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EC number: 204-124-8 | CAS number: 116-09-6
- 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:
- weight of evidence
- Study period:
- 2018/02/14-2018/02/22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2018/02/14-2018/02/22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, 55116 Mainz (15.05.2018)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- The test item was stored in the test facility in a closed vessel at room temperature (16.2 –23.0°C).
- Target gene:
- please refer to table 1
- Species / strain / cell type:
- S. typhimurium TA 97
- Remarks:
- a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9: produced from the livers of male Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight intraperitoneally
- Test concentrations with justification for top dose:
- 5, 2.5, 1.25, 0.63, 0.31, 0.16, 0.08 µL/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO; water
- Justification for choice of solvent/vehicle: According to the study plan, demin. water should have been used as vehicle. Accidently, in the first experiment DMSO was used as vehicle. Therefore, in the second experiment DMSO was used as vehicle, too. This can be seen as uncritical, 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. - Untreated negative controls:
- yes
- 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, 2-amino-anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
- Selection time (if incubation with a selection agent): 24 h
SELECTION AGENT (mutation assays): histidine, ampicillin, UV-radiation, crystal violet solution
NUMBER OF REPLICATIONS: 3 replicates
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (quotient titre/toxicity)
- Any supplementary information relevant to cytotoxicity: Performed in experiment 1 only analogously to the titre control with the maximum dose of test item on maximal-soft agar, two replicates with and without metabolic activation, incubation for 48 hours at 37 ±1°C.
The toxicity of the following concentration was tested: 5μL/plate. Per strain, 2 plates with and without metabolic activation were incubated with the corresponding dose of the test item on maximal soft agar. - 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. - Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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
- Species / strain:
- S. typhimurium TA 97
- Remarks:
- a
- 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
- 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
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: In the second experiment, the test item showed no precipitates on the plates in all tested concentrations.
- Other confounding effects: No signs of toxicity towards the bacteria strains could be observed. The bacterial background lawn was visible and not affected. The number of revertant colonies was not reduced.
Whereas a concentration-dependent response was noted in the presence of S9 the effects seen in the absence of S9 did not reveal a concentration dependency.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%) )
All strains met the criterion of at least 10E9 bacteria/mL, and no inconsistencies were found in the sterility control. All determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls (diagnostic mutagens) showed mutagenic effects with and without metabolic activation and were within the historical control data ranges.
- Conclusions:
- Based on the results of this study it is concluded that Hydroxyacetone is mutagenic in the Salmonella typhimurium strain TA100 (it can be assumed that this effect is indicative for a base-pair substitution) in the absence and presence of metabolic activation under the experimental conditions in this study. There was however some suspicion coming from the sponsor of a potential interaction of the test item with DMSO. As the substance is also well soluble in water a new test with water as solvent was performed to clarify if the effects noted could be caused by the test item or by a potential reaction product of the test item with DMSO.
- Executive summary:
The mutagenic potential of Hydroxyacetone with Baterial Reverse Mutation Test was conducted following OECD guideline 471 and EU guideline B.13/14 and in compliance with GLP criteria. The test item Hydroxyacetone was tested in the Salmonella typhimurium reverse mutation assay with five strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 and TA1535). The test was performed in two experiments in the presence and absence of metabolic activation, with +S9 standing for presence of metabolic activation, and –S9 standing for absence of metabolic activation. Based on the results of the first experiment, the test item was tested up to concentrations of 5 μL/plate in the absence and presence of S9-mix in all bacteria strains using the preincubation method. The test item showed no precipitates on the plates at any of the concentrations. The bacterial background lawn was not reduced at none of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test item showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation. The results of this experiment showed that the test item caused an increase in the number of revertants in the bacteria strain TA100 compared to the solvent control, in the absence and presence of metabolic activation at three concentrations (5, 2.5 and 1.25 μL/plate) exceeding the threshold value of a two fold increase under both conditions. However, whereas a concentration-dependent response was noted in the presence of S9 the effects seen in the absence of S9 did not reveal a concentration-dependency.
