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EC number: 263-034-7 | CAS number: 61789-12-6
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Genetic toxicity in vitro
Description of key information
Bacterial Reverse Mutation Test
LUMULSE GMT-K is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06. Mar. 2018 to 15. Mar.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD Guidelines for the Testing of Chemicals Part 471, adopted 21. Jul. 1997 “Bacterial Reverse Mutation Test“
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Commission Regulation (EC) No. 440/2008, EU-Method B.13/14 adopted 30. May 2008 “Mutagenicity –Reverse mutation test using bacteria”
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- No further details specified in the study report.
- Target gene:
- histidine
- Species / strain / cell type:
- other: TA97a, TA98, TA100, TA102 and TA1535
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- The following nominal concentrations were prepared for the first experiment:
5 μL/plate, 1.5 μL/plate, 0.5 μL/plate, 0.15 μL/plate and 0.05 μL/plate.
The following nominal concentrations were prepared for the second experiment:
5 μL/plate, 2.5 μL/plate, 1.25 μL/plate, 0.63 μL/plate, 0.31 μL/plate, 0.16 μL/plate, 0.08 μL/plate and 0.04 μL/plate.
Test concentrations for the second experiment based on the results from the first experiment. - Vehicle / solvent:
- In a non-GLP pre-test, the solubility of the test item was tested in a concentration of 50 mL/L in demineralized water, dimethyl sulfoxide (DMSO) and acetone.
The test item was sufficiently soluble in DMSO and acetone.
DMSO 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. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethylsulfoxide (DMSO), Demineralised water
- 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:
- Culture of Bacteria
Eight hours before the start of each experiment, one vial permanent culture of each strain was taken from the deep freezer and an aliquot was put into a culture flask containing nutrient broth. After incubation for eight hours at 37 ±1 °C, the cultures were used in the experiment.
During the test, the cultures were stored at room temperature as to prevent changes in the titre.
Conduct of Experiment
Preparations
Different media and solutions were prepared preliminary (exact production dates are documented in the raw data).
On the day of the test, the bacteria cultures were checked for growth visually. The incubation chambers were heated to 37 ±1 °C. The water bath was turned to 43 ±1 °C. The table surface was disinfected.
The S9 mix was freshly prepared and stored at 0 °C.
Experimental Parameters
First Experiment
Concentrations tested: 5 / 1.5 / 0.5 / 0.15 / 0.05 μL/plate
Incubation time: 48 h
Incubation temperature: 37 ±1 °C
Tested strains: TA97a, TA98, TA100, TA102, TA1535
Method: plate incorporation method
Second Experiment
Concentrations tested: 5 / 2.5 / 1.25 / 0.63 / 0.31 / 0.16 / 0.08 / 0.04 μL/plate
Incubation time: 48 h
Incubation temperature: 37 ±1 °C
Tested strains: TA97a, TA98, TA100, TA102, TA1535
Method: pre-incubation method
Description of the Method
General preparation
Per bacteria strain and concentration, three plates with and three plates without metabolic activation (-S9) were used.
For the top agar 100 mL agar basis was melted in a microwave oven, 10 mL of the histidine-biotin-solution 0.5 mM was added, then the mixture was placed in the water bath at 43 ±1 °C.
Plate incorporation method
The following materials were gently vortexed in a test tube and poured onto the selective agar plates:
-100 μL test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control)
-500 μL S9 mix (for test with metabolic activation) or phosphate buffer (for test without metabolic activation).
-100 μL bacteria suspension
-2000 μL overlay agar (top agar)
The plates were closed and left to solidify for a few minutes, then inverted and placed in the dark incubator at 37 ±1 °C.
Pre-incubation method
The following materials were gently vortexed in a test tube and incubated at 37 ±1°C for 20 minutes:
-100 μL test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control)
-500 μL S9 mix (for test with metabolic activation) or phosphate buffer (for test without metabolic activation).
-100 μL bacteria suspension
After the pre-incubation for 20 minutes, 2000 μL top agar was added and the tube was gently vortexed. The mixture was poured onto the selective agar plate. The plates were closed and left to solidify for a few minutes, then inverted and placed in the incubator at 37 ±1 °C. - Rationale for test conditions:
- In accordance with test guidelines
- 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. - Statistics:
- Not specified
- Key result
- Species / strain:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In the second experiment, at he two highest concentrations (5 and 2.5 μL/plate).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- First Experiment
Confirmation of the Criteria and Validity
All strains met the criterion of at least 10e+9 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 were within the historical control data ranges.
