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EC number: 204-611-5 | CAS number: 123-23-9
- Life Cycle description
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test item was considered to be non-mutagenic with and without metabolic activation in bacteria.
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:
- 05 February 2018 - 23 March 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:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Batch No.: 000071307
Purity: 69.9% - Species / strain / cell type:
- other: S. typhimurium TA 97a, TA 98, TA 100, TA102 and TA 1535,
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Concentrations:
- Experiment 1a: 50, 150, 500, 1500 and 5000 µg/plate
- Experiment 1b: TA97a and TA102: 15, 50, 150, 500, 1500 and 5000 µg/plate; TA98 and TA100: 0.5, 1.5, 5, 15, 50, and 150 µg/plate; TA1535: 5, 15, 50, 150, 500 and 1500 µg/plate
- Experiment 2: TA97a and TA102: 39, 78, 156, 313, 625, 1250, 2500 and 5000 µg/plate; TA98 and TA100: 1.2, 2.3, 4.7, 9.4, 18.8, 37.5, 75 and 150 µg/plate; TA1535: 12, 23, 47, 94, 188, 375, 750 and 1500 µg/plate;
Justification for top dose: tested up to recommended maximum test concentration according to OECD 471 in experiment 1a; due to observed toxicity lower concentrations were chosen for the experiment 1b and 2 - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: In a non-GLP pre-test, the solubility of the test item was determined. Based on these results, DMSO was chosen as solvent. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO and demineralised water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: Nitrophenylendiamine and 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: experiment 1a and 1b: in agar (plate incorporation); experiment 2: preincubation
DURATION
- Preincubation period: 20-30 minutes, 37 °C
- Exposure duration: 48-72 hours
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: determination revertant colony number and - Evaluation criteria:
- The mean values and standard deviations of each threefold determination are calculated as well as the increase factor 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 (mean revertants minus mean spontaneous revertants) is given. A substance is considered to have mutagenic potential, if a reproducible increase of re-vertant 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 performed as not mandatory for this test system.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 97
- Remarks:
- TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation was observed - Conclusions:
- The test item was considered to be non-mutagenic with and without metabolic activation in bacteria.
- Executive summary:
A study according to OECD guideline 471 was performed to assess the genotoxic potential of the test item. The test item 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 three 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.