Table 2: Mean Revertants second experiment
Strain | TA97a | TA98 | TA100 | TA102 | TA1535 | ||||||
Induction | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
Demin.water | Mean | 83 |
81 |
31 |
35 |
115 |
116 |
269 |
244 |
26 |
22 |
Sd |
14.4 |
8.1 |
5.1 |
4.7 |
7.5 |
8.4 |
12.2 |
4.0 |
4.0 | 3.5 | |
DMSO | Mean | 76 | 90 | 35 | 33 | 86 | 92 | 307 | 311 | 21 | 21 |
Sd | 11.6 | 10.6 | 3.5 | 6.9 | 8.4 | 12.5 | 46.9 |
6.1 |
3.5 |
1.5 |
|
Positive Controls* |
Mean |
331 |
313 |
441 |
104 |
531 |
1001 |
1320 |
1312 |
331 |
272 |
Sd |
40.1 |
34.0 |
18.9 |
18.0 |
45.5 |
0.0 |
36.7 |
42.3 |
53.3 |
32.0 |
|
f(I) |
4.36 |
3.48 |
12.6 |
3.15 |
4.62 |
10.88 |
4 .30 |
4.22 |
12.73 |
12.95 | |
5 µL/plate | Mean | 73 | 96 | 35 | 34 | 197 | 403 | 256 | 256 | 30 | 32 |
Sd | 6.6 | 29.0 |
0.6 |
8.5 |
18.6 |
22.0 |
61.6 |
42.1 |
2.5 |
5.2 |
|
f(I) | 0.96 | 1.07 | 1.00 | 1.03 | 2.29 | 4.28 | 0.83 | 0.82 |
1.43 |
1.52 |
|
2.5 µL/plate |
Mean |
85 |
116 |
32 |
40 |
152 |
272 |
215 |
216 |
33 |
29 |
Sd |
18.5 |
17.3 |
8.7 |
3.2 |
26.9 |
31.2 |
9.2 |
25.0 |
2.5 |
2.1 |
|
f(l) |
1.12 |
1.29 |
0.91 |
1.21 |
1.77 |
2.96 |
0.70 |
0.69 |
1.57 |
1.38 |
|
1.25 µL/plate |
Mean |
85 |
116 |
30 |
42 |
213 |
162 |
239 |
229 |
29 |
26 |
Sd |
16.0 |
15.9 |
7.5 |
5.7 |
41.6 |
77.5 |
37.2 |
28.1 |
5.1 |
3.5 |
|
f(I) |
1.12 |
1.29 |
0.86 |
1.27 |
2.48 |
1.76 |
0.78 |
0.74 |
1.38 |
1.24 |
|
0.63 µL/plate |
Mean |
87 |
74 |
31 |
30 |
145 |
116 |
227 |
263 |
30 |
26 |
Sd |
6.6 |
2.0 |
9.5 |
5.0 |
4.0 |
28.4 |
30.0 |
12.9 |
1.2 |
3.6 |
|
f(I) |
1.14 |
0.82 |
0.89 |
0.91 |
1.69 |
1.26 |
0.74 |
0.85 |
1.43 |
1.24 |
|
0.31 µL/plate |
Mean |
86 |
93 |
39 |
40 |
119 |
112 |
209 |
261 |
20 |
23 |
Sd |
10.2 |
27.5 |
2.6 |
1.2 |
4.2 |
14.4 |
6.1 |
18.9 |
3.8 |
3.0 |
|
f(I) |
1.13 |
1.03 |
1.11 |
1.21 |
1.38 |
1.22 |
0.68 |
0.84 |
0.95 |
1.10 |
|
0.16 µL/plate |
Mean |
76 |
75 |
39 |
42 |
99 |
100 |
228 |
252 |
17 |
21 |
Sd |
10.0 |
8.2 |
4.7 |
2.5 |
12.7 |
5.9 |
25.0 |
52.9 |
4.4 |
2.5 |
|
f(I) |
1.00 |
0.83 |
1.11 |
1.27 |
1.15 |
1.09 |
0.74 |
0.81 |
0.81 |
1.00 |
|
0.08 µL/plate |
Mean |
69 |
102 |
33 |
40 |
93 |
93 |
237 |
273 |
19 |
18 |
Sd |
10.0 |
15.6 |
5.0 |
4.0 |
17.3 |
16.2 |
26.0 |
68.2 |
1.5 |
3.0 |
|
f(I) |
0.91 |
1.13 |
0.94 |
1.21 |
1.08 |
1.01 |
0.77 |
0.88 |
0.90 |
0.86 |
f(I) = increase factor
* different positive controls were use
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2018/04/11-2018/04/20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, 55116 Mainz (15.05.2018)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- The test item was stored in the test facility in a closed vessel at room temperature (20±5°C)
- Target gene:
- Please refer to table 1
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 97
- Remarks:
- a
- Species / strain / cell type:
- E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9: produced from the livers of male Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight intraperitoneally
- Test concentrations with justification for top dose:
- 0.05, 0.15, 0.5, 1.5, 5 µL/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: water was chosen as vehincle, as there were suspicions coming from the sponsor that the test item might react with DMSO, a solvent used in another recently performed Ames test in which a positive response in TA100 with and without S9 mix under pre-incubation conditions was noted (study 17100906G803 performed at LAUS GmbH, too) - Untreated negative controls:
