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EC number: 246-791-8 | CAS number: 25291-17-2
- 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:
- 03 Feb - 10 Mar 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted Jul 2015
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooct-1-ene
- EC Number:
- 246-791-8
- EC Name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooct-1-ene
- Cas Number:
- 25291-17-2
- Molecular formula:
- C8H3F13
- IUPAC Name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooct-1-ene
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: LabCyte EPI-MODEL24 SIT
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: LabCyte EPI-MODEL24 SIT (Japan Tissue Engineering Co., Ltd.)
- Tissue batch number(s): LCE24-170206-A
- Delivery date: 07 Feb 2017
- Expiry date: 10 Feb 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Tissues were rinsed fifteen times or more with PBS (without Mg2+ and Ca2+). Remaining PBS was removed from outside of tissue insert with a sterile cotton swab.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.5 mg/mL
- Incubation time: 180 ± 5 min
- Spectrophotometer: Multimode Microplate Reader (FLUOstar OPTIMA, BMG LABTECH)
- Wavelength: 570 and 650 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the LabCyte EPI-MODEL 24 tissue was assessed by undertaking a MTT cell viability test. The OD was determined to be 1.1 (acceptance criteria 0.8 ≤ OD ≤ 2.5).
- Barrier function: According to the Supplier`s Data Sheet, the IC50 value was determined to be 0.26 (acceptance criteria: 0.14 ≤ IC50 ≤ 0.40).
- Morphology: Observing multilayered epidermis with a stratum corneum according to the Supplier`s Data Sheet.
NUMBER OF REPLICATE TISSUES: Triplicate tissues
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
The test substance did not directly reduce MTT.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability is less than or equal to 50%.
- The test substance is considered to be non-corrosive to skin if the viability is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 µL
NEGATIVE CONTROL
- Amount(s) applied: 25 µL
POSITIVE CONTROL
- Amount(s) applied: 25 µL
- Concentration: 5% (w/v) - Duration of treatment / exposure:
- 15 min ± 30 s (administered in 1 min intervals)
- Duration of post-treatment incubation (if applicable):
- 42 ± 1 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 15 min ± 30 s
- Value:
- 118
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: The test substance did not show a MTT-reducing capacity.
- Tissue-binding test: As a result of tissue-binding test, the staining ratio was -0.2%, thus below 5% and a correction of measurement value was not conducted.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD measured after treatment with the negative control was 0.810, thus in the acceptability range (0.8 ≤ OD ≤ 2.5).
- Acceptance criteria met for positive control: The cell viability was strongly reduced in tissues treated with the positive control. The mean cell viability was 2.7%.
- Acceptance criteria met for variability between replicate measurements: The standard deviations of the cell viabilities in the negative control, positive control and test substance group were 10.8, 0.1 and 1.8%, respectively, and within the acceptability range for the variability (SD ≤ 18.0) according to OECD TG 439.
Any other information on results incl. tables
Table 1: Summary of Results
Group | Tissue Number | OD | Mean OD | Cell Viability (%) | Mean Cell Viability (%) | SD |
Negative control | 1 | 0.902 | 0.810 | 111.4 | 100 | 10.8 |
2 | 0.801 | 98.9 | ||||
3 | 0.727 | 89.8 | ||||
Positive control | 1 | 0.022 | 0.022 | 2.7 | 2.7 | 0.1 |
2 | 0.022 | 2.7 | ||||
3 | 0.021 | 2.6 | ||||
Test substance | 1 | 0.960 | 0.956 | 118.5 | 118.0 | 1.8 |
2 | 0.940 | 116.0 | ||||
3 | 0.967 | 119.4 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the RHE test method the test substance did not show irritant properties.
CLP: not classified
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