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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
Eye irritation
Administrative data
- Endpoint:
- eye 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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- 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
Test animals / tissue source
- Species:
- human
- Strain:
- other: Epiocular™EIT (OCL-200)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL
NEGATIVE CONTROL
- Amount(s) applied: 50 µL
- Lot/batch no.: K6G73
POSITIVE CONTROL
- Amount(s) applied: 50 µL
- Lot/batch no.: 020917ALA - Duration of treatment / exposure:
- 30 ± 2 min (administere in 1 min intervals)
- Duration of post- treatment incubation (in vitro):
- 12 ± 2 min
- Number of animals or in vitro replicates:
- duplicates for each treatment and control group; from each tissue, 2 absorbance measurements after MTT incubation were performed
- Details on study design:
- - RhCE tissue construct used, including batch number: Epiocular™EIT (OCL-200); Test Kit name: OCL-200EIT (manufactured on 16 Feb 2017 by MatTek Corporation); Lot number: 20978; Receipt Date: 20 Feb 2017
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods:
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals: The ability of the test substance to directly reduce MTT and to change the color of the MTT medium was assessed in a pre-experiment. Since the MTT solution colour did not change, the test substance is not presumed to have reduced the MTT. A tissue-binding test was performed with medium without MTT to determine the staining ratio using the following formula:
Staining ratio (%) = OD of the test substance (without MTT) / Mean OD of the negative control substance group (with MTT) x 100
- Number of tissue replicates used per test chemical and controls: 2
- Wavelength: 570 nm
- Spectrophotometer: Multimode Microplate Reader (FLUOstar OPTIMA, BMG Labtech)
- Description of evaluation criteria used: The test substance is considered to be not irritating to eye if the tissue viability is > 60%. The test substance is considered to be irritating to eye if the tissue viability is ≤ 60%.
- Positive and negative control means and acceptance ranges: OD in the negative control substance group is > 0.8 and < 2.5. The cell viability in the positive control substance group is < 50%.
- Acceptable variability between tissue replicates for positive and negative controls and for the test substance: Differences of two tissue cell viabilities in each treatment group are < 20%
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % tissue viability mean value of 2 tissues
- Run / experiment:
- 30 min exposure
- Value:
- 72.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
The optical pre-experiment (colour interference pre-experiment) to investigate the colour change potential of the test substance in MTT medium did not led to a change in colour.
The mean staining ratio was below 60%, therefore the cell viability was corrected by the following formula:
Corrected cell viability (%) = Mean cell viability of the test substance group (%) - Mean staining ratio (%)
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, the OD of the negative control was 1.117, 1.052, 1.005 and 1.047, and thus within the acceptibility range (OD > 0.8 and < 2.5).
- Acceptance criteria met for positive control: Yes, the positive control reduced the cell viability at 36.0% and fulfilled the acceptance criteria.
- Acceptance criteria for variabilties: Differences of two tissue cell viabilities in the negative control substance, the positive control substance and the test substance groups were 5.5%, 4.2% and 2.4%, respectively, and thus < 20%.
Any other information on results incl. tables
Table 1: Summary of Results
Group | Tissue | OD | Mean OD / Tissue | Mean OD of Tissue 1 and 2 | Mean Cell Viability (%) / Tissue | Mean Cell Viability (%) of Tissue 1 and 2 | Corrected Mean Cell Viability (%) * | Difference |
Negative control | 1 | 1.117 | 1.085 | 1.056 | 102.7 | 100 | - | 5.5 |
1.052 | ||||||||
2 | 1.005 | 1.026 | 97.2 | |||||
1.047 | ||||||||
Test substance | 1 | 0.394 | 0.402 | 0.380 | 38.1 | 36.0 | - | 4.2 |
0.410 | ||||||||
2 | 0.351 | 0.358 | 33.9 | |||||
0.364 | ||||||||
Positive control | 1 | 0.775 | 0.786 | 0.773 | 74.4 | 73.2 | 72.4 | 2.4 |
0.797 | ||||||||
2 | 0.745 | 0.760 | 72.0 | |||||
0.774 |
* The cell viability was corrected by the staining ratio
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 RhCE test method the test substance did not show irritant properties.
CLP: not classified
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