- yes
- Remarks:
- solvent
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- methylmethanesulfonate
- other: 4-Nitro-1,2-phenylene diamine, 2-Amino-anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
- Selection time (if incubation with a selection agent): 24 h
SELECTION AGENT (mutation assays): histidine, tryptophan, ampicillin, UV radiation, crystal violet solution
NUMBER OF REPLICATIONS: 3 replicates
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (quotient titre/toxicity)
The toxicity of the following concentration was tested: 5 μL/plate. Per strain, 2 plates with and without metabolic activation were incubated with the corresponding dose of the test item on maximal soft agar. - 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. - Species / strain:
- S. typhimurium TA 97
- Remarks:
- a
- 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
- 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
- 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
- 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
- Species / strain:
- E. coli WP2
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: In all experiments, no precipitation of the test item Hydroxyacetone was observed at any of the tested concentrations up to 5 μL/plate.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
All of the means of all replicates of the spontaneous revertants (in negative and solvent controls) were within the range of the historical data of the test facility. All numbers of revertant colonies of the positive controls were within the range of the historical data of the laboratory and were increased in comparison with the negative controls, which demonstrated the mutagenic potential of the diagnostic mutagens. - Conclusions:
- No increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed in all tested bacteria strains. No concentration-related increase over the tested range was found. Therefore, the test item is stated as not mutagenic under the test conditions of this experiment.
- Executive summary:
This Ames test, using water as vehicle, was performed as there were suspicions coming from the sponsor that the test item might react with DMSO, a solvent used in another recently performed Ames test in which a positive response in TA100 with and without S9 mix under pre-incubation conditions was noted. The mutagenic potential of Hydroxyacetone was tested in the Salmonella typhimurium reverse mutation assay (OECD Guideline 471, GLP). In the first experiment, the test item (dissolved in demin. water) was tested up to concentrations of 5 μL/plate in the absence and presence of S9-mix in the strains TA97a, TA98, TA100, Escherichia coli and TA1535 using the plate incorporation method. The test item showed no precipitates on the plates at any of the concentrations. The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test item showed no signs of toxicity towards the bacteria strains in both, the absence and presence of metabolic activation.
The results of this experiment showed that none of the tested concentrations showed a significant increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation.