In the experiment 1a, the test item (dissolved in DMSO) was tested up to concentrations of 5000 µg/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. Signs of toxicity towards the bacteria strains (no bacterial background lawn and/or no revertant growth) were observed in both the absence and presence of metabolic activation from 150 µg/plate upwards depending on the strain used. Due to the toxicity results in the experiment 1a, in the experiemnt 1b and 2the test item (dissolved in DMSO) was tested up to the following concentrations in the absence and presence of S9-mix: 150 µg/plate (TA98, TA100), 1500 µg/plate (TA1535) and 5000 µg/plate (TA97a, TA102). The test item showed no precipitates on the plates at any of the concentrations. At the concentration 150 µg/plate and upwards (depending on the strain used), signs of toxicity were observed towards the respective bacteria strain with and without metabolic activation. 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 the test item 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
Table 1: Mean Revertants Experiment 1a
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 |
Mean |
329 |
657 |
s.g. |
101 |
323 |
s.g. |
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 |
|
5000 µg/plate |
Mean |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
sd |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
f(I) |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
Background lawn |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
1500 µg/plate |
Mean |
73 |
79 |
0 |
0 |
27 |
46 |
201 |
256 |
12 |
15 |
sd |
10.6 |
12.6 |
0.0 |
0.0 |
5.9 |
4.4 |
32.3 |
4.0 |
1.0 |
4.4 |
|
f(I) |
1.06 |
0.83 |
0.00 |
0.00 |
0.37 |
0.59 |
0.89 |
0.89 |
0.63 |
0.71 |
|
Background lawn |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
|
500 µg/plate |
Mean |
89 |
73 |
1 |
2 |
25 |
35 |
256 |
228 |
19 |
19 |
sd |
20.4 |
6.7 |
0.0 |
1.2 |
3.0 |
4.4 |
13.9 |
44.0 |
3.6 |
4.2 |
|
f(I) |
1.29 |
0.77 |
0.04 |
0.07 |
0.34 |
0.45 |
1.14 |
0.79 |
1.00 |
0.90 |
|
Background lawn |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
|
150 µg/plate |
Mean |
74 |
82 |
3 |
4 |
33 |
44 |
247 |
252 |
22 |
16 |
sd |
10.6 |
19.2 |
3.5 |
1.7 |
7.5 |
1.5 |
38.9 |
32.7 |
1.2 |
1.2 |
|
f(I) |
1.07 |
0.86 |
0.11 |
0.14 |
0.45 |
0.56 |
1.10 |
0.88 |
1.16 |
0.76 |
|
Background lawn |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
|
50 µg/plate |
Mean |
78 |
110 |
28 |
31 |
82 |
78 |
213 |
243 |
21 |
18 |
sd |
10.4 |
21.4 |
3.8 |
2.9 |
5.9 |
10.4 |
36.3 |
28.1 |
5.5 |
2.5 |
|
f(I) |
1.13 |
1.16 |
1.04 |
1.11 |
1.12 |
1.00 |
0.95 |
0.85 |
1.11 |
0.86 |
|
Background lawn |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++= background lawn, + = background lawn reduced, - = no background lawn, sd = standard deviation, f(I) = increase factor,s.g. = strong growth, too strong for counting of revertants
Table 2: Mean Revertants Experiment 1b
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-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 |
Mean |
479 |
463 |
268 |
176 |
379 |
s.g. |
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(I) |
6.47 |
4.21 |
7.05 |
4.89 |
4.12 |
11.00 |
2.75 |
5.31 |
10.48 |
9.72 |
|
5000 µg/plate |
Mean |
6 |
55 |
n.d. |
n.d. |
n.d. |
n.d. |
0 |
0 |
n.d. |
n.d. |
sd |
5.8 |
11.9 |
n.d. |
