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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Dec 2006 - 28 Feb 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- only 200 metaphases per dose were scored
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- only 200 metaphases per dose were scored
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
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
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- other: Chinese hamster lung fibroblasts (CHL/IU)
- Details on mammalian cell type (if applicable):
- - Cell proliferation: doubling time 15 h
- Type and identity of media: L-glutamine (final concentration: 0.292 g/L) and sodium hydrogen carbonate (final concentration: approx. 1.85 g/L) were added to Eagle's minimum essential medium and basel medium (MEM) was prepared. This medium was then supplemented with 10% heat-inactivated NBCS.
- Properly maintained: yes
- Checked for Mycoplasma contamination: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- co-factor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated i.p. with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- Pre-experiment:
6 h treatment: 13.5, 27, 54.1, 108, 216*, 433*, 865*, 1730* and 3460* µg/mL without S9 mix and 13.5, 27, 54.1, 108, 216, 433*, 865*, 1730* and 3460* µg/mL with S9 mix
24 h treatment: 13.5, 27, 54.1, 108*, 216*, 433*, 865*, 1730* and 3460* µg/mL without S9 mix
*selected for scoring of chromosome aberrations
Main experiment:
6 h treatment: 108, 216, 433, 865*, 1730* and 3460* µg/mL with and without S9 mix
24 h treatment: 108, 216, 433, 865*, 1730* and 3460* µg/mL without S9 mix
*selected for scoring of chromosome aberrations - Vehicle / solvent:
- - Vehicle/solvent used: acetone
- Justification for choice of solvent/vehicle: The test substance was not soluble in water or DMSO. The test substance was soluble in acetone at 346 mg/mL and was not indicated any change in colour nor exothermic at room temperature within 2 h after preparation. Therefore, acetone was selected as a solvent.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Remarks:
- mitomycin C (MMC): 0.1 µg/mL (6 h, -S9), 0.05 µg/mL (24 h, -S9); cyclophosphamide (CPA): 6 µg/mL (6 h, +S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 6 and 24 h
- Fixation time (start of exposure up to fixation or harvest of cells): 6 h treatment: 24 h; 24 h treatment: 24 h
SPINDLE INHIBITOR (cytogenetic assays): demecolcine, 50 µL of 10 µg/mL solution
STAIN (for cytogenetic assays): 2 vol% Giemsa solution in 1/15 mol/L PBS (pH 6.8)
NUMBER OF REPLICATIONS: each dose was set in duplicate
NUMBER OF CELLS EVALUATED: 200 metaphases were evaluated per dose
DETERMINATION OF CYTOTOXICITY
- Method: cell growth rate and IC50 value
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- The findings were judged to be positive when the frequencies of cells with structural aberrations or numerical aberrations were 10% or more with a dose-related increase, or the frequencies of aberrant cells were 5% or more both in the chromosomal aberration test and the confirmation test. The other cases were judged to be negative.
Results and discussion
Test results
- Key result
- Species / strain:
- other: Chinese hamster lung fibroblasts (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation was observed at 216 µg/mL and above at the start and end of treatment and at the end of the culture.
- Other confounding effects: Colour change of medium and corrosion of the culture dish were not observed at any doses.
RANGE-FINDING/SCREENING STUDIES: The results of the cell growth inhibition test revealed no cytotoxic properties of the test substance in the short-term treatment with and without metabolic activation and the 24 h treatment, therefore the highest dose for the main study was selected at 3460 µg/mL.
ADDITIONAL INFORMATION ON CYTOTOXICITY: In the short-term treatments with and without metabolic activation and the 24 h treatment, cytotoxic properties of the test substance were not observed. The IC50 value in all experiments was calculated to be > 3460 µg/mL.
Any other information on results incl. tables
Table 1: Results of the main experiment.