table 2 Mean Revertants first experiment
Strain | TA97a | TA98 | TA100 | E.coli | TA1535 | ||||||
Induction | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
Demin. | Mean | 82 | 98 | 41 | 35 | 106 | 110 | 136 | 147 | 16 | 10 |
water | sd | 8.6 | 21.0 | 5.0 | 7.6 | 10.6 | 10.7 | 41.0 | 8.1 | 2.5 | 3.5 |
DMSO | Mean | 83 | 95 | 41 | 36 | 106 | 99 | 151 | 145 | 14 | 16 |
sd | 8.4 | 16.8 | 17.0 | 0.6 | 9.7 | 12.3 | 11.0 | 11.4 | 3.0 | 2.1 | |
Positive Controls* | Mean | 595 | 1001 | 1001 | 188 | 609 | 1001 | 1001 | 1001 | 257 | 131 |
sd | 16.7 | 0.0 | 0.0 | 4.0 | 23.1 | 0.0 | 0.0 | 0.0 | 48.2 | 44.6 | |
f(I) | 7.17 | 10.54 | 24.41 | 5.22 | 5.75 | 10.11 | 6.63 | 6.90 | 16.06 | 8.19 | |
5 µL/plate | Mean | 82 | 89 | 38 | 48 | 91 | 109 | 136 | 141 | 20 | 14 |
sd | 9.7 | 16.0 | 4.9 | 3.2 | 22.5 | 23.4 | 7.2 | 7.0 | 2.9 | 1.7 | |
f(I) | 1.00 | 0.91 | 0.93 | 1.37 | 0.86 | 0.99 | 1.00 | 0.96 | 1.25 | 1.40 | |
1.5 µL/plate | Mean | 89 | 101 | 36 | 41 | 85 | 104 | 143 | 155 | 15 | 16 |
sd | 24.3 | 19.8 | 2.1 | 0.6 | 7.0 | 14.0 | 15.1 | 13.6 | 3.0 | 3.2 | |
f(I) | 1.09 | 1.03 | 0.88 | 1.17 | 0.80 | 0.95 | 1.05 | 1.05 | 0.94 | 1.60 | |
0.5 µL/plate | Mean | 89 | 87 | 42 | 39 | 95 | 95 | 139 | 145 | 14 | 13 |
sd | 20.3 | 14.2 | 4.6 | 7.0 | 18.7 | 11.0 | 5.7 | 10.7 | 4.0 | 2.5 | |
f(I) | 1.09 | 0.89 | 1.02 | 1.11 | 0.90 | 0.86 | 1.02 | 0.99 | 0.88 | 1.30 | |
0.15 µL/plate | Mean | 76 | 78 | 36 | 42 | 98 | 113 | 149 | 147 | 12 | 16 |
sd | 13.0 | 5.6 | 4.0 | 5.9 | 13.5 | 11.7 | 10.2 | 4.0 | 1.5 | 3.1 | |
f(I) | 0.93 | 0.80 | 0.88 | 1.20 | 0.92 | 1.03 | 1.10 | 1.00 | 0.75 | 1.60 | |
0.05 µL/plate | Mean | 91 | 94 | 38 | 33 | 101 | 106 | 149 | 143 | 14 | 13 |
sd | 20.5 | 9.5 | 3.8 | 2.1 | 2.3 | 5.3 | 6.2 | 7.0 | 3.1 | 2.6 | |
f(I) | 1.11 | 0.96 | 0.93 | 0.94 | 0.95 | 0.96 | 1.10 | 0.97 | 0.88 | 1.30 |
f(I) 0 increase factor
* different positive controls were used
1001 colonies per plate means the bacteria growth was too strong for counting
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2018/04/11-2018/04/20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, 55116 Mainz (15.05.2018)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- The test item was stored in the test facility in a closed vessel at room temperature (20±5°C)
- Target gene:
- please refer to table 1
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 97
- Remarks:
- a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9: produced from the livers of male Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight intraperitoneally
- Test concentrations with justification for top dose:
- 0.16, 0.31, 0.63, 1.25, 2.5, 5
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: water was chosen as vehicle, as there were suspicions coming from the sponsor that the test item might react with DMSO, a solvent used in another recently performed Ames test in which a positive response in TA100 with and without S9 mix under pre-incubation conditions was noted (study 17100906G803 performed at LAUS GmbH, too) - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylene diamine, 2-amino-anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
- Selection time (if incubation with a selection agent): 24 h
SELECTION AGENT (mutation assays): histidine, tryptophan, ampicillin, UV radiation, crystal violet solution
NUMBER OF REPLICATIONS: 3 replicates - 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. - Key result
- Species / strain:
- S. typhimurium TA 97
- Remarks:
- a
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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
- 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
- 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
- Species / strain:
- E. coli WP2
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: In the second experiment, the test item showed no precipitates on the plates in all tested concentrations.
- Other confounding effects: No signs of toxicity towards the bacteria strains could be observed. The bacterial background lawn was visible and not affected. The number of revertant colonies was not reduced.
An increase in the number of revertants in the treatments with and without metabolic activation was noted under this test condition for the bacteria strains TA98, TA100 and TA1535. The increase factor was clearly below the threshold of 2.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
All strains met the criterion of at least 109 bacteria/mL, and no inconsistencies were found in the sterility control. All determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls (diagnostic mutagens) showed mutagenic effects with and without metabolic activation and were within the historical control data ranges.