n.d. |
n.d. |
n.d. |
0.0 |
0.0 |
n.d. |
n.d. |
|
f(I) |
0.08 |
0.50 |
n.d. |
n.d. |
n.d. |
n.d. |
0.00 |
0.00 |
n.d. |
n.d. |
|
Background lawn |
++ |
++ |
|
|
|
|
- |
- |
n.d. |
n.d. |
|
1500 µg/plate |
Mean |
76 |
91 |
n.d. |
n.d. |
n.d. |
n.d. |
221 |
213 |
3 |
3 |
sd |
5.5 |
22.0 |
n.d. |
n.d. |
n.d. |
n.d. |
4.6 |
24.1 |
1.7 |
1.2 |
|
f(I) |
1.03 |
0.83 |
n.d. |
n.d. |
n.d. |
n.d. |
0.92 |
0.86 |
0.12 |
0.17 |
|
Background lawn |
++ |
++ |
|
|
|
|
++ |
++ |
++ |
++ |
|
500 µg/plate |
Mean |
74 |
87 |
n.d. |
n.d. |
n.d. |
n.d. |
227 |
251 |
20 |
17 |
sd |
11.1 |
17.1 |
n.d. |
n.d. |
n.d. |
n.d. |
12.9 |
48.1 |
2.1 |
0.6 |
|
f(I) |
1.00 |
0.79 |
n.d. |
n.d. |
n.d. |
n.d. |
0.95 |
1.01 |
0.77 |
0.94 |
|
Background lawn |
++ |
++ |
|
|
|
|
++ |
++ |
++ |
++ |
|
150 µg/plate |
Mean |
77 |
93 |
6 |
7 |
0 |
0 |
223 |
199 |
19 |
17 |
sd |
11.5 |
9.5 |
2.9 |
1.7 |
0.0 |
0.0 |
14.0 |
9.2 |
3.5 |
0.0 |
|
f(I) |
1.04 |
0.85 |
0.16 |
0.19 |
0.00 |
0.00 |
0.93 |
0.80 |
0.73 |
0.94 |
|
Background lawn |
++ |
++ |
++ |
++ |
- |
- |
++ |
++ |
++ |
++ |
|
50 µg/plate |
Mean |
96 |
116 |
32 |
35 |
102 |
102 |
220 |
196 |
20 |
16 |
sd |
13.4 |
7.2 |
4.4 |
5.8 |
18.5 |
12.2 |
20.8 |
21.2 |
3.0 |
4.0 |
|
f(I) |
1.30 |
1.05 |
0.84 |
0.97 |
1.15 |
1.12 |
0.92 |
0.79 |
0.77 |
0.89 |
|
Background lawn |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
|
15 µg/plate |
Mean |
77 |
101 |
37 |
37 |
75 |
92 |
203 |
229 |
17 |
18 |
sd |
14.0 |
10.3 |
2.5 |
5.2 |
9.2 |
8.7 |
20.5 |
30.0 |
1.0 |
2.0 |
|
f(I) |
1.04 |
0.92 |
0.97 |
1.03 |
0.84 |
1.01 |
0.85 |
0.92 |
0.65 |
1.00 |
|
Background lawn |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
|
5 µg/plate |
Mean |
n.d. |
n.d. |
30 |
33 |
95 |
93 |
n.d. |
n.d. |
19 |
17 |
sd |
n.d. |
n.d. |
3.5 |
1.7 |
18.9 |
9.5 |
n.d. |
n.d. |
3.6 |
2.1 |
|
f(I) |
n.d. |
n.d. |
0.79 |
0.92 |
1.07 |
1.02 |
n.d. |
n.d. |
0.73 |
0.94 |
|
Background lawn |
|
|
++ |
++ |
++ |
++ |
|
|
++ |
++ |
|
1.5 µg/plate |
Mean |
n.d. |
n.d. |
32 |
34 |
101 |
106 |
n.d. |
n.d. |
n.d. |
n.d. |
sd |
n.d. |
n.d. |
8.1 |
3.5 |
5.0 |
11.9 |
n.d. |
n.d. |
n.d. |
n.d. |
|
f(I) |
n.d. |
n.d. |
0.84 |
0.94 |
1.13 |
1.16 |
n.d. |
n.d. |
n.d. |
n.d. |
|
Background lawn |
|
|
++ |
++ |
++ |
++ |
|
|
|
|
|
0.5 µg/plate |
Mean |
n.d. |
n.d. |
34 |
36 |
99 |
101 |
n.d. |
n.d. |
n.d. |
n.d. |
sd |
n.d. |
n.d. |
2.5 |
2.9 |
9.9 |
4.2 |
n.d. |
n.d. |
n.d. |
n.d. |
|
f(I) |
n.d. |
n.d. |
0.89 |
1.00 |
1.11 |
1.11 |
n.d. |
n.d. |
n.d. |
n.d. |
|
Background lawn |
|
|
++ |
++ |
++ |
++ |
|
|
|
|
++= background lawn, + = background lawn reduced, - = no background lawn, sd = standard deviation, n.d. = not determined, due to the toxicity results of the experiment 1a, f(I) = increase factor,s.g. = strong growth, too strong for counting of revertants. * Different positive controls were used
Table 3: Mean Revertants Experiment 2 (TA97a, TA102)
Strain |
TA97a |
TA102 |
|||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
79 |
76 |
308 |
284 |
sd |
3.2 |
11.3 |
35.6 |
30.2 |
|
DMSO |
Mean |
79 |
95 |
308 |
261 |
sd |
15.9 |
5.8 |
55.6 |
64.0 |
|
Positive |
Mean |
577 |
433 |
1339 |
1181 |
