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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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Eye irritation
Administrative data
- Endpoint:
- eye irritation: 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted October 09, 2017
- 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
- Specific details on test material used for the study:
- Test item information
Identification: Tétradécafluorohexane
Appearance: Clear colourless liquid
Batch: 57 A
Purity/Composition: 99.25%
Test item storage: At room temperature protected from light
Stable under storage conditions until: 21 February 2020 (expiry date)
Additional information
Test Facility test item number: 209384/A
Purity/Composition correction factor: No correction factor required
Test item handling: No specific handling conditions required
Stability at higher temperatures: Stable
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Source: Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands),
where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
Transport: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 %µL
- Duration of treatment / exposure:
- 10 +/- 1 minutes
- Duration of post- treatment incubation (in vitro):
- 120 +/- 10 minutes
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. -0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 1.6
- Positive controls validity:
- valid
- Remarks:
- 40
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Value:
- ca. -0.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 1.8
- Positive controls validity:
- valid
- Remarks:
- 16
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- fluorescein retention score
- Value:
- ca. 0.008
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- -0.0016
- Positive controls validity:
- valid
- Remarks:
- 1.625
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. Altough the negative control treated corneas were translucent, all results are within the acceptability range therefore this has no impact on the study result. The mean in vitro irritancy score of the positive control (Ethanol) was 40 and within two standard deviations of the current historical positive control mean (Appendix 3, Table 6). It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
Any other information on results incl. tables
Tétradécafluorohexane was tested neat.
Table 1of Appendix 1summarizes the opacity, permeability and in vitro irritancy scores of Tétradécafluorohexane and the controls. The opacity, permeability and in vitro scores of the individual corneas are shown in Table 2- 5.
The individual in vitro irritancy scores for the negative controls ranged from 0.8 to 2.7. The corneas treated with the negative control item were translucent after the 10 minutes of treatment. All values were within the historical control database. The individual positive control in vitro irritancy scores ranged from 31 to 48 (Appendix 2,Table 5). The corneas treated with the positive control item were turbid after the 10 minutes of treatment.
The corneas treated with Tétradécafluorohexane showed opacity values ranging from -0.9 to
-0.5 and permeability values ranging from 0.006 to 0.011. The corneas were translucent after the 10 minutes of treatment with Tétradécafluorohexane. No pH effect of the test item was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from -0.7 to -0.4 after 10 minutes of treatment with Tétradécafluorohexane.
Table 1
Summary of Opacity, Permeability and In Vitro Scores
Treatment |
Mean Opacity1 |
Mean Permeability1 |
Mean In vitro Irritation Score1, 2 |
Negative control |
1.8 |
-0.016 |
1.6 |
Positive control (Ethanol) |
16 |
1.625 |
40 |
Test item |
-0.7 |
0.008 |
-0.5 |
1 Calculated using the negative control mean opacity and mean permeability values for the positive control and test item.
2 In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
Individual Opacity, Permeability and in vitro Score
Table 2 Opacity Score
Treatment |
Opacity before treatment |
Opacity after treatment |
Final Opacity1 |
Negative control corrected Final Opacity2 |
Mean Final Opacity |
|
|
||||||
Negative control |
4.7 |
6.2 |
1.4 |
|
1.8 |
|
4.5 |
5.5 |
1.0 |
||||
3.9 |
6.8 |
2.9 |
||||
|
||||||
Positive control |
2.0 |
18.3 |
16.3 |
14 |
16 |
|
3.5 |
20.8 |
17.4 |
16 |
|||
4.4 |
23.3 |
18.9 |
17 |
|||
|
||||||
Test item |
3.7 |
4.8 |
1.2 |
-0.6 |
-0.7 |
|
3.9 |
5.2 |
1.3 |
-0.5 |
|||
4.4 |
5.3 |
0.9 |
-0.9 |
Calculations are made without rounding off.
1Final Opacity = Opacity after treatment – Opacity before treatment.
2Negative control corrected Final Opacity = Final opacity – Mean final opacity negative control.
