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EC number: 211-681-0 | CAS number: 685-63-2
- 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 gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03-AUG-1992 to 22-OCT-1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Ames et al. (1975)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,1,2,3,4,4-hexafluorobuta-1,3-diene
- EC Number:
- 211-681-0
- EC Name:
- 1,1,2,3,4,4-hexafluorobuta-1,3-diene
- Cas Number:
- 685-63-2
- Molecular formula:
- C4F6
- IUPAC Name:
- hexafluorobuta-1,3-diene
- Test material form:
- gas under pressure: liquefied gas
- Details on test material:
- - Name of test material (as cited in study report): Perfluorobutadiene
Constituent 1
Method
- Target gene:
- Histidine and tryptophan
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 microsomal fraction from Aroclor 1254-treated rat liver
- Test concentrations with justification for top dose:
- - 1st experiment: 0.3125, 0.625, 1.25, 2.5, 5 and 7.5% (v/v)
- 2nd experiment: 0.015, 0.05, 0.15, 0.5, 1.5 and 5% (v/v) - Vehicle / solvent:
- - Vehicle used: air
- Justification for choice of vehicle: the test substance is a gas
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- air
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- methylmethanesulfonate
- other: 4-acetylaminofluorene (4-AAF), vinyl chloride (gaseous positive control)
- Remarks:
- Methylmethanesulfonate (MMS) was dissolved in sterile, ultra-pure water. 9-aminoacridine (9-AA) and 4-acetylaminofluorene (4-AAF) were dissolved in dimethylsulphoxide (DMSO).
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
For use of S. typhimurium strains, top agar was prepared by adding 5 mL of 1 mM L-histidine and 1 mM biotin solution to 100 mL of dilute agar. For use of E. coli strain, top agar was prepared by adding 1 mL of 1.35 mM L-tryptophan to 100 mL dilute agar. Each top agar was thoroughly mixed prior to use. Agar preparations were kept in a water bath at a temperature not exceeding 45°C.
In the course of testing the substance, 2 mL of soft agar was dispensed to a small, plastic sterile tube. This was followed by 0.5 mL of S9 mix or 0.05 M phosphate buffer (pH 7.4) and, finally, the bacteria (0.1 mL). Continually cooling, the tube contents were mixed and then poured in minimal medium plates prepared in-house. These plates contained 25 mL 1.5% BBL purified agar in Vogel-Bonner Medium E with 2% glucose. When the soft agar had set, the plates were inverted and metal spacers inserted under the lids. The plates were then placed in wide-necked, straight-sided flasks of known volume (6.25 L). The greased lids were replaced and the openings filled with either Quickfit Dreschel tops (T-junctions) through which the gas passed into the jars, or suba-seal caps through which the gas was injected into the jars. The latter method was used when the concentrations to be tested were very low.
The method used for dosing the toxicity test and the gaseous positive control was to take, simultaneously, hydrocarbon-free air and test gas through separate calibrated rotameters and allowing the gases to mix before they passed into the incubation jars. Approximately 25 L of gas/air mixture were allowed to flush through each incubation jar before entrance and exit taps were switched off. In all cases, before plates were removed from the jars after 48-h incubation, at least 50 L of air were passed through the system to clear the test atmosphere.
The following control groups were established, duplicate plates being poured for each mean datum point:
- Air-only controls plated in duplicate with each strain used, both in the presence and absence of S9 mix.
- Gas control: vinyl chloride tested at 30% in air with S. typhimurium TA 1535 and TA 100 in the presence and absence of S9 mix.
- With S9 mix - non-gaseous control: 4-AAF tested at 1000 µg/plate with S. typhimurium TA 1538 and TA 98.
- Without S9 mix - non-gaseous control: 9-AA tested at 80 µg/plate with S. typhimurium TA 1537 and MMS at 200 µg/plate with E. coli.
DURATION
- Exposure duration: 48 h at 37°C
- Expression time (cells in growth medium): 24 h at 37°C following the initial 48-h incubation period
NUMBER OF REPLICATES: duplicate plates were prepared for each bacterial strain and dose level in both the presence and absence of S9 mix and for each of the two independent tests.
METHOD OF EVALUATION: colonies were counted using a Biotran III automated counter at a maximum sensitivity (i.e., colonies of 0.1 mm or more in diameter).
