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EC number: 204-126-9 | CAS number: 116-14-3
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:
- 1/30/86 - 2/26/86
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Ames-114, Editon 4
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tetrafluoroethylene
- EC Number:
- 204-126-9
- EC Name:
- Tetrafluoroethylene
- Cas Number:
- 116-14-3
- Molecular formula:
- C2F4
- IUPAC Name:
- tetrafluoroethene
- Details on test material:
- - Name of test material (as cited in study report): tetrafluoroethylene
- Substance type: pure active substance
- Physical state: gas
- Analytical purity: 99.12
- Impurities (identity and concentrations): 0.88% octafluorocyclobutane
- Composition of test material, percentage of components:
- Lot/batch No.: 10223
- Stability under test conditions: The test material was determined to be stable throughout the exposure phase of the study. The sample analysis were performed at Haskell Laboratory.
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: TA 1537, TA 1535, TA 100, TA98 and TA 97
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 0, 0.5, 3, 4 or 5%
- Vehicle / solvent:
- air; control air.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- 2-amino anthracene (2-AA); N-methyl-N'-nitroso-N-nitroguanidine (MNNG); 2-Nitrofluorene (2-NF); for strains TA1535 and TA100 vinyl chloride (VC)
- Positive control substance:
- other: 2-aminoanthracene, 9-aminoacridine, N-methyl-N'-nitrosoguanidine, 2-nitrofluorene. The solvent used for these positive indicators was DMSO. For strains TA1535 and TA100, vinyl chloride mixed with air was used in activated treatments.
- Details on test system and experimental conditions:
- 48 hours exposure
- Evaluation criteria:
- Classification:
A test sample is classified as POSITIVE when:
a) The number of induced revertants at one or more of the test sample concentrations are at least two times greater than the nunber of revertants in the solven control. The dose levels must have a probability of less than 0.01 that the number of induced revertants are the same as the spontaneous revertant number.
And
b) The probability is less than 0.01 that there is not a positive correlation between the number of revertants and increasing concentrations of the test sample.
A test sample is classified as NEGATIVE when:
a) The probability is greater than 0.05 that the numbers of revertants at each of the test sample concentrations studies are not greater than the number of revertants in the solvent control.
And
b) The probability is greater than 0.05 that there is not a positive correlation between the numbers of revertants and increasing concentrations of the test sample.
A test sample is classified as EQUIVOCAL when:
a) neither the criteria for a positve or negative are satisfied. - Statistics:
- Individual sets of data consisting of two acceptable trials performed in each strain with or without activation were analysed according to the statistical method of R.D. Snee and J.D Irr (Mutation Research 128: 115-125, 1984). The power transformation for this assay was established as 0.20. The probability values were determined on the transformed data based on the analysis of Dunnet (Dunlap, W.P. , Marx, M.S., and G.J. Agamy Behavioural Research Methods and Instrumentation 13:363-366, 1981).
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium strains TA1535, TA97, TA98 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
In the cytoxicity assessment with strain TA 98 (Table 1) TFE was evaluated up to an approximate concentration of 5.0% (5.5% measured). This maximum concentration (1/2 the lower flammability limit of TFE in air) was chosen to avoid possible safety hazards. Based on the cytotoxicity results, mutagenicity testing, both with and without metabolic activation, was conducted at approximate concentrations of 1, 3, 4 and 5 %.The mutagenicity data obtained from strains TA1535, TA97, TA98 and TA100 are presented in Tables 2 - 5 repectively. Actual measured concentrations, as reported in the tables, ranged from 0.5 to 4.8% TFE. No significant increases in revertants or positive linear dose-responses were seen in any of the strains. Under the conditions of this assay TFE was negative.
