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EC number: 216-036-7 | CAS number: 1478-61-1
- 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:
- 28 July - 28 September 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- EC Number:
- 216-036-7
- EC Name:
- 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- Cas Number:
- 1478-61-1
- Molecular formula:
- C15H16O2
- IUPAC Name:
- 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenol
- Test material form:
- solid
- Details on test material:
- Storage: ambient (5 °C – 30 °C), dark, dry
Constituent 1
- Specific details on test material used for the study:
- RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: n/a
- Specific activity: n/a
- Locations of the label: n/a
- Expiration date of radiochemical substance: n/a
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
- Stability under test conditions: unstable after repeated contact to air and light
- Solubility and stability of the test substance in the solvent/vehicle: Fully miscible in DMSO (dimethyl sulfoxide) and assumed stable.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was dissolved in in dimethyl sulphoxide by mixing on a vortex mixer on the day of each experiment. Formulated test item was used within 1 hour of preparation.
- Preliminary purification step (if any): No
- Final dilution of a dissolved solid, stock liquid or gel: Concentration of stock solution = 50 mg/mL.
- Final preparation of a solid: n/a
FORM AS APPLIED IN THE TEST (if different from that of starting material): n/a
OTHER SPECIFICS: No
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- Pre-experiment tester strains TA 98 and TA 100: 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate
Main Experiment I:0.100, 0.316, 1.00, 3.16, 10.0, 31.6, 100 and 316 µg/plate, in addition1000 µg/plate only for TA 102 (+/-S9)
Main Experiment II: 0.100, 0.316, 1.00, 3.16, 10.0, 31.6, 100 and 316 µg/plate (+/-S9) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: guideline recommended
Controls
- Untreated negative controls:
- yes
- Remarks:
- (A. dest., Eurofins Munich, Lot No. 170627,170710)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene, 4-nitro-o-phenylene-diamine
- Details on test system and experimental conditions:
- Mutation Experiment:
4,4‘-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol was tested for mutation (and toxicity) in five strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537 and TA102), using plate incorporation test (experiment I) and the pre-incubation test (experimentII), using triplicate plates for test article, vehicle and positive controls with and without metabolic activation.
For the plate incorporation test, the following materials were mixed in a test tube and poured over the surface of a minimal agar plate:
• 100 μL test solution at each dose level, solvent control negative control or reference mutagen solution (positive control)
• 500 μL S9 mix (for testing with metabolic activation) or S9 mix substitution buffer (for testing without S9)
• 100 μL bacteria suspension (cf. Preparation of Bacteria, pre-culture of the strain)
• 2000 μL
• overlay agar.
For the pre-incubation method 100 μL of the test item preparation was pre-incubated with the tester strains (100 μL) and sterile buffer or the metabolic activation system (500 μL) for 60 min at 37 °C prior to adding the overlay agar (2000 μL) and pouring onto the surface of a minimal agar plate.
For each strain and dose level, including the controls, three plates were used.
After solidification, the plates were inverted and incubated at 37 °C for at least 48 h in the dark.
Data recording and cytotoxicity evaluation:
The colonies were counted using a ProtoCOL counter (Meintrup DWS Laborgeräte GmbH). If precipitation of the test item precluded automatic counting the revertant colonies were counted by hand. In addition, tester strains with a low spontaneous mutation frequency like TA 1535 and TA 1537 were counted manually.
