Registration Dossier
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EC number: 241-143-0 | CAS number: 17084-13-8
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:
- 2016-02-17 to 2016-03-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21st July, 1997.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 30, 2008.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Potassium hexafluorophosphate
- EC Number:
- 241-143-0
- EC Name:
- Potassium hexafluorophosphate
- Cas Number:
- 17084-13-8
- Molecular formula:
- F6P.K
- IUPAC Name:
- potassium hexafluoro-λ⁵-phosphanuide
- Test material form:
- solid: crystalline
- Details on test material:
- - State of aggregation: solid
- Other: crystalline powder,
Colour: white
hygroscopic
Constituent 1
Method
- Target gene:
- histidine operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: rfa-, uvrB-, R-factor mutation
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: rfa-, uvrB-, R-factor mutation
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: rfa-, R-factor mutation
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: rfa-, uvrB- mutation
- Species / strain / cell type:
- S. typhimurium TA 1537
- Additional strain / cell type characteristics:
- other: rfa-, uvrB- mutation
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomal fraction from induced male Wistar rat
- Test concentrations with justification for top dose:
- 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate. The top dose applied in the main experiments was chosen according to the results of the pre-experiment (for details see "any other information on results").
- Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: The solvent was compatible with the survival of the bacteria and the S9 activity.
Controls
- Untreated negative controls:
- yes
- Remarks:
- aqua dest.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO, AppliChem Lot No. 4l013997 and 0000695964
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-NOPD: 4-nitro-o-phenylene-diamine; 2-AA: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation and preincubation
- Cell density at seeding: 100 µL of a preparation of bacteria in the late exponential or early stationary phase of growth (approx. 1.00E+09 cells/mL) were used.
NUMBER OF REPLICATIONS: 3
DURATION:
- Preincubation period: 60 min at 37 °C
- Exposure duration: 48 h at 37 °C
DETERMINATION OF CYTOTOXICITY
- Method: detected by a clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control. - Evaluation criteria:
- The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean values of the solvent control (the exact and not the rounded values are used for calculation). A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher
than the reversion rate of the solvent control. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary. A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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
- Key result
- Species / strain:
- S. typhimurium TA 102
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not reported
- Effects of osmolarity: not reported
- Evaporation from medium: not reported
- Water solubility: test item was dissolved in DMSO
- Precipitation: none
RANGE-FINDING/SCREENING STUDIES: The toxicity of the test item was determined with tester strains TA 98 and TA 100 in a pre-experiment. Eight concentrations were tested for toxicity and induction of mutations with three plates each. The experimental conditions in this pre-experiment were the same as described for the main experiment I (plate incorporation test). The test item was tested in the pre-experiment with the following concentrations: 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: Toxicity may be detected by a clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control.
HISTORICAL CONTROL DATA: see section "any other information on results incl. tables".
Any other information on results incl. tables
No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation).
No toxic effects of the test item were noted in any of the five tester strains used up to the highest dose group evaluated with and without metabolic activation in experiment I and II.
The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments.
In tester strain TA 1537 in experiment I (plate incorporation test) a mutation factor of 3.0 was observed. However, the corresponding revertant colony number was within the range of the historical negative control data, no dose-response relationship was observed and the effect could not be reproduced in experiment II (pre-incubation test). Thus, the effect was considered as not biologically relevant.
