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EC number: - | CAS number: -
- 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:
- From 14 Oct 2003 to 18 Nov 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- Cesium potassium fluoroaluminate, purity 100%
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from rat liver cells
- Test concentrations with justification for top dose:
- Experiment 1: 0, 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate
Experiment 2: 0, 100, 333, 1000, 3330 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:ethanol
- Justification for choice of solvent/vehicle: one of those recommended by guidelines
Controls
- Untreated negative controls:
- yes
- Remarks:
- solvent served as control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: daunomycin
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
CELL CULTURE
Preparation of bacterial cultures
Samples of frozen stock cultures of bacteria were transferred into enriched nutrient broth (Oxoid no.2) and incubated in a shaking incubator (37°C, 150 spm), until the cultures reached an optical density of 1.0 ± 0.1 at 700 nm (109 cells/ml). Freshly grown cultures of each strain were used for a test.
Permeabilization of the Escherichia coli strain
WP2uvrA bacteria were washed twice in 0.25 the original volume of ice-cold 0.12 M Tris-HCI buffer pH 8.0, then gently resuspended in 0.2 vol. 0.12 M Tris-HCI, 0.5 mM EDTA pH 8.0, and shaken for 2.5 min at 37°C. MgCl2 was then added to a final concentration of 10 mM. The cells were centrifuged and resuspended in the original volume of nutrient broth.
Agar plates
Agar plates (0 9 cm) contained 25 ml glucose agar medium. Glucose agar medium contained per liter: 18 g purified agar (Oxoid, code L28) in Vogel-Bonner Medium E, 20 g glucose.
N.B. The agar plates for the test with the Salmonella typhimurium strains also contained 12.5 µg/plate biotin and 15 µg/plate histidine and the agar plates for the test with the Escherichia coli strain contained 15 µg/plate tryptophan.
Top agar
Milli-Q water containing 0.6% (w/v) bacteriological agar (Oxoid, code L11) and 0.5% (w/v) Sodium Chloride was heated to dissolve the agar. Samples of 3 ml top agar were transferred into 10 ml glass tubes with metal caps. Top agar tubes were autoclaved for 20 min at 121 ± 3°C.
Environmental conditions
All incubations were carried out in the dark at 37 ± 1°C. The temperature was monitored during the experiment.
DOSE RANGE-FINDING TEST
Selection of an adequate range of doses was based on a dose range finding test with strain TA100 and the WP2uvrA strain, both with and without S9-mix. Eight concentrations, 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate were tested in triplicate. This dose range finding test was reported as a part of the first experiment of the mutation assay. The highest concentration of Cesium potassium fluoroaluminate (Cesium 5.64% w/w) used in the subsequent mutation assay was 5 mg/plate.
MUTATION ASSAY
At least five different doses (increasing with approximately half-log steps) of the test substance were tested in triplicate in each strain.
The test substance was tested both in the absence and presence of S9-mix in each strain, in two independent experiments.
Top agar in top agar tubes was molten and heated to 45°C. The following solutions were successively added to 3 ml molten top agar: 0.1 ml of a fresh bacterial culture {109 cells/ml) of one of the tester strains, 0.1 ml of a dilution of the test substance in ethanol and either 0.5 ml S9-mix (in case of activation assays) or 0.5 ml 0.1 M phosphate buffer (in case of non-activation assays). The ingredients were mixed on a Vortex and the content of the top agar tube was poured onto a selective agar plate. After solidification of the top agar, the plates were turned and incubated in the dark at 37 ± 1°C for 48 h. After this period revertant colonies (histidine independent (His+) for Salmonella typhimurium bacteria and tryptophan independent (Trp+) for Escherichia coli) were counted.
COLONY COUNTING
The revertant colonies (histidine independent c.q. tryptophan independent) were counted automatically with a Protes model 50000 colony counter or manually, if less than 40 colonies per plate were present. - Evaluation criteria:
- No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) lt induces a number of revertant colonies, dose related, greater than two-times the number of revertants induced by the solvent control in any of the tester strains, either with or without metabolic activation.
However, any mean plate count of less than 20 is considered to be not significant.
b) The positive response should be reproducible in at least one independently repeated experiment. The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Cesium potassium fluoro aluminate (Cesium 5.64% w/w) was tested in the tester strains TA100 and WP2uvrA with concentrations of 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate in the absence and presence of S9-mix.
This dose range finding test is reported as a part of the first experiment of the mutation test.
Precipitate
The test substance precipitated in the top agar at concentrations of 1000 µg/plate and upwards. Precipitation of Cesium potassium fluoro aluminate on the plates was observed at the start of the incubation period at concentrations of 1000 µg/plate and upwards and no precipitate was observed at the end of the incubation period in all tester strains.
Toxicity
To determine the toxicity of Cesium potassium fluoro aluminate, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined.
No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
COMPARISON WITH HISTORICAL CONTROL DATA:
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Any other information on results incl. tables
All results are expressed as mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and one Escherichia coli strain.