Cytotoxicity can be detected by a clearing or rather diminution of the background lawn (indicated as "N" or "B", respectively in the result tables) 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:
- 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 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
- 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:
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Experiment I (Plate-incorporation Test) Results
Tester Strain: TA98
Treatment
|
Dose/plate
|
|
REVERTANT COLONIES PER PLATE
|
MUTATION FACTOR |
||||||
|
Without activation (-S9) |
With activation (+S9) |
||||||||
|
Counts |
Mean |
SD |
Counts |
Mean |
SD |
-S9 |
+S9 |
||
A. dest.
|
31 18 33 |
27 |
8.1 |
25 28 29 |
27 |
2.1 |
0.9 |
1 |
||
DMSO
|
34 27 28 |
30 |
3.8 |
35 21 27 |
28 |
7.0 |
1.0 |
1.0 |
||
Test Item
|
0.100 μg |
27 19 39 |
28 |
10.1 |
33 38 39 |
37 |
3.2 |
1.0
|
1.3 |
|
Test Item |
0.316 μg |
33 30 33 |
32 |
1.2 |
37 34 37 |
36 |
1.7 |
1.1
|
1.3 |
|
Test Item |
1.00 μg |
34 26 22 |
27 |
6.1 |
33 31 37 |
33 |
1.5
|
0.9 |
1.2 |
|
Test Item |
3.16 μg |
24 24 26 |
25 |
1.2 |
31 29 35 |
32 |
3.1 |
0.8 |
1.1 |
|
Test Item |
10.0 μg |
32 22 21 |
25 |
6.1
|
33 33 29 |
32 |
2.3 |
0.8 |
1.1 |
|
Test Item |
31.6 μg |
32 16 32 |
27 |
92 |
24 44 24 |
31 |
11.5 |
0.9 |
1.1 |
|
Test Item |
100 μg |
20 B 20 B 13 B |
18 |
4.0 |
26 22 26 |
25 |
2.3
|
0.6 |
09 |
|
Test Item |
316 μg |
10 B 1 B 0 B |
4 |
5.5 |
0 B 0 B 0 B |
0 |
0.0 |
0.1
|
0.0 |
|
4-NOPD |
10 μg |
249 340 288 |
292 |
45.7 |
/ / / |
/ |
/ |
9.9 |
/ |
|
2-AA |
2.5 μg |
/ / / |
/ |
/ |
2002 1486 1563 |
1684 |
278.4 |
/ |
60.9 |
Taster Strain: TA100
Treatment
|
Dose/plate
|
|
REVERTANT COLONIES PER PLATE
|
MUTATION FACTOR |
||||||
|
Without activation (-S9) |
With activation (+S9) |
||||||||
|
Counts |
Mean |
SD |
Counts |
Mean |
SD |
-S9 |
+S9 |
||
A. dest.
|
106 87 103 |
99 |
10.2 |
91 77 86 |
85 |
7.1 |
1.1 |
1.0 |
||
DMSO
|
105 80 83 |
89 |
13.7 |
83 99 82 |
88 |
9.5 |
1.0 |
1.0 |
||
Test Item
|
0.100 μg |
85 72 110 |
89 |
19.3 |
87 73 82 |
81 |
7.1 |
1.0
|
0.9 |
|
Test Item |
0.316 μg |
71 78 71 |
73 |
4.0 |
101 89 99 |
96 |
6.4 |
0.8
|
1.1 |
|
Test Item |
1.00 μg |
102 102 72 |
92 |
17.3 |
86 83 87 |
85 |
2.1
|
1.0 |
1.0 |