- Conclusions:
- Based on the results of this study it is concluded that Hydroxyacetone is mutagenic in the Salmonella typhimurium strain TA97a in the absence and presence of metabolic activation, but it is not mutagenic in the Salmonella typhimurium strains TA98, TA100 and TA1535 and in the Escherichia coli (WP2) strain in the absence and presence of metabolic activation under the experimental conditions used in this study. Overall, taken the findings of both studies together, there are indications for a mutagenic potential of Hydroxyacetone in the Ames test.
- Executive summary:
This Ames test, using water as vehicle, was performed as there were suspicions coming from the sponsor that the test item might react with DMSO, a solvent used in another recently performed Ames test in which a positive response in TA100 with and without S9 mix under pre-incubation conditions was noted (study 1710096G803 performed at LAUS GmbH, too). The mutagenic potential of Hydroxyacetone was tested in the Salmonella typhimurin reverse mutation assay (OECD Guideline 471, GLP) with five strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 and TA1535). The test was performed in two experiments in the presence and absence of metabolic activation, with +S9 standing for presence of metabolic activation, and -S9 standing for absence of metabolic activation using demin. water as solvent. Based on the first experiment, the test item was tested up to concentrations of 5 μL/plate in the absence and presence of S9-mix in all bacteria strains using the pre-incubation method. The test item showed no precipitates on the plates at any of the concentrations. The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test item showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation. The results of this experiment showed that the test item caused an increase in the number of revertants in the bacteria strain TA97a (it can be assumed that this effect is indicative for a frame-shift mutation event) compared to the solvent control, in both the absence and presence of metabolic activation. An increase in the number of revertants in the treatments with and without metabolic activation was noted under this test condition for the bacteria strains TA98, TA100 and TA1535. But the increase factor was clearly below the threshold of 2. However, the effect noted in TA100 (it can be assumed that this effect is indicative for a base-pair substitution) in the study 17100906G803 (performed also at LAUS GmbH with the same test item) using DMSO as solvent was not reproduced.
table 2 Mean Revertants first experiment
Strain | TA97a | TA98 | TA100 | E.coli | TA1535 | |||||||
Induction | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | ||
Demin.water | Mean | 80 | 86 | 44 | 47 | 103 | 113 | 143 | 157 | 15 | 16 | |
sd | 16.6 | 8.4 | 7.2 | 6.9 | 19.0 | 10.1 | 11.4 | 19.7 |
2.0 |
3.8 |
||
DMSO |
Mean |
74 |
85 |
47 |
45 |
86 |
81 |
142 |
152 |
17 |
15 |
|
sd |
5.9 |
2.3 |
13.5 |
14.5 |
4.4 |
3.1 |
6.9 |
20.8 |
2.3 |
1.5 |
||
Positive Controls* |
Mean |
536 |
443 |
504 |
336 |
244 |
1001 |
1001 |
1001 |
233 |
76 |
|
sd |
27.7 |
88.1 |
65.5 |
57.7 |
16.0 |
0.0 |
0.0 |
0.0 |
88.9 |
16.0 |
||
f(I) |
7.24 | 5.21 | 10.72 | 7.47 | 2.37 | 12.36 | 7.05 | 6.59 | 15.53 | 5.07 | ||
5 µL/plate
|
Mean | 239 | 274 | 84 | 88 | 166 |
161 |
118 |
147 |
27 |
25 |
|
sd |
62.3 |
62.6 |
21.7 |
6.6 |
8.3 |
6.0 |
37.7 |
9.8 |
4.7 |
6.0 |
||
f(I) |
2.99 |
3.19 |
1.91 |
1.87 |
1.61 |
1.42 |
0.83 |
0.94 |
1.80 |
1.56 |
||
2.5 µL/plate
|
Mean |
288 |
243 |
59 |
77 |
155 |
160 |
139 |
143 |
22 |
20 |
|
sd |
36.7 |
35.2 |
21.7 |
12.1 |
5.0 |
4.6 |
18.1 |
41.1 |
1.2 |
2.6 |
||
f(I) |
3.6 |
2.83 |
1.34 |
1.64 |
1.50 |
1.42 |
0.97 |
0.91 |
1.47 |
1.25 |
||
1.25 µL/plate |
Mean |
88 |
88 |
51 |
50 |
105 |
116 |
140 |
111 |
17 |
21 |
|
sd |
10.6 |
17.0 |
15.2 |
19.1 |
12.5 |
12.5 |
5.6 |
21.9 |
0.6 |
2.5 |
||
f(I) |
1.10 |
1.02 |
1.16 |
1.06 |
1.02 |
1.03 |
0.98 |
0.71 |
1.13 |
1.31 |