Test item |
Concentration in µg/mL |
Cell growth rate (%) |
Frequency of cells with aberrations (%)* |
|
Structural aberration |
Numerical aberration |
|||
Exposure period 6 h, preparation interval 24 h, without S9 mix |
||||
Acetone |
0 |
100 |
0.5 |
0.0 |
MMC |
0.1 |
ND |
64.5 |
0.0 |
Test substance |
865P |
89.7 |
3.5 |
2.5 |
1730P |
94.0 |
0.0 |
0.5 |
|
3460P |
90.4 |
1.5 |
1.0 |
|
Exposure period 6 h, preparation interval 24 h, with S9 mix |
||||
Acetone |
0 |
100 |
0.0 |
0.5 |
CPA |
6 |
ND |
41.0 |
0.5 |
Test substance |
865P |
74.9 |
2.0 |
1.0 |
1730P |
90.1 |
1.5 |
0.5 |
|
3460P |
85.3 |
1.0 |
0.5 |
|
Exposure period 24 h, preparation interval 24 h, without S9 mix** |
||||
Acetone |
0 |
100 |
2.0 |
3.0 |
MMC |
0.05 |
ND |
76.0 |
0.5 |
Test substance |
865P |
85.9 |
1.0 |
0.5 |
1730P |
87.5 |
2.5 |
1.0 |
|
3460P |
91.0 |
2.5 |
2.0 |
*: the frequency of cells with chromosomal aberrations was calculated by observing 200 metaphases per dose
**: the medium was exchanged before the demecolcine solution was added 2 h prior to cell harvest to remove the precipitation of the test substance
CPA: cyclophosphamide
MMC: mitomycin C
ND: not detected
P: precipitation of the test substance occurred
Table 2: Results of cell growth inhibition
Frequency of cells with aberrations (%) * | ||||||
Substance | Concentration in µg/mL | Treatment - recovery time (h) | S9 mix | Cell Growth rate (%) | Strucutral aberration | Numerical aberration |
Acetone | 0 | 6-18 | - | 100 | 0.0 | 0.0 |
Test item | 13.5 | 6-18 | - | 98.8 | n.o. | n.o. |
27.0 | 6-18 | - | 95.6 | n.o. | n.o. | |
54.1 | 6-18 | - | 91.4 | n.o. | n.o. | |
108 | 6-18 | - | 88.1 | n.o. | n.o. | |
216 | 6-18 | - | 78.9 | 0.0 | 0.0 | |
433 | 6-18 | - | 75.4 | 2.0 | 2.0 | |
865 | 6-18 | - | 68.0 | 0.0 | 0.0 | |
1730 | 6-18 | - | 75.6 | 4.0 | 2.0 | |
3460 | 6-18 | - | 84.1 | 2.0 | 2.0 | |
Acetone | 0 | 6-18 | + | 100 | 0.0 | 0.0 |
Test item | 13.5 | 6-18 | + | 91.1 | n.o. | n.o. |
27.0 | 6-18 | + | 89.7 | n.o. | n.o. | |
54.1 | 6-18 | + | 99.6 | n.o. | n.o. | |
108 | 6-18 | + | 93.5 | n.o. | n.o. | |
216 | 6-18 | + | 88.9 | n.o. | n.o. | |
433 | 6-18 | + | 80.7 | 0.0 | 0.0 | |
865 | 6-18 | + | 84.0 | 4.0 | 2.0 | |
1730 | 6-18 | + | 87.5 | 0.0 | 2.0 | |
3460 | 6-18 | + | 74.7 | 0.0 | 0.0 | |
Acetone | 0 | 24-0 | - | 100 | 0.0 | 0.0 |
Test item | 13.5 | 24-0 | - | 95.1 | n.o. | n.o. |
27.0 | 24-0 | - | 92.0 | n.o. | n.o. | |
54.1 | 24-0 | - | 92.1 | n.o. | n.o. | |
108 | 24-0 | - | 84.9 | 0.0 | 0.0 | |
216 | 24-0 | - | 74.2 | 0.0 | 0.0 | |
433 | 24-0 | - | 82.1 | 0.0 | 0.0 | |
865 | 24-0 | - | 84.0 | few meta | ||
1730 | 24-0 | - | 71.0 | few meta | ||
3460 | 24-0 | - | 78.6 | few meta |
n.o.: not observed
few meta: the frequency of metaphases was extremely few
* The frequency of cells with chromosomal aberrations was calculated by observing 50 metaphases per dose. The highest dose was set at 3460 µg/mL equivalent to 10 mmol/L, as the maximum dose in case of no cytotoxicity on the guidelines, the dose levels based on a geometric progression of 2 were selected.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
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