|
Test Item |
3.16 μg |
95 79 96 |
90 |
9.5 |
86 83 87 |
84 |
8.7 |
1.0 |
1.0 |
|
Test Item |
10.0 μg |
93 76 82 |
84 |
8.6
|
73 85 92 |
83 |
9.6 |
0.9 |
0.9 |
|
Test Item |
31.6 μg |
89 91 96 |
92 |
3.6 |
87 91 105 |
94 |
9.5 |
1.0 |
1.1 |
|
Test Item |
100 μg |
0B 0B 0B |
0 |
0.0 |
83 B 60 B 54 B |
66 |
15.3
|
0.0 |
0.7 |
|
Test Item |
316 μg |
0 N 0 N 0 N |
0 |
0.0 |
0 B 0 B 0 B |
0 |
0.0 |
0.0
|
0.0 |
|
NaN3 |
10 μg |
644 772 792 |
736 |
80.3 |
/ / / |
/ |
/ |
8.2 |
/ |
|
2-AA |
2.5 μg |
/ / / |
/ |
/ |
1051 1576 1314 |
1314 |
262.5 |
/ |
14.9 |
ester Strain: TA1535
Treatment
|
Dose/plate
|
|
REVERTANT COLONIES PER PLATE
|
MUTATION FACTOR |
||||||
|
Without activation (-S9) |
With activation (+S9) |
||||||||
|
Counts |
Mean |
SD |
Counts |
Mean |
SD |
-S9 |
+S9 |
||
A. dest.
|
24 21 21 |
22 |
1.7 |
28 22 20 |
23 |
4.2 |
1.2 |
1.2 |
||
DMSO
|
15 22 18 |
18 |
3.5 |
20 18 20 |
19 |
1.2 |
1.0 |
1.0 |
||
Test Item
|
0.100 μg |
19 24 22 |
22 |
2.5 |
17 15 20 |
17 |
2.5 |
1.2
|
0.9 |
|
Test Item |
0.316 μg |
17 29 18 |
21 |
6.7 |
18 20 19 |
19 |
1.0 |
1.2
|
1.0 |
|
Test Item |
1.00 μg |
21 26 23 |
23 |
2.5 |
19 26 21 |
22 |
3.6
|
1.3 |
1.1 |
|
Test Item |
3.16 μg |
21 18 23 |
21 |
2.5 |
15 25 16 |
19 |
5.5 |
1.1 |
1.0 |
|
Test Item |
10.0 μg |
17 21 21 |
20 |
2.3
|
24 25 17 |
22 |
4.4 |
1.1 |
1.1 |
|
Test Item |
31.6 μg |
24 12 21 |
19 |
6.2 |
29 10 13 |
21 |
9.7 |
1.0 |
1.1 |
|
Test Item |
100 μg |
0B 0B 0B |
0 |
0.0 |
7 B 3 B 2 B |
4 |
2.6
|
0.0 |
0.2 |
|
Test Item |
316 μg |
0 N 0 N 0 N |
0 |
0.0 |
0 B 0 B 0 B |
0 |
0.0 |
0.0
|
0.0 |
|
NaN3 |
10 μg |
716 825 749 |
763 |
55.9 |
/ / / |
/ |
/ |
41.6 |
/ |
|
2-AA |
2.5 μg |
/ / / |
/ |
/ |
129 92 158 |
126 |
33.1 |
/ |
65 |
Tester Strain: TA3537
Treatment
|
Dose/plate
|
|
REVERTANT COLONIES PER PLATE
|
MUTATION FACTOR |
||||||
|
Without activation (-S9) |
With activation (+S9) |
||||||||
|
Counts |
Mean |
SD |
Counts |
Mean |
SD |
-S9 |
+S9 |
||
A. dest.
|
12 12 13 |
12 |
0.6 |
9 8 9 |
9 |
0.6 |
1.0 |
1.1 |
||
DMSO
|
11 14 11 |
12 |
1.7 |
7 7 10 |
8 |
1.7 |
1.0 |
1.0 |
||
Test Item
|
0.100 μg |
12 12 11 |
12 |
0.6 |
10 11 10 |
10 |
0.6 |
1.0
|
1.3 |
|
Test Item |
0.316 μg |
13 11 12 |
12 |
1.0 |
9 9 9 |
9 |
0.0 |
1.0
|
1.1 |
|
Test Item |
1.00 μg |
12 10 14 |
