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EC number: - | CAS number: -
- Life Cycle description
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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:
- 09 Jan - 18 May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- adopted 2008
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Mainz, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- Range-finding test:
5 µL/plate with and without metabolic activation
Experiment 1:
0.05, 0.15, 0.5, 1,5 and 5 µL/plate with and without metabolic activation
Experiment 2a:
0.08, 0.16, 0.31, 0.63, 1.25, 2.5 and 5 µL/plate with and without metabolic activation
Experiment 2b:
0.3, 0.6, 1.1, 2.2, 4.4, 6.6 and 8.8 µL/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: demineralized water
- Justification for choice of solvent/vehicle: Demineralized water was chosen as vehicle, because the test item was sufficiently soluble and this solvent does not have any effects on the viability of the bacteria or the number of spontaneous revertants in the tested concentrations.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-nitro-1,2-phenylene diamine: 20 µg/plate for TA97a, TA98 and TA102 without S9 mix; 2-aminoanthracene: 1 µg/plate for TA97a, TA100, TA102 and TA1535 with S9 mix
- Remarks:
- Each batch of S9 is characterized with a mutagen that requires metabolic activation by microsomal enzymes (e.g., benzo(a)pyrene).
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, range-finding study, Experiment 1); preincubation (Experiment 2a and 2b)
DURATION
- Preincubation period: 20 min (Experiment 2a and 2b)
- Exposure duration: 48 h (Experiment 1, 2a and 2b)
NUMBER OF REPLICATIONS: triplicates each in three independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: bacterial background lawn; number of revertants - Evaluation criteria:
- The colonies were counted visually and the numbers were recorded. A validated spreadsheet software (Microsoft Excel®) was used to calculate mean values and standard deviations of each treatment, solvent control and positive control.
The mean values and standard deviations of each threefold determination was calculated as well as the increase factor f(l) of revertant induction (mean revertants divided by mean spontaneous revertants) of the test item solutions and the positive controls. Additionally, the absolute number of revertants (Rev. Abs.) (mean revertants minus mean spontaneous revertants) was given.
A substance is considered to have mutagenic potential, if a reproducible increase of revertant colonies per plate exceeding an increase factor of 2 in at least one strain can be observed. A concentration-related increase over the range tested is also taken as a sign of mutagenic activity.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 97a
- 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
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: S. typhimurium TA97a, TA98, TA100, TA102, TA1535
- 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: The test item showed no precipitates on the plates at all tested concentrations in all experiments.
RANGE-FINDING/SCREENING STUDIES: No toxicity of the test item was observed at the limit concentration of 5 µL/plate in all tester strains with and without metabolic activation.
HISTORICAL CONTROL DATA
- Positive historical control data: All positive controls showed mutagenic effects with and without metabolic activation and were within the historical control data ranges (please refer to "any other information on results incl. tables").
- Negative (solvent/vehicle) historical control data: All determined values (Experiment 1 and 2a) and nearly all (Experiment 2b) determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory (please refer to "any other information on results incl. tables"). Bacteria strains are living biological systems, therefore variations in behaviour are not unusual. Each bacteria strain in this study has its own characteristic spontaneous revertant colony number. Day to day variations in the number of spontaneous revertant colonies are usual. The variations of the values of all bacteria strains lie in an acceptable range. Evaluation of the mutagenicity of the test item and validity of the study was not affected by these variations; this is why no critical impact on the outcome of the study is expected.