Solubility and Toxicity
In the first experiment, the test item showed no precipitates on the plates in all tested concentrations.
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.
Mutagenicity
No significant 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.
Therefore, the test item is stated as not mutagenic under the test conditions.
To verify this result, a further experiment was performed.
Second Experiment
Confirmation of the Criteria and Validity
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 see chapter 15, page 41). All positive controls (diagnostic mutagens) showed mutagenic effects with and without metabolic activation and were within the historical control data ranges.
Solubility and Toxicity
In the second experiment, the test item showed no precipitates on the plates in all tested concentrations.
The test item showed signs of toxicity towards the bacteria strain TA100 in both the absence and presence of metabolic activation in the two highest concentrations (5 and 2.5 μL/plate).
The bacterial background lawn was not reduced at any of the concentrations.
Mutagenicity
No significant 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.
Therefore, the test item is stated as not mutagenic under the test conditions. - Conclusions:
- The test item LUMULSE GMT-K showed no increase in the number of revertants in all bacteria strains in both experiments.
All negative and all strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that LUMULSE GMT-K is not mutagenic in the Salmonella typhimurium test strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in the present study. - Executive summary:
Title of Study: Determination of the mutagenic potential of LUMULSE GMT-K with the Bacterial Reverse Mutation Test following OECD 471 and EU B.13/14
Findings and Results:
Two valid experiments were performed.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
The test item LUMULSE GMT-K 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.
Experiment 1:
In the first experiment, the test item (dissolved in DMSO) was tested up to concentrations of 5 μL/plate in the absence and presence of S9-mix in the strains TA97a, TA98, TA100, TA102 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.
Experiment 2:
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 test item showed signs of toxicity towards the bacteria strain TA100 in both the absence and presence of metabolic activation in the two highest concentrations (5 and 2.5 μL/plate).
The bacterial background lawn was not reduced at any of the concentrations.
The results of this experiments showed that the test item caused no increase in the number of revertants in all bacteria strains compared to the solvent control, in both the absence and presence of metabolic activation. The test item did not induce a dose-related increase in the number of revertants colonies in all strains, in the presence and absence of metabolic activation.