Table 3
Permeability Score Individual Values (Uncorrected)
Treatment |
Dilutionfactor |
OD490 1 |
OD490 2 |
OD490 3 |
Average OD |
Final OD |
Mean final negative control |
|
|||||||
Negative control |
1 |
-0.017 |
-0.017 |
-0.017 |
-0.017 |
-0.017 |
-0.016 |
1 |
-0.016 |
-0.016 |
-0.016 |
-0.016 |
-0.016 |
||
1 |
-0.016 |
-0.016 |
-0.016 |
-0.016 |
-0.016 |
||
|
|
||||||
Positive control |
6 |
0.272 |
0.276 |
0.277 |
0.275 |
1.650 |
|
6 |
0.349 |
0.345 |
0.342 |
0.345 |
2.072 |
||
1 |
0.931 |
0.943 |
0.945 |
0.940 |
0.940 |
||
|
|||||||
Test item |
1 |
-0.010 |
-0.010 |
-0.011 |
-0.010 |
-0.010 |
|
1 |
-0.009 |
-0.010 |
-0.011 |
-0.010 |
-0.010 |
||
1 |
-0.010 |
-0.008 |
0,001 |
-0.009 |
-0.009 |
Calculations are made without rounding off.
Table 4
Permeability Score Individual Values (Corrected)
Treatment |
Dilution factor |
Negative control correctedOD49011 |
Negative control correctedOD49021 |
Negative control correctedOD49031 |
Negative control correctedOD490 Average |
Negative control corrected final OD490 |
Average OD |
|
|||||||
Positive control |
6 |
0.288 |
0.292 |
0.293 |
0.291 |
1.748 |
1.625 |
6 |
0.365 |
0.361 |
0.358 |
0.362 |
2.170 |
||
1 |
0.947 |
0.959 |
0.961 |
0.956 |
0.956 |
||
|
|||||||
Test item |
1 |
0.006 |
0.006 |
0.005 |
0.006 |
0.006 |
0.008 |
1 |
0.007 |
0.006 |
0.005 |
0.006 |
0.006 |
||
1 |
0.006 |
0.008 |
0.017 |
0.011 |
0.011 |
Calculations are made without rounding off.
1OD490values corrected for the mean final negative control permeability (-0.016).
Table 5
In Vitro Irritancy Score
Treatment |
Final Opacity2 |
Final OD 2 490 |
In vitro Irritancy Score1 |
|
|||
Negative control |
1.4 |
-0.017 |
1.2 |
1.0 |
-0.016 |
0.8 |
|
2.9 |
-0.016 |
2.7 |
|
|
|||
Positive control |
14 |
1.748 |
41 |
16 |
2.170 |
48 |
|
17 |
0.956 |
31 |
|
|
|||
Test item |
-0.6 |
0.006 |
-0.5 |
-0.5 |
0.006 |
-0.4 |
|
-0.9 |
0.011 |
-0.7 |
1 In vitro irritancy score (IVIS) = opacity value + (15 x OD490value).
2 Positive control and test item are corrected for the negativecontrol.
Table 6
Historical Control Data for the BCOP Studies
|
Negative control |
Positive control |
||
Opacity |
Permeability |
In vitro Irritancy Score |
In vitro Irritancy Score |
|
Range |
-2.9 – 3.0 |
-0.034 – 0.100 |
-2.8 – 3.0 |
28.0 – 110.9 |
Mean |
0.25 |
0.00 |
0.31 |
55.03 |
SD |
1.13 |
0.01 |
1.19 |
15.08 |
n |
118 |
118 |
118 |
94 |
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 May 2015 to May 2018.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, since Tétradécafluorohexane induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
- Executive summary:
The objective of this study was to evaluate the eye hazard potential of Tétradécafluorohexane as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea using the Bovine Corneal Opacity and Permeability test (BCOP test).
This report describes the potency of chemicals to induce serious eye damage using isolated bovine corneas. The eye damage of Tétradécafluorohexane was tested through topical application for 10 minutes.
The study procedures described in this report were based on the most recent OECD guideline. Batch 57 A of Tétradécafluorohexane was a clear colorless liquid with a purity of 99.25%.
The test item was applied as it is (750 µL) directly on top of the corneas.
The negative control responses for opacity and permeability were less than the upper limitsof the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 40 and was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
Tétradécafluorohexane did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.5 after 10 minutes of treatment.
In conclusion, since Tétradécafluorohexane induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
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