Any other information on results incl. tables
Table 1: Mean number of revertants Experiment 1
Strain | TA97a | TA98 | TA100 | TA102 | TA1535 | ||||||
Metabolic activation | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
Demin. water | Mean | 73 | 81 | 26 | 25 | 77 | 93 | 308 | 353 | 19 | 23 |
sd | 7.6 | 11.3 | 4.7 | 6.2 | 7.5 | 7.0 | 45.1 | 4.6 | 1.0 | 4.2 | |
DMSO | Mean | 67 | 85 | 26 | 29 | 72 | 83 | 305 | 292 | 19 | 21 |
sd | 3.6 | 13.0 | 3.6 | 6.5 | 7.8 | 9.5 | 45.5 | 56.7 | 3.8 | 4.7 | |
Positive controls | Mean | 520 | 609 | 407 | 86 | 324 | 1001 | 1005 | 1363 | 224 | 247 |
sd | 84.3 | 136.8 | 56.0 | 6.8 | 55.6 | 0.0 | 334.9 | 224.2 | 49.2 | 48.1 | |
f(I) | 7.76 | 7.16 | 15.65 | 2.97 | 4.21 | 12.06 | 3.30 | 4.67 | 11.79 | 11.76 | |
5 µL/plate | Mean | 68 | 72 | 29 | 30 | 75 | 70 | 304 | 376 | 20 | 19 |
sd | 3.5 | 16.3 | 3.5 | 9.0 | 9.0 | 13.6 | 76.6 | 8.0 | 2.5 | 1.7 | |
f(I) | 0.93 | 0.89 | 1.12 | 1.20 | 0.97 | 0.75 | 0.99 | 1.07 | 1.05 | 0.83 | |
1.5 µL/plate | Mean | 73 | 64 | 27 | 33 | 76 | 81 | 340 | 367 | 17 | 21 |
sd | 9.6 | 5.5 | 7.2 | 7.0 | 12.4 | 7.6 | 56.7 | 26.0 | 2.5 | 3.6 | |
f(I) | 1.00 | 0.79 | 1.04 | 1.32 | 0.99 | 0.87 | 1.10 | 1.04 | 0.89 | 0.91 | |
0.5 µL/plate | Mean | 71 | 70 | 24 | 24 | 83 | 80 | 368 | 351 | 20 | 15 |
sd | 4.2 | 12.1 | 4.6 | 6.1 | 9.1 | 11.5 | 30.2 | 12.2 | 2.1 | 3.2 | |
f(I) | 0.97 | 0.86 | 0.92 | 0.96 | 1.08 | 0.86 | 1.19 | 0.99 | 1.05 | 0.65 | |
0.15 µL/plate | Mean | 75 | 78 | 24 | 28 | 82 | 92 | 353 | 307 | 22 | 21 |
sd | 5.0 | 19.7 | 5.5 | 7.0 | 8.2 | 14.4 | 30.3 | 24.4 | 2.6 | 2.1 | |
f(I) | 1.03 | 0.96 | 0.92 | 1.12 | 1.06 | 0.99 | 1.15 | 0.87 | 1.16 | 0.91 | |
0.05 µL/plate | Mean | 82 | 79 | 31 | 27 | 81 | 73 | 333 | 289 | 20 | 18 |
sd | 17.4 | 10.8 | 0.0 | 4.7 | 15.1 | 9.6 | 33.5 | 34.0 | 2.6 | 4.0 | |
f(I) | 1.12 | 0.98 | 1.19 | 1.08 | 1.05 | 0.78 | 1.08 | 0.82 | 1.05 | 0.78 |
Table 2: Mean number of revertants Experiment 2a
Strain | TA97a | TA98 | TA100 | TA102 | TA1535 | ||||||
Metabolic activation | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
Demin. water | Mean | 89 | 106 | 32 | 30 | 104 | 103 | 267 | 317 | 26 | 24 |
sd | 13.1 | 6.8 | 14.2 | 5.5 | 25.4 | 24.8 | 40.3 | 30.0 | 4.6 | 6.5 | |
DMSO | Mean | 85 | 91 | 26 | 30 | 92 | 113 | 301 | 307 | 21 | 24 |