sd |
182.5 |
32.3 |
72.6 |
257.2 |
|
f(I) |
7.30 |
4.56 |
4.35 |
4.52 |
|
5000 µg/plate |
Mean |
4 |
14 |
33 |
29 |
sd |
1.0 |
2.1 |
12.4 |
21.4 |
|
f(I) |
0.05 |
0.15 |
0.11 |
0.11 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
2500 µg/plate |
Mean |
18 |
27 |
229 |
295 |
sd |
7.4 |
7.6 |
47.7 |
26.6 |
|
f(I) |
0.23 |
0.28 |
0.74 |
1.13 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
1250 µg/plate |
Mean |
82 |
80 |
233 |
331 |
sd |
0.6 |
7.5 |
32.3 |
61.2 |
|
f(I) |
1.04 |
0.84 |
0.76 |
1.27 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
625 µg/plate |
Mean |
80 |
84 |
259 |
347 |
sd |
13.9 |
7.1 |
18.9 |
57.7 |
|
f(I) |
1.01 |
0.88 |
0.84 |
1.33 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
313 µg/plate |
Mean |
79 |
85 |
321 |
273 |
sd |
3.5 |
18.6 |
2.3 |
45.5 |
|
f(I) |
1.00 |
0.89 |
1.04 |
1.05 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
156 µg/plate |
Mean |
77 |
76 |
301 |
240 |
sd |
6.7 |
9.6 |
35.9 |
4.0 |
|
f(I) |
0.97 |
0.80 |
0.98 |
0.92 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
78 µg/plate |
Mean |
71 |
67 |
264 |
263 |
sd |
11.3 |
2.5 |
0.0 |
39.5 |
|
f(I) |
0.90 |
0.71 |
0.86 |
1.01 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
39 µg/plate |
Mean |
71 |
84 |
261 |
241 |
sd |
10.6 |
25.2 |
24.1 |
24.1 |
|
f(I) |
0.90 |
0.88 |
0.85 |
0.92 |
|
Background lawn |
++ |
++ |
++ |
++ |
++= background lawn, + = background lawn reduced, - = no background lawn, sd = standard deviation, f(I) = increase factor,* Different positive controls were used
Table 4: Mean Revertants Experiment 2 (TA98, TA100)
Strain |
TA98 |
TA100 |
|||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
37 |
37 |
85 |
93 |
sd |
5.9 |
8.7 |
9.5 |
12.5 |
|
DMSO |
Mean |
37 |
42 |
75 |
84 |
sd |
3.6 |
3.1 |
18.9 |
7.6 |
|
Positive |
Mean |
621 |
264 |
699 |
717 |
sd |
56.8 |
18.3 |
25.7 |
37.0 |
|
f(I) |
16.78 |
6.29 |
8.22 |
8.54 |
|
150 µg/plate |
Mean |
3 |
5 |
15 |
16 |
sd |
0.6 |
1.7 |
3.1 |
2.6 |
|
f(I) |
0.08 |
0.12 |
0.20 |
0.19 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
75 µg/plate |
Mean |
34 |
37 |
88 |
78 |
sd |
3.5 |
9.3 |
6.4 |
3.1 |
|
f(I) |
0.92 |
0.88 |
1.17 |
0.93 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
37.5 µg/plate |
Mean |
44 |
44 |
76 |
86 |
sd |
4.7 |
4.5 |
7.6 |
5.8 |
|
f(I) |
1.19 |
1.05 |
1.01 |
1.02 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
18.8 µg/plate |
Mean |
40 |
30 |
84 |
72 |
sd |
5.6 |
7.8 |
4.0 |
1.7 |
|
f(I) |
1.08 |
0.71 |
1.12 |
0.86 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
9.4 µg/plate |
Mean |
42 |
46 |
82 |
77 |
sd |
1.0 |
12.9 |
1.7 |
4.6 |
|
f(I) |
1.14 |
1.10 |
1.09 |
0.92 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
4.7 µg/plate |
Mean |
38 |
37 |
76 |
77 |
sd |
4.6 |
9.3 |
7.2 |
3.8 |
|
f(I) |
1.03 |
0.88 |
1.01 |
0.92 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
2.3 µg/plate |
Mean |
36 |
35 |
82 |
87 |
sd |
5.0 |
8.1 |
6.9 |
8.7 |
|
f(I) |
0.97 |
0.83 |
1.09 |
1.04 |
|
Background lawn |
++ |
++ |
++ |
++ |
|
1.2 µg/plate |
Mean |
38 |
33 |
92 |
87 |
sd |
10.3 |
3.8 |
13.7 |
3.1 |
|
f(I) |
1.03 |
0.79 |
1.23 |
1.04 |
|
