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EC number: 605-263-0 | CAS number: 161611-74-1
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25-Oct-2016 to 26-Jan-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD test Guideline No. 431 and EU Method B.40 BIS. Furthermore, functional model conditions and references to historical control data are included in the report.
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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- Adopted July 29, 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UE Method B.40 BIS (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- 605-263-0
- EC Number:
- 605-263-0
- Cas Number:
- 161611-74-1
- Molecular formula:
- C4F6O3
- IUPAC Name:
- 605-263-0
- Test material form:
- liquid
- Details on test material:
- - Physical state: Colourless liquid; odorless
- Storage condition of test material: At room temperature
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Following the REACH bottom-up strategy, the EpiDerm™ Human Skin Model method was used to assess skin corrosion as recommended in the OECD test guideline No. 431.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi-200-Kit, MatTek Corporation (Ashland, MA, USA).
- Lot number: 24940 Kits J and K
- Production Date: no data
- Shipping date: no data
- Delivery date: no data
- Date received: no data
- Date of initiation of testing: December 06, 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 and 60 minutes at 37 °C in a humidified atmosphere of 5% CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: After the exposure period, the tissues were washed with phosphate buffered saline (Invitrogen Corporation, Breda, The Netherlands) to remove residual test item. Rinsed tissues were kept in 24 well plates on 300 μl DMEM medium until 6 tissues (= one application time) were dosed and rinsed.
- Observable damage in the tissue due to washing: none reported
- Modifications to validated SOP: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL MTT solution
- Incubation time: 3 hours at 37 °C, 5% CO2 in air
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
- Filter: without reference filter
- Linear OD range of spectrophotometer: not reported
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD (540-570 nm): 1.744 +/- 0.093 [1.0-3.0]
- Barrier function: ET-50: 5.21 hrs [4.77-8.72 hrs]
- Morphology: 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.
- Contamination: No contamination
NUMBER OF REPLICATE TISSUES: 4 tissues per test item together with a negative control and positive control
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Not needed
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
A test item is considered corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after 3-minute treatment compared to the negative control tissues is decreased below 50%.
b) In addition, a test item considered non-corrosive (viability >= 50%) after the 3-minute treatment is considered corrosive if the relative tissue viability after 1-hour treatment with the test item is decreased below 15%.
A test item is considered non corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%.
b) In addition, the relative tissue viability after the 1-hour treatment is not decreased below 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL of the undiluted test item.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL of Milli-Q water was used as supplied
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL of 8.0 N Potassium Hydroxide was used as supplied - Duration of treatment / exposure:
- 3 and 60 minutes.
- Duration of post-treatment incubation (if applicable):
- not applicable
- Number of replicates:
- 4 tissues per test item together with a negative control and positive control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes exposure
- Value:
- 98
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 7%
- Remarks on result:
- other: No indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes exposure
- Value:
- 46
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 14%
- Remarks on result:
- other: No indication of corrosion
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: Not reported
- Direct-MTT reduction: None
- Colour interference with MTT: None
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
Any other information on results incl. tables
Table 7.3.1/1: Mean absorption in the in vitro skin corrosion test with Perfluoro methoxy dioxole
3 -minute application | 1 -hour application | |||||||||
A (OD570) | B (OD570) | Mean (OD570) |
SD | A (OD570) | B (OD570) | Mean (OD570) | SD | |||
Negative control | 1.698 | 1.618 | 1.658 | +/- | 0.056 | 1.440 | 1.371 | 1.406 | +/- | 0.049 |
Test item | 1.719 | 1.531 | 1.625 | +/- | 0.133 | 0.678 | 0.608 | 0.643 | +/- | 0.049 |
Positive control | 0.125 | 0.114 | 0.120 | +/- | 0.008 | 0.234 | 0.170 | 0.202 | +/- | 0.046 |
OD = Optical Density
SD = Standard Deviation
Duplicate exposures are indicated by A and B.
In this table the values are corrected for background absorption (0.0424). Isopropanol was used to measure the background absorption.
Table 7.3.1/2: Mean tissue viability in the in vitro skin corrosion test with Perfluoro methoxy dioxole
3-minute application viability (percentage of control) |
1-hour application viability (percentage of control) |
|
Negative control | 100 (4.7) | 100 (4.8) |
Test item | 98 (11) | 46 (10) |
Positive control | 7 (9.0) | 14 (28) |
( ): Coefficient of variation between tissue replicates
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, Perfluoro methoxy dioxole is not corrosive to skin.
- Executive summary:
An in vitro skin corrosion study was performed according to the most recent OECD Guideline 431, EU Method B.40 BIS and in compliance with GLP, using the EpiDerm™ Human Skin Model.
The test item was applied undiluted (50 μl for 3 minutes exposure and an excess amount for the 1-hour exposure) directly on top of the skin tissue. Since the test item was volatile, an excess amount of the test item was applied every 15 minutes for the 1-hour exposure.
The positive control had a mean relative tissue viability of 14% after the 1-hour exposure. This is within the acceptability range for the positive control (<15%). 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 (1.324 – 2.615 for 3 minute exposure and 1.361 – 2.352 for 1 hour exposure). In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was =< 11%, indicating that the test system functioned properly (acceptability value:≤30%).
The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 98% and 46%, respectively. Because the mean relative tissue viability for Perfluoro methoxy dioxole was not below 50% compared to control after the 3-minute treatment and not below 15% after the 1-hour treatment Perfluoro methoxy dioxole is considered to be not corrosive.
Finally, it is concluded that this test is valid and that Perfluoro methoxy dioxole is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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