sd | 5.5 | 28.9 | 8.1 | 5.1 | 8.0 | 22.9 | 40.3 | 62.3 | 0.6 | 2.1 | |
Positive controls | Mean | 599 | 671 | 212 | 165 | 339 | 1001 | 1331 | 1485 | 223 | 228 |
sd | 176.4 | 119.5 | 33.0 | 8.3 | 24.1 | 0.0 | 23.1 | 28.1 | 20.1 | 16.0 | |
f(I) | 7.05 | 7.37 | 8.15 | 5.50 | 3.26 | 8.86 | 4.42 | 4.84 | 8.58 | 9.50 | |
5 µL/plate | Mean | 81 | 97 | 25 | 28 | 99 | 141 | 209 | 232 | 25 | 26 |
sd | 1.2 | 6.4 | 1.5 | 7.8 | 1.2 | 18.1 | 62.8 | 52.0 | 2.3 | 5.3 | |
f(I) | 0.91 | 0.92 | 0.78 | 0.93 | 0.95 | 1.37 | 0.78 | 0.73 | 0.96 | 1.08 | |
2.5 µL/plate | Mean | 87 | 100 | 30 | 30 | 121 | 115 | 260 | 303 | 19 | 25 |
sd | 17.3 | 27.0 | 3.5 | 2.3 | 8.1 | 1.2 | 21.2 | 22.7 | 2.5 | 5.5 | |
f(I) | 0.98 | 0.94 | 0.94 | 1.00 | 1.16 | 1.12 | 0.97 | 0.96 | 0.73 | 1.04 | |
1.25 µL/plate | Mean | 86 | 92 | 28 | 34 | 104 | 97 | 275 | 327 | 26 | 24 |
sd | 13.1 | 16.1 | 0.6 | 2.0 | 18.5 | 12.1 | 31.1 | 50.6 | 4.0 | 2.0 | |
f(I) | 0.97 | 0.87 | 0.88 | 1.13 | 1.00 | 0.94 | 1.03 | 1.03 | 1.00 | 1.00 | |
0.63 µL/plate | Mean | 72 | 66 | 23 | 34 | 106 | 114 | 252 | 265 | 20 | 24 |
sd | 21.5 | 12.4 | 2.6 | 1.5 | 15.6 | 18.4 | 4.0 | 82.0 | 0.6 | 2.5 | |
f(I) | 0.81 | 0.62 | 0.72 | 1.13 | 1.02 | 1.11 | 0.94 | 0.84 | 0.77 | 1.00 | |
0.31 µL/plate | Mean | 85 | 104 | 29 | 33 | 85 | 113 | 251 | 311 | 21 | 21 |
sd | 8.7 | 22.3 | 8.6 | 1.7 | 16.0 | 13.3 | 30.0 | 34.0 | 2.6 | 4.5 | |
f(I) | 0.96 | 0.98 | 0.91 | 1.10 | 0.82 | 1.10 | 0.94 | 0.98 | 0.81 | 0.88 | |
0.16 µL/plate | Mean | 87 | 95 | 31 | 34 | 96 | 89 | 280 | 275 | 23 | 24 |
sd | 20.4 | 16.3 | 2.5 | 1.7 | 14.3 | 17.1 | 16.0 | 53.7 | 6.2 | 4.9 | |
f(I) | 0.98 | 0.90 | 0.97 | 1.13 | 0.92 | 0.86 | 1.05 | 0.87 | 0.88 | 1.00 | |
0.08 µL/plate | Mean | 79 | 90 | 34 | 34 | 90 | 107 | 245 | 285 | 25 | 27 |
sd | 17.5 | 13.1 | 2.1 | 5.9 | 17.6 | 26.9 | 31.1 | 26.6 | 8.5 | 2.9 | |
f(I) | 0.89 | 0.85 | 1.06 | 1.13 | 0.87 | 1.04 | 0.92 | 0.90 | 0.96 | 1.13 |
Table 3: Mean number of revertants Experiment 2b
Strain | TA97a | TA98 | TA100 | TA102 | TA1535 | ||||||
Metabolic activation | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
Demin. water | Mean | 82 | 120 | 43 | 42 | 147 | 140 | 288 | 287 | 36 | 40 |
sd | 8.2 | 36.5 | 3.6 | 4.7 | 4.7 | 9.0 | 34.2 | 32.3 | 5.7 | 2.3 | |