Based on the results of this study it is concluded that LUMULSE GMT-K is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.
Reference
Survey of the Findings
The mean revertant values of the three replicates are presented in the following tables.
Mean Revertants First Experiment
Strain Induction |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
||
Demin. Water |
Mean |
73 |
84 |
36 |
33 |
92 |
108 |
249 |
259 |
21 |
22 |
sd |
7.6 |
5.1 |
6.2 |
5.5 |
8.0 |
15.9 |
26.6 |
53.3 |
1.2 |
1.5 |
|
DMSO |
Mean |
74 |
110 |
38 |
36 |
89 |
91 |
239 |
249 |
26 |
18 |
sd |
5.2 |
21.1 |
4.4 |
11.9 |
9.2 |
1.2 |
28.9 |
46.0 |
1.7 |
0.6 |
|
Positive Controls* |
Mean |
479 |
463 |
268 |
176 |
379 |
1001 |
657 |
1323 |
220 |
175 |
sd |
67.2 |
132.3 |
28.0 |
24.3 |
62.3 |
0.0 |
9.2 |
60.0 |
10.6 |
31.1 |
|
f(l) |
6.47 |
4.21 |
7.05 |
4.89 |
4.12 |
11.00 |
2.75 |
5.31 |
10.48 |
9.72 |
|
5 μL/plate |
Mean |
89 |
78 |
26 |
34 |
74 |
80 |
245 |
211 |
39 |
28 |
sd |
7.8 |
14.4 |
3.5 |
4.0 |
6.2 |
5.1 |
22.7 |
52.1 |
5.7 |
4.5 |
|
f(l) |
1.20 |
0.71 |
0.68 |
0.94 |
0.83 |
0.88 |
1.03 |
0.85 |
1.50 |
1.56 |
|
1.5 μL/plate |
Mean |
66 |
95 |
38 |
40 |
90 |
104 |
203 |
233 |
23 |
21 |
sd |
14.4 |
15.3 |
1.0 |
0.0 |
10.8 |
10.6 |
38.4 |
39.5 |
4.7 |
3.1 |
|
f(l) |
0.89 |
0.86 |
1.00 |
1.11 |
1.01 |
1.14 |
0.85 |
0.94 |
0.88 |
1.17 |
|
0.5 μL/plate |
Mean |
74 |
85 |
33 |
37 |
79 |
95 |
200 |
307 |
24 |
29 |
sd |
1.2 |
13.0 |
4.0 |
4.0 |
7.0 |
13.2 |
28.8 |
26.6 |
4.7 |
6.6 |
|
f(l) |
1.00 |
0.77 |
0.87 |
1.03 |
0.89 |
1.04 |
0.84 |
1.23 |
0.92 |
1.61 |
|
0.15 μL/plate |
Mean |
86 |
71 |
35 |
41 |
84 |
110 |
252 |
272 |
27 |
21 |
sd |
7.2 |
11.7 |
4.4 |
5.1 |
4.0 |
4.0 |
42.1 |
31.2 |
6.1 |
3.1 |
|
f(l) |
1.16 |
0.65 |
0.92 |
1.14 |
0.94 |
1.21 |
1.05 |
1.09 |
1.04 |
1.17 |
|
0.05 μL/plate |
Mean |
68 |
105 |
32 |
30 |
103 |
82 |
276 |
307 |
37 |
29 |
sd |
6.4 |
15.3 |
5.1 |
3.1 |
11.4 |
3.0 |
38.6 |
46.0 |
2.0 |
2.6 |
|
f(l) |
0.92 |
0.95 |
0.84 |
0.83 |
1.16 |
0.90 |
1.15 |
1.23 |
1.42 |
1.61 |
f(l) = increase factor
* Different positive controls were used
1001 colonies per plate means the bacteria growth was too strong for counting
Mean Revertants Second Experiment
Strain Induction |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
||
Demin. Water |
Mean |
79 |
76 |
37 |
37 |
85 |
93 |
308 |
284 |
10 |
12 |
sd |
3.2 |
11.3 |
5.9 |
8.7 |
9.5 |
12.5 |
35.6 |
30.2 |
2.1 |
3.5 |
|
DMSO |
Mean |
79 |
95 |
37 |
42 |
75 |
84 |
308 |
261 |
11 |
12 |
sd |
15.9 |
5.8 |
3.6 |
3.1 |
18.9 |
7.6 |
55.6 |
64.0 |
2.5 |
4.0 |
|
Positive Controls* |
Mean |
577 |
433 |
621 |
264 |
699 |
717 |
1339 |
1181 |
249 |
113 |
sd |
182.5 |
32.3 |
56.8 |
18.3 |
25.7 |
37.0 |
72.6 |
257.2 |
72.0 |
29.5 |
|
f(l) |
7.30 |
4.56 |
16.78 |
6.29 |
8.22 |
8.54 |
4.35 |
4.52 |
24.90 |
9.42 |
|
5 μL/plate |
Mean |
74 |
98 |
39 |
33 |
3 |
5 |
315 |
221 |
10 |