Experiment 1: Mutagenic response of Cesium potassium fluoroaluminate in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay
WITHOUT S9 mix:
Dose (µg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
Positive control |
803 ± 23 |
515 ± 44 |
594 ± 16 |
766 ± 118 |
692 ± 23 |
Solvent control |
16 ± 1 |
13 ± 3 |
28 ± 3 |
121 ± 17 |
7 ± 2 |
3 |
|
|
|
126 ± 14 |
6 ± 1 |
10 |
|
|
|
115 ± 2 |
6 ± 2 |
33 |
|
|
|
118 ± 12 |
9 ± 3 |
100 |
16 ± 2 |
16 ± 2 |
31 ± 4 |
104 ± 12 |
10 ± 1 |
333 |
14 ± 2 |
14 ± 1 |
35 ± 9 |
98 ± 9 |
7 ± 3 |
1000 |
20 ± 5 |
16 ± 1 |
28 ± 2 |
107 ± 12 |
9 ± 2 |
3330 |
16 ± 1 |
16 ± 2 |
24 ± 1 |
77 ± 5 |
6 ± 1 |
5000 |
15 ± 2 |
10 ± 2 |
27 ± 4 |
81 ± 10 |
7 ± 1 |
WITH S9 mix:
Dose (µg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
Positive control |
352 ± 19 |
333 ± 11 |
795 ± 21 |
771 ± 20 |
220 ± 18 |
Solvent control |
19 ± 2 |
16 ± 3 |
40 ± 3 |
122 ± 16 |
7 ± 3 |
3 |
|
|
|
113 ± 13 |
6 ± 2 |
10 |
|
|
|
114 ± 9 |
8 ± 3 |
33 |
|
|
|
115 ± 15 |
7 ± 3 |
100 |
21 ± 2 |
11 ± 2 |
34 ± 2 |
101 ± 12 |
5 ± 2 |
333 |
20 ± 2 |
9 ± 1 |
36 ± 2 |
96 ± 9 |
8 ± 3 |
1000 |
17 ± 3 |
11 ± 2 |
39 ± 2 |
102 ± 3 |
8 ± 1 |
3330 |
18 ± 2 |
15 ± 2 |
30 ± 1 |
79 ± 4 |
7 ± 2 |
5000 |
16 ± 1 |
12 ± 2 |
34 ± 6 |
84 ± 6 |
8 ± 1 |
Experiment 2: Mutagenic response of Cesium potassium fluoroaluminate in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay
WITHOUT S9 mix:
Dose (µg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 100 WP2 uvrA |
Positive control |
627 ± 30 |
568 ± 56 |
666 ± 44 |
1008 ± 88 |
957 ± 48 |
Solvent control |
15 ± 3 |
5 ± 2 |
17 ± 3 |
106 ± 2 |
11 ± 4 |
100 |
10 ± 4 |
7 ± 4 |
18 ± 3 |
104 ± 5 |
12 ± 5 |
333 |
11 ± 2 |
5 ± 3 |
15 ± 3 |
130 ± 8 |
12 ± 3 |
1000 |
11 ± 3 |
7 ± 4 |
15 ± 3 |
116 ± 2 |
11 ± 1 |
3330 |
11 ± 1 |
6 ± 3 |
14 ± 3 |
92 ± 9 |
8 ± 2 |
5000 |
9 ± 3 |
4 ± 1 |
12 ± 2 |
78 ± 12 |
11 ± 5 |
WITH S9 mix:
Dose (µg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
Positive control |
117± 17 |
91 ± 26 |
383 ± 15 |
811 ± 102 |
128 ± 12 |
Solvent control |
14 ± 2 |
4 ± 1 |
26 ± 3 |
90 ± 8 |
18 ± 2 |
100 |
8 ± 3 |
4 ± 2 |
24 ± 3 |
104 ± 6 |
17 ± 3 |
333 |
10 ± 3 |
5 ± 2 |
28 ± 6 |
122 ± 2 |
14 ± 4 |
1000 |
6 ± 0 |
5 ± 3 |
24 ± 3 |
105 ± 5 |
15 ± 4 |
3330 |
7 ± 1 |
4 ± 2 |
21 ± 5 |
103 ± 10 |
17 ± 2 |
5000 |
9 ± 3 |
3 ± 1 |
19 ± 4 |
105 ± 5 |
10 ± 2 |
Solvent control: 0.1 ml ethanol
The S9-mix contained 9.5% (v/v) S9 fraction
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that Cesium potassium fluoroaluminate is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
- Executive summary:
Cesium potassium fluoroaluminate was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA 1537, TA 100 and TA98) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli WP2uvrA. The test was performed in two independent experiments in the presence and absence of S9-mix (Aroclor-1254 induced rat liver S9-mix), according to the OECD 471 guideline and under GLP conditions. The test substance was suspended in ethanol.
ln the dose range finding test, Cesium potassium fluoroaluminate was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA.
ln the first and in the second mutation assay, Cesium potassium fluoroaluminate was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix. In dose range-finding, first and second experiment, the bacterial background lawn was not reduced at any of the concentrations tested and no decrease in the number of revertants was observed.
The presence of 5 and 9.5% (v/v) liver microsomal activation did not influence these findings. Cesium potassium fluoroaluminate did not induce a dose-related, two-fold increase in the number of revertant (His+) colonies in each of the four tester strains (TA 1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment. Based on the results of this study it is concluded that Cesium potassium is not mutagenic in the Salmonella typhimurium and in the Escherichia coli reverse mutation assay.
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