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EC number: 244-479-6 | CAS number: 21615-47-4
- 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
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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 -13 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 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- yes
- Remarks:
- missing DMSO (solvent for positive controls) control
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ammonium undecafluorohexanoate
- EC Number:
- 244-479-6
- EC Name:
- Ammonium undecafluorohexanoate
- Cas Number:
- 21615-47-4
- Molecular formula:
- C6H4F11NO2
- IUPAC Name:
- 2,2,3,3,4,4,5,5,6,6,6-Undecafluorohexanoic acid, ammonium salt (1:1)
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains)
trp operon (for E. coli strain)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital (one time at 30 mg/kg bw and three times at 60 mg/kg bw) and 5,6-benzoflavone (one time at 80 mg/kg bw)
- Test concentrations with justification for top dose:
- The test substance was corrected by the purity (50%) before preparation of dosing solutions.
Experiment 1: 4.88, 19.5, 78.1, 313, 1250 and 5000 µg/mL
Experiment 2: 313, 625, 1250, 2500 and 5000 µg/mL - Vehicle / solvent:
- - Vehicle/solvent used: destilled water (test substance and NaN3), DMSO (AF-2, ICR-191 and 2AA)
- Justification for choice of solvent/vehicle: The solvent was chosen based on a good solubililty and stability (no change in color, exothermic reaction nor gas generation at room temperature within 4 h) at 50 mg/mL .
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 2-Aminoanthracene (2AA); 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamine (AF-2); ICR-191
- Remarks:
- Efficasy of S9-mix was characterised with benzo(a)pyrene and 9,10-dimethylanthracene (mutagens that requires metabolic activation by microsomal enzymes).
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
- Cell density at seeding:
Experiment 1: 2.9, 3.2, 6.9, 4.5 and 3.7 x10E9 cells/mL for TA100, TA1535, WP2uvrA, TA98 and TA1535, respectively
Experiment 2: 2.5, 3.2, 6.6, 4.7 and 3.4 x10E9 cells/mL for TA100, TA1535, WP2uvrA, TA98 and TA1535, respectively
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: Triplicates each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn observed using a stereomicroscope
- OTHER: All plates were counted with a colony analyzer (CA-1 lD, SYSTEM SCIENCE). Square correction and miscounting correction were conducted when counting with the colony analyzer. - Evaluation criteria:
- The test substance was judged to be positive when the number of revertant colonies increased to twice or more than that in the negative control and when the responses were dose-related and/or reproducible.
- Statistics:
- Mean values and standard deviations were calculated.
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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test substance was observed in either the presence or absence of S9 mix.
HISTORICAL CONTROL DATA : The test results showed that the numbers of revertant colonies in the negative and positive controls were within the range of the historical data at the testing facility.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Bacterial growth inhibition was not observed at any test condition.
Any other information on results incl. tables
Table 1. Results of experiment 1 (pre-incubation method)
|
Number of revertant colonies per plate |
||||
S9-Mix |
Without |
||||
Test substance (µg/plate) |
TA 100 |
TA 1535 |
WP2 uvr A |
TA 98 |
TA1537 |
SC |
133 ± 10 |
13 ± 3 |
32 ± 7 |
16 ± 2 |
16 ± 3 |
4.88 |
136 ± 17 |
9 ± 5 |
34 ± 8 |
15 ± 4 |
16 ± 1 |
19.5 |
119 ± 7 |
14 ± 4 |
37 ± 8 |
15 ± 2 |
18 ± 8 |
78.1 |
130 ± 15 |
9 ± 2 |
39 ± 2 |
17 ± 3 |
19 ± 7 |
313 |
136 ± 13 |
10 ± 5 |
36 ± 6 |
17 ± 3 |
16 ± 10 |
1250 |
149 ± 4 |
10 ± 4 |