DMSO | Mean | 108 | 118 | 40 | 37 | 138 | 139 | 261 | 281 | 35 | 37 |
sd | 12.2 | 25.7 | 1.2 | 1.5 | 2.5 | 1.5 | 32.1 | 34.9 | 4.0 | 3.6 | |
Positive controls | Mean | 656 | 533 | 461 | 177 | 792 | 1001 | 1272 | 1288 | 208 | 165 |
sd | 72.3 | 34.0 | 53.3 | 57.9 | 27.7 | 0.0 | 162.4 | 367.4 | 10.6 | 15.1 | |
f(I) | 6.07 | 4.52 | 11.53 | 4.78 | 5.39 | 7.20 | 4.87 | 4.58 | 5.78 | 4.46 | |
8.8 µL/plate | Mean | 89 | 154 | 38 | 39 | 124 | 139 | 215 | 273 | 34 | 31 |
sd | 6.7 | 2.3 | 2.9 | 7.6 | 14.8 | 24.1 | 28.1 | 40.1 | 5.6 | 0.6 | |
f(I) | 1.09 | 1.28 | 0.88 | 0.93 | 0.84 | 0.99 | 0.75 | 0.95 | 0.94 | 0.78 | |
6.6 µL/plate | Mean | 118 | 127 | 40 | 44 | 145 | 144 | 265 | 271 | 32 | 31 |
sd | 33.7 | 16.2 | 2.1 | 6.7 | 9.6 | 6.0 | 36.3 | 30.3 | 2.6 | 4.0 | |
f(I) | 1.44 | 1.06 | 0.93 | 1.05 | 0.99 | 1.03 | 0.92 | 0.94 | 0.89 | 0.78 | |
4.4 µL/plate | Mean | 94 | 120 | 38 | 35 | 150 | 125 | 253 | 239 | 35 | 33 |
sd | 31.1 | 38.7 | 2.9 | 3.2 | 16.2 | 36.8 | 37.2 | 16.2 | 5.6 | 4.9 | |
f(I) | 1.15 | 1.00 | 0.88 | 0.83 | 1.02 | 0.89 | 0.88 | 0.83 | 0.97 | 0.83 | |
2.2 µL/plate | Mean | 102 | 95 | 36 | 41 | 171 | 119 | 247 | 200 | 39 | 30 |
sd | 24.8 | 11.5 | 2.3 | 3.5 | 8.4 | 41.1 | 87.3 | 36.0 | 2.5 | 7.0 | |
f(I) | 1.24 | 0.79 | 0.84 | 0.98 | 1.16 | 0.85 | 0.86 | 0.70 | 1.08 | 0.75 | |
1.1 µL/plate | Mean | 130 | 135 | 38 | 33 | 131 | 132 | 216 | 233 | 40 | 29 |
sd | 2.1 | 7.5 | 7.4 | 1.5 | 2.3 | 2.6 | 42.3 | 12.9 | 2.1 | 7.2 | |
f(I) | 1.59 | 1.13 | 0.88 | 0.79 | 0.89 | 0.94 | 0.75 | 0.81 | 1.11 | 0.73 | |
0.6 µL/plate | Mean | 132 | 117 | 41 | 37 | 139 | 133 | 245 | 321 | 37 | 36 |
sd | 11.1 | 18.6 | 5.1 | 6.1 | 15.7 | 4.2 | 28.9 | 33.3 | 1.5 | 6.2 | |
f(I) | 1.61 | 0.98 | 0.95 | 0.88 | 0.95 | 0.95 | 0.85 | 1.12 | 1.03 | 0.90 | |
0.3 µL/plate | Mean | 125 | 121 | 42 | 39 | 145 | 135 | 241 | 260 | 39 | 42 |
sd | 17.0 | 6.1 | 4.2 | 4.9 | 18.2 | 9.7 | 47.4 | 14.4 | 4.0 | 3.5 | |
f(I) | 1.52 | 1.01 | 0.98 | 0.93 | 0.99 | 0.96 | 0.84 | 0.91 | 1.08 | 1.05 |
Applicant's summary and conclusion
- Conclusions:
- The test substance is not mutagenic in the Salmonella typhimurium tester strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in the present study.
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