Table 2: results of the pre-experiment. Mutation factor= mean revertants (test item)/mean revertants (vehicle control)
Substance |
Dose (µg/plate) |
TA 98 Mutation factor |
TA 100 Mutation factor |
||
|
|
Without S9 |
With S9 |
Without S9 |
With S9 |
DMSO |
Solvent control |
1 |
1 |
1 |
1 |
4-NOPD |
10 |
13.6 |
- |
- |
- |
NaN3 |
10 |
- |
- |
6.4 |
- |
2-AA |
2.5 |
- |
68.6 |
- |
15.8 |
Test item |
3.16 |
0.8 |
1.2 |
1 |
0.9 |
10 |
1.2 |
1.2 |
1 |
1 |
|
31.6 |
1 |
1.2 |
0.9 |
1 |
|
100 |
1 |
1.1 |
0.9 |
1 |
|
316 |
0.8 |
1 |
0.9 |
1 |
|
1000 |
1 |
1.1 |
1 |
1 |
|
2500 |
0.9 |
1.3 |
1 |
1.2 |
|
5000 |
1 |
1.1 |
0.9 |
1 |
|
Table 3: Results Experiment I (Plate-incorporation Test). Tester strain: TA 98. Mutation factor= mean revertants (test item)/mean revertants (vehicle control)
Treatment |
Dose (µg/plate) |
Revertant colonies per plate (mean) |
Mutation factor |
||
|
|
Without S9 |
With S9 |
Without S9 |
With S9 |
Aqua dest. |
|
28 |
33 |
1 |
1.2 |
DMSO |
|
28 |
26 |
1 |
1 |
Test item |
31.6 |
30 |
31 |
1 |
1.2 |
|
100 |
28 |
28 |
1 |
1.1 |
|
316 |
22 |
26 |
0.8 |
1 |
|
1000 |
28 |
29 |
1 |
1.1 |
|
2500 |
25 |
33 |
0.9 |
1.3 |
|
5000 |
28 |
28 |
1 |
1.1 |
4-NOPD |
10 |
385 |
- |
13.6 |
- |
2-AA |
2.5 |
- |
1806 |
- |
68.6 |
Table 4: Results Experiment I (Plate-incorporation Test). Tester strain: TA 100. Mutation factor= mean revertants (test item)/mean revertants (vehicle control)
Treatment |
Dose (µg/plate) |
Revertant colonies per plate (mean) |
Mutation factor |
||
|
|
Without S9 |
With S9 |
Without S9 |
With S9 |
Aqua dest. |
|
92 |
98 |
0.9 |
1 |
DMSO |
|
99 |
98 |
1 |
1 |
Test item |
31.6 |
94 |
101 |
0.9 |
1 |
|
100 |
91 |
100 |
0.9 |
1 |
|
316 |
86 |
97 |
0.9 |
1 |
|
1000 |
97 |
98 |
1 |
1 |
|
2500 |
97 |
113 |
1 |
1.2 |
|
5000 |
90 |
100 |
0.9 |
1 |
NaN3 |
10 |
640 |
- |
6.4 |
- |
2-AA |
2.5 |
- |
1549 |
- |
15.8 |
Table 5: Results Experiment I (Plate-incorporation Test). Tester strain: TA 1535. Mutation factor= mean revertants (test item)/mean revertants (vehicle control)
Treatment |
Dose (µg/plate) |
Revertant colonies per plate (mean) |
Mutation factor |
||
|
|
Without S9 |
With S9 |
Without S9 |
With S9 |
Aqua dest. |
|
9 |
6 |
0.9 |
0.8 |
DMSO |
|
10 |
8 |
1 |
1 |
Test item |
31.6 |
18 |
11 |
1.7 |
1.3 |
|
100 |
12 |
9 |
1.1 |
1.1 |
|
316 |
11 |
7 |
1 |
0.9 |
|
1000 |
12 |
7 |
1.2 |
0.8 |
|
2500 |
12 |
8 |
1.2 |
1 |
|
5000 |
15 |
9 |
1.5 |
1 |
NaN3 |
10 |
934 |
- |
90.4 |
- |
2-AA |
2.5 |
- |
145 |
- |
17.4 |
Table 6: Results Experiment I (Plate-incorporation Test). Tester strain: TA 1537. Mutation factor= mean revertants (test item)/mean revertants (vehicle control)
Treatment |
Dose (µg/plate) |
Revertant colonies per plate (mean) |
Mutation factor |
||
|
|
Without S9 |
With S9 |
Without S9 |
With S9 |
Aqua dest. |
|
7 |
7 |
1.2 |
1.8 |
DMSO |
|
6 |
4 |
1 |
1 |
Test item |
31.6 |
8 |
8 |
1.3 |
1.9 |
|
100 |
5 |
9 |
0.9 |
2.3 |
|
316 |
6 |
7 |
1 |
1.8 |
|
1000 |
3 |
5 |
0.6 |
1.3 |
|
2500 |
9 |
7 |
1.4 |
1.7 |
|
5000 |
7 |
12 |
1.2 |
3 |
4-NOPD |
40 |
93 |
- |
15.5 |
- |
2-AA |
2.5 |
- |
184 |
- |
46.1 |
Table 7: Results Experiment I (Plate-incorporation Test). Tester strain: TA 102. Mutation factor= mean revertants (test item)/mean revertants (vehicle control)
Treatment |
Dose (µg/plate) |
Revertant colonies per plate (mean) |