Table 1: Genotoxicity in Salmonella Typhimurium Strain TA98
| Compound | Concentration | Without Activation | With Activation |
| % | Colonies / Plate (duplicate Plates)a | Colonies /Plate (duplicate Plates) | |
| TFE | 0 (control) | 32, 22 | 1038, 1156 |
| '' | 1.6 | 18, 5 | 938, 985 |
| '' | 3.4 | 23, 36 | 1248, 1182 |
| '' | 4.3 | 21, 6 | 1043, 1180 |
| '' | 5.5 | 34, 36 | 1101, 1065 |
a Non-activated results were unexplainably low. However, due to a limited supply of TFE, the mutagenicity trials proceded tested up to the maximal allowed concentration of 5% (estimated) of TFE.
Table 2: Mutagenic Activity of TFE in Salmonella Typhimurium Strain TA1535
| Compound | Concentration | Revertants per Plate (Duplicate Plates) | |||
| % | Without Activation | With Activation | |||
| Trial 1 | Trial 2 | Trial 1 | Trial 2 | ||
| TFE | 0 (Control) | 22, 25 | 20, 27 | 19, 23 | 20, 19 |
| '' | 0.49 +/- 0.02 | --, -- | 26,21 | ||
| '' | 0.82 +/- 0.03 | 22, 26 | --, -- | 19, 25 | --, -- |
| '' | 0.92 +/- 0.02 | --, -- | 27, 21 | --, -- | 17, 21 |
| '' | 1.39 +/- 0.02 | 34, 35 | --, -- | 18, 16 | --, -- |
| '' | 2.04 +/- 0.05 | --, -- | 26, 29 | --, -- | 23, 26 |
| '' | 2.79 +/- 0.10 | --, -- | 21, 36 | --, -- | 25, 26 |
| '' | 2.87 +/- 0.00 | 28, 33 | --, -- | 15, 13 | --, -- |
| '' | 3.17 +/- 0.02 | --, -- | 27, 30 | --, -- | 29, 26 |
| '' | 3.69 +/- 0.13 | 33, 27 | --, -- | 13, 14 | --, -- |
| '' | 4.82 +/- 0.02 | 29, 29 | --, -- | 4, 19 | --, -- |
| MNNG | 4 (ug/plate) | 2372, 2551 | 3630,2592 | ||
| VC | 1.5a | 99, 128 | --, -- | ||
| 2.2a | --, -- | 115, 79 | |||
aonly one chamber was used for VC exposure
Table 3: Mutagenic Activity of TFE in Salmonella Typhimurium Strain TA97
Compound |
Concentration |
Revertants per Plate (Duplicate Plates) |
|||
|
% |
Without Activation |
With Activation |
||
|
|
Trial 1 |
Trial 2 |
Trial 1 |
Trial 2 |
TFE |
0 (Control) |
143, 159 |
146, 144 |
182, 197 |
190, 171 |
'' |
0.49 +/- 0.02 |
--, -- |
147, 156 |
--, -- |
187, 168 |
'' |
0.82 +/- 0.03 |
162, 157 |
--, -- |
215, 196 |
--, -- |
'' |
0.92 +/- 0.02 |
--, -- |
157, 147 |
--, -- |
156, 159 |
'' |
1.39 +/- 0.02 |
156, 142 |
--, -- |
166, 198 |
--,-- |
'' |
2.04 +/- 0.05 |
--, -- |
140, 129 |
--. -- |
168, 146 |
'' |
2.79 +/- 0.10 |
--, -- |
116, 119 |
--, -- |
175, 197 |
'' |
2.87 +/- 0.00 |
135, 142 |
--, -- |
198, 186 |
--, -- |
'' |
3.17 +/- 0.02 |
--, -- |
134, 142 |
--, -- |
155, 172 |
'' |
3.69 +/- 0.13 |
144, 151 |
--, -- |
191, 174 |
--, -- |
'' |
4.82 +/- 0.02 |
147, 129 |
--, -- |
183, 205 |
--, -- |
9 -AAc |
50 (ug/plate) |
918 , 512 |
630, 409 |
|
|
2AA |
1 (ug/plate) |
|
|
998, 1154 |
988, 889 |
|
|
|
|
|
|