Background lawn |
++ |
++ |
++ |
++ |
++= background lawn, + = background lawn reduced, - = no background lawn, sd = standard deviation, f(I) = increase factor,* Different positive controls were used
Table 5: Mean Revertants Experiment 2 (TA1535)
Strain |
TA1535 |
||
Induction |
-S9 |
+S9 |
|
Demin. water |
Mean |
10 |
12 |
sd |
2.1 |
3.5 |
|
DMSO |
Mean |
11 |
12 |
sd |
2.5 |
4.0 |
|
Positive |
Mean |
249 |
113 |
sd |
72.0 |
29.5 |
|
f(I) |
24.90 |
9.42 |
|
1500 µg/plate |
Mean |
2 |
3 |
sd |
0.6 |
1.2 |
|
f(I) |
0.18 |
0.25 |
|
Background lawn |
++ |
++ |
|
750 µg/plate |
Mean |
12 |
13 |
sd |
0.6 |
1.2 |
|
f(I) |
1.09 |
1.08 |
|
Background lawn |
++ |
++ |
|
375 µg/plate |
Mean |
12 |
12 |
sd |
1.7 |
1.2 |
|
f(I) |
1.09 |
1.00 |
|
Background lawn |
++ |
++ |
|
188 µg/plate |
Mean |
12 |
15 |
sd |
2.1 |
2.1 |
|
f(I) |
1.09 |
1.25 |
|
Background lawn |
++ |
++ |
|
94 µg/plate |
Mean |
12 |
13 |
sd |
1.2 |
3.2 |
|
f(I) |
1.09 |
1.08 |
|
Background lawn |
++ |
++ |
|
47 µg/plate |
Mean |
9 |
10 |
sd |
1.5 |
1.5 |
|
f(I) |
0.82 |
0.83 |
|
Background lawn |
++ |
++ |
|
23 µg/plate |
Mean |
11 |
9 |
sd |
3.5 |
1.5 |
|
f(I) |
1.00 |
0.75 |
|
Background lawn |
++ |
++ |
|
12 µg/plate |
Mean |
11 |
13 |
sd |
1.5 |
1.2 |
|
f(I) |
1.00 |
1.08 |
|
Background lawn |
++ |
++ |
++= background lawn, + = background lawn reduced, - = no background lawn, sd = standard deviation, f(I) = increase factor,* Different positive controls were used
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study according to OECD guideline 471 was performed to assess the genotoxic potential of the test item. The test item 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 three 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.
In the experiment 1a, the test item (dissolved in DMSO) was tested up to concentrations of 5000 µg/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. Signs of toxicity towards the bacteria strains (no bacterial background lawn and/or no revertant growth) were observed in both the absence and presence of metabolic activation from 150 µg/plate upwards depending on the strain used. Due to the toxicity results in the experiment 1a, in the experiemnt 1b and 2the test item (dissolved in DMSO) was tested up to the following concentrations in the absence and presence of S9-mix: 150 µg/plate (TA98, TA100), 1500 µg/plate (TA1535) and 5000 µg/plate (TA97a, TA102). The test item showed no precipitates on the plates at any of the concentrations. At the concentration 150 µg/plate and upwards (depending on the strain used), signs of toxicity were observed towards the respective bacteria strain with and without metabolic activation. 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 the test item 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
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The results indicate that the substance is non-mutagenic. Based on available data on genetic toxicity, the test item is not classified for genetic toxicity according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EC) No 2017/776.
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