DETERMINATION OF CYTOTOXICITY
- Method: a toxicity test using strain TA 100 only was performed in the presence and absence of S9 mix to establish suitable dose levels for the mutation tests. One plate of 10, 50 and 100% (v/v) exposure levels each was used.
OTHER EXAMINATIONS: the plates were examined for precipitates and, microscopically, for microcolony growth. - Rationale for test conditions:
- Standard test conditions were adapted to test the gaseous substance.
- Evaluation criteria:
- A test was considered acceptable if for each strain:
- The bacteria demonstrated their typical responses to crystal violet, ampicillin and UV light.
- At least one of the vehicle control plates were within the following ranges: TA 1535, 4-30; TA 1537, 1-20, TA98, 10-60, TA 100, 60-200, TA 1538, 10-35 and E. coli WP2urvA (pKM101), 10-100.
- On at least one of the positive control plates there were x 2 the mean vehicle control mutant numbers per plate. If the mean colony count on the vehicle control plates was less than 10, then a value of 10 was assumed for assessment purposes. In such cases a minimum count of 20 was required before a significant mutagenic response was identified.
- No toxicity or contamination was observed in at least 4 dose levels.
- In cases where a mutagenic response was observed, that no more than one dose level was discarded before the dose which gave the highest significant mean colony number.
Where these criteria were met, a significant mutagenic response was recorded if there was:
- For S. typhimurium strains TA 1535, TA 1537, TA 1538 and TA 98 and for E. coli, at least a doubling of the mean concurrent vehicle control values at some concentration of the test substances and, for S. typhimurium strains TA 100, a 1.5-fold increase over the control value. If the mean colony count on the vehicle control plates was less than 10, than a value of 10 was assumed for assessment purposes. In such cases a minimum count of 20 was required before a significant mutagenic response was identified.
- A reproducible effect in independent tests. - Statistics:
- No data available
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At the highest dose level of 7.5% in test 1 (without S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from the dose level of 1.5% in the main tests, with and without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from the dose level of 1.5% in the main tests, with and without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from the dose level of 5% in the main test, with and without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from the dose level of 1.5% in the main tests, with and without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from the dose level of 1.5% in the main tests, with and without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY: In the preliminary toxicity assay, high toxicity to S. typhimurium TA 100 strain was observed at all 3 concentrations of test gas used (i.e., 10, 50 and 100% (v/v)). At the 10% exposure level, some remnants of the background lawn of microcolonies were apparent although no revertant colonies were present. All subsequent exposures resulted in complete killing of the bacteria.
7.5% v/v was therefore selected as top dose for the test 1 of the main assay.
5% was selected as top dose in test 2 and 3 of the main assay.
Any other information on results incl. tables
Results are presented as mean number of revertants from duplicate plates in 3 separate tests
Applicant's summary and conclusion
- Conclusions:
- The test substance was not mutagenic to Salmonella typhimurium or Escherichia coli when tested as a gas at exposure levels extending into the toxic range.
- Executive summary:
The test substance was tested as gas for mutagenic activity in Salmonella typhimurium and Escherichia coli according to a protocol equivalent to OECD guideline 471 (adapted for a gaseous exposure) and in compliance with good laboratory practices (GLP).
Five S. typhimurium strains TA1535, TA1537, TA1538, TA98, TA100, and one E. coli strain WP2uvrA were used in two independent experiments performed in duplicate, using a plate incorporation method. The tests were conducted at exposure levels ranging from 0.015 to 7.5% v/v, on agar plates placed in 6.25 litres jars and exposed to the gas for 48 hours, in the presence and absence of an Aroclor 1254 induced rat liver preparation and co-factors (S9 mix) required for mixed-function oxidase activity.
A toxicity test using S. typhimurium strain TA 100 only was performed in the presence and absence of S9 mix to establish suitable dose levels for the mutation tests. One plate of 10, 50 and 100% (v/v) exposure levels each was used. Toxicity was observed at all 3 concentrations of test gas used. At the 10% exposure level, some remnants of the background lawn of microcolonies were apparent although no revertant colonies were present. All subsequent exposures resulted in complete killing of the bacteria.
No mutagenic activity was observed in any of the six bacterial strains used. The lowest exposure level where toxicity to the bacteria strains was recorded was 1.5%. The positive and negative controls were within respective normal ranges.
It was concluded that the test substance was not mutagenic to Salmonella typhimurium or Escherichia coli when tested as a gas at exposure levels extending into the toxic range.
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