Mutation factor |
||
|
|
Without S9 |
With S9 |
Without S9 |
With S9 |
Aqua dest. |
|
308 |
389 |
1.1 |
1.2 |
DMSO |
|
293 |
333 |
1 |
1 |
Test item |
31.6 |
262 |
350 |
0.9 |
1.1 |
|
100 |
264 |
326 |
0.9 |
1 |
|
316 |
289 |
305 |
1 |
0.9 |
|
1000 |
273 |
312 |
0.9 |
0.9 |
|
2500 |
302 |
338 |
1 |
1 |
|
5000 |
284 |
317 |
1 |
1 |
MMS |
1 |
2297 |
- |
7.8 |
- |
2-AA |
2.5 |
- |
788 |
- |
2.4 |
Table 8: Results Experiment II (Pre-incubation test). Tester strain: TA 98. Mutation factor= mean revertants (test item)/mean revertants (vehicle control)
Treatment |
Dose (µg/plate) |
Revertant colonies per plate (mean) |
Mutation factor |
||
|
|
Without S9 |
With S9 |
Without S9 |
With S9 |
Aqua dest. |
|
29 |
27 |
1.1 |
1 |
DMSO |
|
26 |
26 |
1 |
1 |
Test item |
31.6 |
24 |
25 |
0.9 |
1 |
|
100 |
27 |
31 |
1 |
1.2 |
|
316 |
17 |
21 |
0.7 |
0.8 |
|
1000 |
18 |
31 |
0.7 |
1.2 |
|
2500 |
30 |
29 |
1.2 |
1.1 |
|
5000 |
23 |
28 |
0.9 |
1.1 |
4-NOPD |
10 |
422 |
- |
16.2 |
- |
2-AA |
2.5 |
- |
2179 |
- |
82.7 |
Table 9: Results Experiment II (Pre-incubation test). Tester strain: TA 100. Mutation factor= mean revertants (test item)/mean revertants (vehicle control)
Treatment |
Dose (µg/plate) |
Revertant colonies per plate (mean) |
Mutation factor |
||
|
|
Without S9 |
With S9 |
Without S9 |
With S9 |
Aqua dest. |
|
65 |
84 |
1 |
1.1 |
DMSO |
|
65 |
74 |
1 |
1 |
Test item |
31.6 |
68 |
84 |
1 |
1.1 |
|
100 |
72 |
83 |
1.1 |
1.1 |
|
316 |
63 |
74 |
1 |
1 |
|
1000 |
54 |
76 |
0.8 |
1 |
|
2500 |
48 |
78 |
0.7 |
1 |
|
5000 |
62 |
88 |
0.9 |
1.2 |
4-NOPD |
10 |
372 |
- |
5.7 |
- |
2-AA |
2.5 |
- |
1698 |
- |
22.8 |
Table 10: Results Experiment II (Pre-incubation test). Tester strain: TA 1535. Mutation factor= mean revertants (test item)/mean revertants (vehicle control)
Treatment |
Dose (µg/plate) |
Revertant colonies per plate (mean) |
Mutation factor |
||
|
|
Without S9 |
With S9 |
Without S9 |
With S9 |
Aqua dest. |
|
18 |
16 |
1 |
1.1 |
DMSO |
|
18 |
15 |
1 |
1 |
Test item |
31.6 |
21 |
14 |
1.2 |
0.9 |
|
100 |
17 |
10 |
0.9 |
0.7 |
|
316 |
16 |
13 |
0.9 |
0.8 |
|
1000 |
26 |
13 |
1.5 |
0.8 |
|
2500 |
22 |
13 |
1.2 |
0.9 |
|
5000 |
20 |
13 |
1.2 |
0.8 |
4-NOPD |
10 |
985 |
- |
55.7 |
- |
2-AA |
2.5 |
- |
201 |
- |
13.4 |
Table 11: Results Experiment II (Pre-incubation test). Tester strain: TA 1537. Mutation factor= mean revertants (test item)/mean revertants (vehicle control)
Treatment |
Dose (µg/plate) |
Revertant colonies per plate (mean) |
Mutation factor |
||
|
|
Without S9 |
With S9 |
Without S9 |
With S9 |
Aqua dest. |
|
6 |
5 |
1.1 |
1.2 |
DMSO |
|
6 |
4 |
1 |
1 |
Test item |
31.6 |
6 |
5 |
1.1 |
1.2 |
|
100 |
6 |
8 |
1.1 |
1.8 |
|
316 |
4 |
5 |
0.8 |
1.2 |
|
1000 |
6 |
5 |
1.1 |
1.2 |
|
2500 |
4 |
7 |
0.8 |
1.6 |
|
5000 |
7 |
7 |
1.2 |
1.6 |
4-NOPD |
40 |
74 |
- |
13.1 |
- |
2-AA |
2.5 |
- |
207 |
- |
47.8 |
Table 12: Results Experiment II (Pre-incubation test). Tester strain: TA 102. Mutation factor= mean revertants (test item)/mean revertants (vehicle control)
Treatment |
Dose (µg/plate) |
Revertant colonies per plate (mean) |
Mutation factor |
||
|
|
Without S9 |
With S9 |
Without S9 |
With S9 |
Aqua dest. |
|
222 |
295 |
1.1 |
1.1 |
DMSO |
|
196 |
275 |
1 |
1 |
Test item |
31.6 |
197 |
252 |
1 |
0.9 |
|
100 |
203 |
257 |
1 |
0.9 |
|
316 |
200 |
233 |
1 |
0.8 |
|
