tétradécafluorohexane is not corrosive in the in vitro skin corrosion test under the experimental conditions described in the report.
- Executive summary:
The objective of this study was to evaluate Tétradécafluorohexane for its ability to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of Tétradécafluorohexane was tested through topical application for 3 minutes and 1 hour.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch 57 A of Tétradécafluorohexane was a clear colourless liquid. Tétradécafluorohexane was applied undiluted (50 µL) directly on top of the skin tissue.
The positive control had a mean relative tissue viability of 5.6% after the 1-hour exposure.The absolute mean OD570(optical density at 570 nm) of the negative control tissues waswithin the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upperacceptance limit£2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was£17%, indicating that the test system functioned properly.
Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with Tétradécafluorohexane compared to the negative control tissues was 97% and 95%, respectively. Because the mean relative tissue viability for Tétradécafluorohexane was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment Tétradécafluorohexane is considered to be not corrosive.
In conclusion, Tétradécafluorohexane is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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