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EC number: 240-986-1 | CAS number: 16924-00-8
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11th April 2000 to 25th April 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no deviations from standard test guidelines and no methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Dipotassium heptafluorotantalate
- EC Number:
- 240-986-1
- EC Name:
- Dipotassium heptafluorotantalate
- Cas Number:
- 16924-00-8
- Molecular formula:
- F7Ta.2K
- IUPAC Name:
- Tantalate(2-), heptafluoro-, potassium (1:2)
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Potassium fluorotantalate
- Substance type: White crystals
- Storage condition of test material: Room temperature
Constituent 1
Method
- Target gene:
- S. typhimurium: Histidine locus
E. coli: Tryptophan locus
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Strains were kept in nutrient broth cultures and stored at -80ºC. Dimethyl sulphoxide was added to the cultures at 8% v/v as a cryopreservative.
- Properly maintained: yes
- Each batch was tested for cell membrane permeability, sensitivity to UV light and the pKM101 plasmid. Responses to a series of diagnostic mutagens were also tested.
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Strains were kept in nutrient broth cultures and stored at -80ºC. Dimethyl sulphoxide was added to the cultures at 8% v/v as a cryopreservative.
- Properly maintained: yes
- Each batch was tested for cell membrane permeability, sensitivity to UV light and the pKM101 plasmid. Responses to a series of diagnostic mutagens were also tested.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 5000, 1500, 500, 150, 50, 15 and 5 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: 1% methyl cellulose
- Justification for choice of solvent/vehicle: Test material is insoluble in; water, dimethyl sulphoxide, ethanol, acetone and hexane. After grinding the test material with methyl cellulose an dosable suspension was formed.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 1% methyl cellulose
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide (AF-2) and 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: First test: in agar (plate incorporation). Second test: preincubation
First test
- 0.1 mL of a 10 hour bacterial culture and 0.5 mL S-9 mix or 0.5 mL 0.1 M sodium phosphate buffer (pH 7.4) were placed in glass bottles. 100 µL of the test solution was added, followed immediately by 2 mL of molten agar containing 0.05 mM histidine/biotin/tryptophan. The mixture was thoroughly shaken and overlaid onto previously prepared petri dishes containing 25 mL minimal agar. All plates were incubated at 37 ºC for approximately 72 hours. After this period, the appearance of the background bacterial lawn was examined and revertant colonies counted.
Second Test
- A second test was performed due to the negative response of the first test with a variation in procedure. A pre-incubation assay was used in which the bottles contained mixtures of bacteria, buffer or S9 mix and test solution were incubated at 37 ºC for 30 minutes with shaking before the addition of the agar overlay. Only 5 concentrations of the test material were used: 5000, 1500, 500, 150 and 50 µg/plate.
NUMBER OF REPLICATIONS: Each concentration was performed on 3 plates
EXAMINATIONS: After the total incubation period the plates were examined and colony numbers quantified for comparison. - Evaluation criteria:
- - If the plates treated with the test material produce an increase in colony numbers of at least twice the concurrent vehicle controls, with evidence of a positive dose-relationship, in two separate experiments, with any bacterial strain either in the presence or absence of S9 mix, it is considered to show evidence of mutagenic activity in the test material.
- If exposure to the test material does not produce reproducible increase of at least 1.5 times the concurrent vehicle controls, in either mutation test, it is considered to show no mutagenic activity in the test material.
- If there is no clear positive response then the results will be subjected to statistical analysis. - Statistics:
- The statistical analysis will be performed as described in Mahon et al (1989) and will normally be analysis of variance followed by a Dunnett's test.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No precipitation or thinning of background lawn was observed in either Test 1 or Test 2 at any test substance concentration in either the absence or presence of S9.
There were no significant increases in the number of revertant colonies compared to the vehicle control in either Test 1 or Test 2 at any test substance concentration in either the absence or presence of S9.