12 |
2.0 |
8 6 9 |
8 |
1.5
|
1.0 |
1.0 |
|
Test Item |
3.16 μg |
11 10 12 |
11 |
1.0 |
8 11 7 |
9 |
2.1 |
0.9 |
1.1 |
|
Test Item |
10.0 μg |
11 10 12 |
11 |
1.0
|
12 10 7 |
10 |
2.5 |
0.9 |
1.2 |
|
Test Item |
31.6 μg |
13 12 9 |
11 |
2.1 |
9 8 8 |
8 |
0.6 |
0.9 |
1.0 |
|
Test Item |
100 μg |
5B 7B 4B |
5 |
1.5 |
4 B 2 B 1 B |
2 |
1.5
|
0.4 |
0.3 |
|
Test Item |
316 μg |
1B 2B 1B |
1 |
0.6 |
0 B 0 B 0 B |
0 |
0.0 |
0.1
|
0.0 |
|
4-NOPD |
10 μg |
79 71 84 |
78 |
6.6 |
/ / / |
/ |
/ |
6.5 |
/ |
|
2-AA |
2.5 μg |
/ / / |
/ |
/ |
222 245 229 |
232 |
11.8 |
/ |
29.0 |
Tester Strain: TA102
Treatment
|
Dose/plate
|
|
REVERTANT COLONIES PER PLATE
|
MUTATION FACTOR |
||||||||
|
Without activation (-S9) |
With activation (+S9) |
||||||||||
|
Counts |
Mean |
SD |
Counts |
Mean |
SD |
-S9 |
+S9 |
||||
A. dest.
|
241 248 223 |
237 |
12.9 |
297 261 258 |
272 |
21.7 |
1.3 |
1.3 |
||||
DMSO
|
204 192 167 |
188 |
18.9 |
214 219 193 |
209 |
13.8 |
1.0 |
1.0 |
||||
Test Item
|
0.100 μg |
224 211 242 |
226 |
15.6 |
272 277 244 |
264 |
17.8 |
1.2
|
1.3 |
|||
Test Item |
0.316 μg |
234 232 195 |
220 |
22.0 |
330 324 344 |
333 |
10.3 |
1.2
|
1.6 |
|||
Test Item |
1.00 μg |
233 202 244 |
226 |
21.8 |
308 284 320 |
304 |
18.3
|
1.2 |
1.5 |
|||
Test Item |
3.16 μg |
218 257 230 |
235 |
20.0 |
276 292 331 |
300 |
28.3 |
1.3 |
1.4 |
|||
Test Item |
10.0 μg |
189 194 169 |
184 |
13.2
|
280 292 209 |
260 |
44.9 |
1.0 |
1.2 |
|||
Test Item |
31.6 μg |
211 192 234 |
212 |
21.0 |
282 345 347 |
325 |
37.0 |
1.1 |
1.6 |
|||
Test Item |
100 μg |
117 B 66 B 84 B |
89 |
25.9 |
206 256 266 |
243 |
32.1
|
1.1 |
1.6 |
|||
Test Item |
316 μg |
0 B 0 B 0 B |
0 |
0.0 |
206 235 216 |
219 |
14.7 |
0.0
|
1.0 |
|||
Test Item |
1000 μg |
0 B 0 B 0 B |
0 |
0.0 |
74 B 53 B 52 |
60 |
12.4 |
0.0 |
1.0 |
|||
MMS |
1 μL |
1355 1884 1837 |
1692 |
292.8 |
/ / / |
/ |
/ |
9.0 |
/ |
|||
2-AA |
2.5 μg |
/ / / |
/ |
/ |
713 779 789 |
760 |
41.3 |
/ | 3.6 |
Table 2: Experiment II(Pre-incubation Test) Results II
Tester Strain: TA98
Treatment
|
Dose/plate
|
|
REVERTANT COLONIES PER PLATE
|
MUTATION FACTOR |
||||||
|
Without activation (-S9) |
With activation (+S9) |
||||||||
|
Counts |
Mean |
SD |
Counts |
Mean |
SD |
-S9 |
+S9 |
||
A. dest.
|
27 24 24 |
25 |