11 |
sd |
13.1 |
10.8 |
3.5 |
4.0 |
1.5 |
6.9 |
52.2 |
32.6 |
1.5 |
1.0 |
|
f(l) |
0.94 |
1.03 |
1.05 |
0.79 |
0.04 |
0.06 |
1.02 |
0.85 |
0.91 |
0.92 |
|
2.5 μL/plate |
Mean |
72 |
93 |
36 |
34 |
20 |
28 |
235 |
191 |
11 |
11 |
sd |
12.4 |
14.2 |
2.6 |
6.1 |
11.4 |
11.0 |
12.2 |
22.0 |
1.2 |
1.7 |
|
f(l) |
0.91 |
0.98 |
0.97 |
0.81 |
0.27 |
0.33 |
0.76 |
0.73 |
1.00 |
0.92 |
|
1.25 μL/plate |
Mean |
75 |
89 |
43 |
38 |
82 |
76 |
261 |
216 |
7 |
10 |
sd |
9.5 |
15.5 |
2.9 |
6.4 |
12.2 |
2.1 |
42.8 |
22.3 |
0.6 |
1.0 |
|
f(l) |
0.95 |
0.94 |
1.16 |
0.90 |
1.09 |
0.90 |
0.85 |
0.83 |
0.64 |
0.83 |
|
0.63 μL/plate |
Mean |
86 |
88 |
41 |
34 |
82 |
84 |
256 |
261 |
10 |
11 |
sd |
5.2 |
21.1 |
7.0 |
2.3 |
10.4 |
10.6 |
21.2 |
103.2 |
2.5 |
1.0 |
|
f(l) |
1.09 |
0.93 |
1.11 |
0.81 |
1.09 |
1.00 |
0.83 |
1.00 |
0.91 |
0.92 |
|
0.31 μL/plate |
Mean |
73 |
98 |
31 |
39 |
87 |
75 |
229 |
227 |
10 |
11 |
sd |
10.1 |
17.9 |
3.1 |
6.1 |
7.4 |
10.0 |
32.6 |
16.2 |
0.6 |
2.9 |
|
f(l) |
0.92 |
1.03 |
0.84 |
0.93 |
1.16 |
0.89 |
0.74 |
0.87 |
0.91 |
0.92 |
|
0.16 μL/plate |
Mean |
72 |
82 |
33 |
40 |
77 |
77 |
253 |
275 |
10 |
11 |
sd |
8.0 |
0.6 |
3.0 |
8.1 |
13.0 |
2.1 |
12.9 |
9.2 |
1.7 |
1.0 |
|
f(l) |
0.91 |
0.86 |
0.89 |
0.95 |
1.03 |
0.92 |
0.82 |
1.05 |
0.91 |
0.92 |
|
0.08 μL/plate |
Mean |
79 |
80 |
34 |
39 |
81 |
78 |
224 |
279 |
12 |
12 |
sd |
13.8 |
1.0 |
4.6 |
6.0 |
4.6 |
9.3 |
43.3 |
25.7 |
0.6 |
2.5 |
|
f(l) |
1.00 |
0.84 |
0.92 |
0.93 |
1.08 |
0.93 |
0.73 |
1.07 |
1.09 |
1.00 |
|
0.04 μL/plate |
Mean |
73 |
78 |
38 |
37 |
84 |
83 |
248 |
269 |
13 |
11 |
sd |
22.0 |
7.6 |
3.1 |
8.1 |
10.0 |
8.1 |
8.0 |
14.0 |
2.5 |
1.0 |
|
f(l) |
0.92 |
0.82 |
1.03 |
0.88 |
1.12 |
0.99 |
0.81 |
1.03 |
1.18 |
0.92 |
f(l) = increase factor
* Different positive controls were used
Positive Controls
-Without metabolic activation:
4-Nitro-1,2-phenylene diamine (NPD) in DMSO, 20 μg/plate
Sodium azide (Na-azide) in demineralized water, 1 μg/plate
-With metabolic activation:
2-Amino anthracene (2-AA) in DMSO, 1 μg/plate
Benzo-a-pyrene (BaP) in DMSO, 20 μg/plate
Diagnostic Mutagens (colonies per plate) – First Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Substance |
NPD |
2-AA |
NPD |
BaP |
Na-azide |
2-AA |
NPD |
2-AA |
Na-azide |
2-AA |
Repl. 1 |
552 |
612 |
236 |
164 |
444 |
1001 |
652 |
1264 |
228 |
200 |
Repl. 2 |
464 |
416 |
288 |
160 |
320 |
1001 |
668 |
1320 |
208 |
140 |
Repl. 3 |
420 |
360 |
280 |
204 |
372 |
1001 |
652 |
1384 |
224 |
184 |
Mean |
479 |
463 |
268 |
176 |
379 |
1001 |
657 |
1323 |
220 |
175 |
sd |
67.2 |
132.3 |
28.0 |
24.3 |
62.3 |
0.0 |
9.2 |
60.0 |
10.6 |
31.1 |
f(l) |
6.47 |
4.21 |
7.05 |
4.89 |
4.12 |
11.00 |
2.75 |
5.31 |
10.48 |
9.72 |
Rev. abs. |
405 |
353 |
230 |
140 |
287 |
910 |
418 |
1074 |
199 |
157 |
f(l) = increase factor
Rev. abs. = absolute revertants
1001 colonies per plate means the bacteria growth was too strong for counting.