1000 |
177 |
201 |
0.9 |
0.7 |
|
2500 |
172 |
236 |
0.9 |
0.9 |
|
5000 |
215 |
283 |
1.1 |
1 |
MMS |
1 |
1559 |
- |
7.9 |
- |
2-AA |
2.5 |
- |
698 |
- |
2.5 |
HISTORICAL CONTROL DATA:
Table 13: Historical laboratory control data of the negative control (in 2012-2014) without S9 (-S9)
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
Mean |
22.3 |
95.5 |
10.9 |
7.5 |
230.5 |
SD |
4.8 |
18.1 |
5.1 |
2.4 |
47.8 |
Min |
13 |
61 |
4 |
2 |
136 |
Max |
48 |
182 |
35 |
27 |
415 |
RSD [%] |
21.6 |
18.9 |
46.8 |
31.4 |
20.8 |
n |
1159 |
1281 |
1043 |
1043 |
684 |
Table 14: Historical laboratory control data of the positive control (in 2012-2014) without S9 (-S9)
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
Substance, concentration per plate |
4-NOPD 10 µg |
NaN3 10 µg |
NaN3 10 µg |
4-NOPD 40 µg |
MMS 1 µL |
Mean |
443.7 |
704.8 |
858.3 |
93.2 |
1733.5 |
SD |
183.1 |
272.7 |
320.2 |
27.3 |
408.3 |
Min |
192 |
132 |
34 |
30 |
162 |
Max |
2213 |
1498 |
1472 |
273 |
3181 |
RSD [%] |
41.3 |
38.7 |
37.3 |
29.3 |
23.6 |
n |
1172 |
1285 |
1042 |
1054 |
688 |
Table 15: Historical laboratory control data of the negative control (in 2012-2014) with S9 (+S9)
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
Mean |
29.9 |
103.4 |
9.1 |
7.6 |
290.9 |
SD |
6.2 |
17.4 |
3.3 |
2.7 |
65.3 |
Min |
13 |
68 |
4 |
3 |
91 |
Max |
61 |
194 |
34 |
31 |
495 |
RSD [%] |
20.9 |
16.8 |
36.1 |
35.3 |
22.4 |
n |
1157 |
1286 |
1042 |
1040 |
683 |
Table 16: Historical laboratory control data of the positive control (in 2012-2014) with S9 (+S9)
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
Substance, concentration per plate |
2-AA 2.5 µg |
2-AA 2.5 µg |
2-AA 2.5 µg |
2-AA 2.5 µg |
2-AA 10 µg |
Mean |
2318 |
1839.6 |
100 |
218.6 |
663.9 |
SD |
573.6 |
455.1 |
60.6 |
85.2 |
176.6 |
Min |
128 |
169 |
19 |
28 |
137 |
Max |
3606 |
3132 |
1011 |
489 |
2001 |
RSD [%] |
24.7 |
24.7 |
60.6 |
39 |
26.6 |
n |
1156 |
1284 |
1041 |
1039 |
688 |
Applicant's summary and conclusion
- Conclusions:
- In the described mutagenicity test and under the experimental conditions reported, the test item did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore, the test item is considered to be non-mutagenic in this bacterial reverse mutation assay. - Executive summary:
In a guideline study according to OECD 471, potassium hexafluorophosphate was investigated for its potential to induce gene mutations according to the plate incorporation test and the pre-incubation test using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102. In two independent experiments, concentrations of 31.6, 100, 316, 1000, 2500 and 5000 µg/plate were used. Each assay was conducted with and without metabolic activation.
No precipitation of the test item was observed in any tester strain with and without metabolic activation.
No toxic effects of the test item were noted in any of the five tester strains used up to the highest dose group evaluated with and without metabolic activation.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with the test item at any concentration level, neither in the presence nor absence of metabolic activation.
The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments.
Therefore, the test item is considered to be non-mutagenic.
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