Full details of results for the test material (table 2) and positive controls (table 3) can be seen in the field "Any other information on results incl. tables". - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 2. Revertant colony counts obtained per plate
Test | Strain | Concentration | S9 mix | Mean revertant colony counts | SD |
(µg/plate) | |||||
1 | TA 1535 | 5000 | - | 11 | 4 |
1500 | - | 13 | 6 | ||
500 | - | 14 | 2 | ||
150 | - | 15 | 5 | ||
50 | - | 13 | 8 | ||
15 | - | 13 | 2 | ||
5 | - | 13 | 2 | ||
Vehicle | - | 18 | 1 | ||
5000 | + | 11 | 3 | ||
1500 | + | 12 | 2 | ||
500 | + | 17 | 5 | ||
150 | + | 15 | 4 | ||
50 | + | 17 | 2 | ||
15 | + | 13 | 2 | ||
5 | + | 12 | 5 | ||
Vehicle | + | 16 | 4 | ||
TA 1537 | 5000 | - | 6 | 4 | |
1500 | - | 6 | 2 | ||
500 | - | 7 | 3 | ||
150 | - | 11 | 3 | ||
50 | - | 7 | 2 | ||
15 | - | 6 | 2 | ||
5 | - | 11 | 5 | ||
Vehicle | - | 10 | 2 | ||
5000 | + | 8 | 1 | ||
1500 | + | 11 | 4 | ||
500 | + | 11 | 2 | ||
150 | + | 12 | 4 | ||
50 | + | 10 | 4 | ||
15 | + | 12 | 3 | ||
5 | + | 9 | 3 | ||
Vehicle | + | 14 | 4 | ||
TA 98 | 5000 | - | 23 | 2 | |
1500 | - | 24 | 2 | ||
500 | - | 20 | 2 | ||
150 | - | 25 | 7 | ||
50 | - | 19 | 2 | ||
15 | - | 22 | 7 | ||
5 | - | 25 | 1 | ||
Vehicle | - | 25 | 1 | ||
5000 | + | 30 | 1 | ||
1500 | + | 26 | 3 | ||
500 | + | 25 | 1 | ||
150 | + | 27 | 9 | ||
50 | + | 26 | 4 | ||
15 | + | 27 | 3 | ||
5 | + | 24 | 5 | ||
Vehicle | + | 30 | 5 | ||
TA 100 | 5000 | - | 92 | 9 | |
1500 | - | 112 | 15 | ||
500 | - | 98 | 8 | ||
150 | - | 98 | 3 | ||
50 | - | 98 | 20 | ||
15 | - | 119 | 17 | ||
5 | - | 123 | 5 | ||
Vehicle | - | 113 | 7 | ||
5000 | + | 76 | 2 | ||
1500 | + | 108 | 4 | ||
500 | + | 111 | 10 | ||
150 | + | 117 | 15 | ||
50 | + | 115 | 21 | ||
15 | + | 118 | 16 | ||
5 | + | 97 | 11 | ||
Vehicle | + | 114 | 6 | ||
CM 891 | 5000 | - | 181 | 17 | |
1500 | - | 242 | 4 | ||
500 | - | 194 | 19 | ||
150 | - | 206 | 7 | ||
50 | - | 220 | 19 | ||
15 | - | 238 | 12 | ||
5 | - | 213 | 3 | ||
Vehicle | - | 235 | 22 | ||
5000 | + | 215 | 30 | ||
1500 | + | 228 | 9 | ||
500 | + | 189 | 19 | ||
150 | + | 209 | 5 | ||
50 | + | 203 | 4 | ||
15 | + | 210 | 45 | ||
5 | + | 210 | 5 | ||
Vehicle | + | 221 | 12 | ||
2 | TA 1535 | 5000 | - | 15 | 2 |
1500 | - | 18 | 2 | ||
500 | - | 12 | 2 | ||
150 | - | 15 | 4 | ||
50 | - | 9 | 1 | ||
Vehicle | - | 14 | 1 | ||
5000 | + | 14 | 0 | ||
1500 | + | 14 | 5 | ||
500 | + | 12 | 2 | ||
150 | + | 14 | 1 | ||
50 | + | 14 | 1 | ||
Vehicle | + | 14 | 3 | ||
TA 1537 | 5000 | - | 11 | 2 | |
1500 | - | 10 | 4 | ||
500 | - | 10 | 3 | ||
150 | - | 8 | 1 | ||
50 | - | 10 | 2 | ||
Vehicle | - | 10 | 1 | ||
5000 | + | 11 | 3 | ||
1500 | + | 11 | 4 | ||
500 | + | 9 | 2 | ||
150 | + | 13 | 2 | ||
50 | + | 13 | 2 | ||
Vehicle | + | 12 | 2 | ||
TA 98 | 5000 | - | 27 | 6 | |
1500 | - | 23 | 3 | ||
500 | - | 23 | 4 | ||