||
0.63 µL/plate |
Mean |
75 |
85 |
46 |
48 |
105 |
127 |
124 |
137 |
21 |
28 |
|
sd |
7.6 |
4.2 |
15.5 |
14.7 | 16.4 | 21.8 | 23.5 | 8.7 | 3.8 | 7.0 | ||
f(I) | 0.94 | 0.99 | 1.05 | 1.02 | 1.02 | 1.12 | 0.87 | 0.87 |
1.40 |
1.75 |
||
0.31 µL/plate |
Mean |
87 |
98 |
45 |
48 |
119 |
116 |
122 |
123 |
26 |
25 |
|
sd |
16.8 |
27.6 |
3.6 |
0.6 |
6.2 |
8.5 |
7.6 |
14.4 |
10.1 |
4.0 |
||
f(I) |
1.09 |
1.14 |
1.02 |
1.02 |
1.16 |
1.03 |
0.85 |
0.78 |
1.73 |
1.56 |
||
0.16 µL/plate | Mean | 98 | 103 | 41 | 41 | 111 | 88 | 122 | 129 | 22 | 27 | |
sd | 21.5 | 10.1 | 5.9 | 13.9 | 23.7 | 15.1 | 19.7 | 39.7 | 9.5 | 8.1 | ||
f(I) | 1.23 | 1.20 | 0.93 | 0.87 | 1.08 | 0.78 | 0.85 | 0.82 | 1.47 | 1.69 |
f(I) 0 increase factor
* different positive controls were used
1001 colonies per plate means the bacteria growth was too strong for counting
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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, 55116 Mainz (15.05.2018)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hydroxyacetone
- EC Number:
- 204-124-8
- EC Name:
- Hydroxyacetone
- Cas Number:
- 116-09-6
- Molecular formula:
- C3H6O2
- IUPAC Name:
- 1-hydroxypropan-2-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- The test item was stored in the test facility in a closed vessel at room temperature (16.2 –23.0°C).
Method
- Target gene:
- please refer to table 1
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Remarks:
- a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9: produced from the livers of male Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight intraperitoneally
- Test concentrations with justification for top dose:
- 5, 1.5, 0.5, 0.15, 0.05 µL/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO; water
- Justification for choice of solvent/vehicle: According to the study plan, demin. water should have been used as vehicle. Accidently, in the first experiment DMSO was used as vehicle. Therefore, in the second experiment DMSO was used as vehicle, too. This can be seen as uncritical, 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:
- yes
- 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, 2-Amino-anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
- Selection time (if incubation with a selection agent): 24 h
SELECTION AGENT (mutation assays): histidine, ampicillin, UV-radiation, crystal violet solution
NUMBER OF REPLICATIONS: 3 replicates
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (quotient titre/toxicity)
- Any supplementary information relevant to cytotoxicity: Performed in experiment 1 only analogously to the titre control with the maximum dose of test item on maximal-soft agar, two replicates with and without metabolic activation, incubation for 48 hours at 37 ±1°C.
The toxicity of the following concentration was tested: 5μL/plate. Per strain, 2 plates with and without metabolic activation were incubated with the corresponding dose of the test item on maximal soft agar. - 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
- Species / strain:
- S. typhimurium TA 97
- Remarks:
- a
- 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
- 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
- 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
- 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
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: In the first experiment, the test item showed no precipitates on the plates in all tested concentrations.
- Other confounding effects: No increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
All strains met the criterion of at least 109 bacteria/mL, and no inconsistencies were found in the sterility control. All determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory (historical data of the laboratory). All positive controls (diagnostic mutagens) showed mutagenic effects with and without metabolic activation and nearly all (one exception) were within the historical control data ranges.