31 ± 9 |
21 ± 4 |
16 ± 3 |
5000 |
132 ± 20 |
16 ± 6 |
34 ± 7 |
18 ± 7 |
15 ± 3 |
Positive Control |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
Dose (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
0.5 |
Number of revertant colonies/plate |
899 ± 70 |
361 ± 31 |
164 ± 8 |
478 ± 27 |
720 ± 42 |
S9-Mix |
With |
||||
Test substance (µg/plate) |
TA 100 |
TA 1535 |
WP2 uvr A |
TA 98 |
TA 1537 |
SC |
139 ± 17 |
10 ± 2 |
29 ± 3 |
24 ± 3 |
20 ± 10 |
4.88 |
119 ± 9 |
15 ± 6 |
33 ± 7 |
24 ± 5 |
20 ± 3 |
19.5 |
134 ± 12 |
14 ± 3 |
35 ± 11 |
24 ± 5 |
20 ± 3 |
78.1 |
135 ± 16 |
6 ± 2 |
37 ± 10 |
31 ± 15 |
18 ± 3 |
313 |
126 ± 8 |
12 ± 1 |
34 ± 4 |
27 ± 5 |
17 ± 7 |
1250 |
117 ± 10 |
7 ± 1 |
32 ± 6 |
20 ± 1 |
22 ± 10 |
5000 |
113 ± 17 |
8 ± 4 |
40 ± 2 |
26 ± 6 |
22 ± 5 |
Positive Control |
2AA |
2AA |
2AA |
2AA |
2AA |
Dose (µg/plate) |
1 |
2 |
10 |
0.5 |
2 |
Number of revertant colonies/plate |
1517 ± 53 |
368 ± 11 |
627 ± 56 |
506 ± 26 |
250 ± 35 |
SC = Solvent Control (distilled water) NaN3: sodium acide; 2AA: 2-Aminoanthracene; AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamine |
Table 2. Results of experiment 2 (pre-incubation method)
|
Number of revertant colonies per plate |
||||
S9-Mix |
Without |
||||
Test substance (µg/plate) |
TA 100 |
TA 1535 |
WP2 uvr A |
TA 98 |
TA1537 |
SC |
131 ± 12 |
13 ± 5 |
38 ± 4 |
18 ± 6 |
22 ± 2 |
313 |
123 ± 26 |
12 ± 1 |
30 ± 8 |
26 ± 8 |
19 ± 2 |
625 |
144 ± 23 |
14 ± 3 |
34 ± 8 |
21 ± 3 |
19 ± 8 |
1250 |
142 ± 20 |
9 ± 2 |
34 ± 10 |
19 ± 4 |
22 ± 3 |
2500 |
143 ± 2 |
9 ± 5 |
29 ± 8 |
20 ± 5 |
18 ± 2 |
5000 |
133 ± 20 |
10 ± 2 |
30 ± 8 |
17 ± 5 |
17 ± 5 |
Positive Control |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
Dose (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
0.5 |
Number of revertant colonies/plate |
969 ± 45 |
324 ± 32 |
157 ± 5 |
575 ± 39 |
658 ± 55 |
S9-Mix |
With |
||||
Test substance (µg/plate) |
TA 100 |
TA 1535 |
WP2 uvr A |
TA 98 |
TA 1537 |
SC |
144 ± 8 |
11 ± 3 |
36 ± 7 |
29 ± 11 |
25 ± 0 |
313 |
109 ± 13 |
8 ± 5 |
31 ± 8 |
28 ± 4 |
27 ± 7 |
625 |
123 ± 18 |
9 ± 3 |
33 ± 10 |
30 ± 10 |
27 ± 6 |
1250 |
128 ± 4 |
11 ± 6 |
39 ± 8 |
21 ± 7 |
27 ± 7 |
2500 |
114 ± 5 |
8 ± 2 |
37 ± 3 |
29 ± 4 |
21 ± 6 |
5000 |
114 ± 22 |
9 ± 6 |
35 ± 8 |
26 ± 5 |
26 ± 14 |
Positive Control |
2AA |
2AA |
2AA |
2AA |
2AA |
Dose (µg/plate) |
1 |
2 |
10 |
0.5 |
2 |
Number of revertant colonies/plate |
1757 ± 91 |
385 ± 35 |
585 ± 42 |
485 ± 29 |
274 ± 35 |
SC = Solvent Control (distilled water) NaN3: sodium acide; 2AA: 2-Aminoanthracene; AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamine |
Table 3. Histrorical negative control data (mean ± 3S.D.)
-S9 mix |
+S9mix |
|||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|
Mean S.D. |
119 25 |
11 4 |
32 10 |
20 6 |
12 6 |
124 23 |
11 4 |
31 10 |
29 8 |
14 6 |
UpperLimit Lower Limit |
194 44 |
23 1 |
62 2 |
38 2 |
30 1 |
193 55 |
23 1 |
61 1 |
53 5 |
32 1 |
Table 4. Historical positive control data (mean± 3S.D.)
|
-S9 mix |
+S9mix |
||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|
Chemical |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
2AA |
2AA |
2AA |
2AA |
2AA |
Dose(µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
0.5 |
1 |
2 |
10 |
0.5 |
2 |
Mean S.D. |
854 104 |
312 57 |
112 21 |
498 54 |
635 103 |
1561 194 |
292 35 |
379 101 |
397 40 |
207 39 |
Upper Limit Lower Limit |
1166 542 |
483 141 |
175 49 |
660 336 |
944 326 |
2143 979 |
397 187 |
682 76 |
517 277 |
324 90 |
AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
NaN3: Sodiumazide
2AA.: 2-Aminoanthracene
Test period: From September, 2016 to February, 2017
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the conducted test the substance was not mutagenic in any of the five strains (TA 1535, TA 1537, TA 98, TA 100 and WP2 uvrA) tested with and without metabolic activation.
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