1.7 |
24 31 22 |
26 |
4.7 |
1.1 |
1.1 |
||
DMSO
|
28 18 24 |
23 |
5.0 |
24 26 18 |
23 |
4.2 |
1.0 |
1.0 |
||
Test Item
|
0.100 μg |
27 26 27 |
27 |
0.6 |
37 21 21 |
26 |
9.2 |
1.1
|
1.2 |
|
Test Item |
0.316 μg |
21 18 25 |
21 |
3.5 |
27 24 21 |
24 |
3.0 |
0.9
|
1.1 |
|
Test Item |
1.00 μg |
19 24 25 |
23 |
3.2 |
19 23 19 |
20 |
2.3
|
1.0 |
0.9 |
|
Test Item |
3.16 μg |
20 21 18 |
20 |
1.5 |
18 23 18 |
20 |
2.9 |
0.8 |
0.9 |
|
Test Item |
10.0 μg |
22 21 28 |
24 |
3.8
|
27 17 27 |
24 |
5.8 |
1.0 |
1.0 |
|
Test Item |
31.6 μg |
25 28 23 |
25 |
2.5 |
25 24 23 |
24 |
1.0 |
1.1 |
1.1 |
|
Test Item |
100 μg |
0B 0B 0B |
0 |
0.0 |
2 B 5 B 7 B |
5 |
2.5
|
0.0 |
0.2 |
|
Test Item |
316 μg |
0 N 0 N 0 N |
0 |
0.0 |
0 B 0 B 0 B |
0 |
0.0 |
0.0
|
0.0 |
|
4-NOPD |
10 μg |
250 288 248 |
262 |
22.5 |
/ / / |
/ |
/ |
11.2 |
/ |
|
2-AA |
2.5 μg |
/ / / |
/ |
/ |
340 598 554 |
497 |
138.0 |
/ |
21.9 |
Tester Strain: TA100
Treatment
|
Dose/plate
|
|
REVERTANT COLONIES PER PLATE
|
MUTATION FACTOR |
||||||
|
Without activation (-S9) |
With activation (+S9) |
||||||||
|
Counts |
Mean |
SD |
Counts |
Mean |
SD |
-S9 |
+S9 |
||
A. dest.
|
87 96 88 |
90 |
4.9 |
113 89 99 |
100 |
12.1 |
1.1 |
1.1 |
||
DMSO
|
70 84 85 |
80 |
8.4 |
100 78 87 |
88 |
11.1 |
1.0 |
1.0 |
||
Test Item
|
0.100 μg |
90 93 92 |
92 |
1.5 |
99 76 89 |
88 |
11.5 |
1.2
|
1.0 |
|
Test Item |
0.316 μg |
109 81 76 |
89 |
17.8 |
79 86 71 |
79 |
7.5 |
1.1
|
0.9 |
|
Test Item |
1.00 μg |
104 98 85 |
96 |
9.7 |
74 78 69 |
74 |
4.5
|
1.2 |
0.8 |
|
Test Item |
3.16 μg |
97 75 91 |
88 |
11.4 |
73 79 106 |
86 |
17.6 |
1.1 |
1.0 |
|
Test Item |
10.0 μg |
65 97 75 |
79 |
16.4
|
83 83 75 |
80 |
4.6 |
1.0 |
0.9 |
|
Test Item |
31.6 μg |
51 56 53 |
53 |
2.5 |
105 85 86 |
92 |
11.3 |
0.7 |
1.0 |
|
Test Item |
100 μg |
0B 0B 0B |
0 |
0.0 |
51 B 45 B 52 B |
49 |
3.8
|
0.0 |
0.6 |
|
Test Item |
316 μg |
0 N 0 N 0 N |
0 |
0.0 |
0 N 0 N 0 N |
0 |
0.0 |
0.0
|
0.0 |
|
NaN3 |
10 μg |
516 553 797 |
622 |
152.7 |
/ / / |
/ |
/ |
7.8 |
/ |
|
2-AA |
2.5 μg |
/ / / |
/ |
/ |
1060 666 850 |
859 |
197.1 |
/ |
9.7 |
Tester Strain: TA1535
Treatment
|
Dose/plate
|
|
REVERTANT COLONIES PER PLATE
|
MUTATION FACTOR |
||||||
|
Without activation (-S9) |
With activation (+S9) |
||||||||
|