Diagnostic Mutagens (colonies per plate) – Second Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Substance |
NPD |
2-AA |
NPD |
BaP |
Na-azide |
2-AA |
NPD |
2-AA |
Na-azide |
2-AA |
Repl. 1 |
788 |
468 |
632 |
268 |
688 |
696 |
1272 |
888 |
252 |
115 |
Repl. 2 |
476 |
404 |
560 |
280 |
728 |
760 |
1328 |
1368 |
320 |
142 |
Repl. 3 |
468 |
428 |
672 |
244 |
680 |
696 |
1416 |
1288 |
176 |
83 |
Mean |
577 |
533 |
621 |
264 |
699 |
717 |
1339 |
1181 |
249 |
113 |
sd |
182.5 |
32.3 |
56.8 |
18.3 |
25.7 |
37.0 |
72.6 |
257.2 |
72.0 |
29.5 |
f(l) |
7.30 |
4.56 |
16.78 |
6.29 |
8.22 |
8.54 |
4.35 |
4.52 |
24.90 |
9.42 |
Rev. abs. |
498 |
338 |
584 |
222 |
614 |
633 |
1031 |
920 |
239 |
101 |
f(l) = increase factor
Rev. abs. = absolute revertants
Historical Data of Spontaneous Revertants
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
89 |
94 |
20 |
22 |
92 |
96 |
279 |
297 |
18 |
18 |
Min |
60 |
63 |
6 |
8 |
51 |
64 |
85 |
67 |
6 |
7 |
|
Max |
144 |
138 |
52 |
51 |
141 |
141 |
425 |
511 |
31 |
33 |
|
SD |
18 |
16 |
11 |
10 |
15 |
14 |
58 |
69 |
6 |
6 |
|
Exp 1 |
73 |
84 |
36 |
33 |
92 |
108 |
249 |
259 |
21 |
22 |
|
Exp 2 |
79 |
76 |
37 |
37 |
85 |
93 |
308 |
284 |
10 |
12 |
|
DMSO |
Mean |
88 |
97 |
20 |
21 |
89 |
92 |
278 |
294 |
18 |
17 |
Min |
58 |
67 |
7 |
8 |
44 |
62 |
79 |
80 |
8 |
6 |
|
Max |
135 |
144 |
47 |
50 |
1369 |
199 |
393 |
459 |
33 |
32 |
|
SD |
17 |
17 |
11 |
10 |
16 |
17 |
56 |
61 |
6 |
6 |
|
Exp 1 |
74 |
110 |
38 |
36 |
89 |
91 |
239 |
249 |
26 |
18 |
|
Exp 2 |
79 |
95 |
37 |
42 |
75 |
84 |
308 |
261 |
11 |
12 |
|
Positive Controls* |
Mean |
537 |
520 |
407 |
113 |
490 |
764 |
1110 |
1213 |
264 |
132 |
Min |
264 |
237 |
100 |
39 |
220 |
273 |
491 |
408 |
55 |
45 |
|
Max |
1165 |
1181 |
1001 |
487 |
984 |
1912 |
2331 |
6083 |
515 |
7212 |
|
SD |
173 |
160 |
163 |
90 |
153 |
288 |
423 |
585 |
88 |
82 |
|
Exp 1 |
479 |
463 |
268 |
176 |
379 |
1001 |
657 |
1323 |
220 |
175 |
|
Exp 2 |
577 |
433 |
621 |
264 |
699 |
717 |
1339 |
1181 |
249 |
113 |
*Different positive controls were used
1001 colonies per plate mean the bacteria growth was too strong for counting.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Bacterial Reverse Mutation Test
The test item LUMULSE GMT-K 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.
Experiment 1:
In the first experiment, the test item (dissolved in DMSO) was tested up to concentrations of 5 μL/plate in the absence and presence of S9-mix in the strains TA97a, TA98, TA100, TA102 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.
Experiment 2:
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 test item showed signs of toxicity towards the bacteria strain TA100 in both the absence and presence of metabolic activation in the two highest concentrations (5 and 2.5 μL/plate).
The bacterial background lawn was not reduced at any of the concentrations.
The results of this experiments showed that the test item caused no increase in the number of revertants in all bacteria strains compared to the solvent control, in both the absence and presence of metabolic activation. The test item did not induce a dose-related increase in the number of revertants colonies in all strains, in the presence and absence of metabolic activation.
Based on the results of this study it is concluded that LUMULSE GMT-K is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.
Justification for classification or non-classification
Based on the available information the substance does not meet the criteria for classification as mutagenic in accordance with Regulation 1272/2008 (CLP)
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