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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 Feb - 01 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted Jul 2010
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Since this data was to confirm the safety of the worker in the own company, it was not performed according to GLP.
- Type of study:
- mouse local lymph node assay (LLNA)
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 vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Remarks:
- SPF
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan, Inc
- Age at study initiation: 7 weeks
- Weight at study initiation: 23.2 - 24.1 g (ranges)
- Housing: 4 animals per cage were housed in polycarbonate cages (W 215 x D 320 x H 150 mm).
- Diet: Pelleted diet (MF, Oriental Yeast Co Ltd.), ad libitum
- Water: Chlorinated water, ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 - 24.0
- Humidity (%): 50.0 - 68.0
- Air changes (per hr): 50
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 01 Feb 2017 To: 13 Feb 2017
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 25, 50 and 99.95%
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS: 2 female mice were treated by daily application of 25 μl of the test substance in concentrations of 10, 25, 50 and 99.95% to the dorsal surface of the ear, for 3 consecutive days. The body weight was recorded on Day 1 prior to dosing and on Day 6.
- Irritation: The animals were observed for local skin irritation to the application site once a day.
- Systemic toxicity: The animals were observed for signs of toxicity at least once a day.
- Ear thickness measurements: Ear thickness was measured in triplicate for each ear with the Digital micrometer on Day 1, 3 and 6.
- Erythema scores: Draize scoring system
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by β-scintillation and γ-counting
- Criteria used to consider a positive response: The mean incorporation of 3H-methyl thymidine (DPM/mouse) was calculated for the vehicle treated control group. Then, each value of incorporation of 3H-methyl thymidine in all mice was divided by the mean DPM of the vehicle treated control group to calculate stimulation index (SI). SI of vehicle treated control and test substance group were expressed as means and standard errors. The decision process regards a result as positive when SI of test substance group ≥ 3.
TREATMENT PREPARATION AND ADMINISTRATION: 25 µl of the test material was applied to the entire dorsal surface of each ear of each mouse on Days 1, 2 and 3 in concentrations of 25, 50 and 99.95% in methyl ethyl ketone. The irritation effects on the treatment site were assessed daily. On Day 6 an injection of 250 µl phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each mouse. Approximately five hours later, the draining auricular lymph node of each ear was excised into PBS and pooled per experimental group. A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze and rinsed with PBS. The precipitates were incubated for 18 h at 4°C, centrifuged, resuspended in 1 mL TCA and transferred to 10 mL scintillation fluid before β-scintillation counting. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The mean SI calculated for the positive control substance (25% hexyl cinnamic aldehyde in methyl ethyl ketone) was 22.0 ± 2.2, thus meeting the reliability criteria for the LLNA (SI ≥ 3).
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Variability:
- 0.2
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Variability:
- 0.1
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Variability:
- 0.1
- Test group / Remarks:
- 99.95%
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
The SI of the 25, 50 and 99.95% treatment group was 1.3, 1.3 and 1.1, respectively. None of the test substance concentrations produced as 3-fold increase in 3HTdR incorporation.
EC3 CALCULATION
None of the SI values were above 3 and it is therefore not possible to determine a EC3 concentration.
CLINICAL OBSERVATIONS
No mortality and no signs of systemic toxicity were noted in the test or control animals during the test.
BODY WEIGHTS
Body weight changes were comparable to those observed in the corresponding control group animals over the same period.
Any other information on results incl. tables
Table 1: Summary of Results
Concentration in methyl ethyl ketone (%) | Lymph node weight ± SE | Mean DPM±SE | SI ± SE |
Methyl ethyl ketone | 4.1±0.3 | 425±44 | 1.0±0.1 |
25 | 3.4±0.3 | 535±70 | 1.3±0.2 |
50 | 3.9±0.2 | 535±61 | 1.3±0.1 |
99.95 | 2.9±0.2 | 465±26 | 1.1±0.1 |
Hexyl cinnamic aldehyde (25% in methyl ethyl ketone) | 9.6±0.4 | 9361±940 | 22.0±2.2 |
DPM = Disintegrations per minute
SE = Standard error
SI = Stimulation index
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:
- CLP: not classified
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