Counts |
Mean |
SD |
Counts |
Mean |
SD |
-S9 |
+S9 |
||
A. dest.
|
12 14 13 |
13 |
1.0 |
15 15 16 |
15 |
0.6 |
1.0 |
1.0 |
||
DMSO
|
15 12 14 |
14 |
1.5 |
17 13 16 |
15 |
2.1 |
1.0 |
1.0 |
||
Test Item
|
0.100 μg |
12 14 16 |
14 |
1.5 |
13 15 14 |
14 |
1.0 |
1.0
|
0.9 |
|
Test Item |
0.316 μg |
14 14 12 |
13 |
1.2 |
15 12 16 |
14 |
2.1 |
1.0
|
0.9 |
|
Test Item |
1.00 μg |
13 15 15 |
14 |
1.2 |
17 15 16 |
16 |
1.0
|
1.0 |
1.0 |
|
Test Item |
3.16 μg |
16 14 17 |
16 |
1.5 |
18 16 15 |
16 |
1.5 |
1.1 |
1.1 |
|
Test Item |
10.0 μg |
13 15 15 |
14 |
1.2
|
15 16 17 |
16 |
1.0 |
1.0 |
1.0 |
|
Test Item |
31.6 μg |
17 13 13 |
14 |
2.3 |
18 15 16 |
16 |
1.5 |
1.0 |
1.1 |
|
Test Item |
100 μg |
1 B 2 B 3 B |
2 |
0.0 |
2 B 5 B 4 B |
4 |
1.5
|
0.1 |
0.2 |
|
Test Item |
316 μg |
0 N 0 N 0 N |
0 |
0.0 |
0 B 0 B 0 B |
0 |
0.0 |
0.0
|
0.0 |
|
NaN3 |
10 μg |
919 923 915 |
919 |
4.0 |
/ / / |
/ |
/ |
67.2 |
/ |
|
2-AA |
2.5 μg |
/ / / |
/ |
/ |
56 79 53 |
63 |
14.2 |
/ |
4.1 |
Tester Strain: TA1537
Treatment
|
Dose/plate
|
|
REVERTANT COLONIES PER PLATE
|
MUTATION FACTOR |
||||||
|
Without activation (-S9) |
With activation (+S9) |
||||||||
|
Counts |
Mean |
SD |
Counts |
Mean |
SD |
-S9 |
+S9 |
||
A. dest.
|
10 8 10 |
9 |
1.2 |
10 8 11 |
10 |
1.5 |
1.1 |
0.9 |
||
DMSO
|
9 7 9 |
8 |
1.2 |
11 9 11 |
10 |
1.2 |
1.0 |
1.0 |
||
Test Item
|
0.100 μg |
8 11 9 |
9 |
1.5 |
8 9 9 |
9 |
0.6 |
1.1
|
0.8 |
|
Test Item |
0.316 μg |
9 8 11 |
9 |
1.5 |
7 7 11 |
8 |
2.3 |
1.1
|
0.8 |
|
Test Item |
1.00 μg |
8 7 9 |
8 |
1.0 |
8 9 7 |
8 |
1.0
|
1.0 |
0.8 |
|
Test Item |
3.16 μg |
11 8 8 |
9 |
1.7 |
14 0 9 |
8 |
7.1 |
1.1 |
0.9 |
|
Test Item |
10.0 μg |
9 10 9 |
9 |
0.6
|
9 12 8 |
10 |
2.1 |
1.1 |
0.9 |
|
Test Item |
31.6 μg |
8 8 11 |
9 |
1.7 |
8 9 11 |
9 |
1.5 |
1.1 |
09 |
|
Test Item |
100 μg |
1B 2B 2B |
2 |
0.6 |
2 B 3 B 2 B |
2 |
0.6
|
0.2 |
0.2 |
|
Test Item |
316 μg |
0 N 0 N 0 N |
0 |
0.0 |
0 N 0 N 0 N |
0 |
0.0 |
0.0
|
0.0 |
|
4-NOPD |
40 μg |
78 84 89 |
84 |
5.5 |
/ / / |
/ |
/ |
10.0 |
/ |
|
2-AA |
2.5 μg |
/ / / |
/ |
/ |
250 277 218 |
248 |
29.5 |
/ |
24.0 |
Tester Strain: TA102
Treatment
|
Dose/plate
|
|
REVERTANT COLONIES PER PLATE
|
MUTATION FACTOR |
||||||
|
Without activation (-S9) |
With activation (+S9) |
||||||||
|