150 | - | 24 | 3 | ||
50 | - | 20 | 10 | ||
Vehicle | - | 24 | 2 | ||
5000 | + | 26 | 4 | ||
1500 | + | 24 | 2 | ||
500 | + | 27 | 2 | ||
150 | + | 28 | 4 | ||
50 | + | 27 | 2 | ||
Vehicle | + | 29 | 6 | ||
TA 100 | 5000 | - | 113 | 6 | |
1500 | - | 115 | 16 | ||
500 | - | 115 | 7 | ||
150 | - | 111 | 13 | ||
50 | - | 110 | 13 | ||
Vehicle | - | 107 | 7 | ||
5000 | + | 111 | 4 | ||
1500 | + | 124 | 14 | ||
500 | + | 122 | 14 | ||
150 | + | 115 | 9 | ||
50 | + | 117 | 11 | ||
Vehicle | + | 109 | 9 | ||
CM 891 | 5000 | - | 190 | 19 | |
1500 | - | 186 | 6 | ||
500 | - | 199 | 5 | ||
150 | - | 211 | 9 | ||
50 | - | 195 | 9 | ||
Vehicle | - | 189 | 5 | ||
5000 | + | 198 | 10 | ||
1500 | + | 209 | 11 | ||
500 | + | 224 | 8 | ||
150 | + | 217 | 14 | ||
50 | + | 200 | 6 | ||
Vehicle | + | 193 | 13 |
CM 891 - WP2uvrA/pKM101
- absence
+ presence
SD Standard deviation
Table 3. Revertant colony counts per plate for positive controls
Test | Strain | Compound | Concentration | S9 mix | Mean revertant colony counts | SD |
(µg/plate) | ||||||
1 | TA 1535 | NaAz | 0.50 | - | 182 | 34 |
TA 1537 | 9AC | 30.00 | - | 71 | 6 | |
TA 98 | NF | 1.00 | - | 211 | 12 | |
TA 100 | NaAz | 0.50 | - | 402 | 17 | |
CM 891 | AF-2 | 0.05 | - | 2006 | 22 | |
TA 1535 | AA | 2.00 | + | 122 | 6 | |
TA 1537 | B[a]P | 5.00 | + | 69 | 6 | |
TA 98 | B[a]P | 5.00 | + | 229 | 17 | |
TA 100 | B[a]P | 5.00 | + | 750 | 61 | |
CM 891 | AA | 10.00 | + | 1848 | 38 | |
2 | TA 1535 | NaAz | 0.50 | - | 296 | 25 |
TA 1537 | 9AC | 30.00 | - | 125 | 4 | |
TA 98 | NF | 1.00 | - | 180 | 21 | |
TA 100 | NaAz | 0.50 | - | 541 | 9 | |
CM 891 | AF-2 | 0.05 | - | 2365 | 35 | |
TA 1535 | AA | 2.00 | + | 101 | 11 | |
TA 1537 | B[a]P | 5.00 | + | 108 | 11 | |
TA 98 | B[a]P | 5.00 | + | 337 | 19 | |
TA 100 | B[a]P | 5.00 | + | 856 | 28 | |
CM 891 | AA | 10.00 | + | 1836 | 16 |
CM 891 - WP2uvrA/pKM101
- absence
+ presence
SD Standard deviation
NaAz: sodium azide
9AC: 9-aminoacridine
NF: 2-nitrofluorene
AF-2: 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide
AA: 2-aminoanthracene
B[a]P: benzo[a]pyrene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of the test, the test material shows no evidence of mutagenic activity in the bacterial system and therefore is considered to be negative for genotoxicity. - Executive summary:
In a GLP bacterial reverse mutation assay conducted in accordance with standardised guidelines OECD 471, EU Method B.13/14 and EPA OPPTS 870.5100, the genotoxicity of the test substance was determined. Four strains of S. typhimurium and one strain of E. coli were treated in the absence and presence of metabolic activation. Under the conditions of the test, no evidence of mutagenic activity in the bacterial system was observed and the test material was determined to be negative for genotoxicity.
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