Table 4: Mutagenic Activity of TFE in Salmonella Typhimurium Strain TA98
Compound |
Concentration |
Revertants per Plate (Duplicate Plates) |
|||
|
% |
Without Activation |
With Activation |
||
|
|
Trial 1 |
Trial 2 |
Trial 1 |
Trial 2 |
TFE |
0 (Control) |
18, 26 |
16, 19 |
34, 35 |
27, 29 |
'' |
0.49 +/- 0.02 |
--, -- |
19, 23 |
--, -- |
35, 27 |
'' |
0.82 +/- 0.03 |
20, 24 |
--, -- |
28, 31 |
--, -- |
'' |
0.92 +/- 0.02 |
--, -- |
12, 20 |
--, -- |
29, 40 |
'' |
1.39 +/- 0.02 |
16, 20 |
--, -- |
33, 34 |
--, -- |
'' |
2.04 +/- 0.05 |
--, -- |
15, 20 |
--, -- |
26, 29 |
'' |
2.79 +/- 0.10 |
--, -- |
17, 11 |
--, -- |
26, 26 |
'' |
2.87 +/- 0.00 |
21, 14 |
--, -- |
26, 27 |
--, -- |
'' |
3.17 +/- 0.02 |
--, -- |
18, 15 |
--, -- |
25, 26 |
'' |
3.69 +/- 0.13 |
20, 15 |
--, -- |
28, 30 |
--, -- |
'' |
4.82 +/- 0.02 |
17, 23 |
--, -- |
23, 30 |
--, -- |
2 -NF |
25 (ug/plate) |
2529, 2347 |
1934, 2271 |
|
|
2 -AA |
2 |
|
|
1868, 2661 |
3332, 3084 |
|
|
|
|
|
|
Table 5: Mutagenic Activity of TFE in Salmonella Typhimurium Strain TA100
Compound |
Concentration |
Revertants per Plate (Duplicate Plates) |
|||
|
% |
|
|
||
|
|
Trial 1 |
Trial 2 |
Trial 1 |
Trial 2 |
TFE |
0 (Control) |
168, 142 |
174, 163 |
141, 138 |
109, 132 |
'' |
0.49 +/- 0.02 |
--, -- |
142, 128 |
--, -- |
148, 117 |
'' |
0.82 +/- 0.03 |
135, 163 |
--, -- |
130, 133 |
--, -- |
'' |
0.92 +/- 0.02 |
--, -- |
126, 117 |
--, -- |
115, 129 |
'' |
1.39 +/- 0.02 |
118, 130 |
--, -- |
129, 125 |
--, -- |
'' |
2.04 +/- 0.05 |
--, -- |
148, 161 |
--, -- |
135, 140 |
'' |
2.79 +/- 0.10 |
--, -- |
114, 133 |
--, -- |
147, 145 |
'' |
2.87 +/- 0.00 |
149, 170 |
--, -- |
132, 127 |
--, -- |
'' |
3.17 +/- 0.02 |
--, -- |
140, 131 |
--, -- |
134, 131 |
'' |
3.69 +/- 0.13 |
130, 103 |
--, -- |
132, 129 |
--, -- |
'' |
4.82 +/- 0.02 |
131, 135 |
--, -- |
146, 140 |
--, -- |
MNNG |
4 (ug/plate) |
3396, 3238 |
3536, 2780 |
|
|
VC |
1.5a |
|
|
308, 295 |
--, -- |
|
2.2a |
|
|
--, -- |
315, 322 |
a only one chamber was used for VC exposure
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
TFE was not mutagenic in the Ames bacterial reverse mutation assay using Salmonella typhimurium strains TA1535, TA97, TA98 and TA 100, both inthe presence and absence of metabolic activation. - Executive summary:
Tetrafluoroethylene (TFE) was tested for mutagenic activity in Salmonella typhimurium strains TA 1535, TA97, TA98 and TA100 in the presence and absence of a metabolic activation system (S9 Aroclor-treated rat liver homogenate) . Under the conditions of this assay, TFE was negative with or without metabolic activation.
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