Counts |
Mean |
SD |
Counts |
Mean |
SD |
-S9 |
+S9 |
||
A. dest.
|
365 347 321 |
344 |
22.1 |
454 421 425 |
433 |
18.0 |
1.2 |
1.2 |
||
DMSO
|
307 263 297 |
289 |
23.12 |
383 361 325 |
373 |
11.1 |
1.0 |
1.0 |
||
Test Item
|
0.100 μg |
257 301 315 |
291 |
30.4 |
371 354 344 |
350 |
23.3 |
1.0
|
0.9 |
|
Test Item |
0.316 μg |
307 316 314 |
312 |
4.7 |
357 355 344 |
352 |
7.0 |
1.1
|
0.9 |
|
Test Item |
1.00 μg |
256 302 317 |
292 |
31.8 |
365 249 206 |
273 |
82.2
|
1.0 |
0.7 |
|
Test Item |
3.16 μg |
343 343 317 |
338 |
8.1 |
303 249 206 |
345 |
37.1 |
1.2 |
0.9 |
|
Test Item |
10.0 μg |
284 277 299 |
286 |
9.6
|
346 364 360 |
357 |
9.5 |
1.0 |
1.0 |
|
Test Item |
31.6 μg |
336 285 235 |
285 |
50.5 |
353 361 350 |
355 |
5.7 |
1.0 |
1.0 |
|
Test Item |
100 μg |
166 B 133 B 118 B |
139 |
24.6 |
372 354 352 |
359 |
11.0
|
0.5 |
1.0 |
|
Test Item |
316 μg |
31 N 32 N 17 N |
27 |
8.4 |
126 B 280 B 280 B |
229 |
88.9 |
0.1
|
0.6 |
|
MMS |
1 μL |
1471 1507 1559 |
1512 |
44.2 |
/ / / |
/ |
/ |
5.3 |
/ |
|
2-AA |
10 μg |
/ / / |
/ |
/ |
1021 804 840 |
888 |
116.3 |
/ |
2.4 |
SD: Standard-deviation P: Precipitation
B: Background lawn reduced C: Contamination
N: No background lawn
Mutation Factor = Mean revertants (test item)/Mean revertants (vehicle control)
Applicant's summary and conclusion
- Conclusions:
- The test item was considered to be non-mutagenic under the conditions of the test.
- Executive summary:
OECD 471 (2017) - In a reverse gene mutation assay in bacteria, strains TA98, TA100, TA102, TA1535 and TA1537 of S. typhimurium were exposed to 4,4'- [2,2,2 -trifluoro-1 -(trifluoromethyl)ethylidene]diphenol in DMSO at concentrations of 0.100, 0.316, 1.00, 3.16, 10.0, 31.6, 100 and 316 µg/plate, in addition1000 µg/plate only for TA 102 (+/-S9) and 0.100, 0.316, 1.00, 3.16, 10.0, 31.6, 100 and 316 µg/plate (+/-S9).
The test item was tested up to cytotoxic concentrations. All positive controls induced the appropriate responses in the corresponding strains.
There was no evidence of induced mutant colonies over background in the test item treated colonies.
This study was classified as acceptable and it satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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