Any other information on results incl. tables
Table 2: Mean Revertants First Experiment
Strain | TA97a | TA98 | TA100 | TA102 | TA1535 | ||||||
Induction | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
Demin.water | Mean | 69 | 66 | 32 | 27 | 78 | 72 | 225 | 263 | 21 | 19 |
sd | 16.2 | 6.0 | 2.6 | 3.5 | 15.4 | 10.0 | 19.6 | 56.0 | 1.5 | 3.2 | |
DMSO | Mean | 69 | 95 | 27 | 28 | 73 | 78 | 225 | 287 | 19 | 21 |
sd | 10.4 | 14.0 | 6.0 | 1.2 | 12.0 | 9.5 | 16.7 | 18.9 | 3.8 | 3.6 | |
Positive Controls* | Mean | 329 | 657 | 1001 | 101 | 323 | 1001 | 692 | 727 | 257 | 143 |
sd | 99.6 | 79.4 | 0.0 | 24.6 | 54.5 | 0.0 | 36.0 | 47.4 | 14.0 | 23.0 | |
f(I) | 4.77 | 6.92 | 37.07 | 3.61 | 4.14 | 12.83 | 3.08 | 2.53 | 12.24 | 6.81 | |
5µL/plate | Mean | 79 | 96 | 35 | 24 | 79 | 93 | 237 | 281 | 23 | 25 |
sd | 4.9 | 21.5 | 4.0 | 1.7 | 13.6 | 10.0 | 26.6 | 26.6 | 0.6 | 5.5 | |
f(I) | 1.14 | 1.01 | 1.30 | 0.86 | 1.08 | 1.19 | 1.05 | 0.98 | 1.21 | 1.19 | |
1.5µL/plate | Mean | 66 | 85 | 21 | 30 | 85 | 75 | 268 | 229 | 22 | 21 |
sd | 5.0 | 12.2 | 3.6 | 8.1 | 10.1 | 8.9 | 26.2 | 30.6 | 1.0 | 4.2 | |
f(I) | 0.96 | 0.89 | 0.78 | 1.07 | 1.16 | 0.96 | 1.19 | 0.80 | 1.16 | 1.00 | |
0.5µL/plate | Mean | 74 | 81 | 25 | 27 | 83 | 85 | 215 | 241 | 23 | 20 |
sd | 13.6 | 20.1 | 9.8 | 6.1 | 10.1 | 6.0 | 24.1 | 10.1 | 5.1 | 4.4 | |
f(I) | 1.07 | 0.85 | 0.93 | 0.96 | 1.14 | 1.09 | 0.96 | 0.84 | 1.21 | 0.95 | |
0.15 µL/plate | Mean | 80 | 88 | 24 | 19 | 79 | 80 | 248 | 280 | 21 | 20 |
sd | 10.4 | 10.7 | 3.1 | 0.6 | 6.4 | 11.5 | 34.2 | 35.6 | 0.6 | 2.5 | |
f(I) | 1.16 | 0.93 | 0.89 | 0.68 | 1.08 | 1.03 | 1.10 | 0.98 | 1.11 | 0.95 | |
0.05 µL/plate | Mean | 84 | 80 | 22 | 23 | 74 | 77 | 296 | 239 | 17 | 19 |
sd | 11.5 | 9.7 | 3.6 | 7.2 | 15.2 | 14.0 | 30.2 | 36.3 | 2.6 | 1.5 | |
f(I) | 1.22 | 0.84 | 0.81 | 0.82 | 1.01 | 0.99 | 1.32 | 0.83 | 0.89 | 0.90 |
f(I) = increase factor
*different positive controls were used
Applicant's summary and conclusion
- Conclusions:
- The results of this experiment showed that none of the tested concentrations showed a significant increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation. To verify this result, a further experiment was performed.
- Executive summary:
The mutagenic potential of Hydroxyacetone with Baterial Reverse Mutation Test was conducted following OECD guideline 471 and EU guideline B.13/14 and in compliance with GLP criteria. The test item Hydroxyacetone was tested in the Salmonella typhimurium reverse mutation assay with five strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 and TA1535) using the plate incorporation method. The test item (dissolved in DMSO) was tested up to concentrations of 5 μL/plate in the strains TA97a, TA98, TA100, TA102 and TA1535. The test item showed no precipitates on the plates at any of the concentrations. The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test item showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation. As a result of this experiment none of the tested concentrations showed a significant increase in the number of revertants in all tested strains, in the presence and absence of metabolic activation.
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