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EC number: 200-473-5 | CAS number: 60-35-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-08-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data obtained from a guideline study according to OECD Guideline 471 and therefore considered reliable without restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Acetamide
- EC Number:
- 200-473-5
- EC Name:
- Acetamide
- Cas Number:
- 60-35-5
- Molecular formula:
- C2H5NO
- IUPAC Name:
- acetamide
- Test material form:
- solid: crystalline
- Details on test material:
- Name Acetamid
Appearance colorless crystal substance
CAS No. 60-35-5
EINECS-No. 200-473-5
Molecular formula C2H5NO
Molecular weight 59.07 g/mol
Purity content > 99 %
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Details on mammalian cell type (if applicable):
- Mutation Details:
hisD6610, frame shift
uvrB, deletion
rfa, deletion
pKM101, plasmide - Additional strain / cell type characteristics:
- other: histidine deficiency, UV sensitivity, biotine deficiency, lipopolysaccharide side chain deficiency, ampicillin resistence
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- Mutation Details:
hisD3052, frame shift
uvrB, deletion
rfa, deletion
pKM101, plasmide - Additional strain / cell type characteristics:
- other: histidine deficiency, UV sensitivity, biotine deficiency, lipopolysaccharide side chain deficiency, ampicillin resistence
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- Mutation Details:
hisG46, base pair substitution
uvrB, deletion
rfa, deletion
pKM101, plasmide - Additional strain / cell type characteristics:
- other: histidine deficiency, UV sensitivity, biotine deficiency, lipopolysaccharide side chain deficiency, ampicillin resistence
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- Mutation Details:
hisG428, base pair substitution
rfa, deletion
pKM101, plasmide
pAQ1, plasmide - Additional strain / cell type characteristics:
- other: histidine deficiency, lipopolysaccharide side chain deficiency, ampicillin resistence, tetracyclin re-sistance
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- Mutation Details:
hisG46, base pair substitution
uvrB, deletion
rfa, deletion - Additional strain / cell type characteristics:
- other: histidine deficiency, UV sensitivity, biotine deficiency, lipopolysaccharide side chain deficiency
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- First Experiment: 5000 / 1500 / 500 / 150 / 50 µg/plate
Second Experiment: 5000 / 2500 / 1250 / 625 / 313 µg/plate - Vehicle / solvent:
- Demineralized water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene Diamine, 2-Amino-Anthracene
Results and discussion
Test resultsopen allclose all
- 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:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no 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:
- no 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:
- no 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
First Experiment:
Mean Revertants First Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
H2O |
Mean |
109 |
113 |
15 |
13 |
96 |
95 |
364 |
328 |
13 |
16 |
sd |
1.2 |
5.6 |
2.1 |
4.6 |
4.7 |
1.7 |
18.3 |
38.6 |
3.2 |
2.3 |
|
DMSO |
Mean |
112 |
112 |
14 |
16 |
101 |
102 |
340 |
359 |
14 |
14 |
sd |
5.5 |
1.7 |
3.6 |
1.2 |
2.6 |
8.2 |
40.6 |
26.0 |
3.2 |
2.6 |
|
Positive |
Mean |
589 |
529 |
428 |
97 |
456 |
641 |
841 |
764 |
167 |
116 |
sd |
50.6 |
89.9 |
56.0 |
6.1 |
85.1 |
57.5 |
72.6 |
238.3 |
12.1 |
13.3 |
|
f(I) |
5.26 |
4.72 |
30.57 |
6.06 |
4.75 |
6.28 |
2.47 |
2.13 |
12.85 |
8.29 |
|
5000 µg/pl. |
Mean |
118 |
112 |
11 |
12 |
98 |
101 |
219 |
235 |
11 |
11 |
sd |
9.7 |
1.5 |
3.1 |
4.0 |
1.5 |
7.1 |
21.6 |
16.7 |
2.3 |
1.2 |
|
f(I) |
1.08 |
0.99 |
0.73 |
0.92 |
1.02 |
1.06 |
0.60 |
0.72 |
0.85 |
0.69 |
|
1500 µg/pl. |
Mean |
113 |
111 |
8 |
10 |
103 |
111 |
220 |
273 |
10 |
10 |
sd |
2.5 |
1.5 |
1.5 |
0.6 |
11.5 |
28.0 |
13.9 |
47.4 |
1.5 |
0.0 |
|
f(I) |
1.04 |
0.98 |
0.53 |
0.77 |
1.07 |
1.17 |
0.60 |
0.83 |
0.77 |
0.63 |
|
500 µg/pl. |
Mean |
114 |
110 |
10 |
10 |
109 |
90 |
245 |
231 |
15 |
15 |
sd |
2.6 |
1.5 |
3.0 |
1.5 |
20.5 |
2.6 |
8.3 |
25.4 |
2.1 |
1.5 |
|
f(I) |
1.05 |
0.97 |
0.67 |
0.77 |
1.14 |
0.95 |
0.67 |
0.70 |
1.15 |
0.94 |
|
150 µg/pl. |
Mean |
112 |
111 |
15 |
11 |
110 |
98 |
272 |
276 |
12 |
10 |
sd |
1.5 |
1.0 |
1.5 |
1.2 |
14.2 |
9.1 |
50.0 |
20.0 |
1.5 |
0.0 |
|
f(I) |
1.03 |
0.98 |
1.00 |
0.85 |
1.15 |
1.03 |
0.75 |
0.84 |
0.92 |
0.63 |
|
50 µg/pl. |
Mean |
114 |
109 |
13 |
9 |
103 |
99 |
228 |
260 |
11 |
12 |
sd |
4.6 |
1.0 |
0.6 |
2.9 |
4.5 |
6.1 |
62.4 |
41.8 |
0.6 |
2.1 |
|
f(I) |
1.05 |
0.96 |
0.87 |
0.69 |
1.07 |
1.04 |
0.63 |
0.79 |
0.85 |
0.75 |
|
Second Experiment:
Mean Revertants Second Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
H2O |
Mean |
109 |
116 |
13 |
17 |
98 |
106 |
303 |
307 |
11 |
12 |
sd |
5.7 |
2.1 |
1.7 |
3.1 |
7.0 |
13.3 |
56.8 |
40.1 |
0.6 |
1.0 |
|
DMSO |
Mean |
113 |
114 |
14 |
19 |
106 |
105 |
329 |
284 |
10 |
14 |
sd |
1.5 |
2.6 |
2.0 |
2.6 |
11.8 |
11.0 |
30.3 |
85.1 |
3.2 |
2.3 |
|
Positive |
Mean |
489 |
579 |
439 |
94 |
608 |
649 |
884 |
873 |
108 |
92 |
sd |
30.3 |
43.9 |
22.7 |
12.5 |
68.2 |
32.3 |
106.7 |
30.0 |
8.3 |
12.4 |
|
f(I) |
4.33 |
5.08 |
31.36 |
4.95 |
6.20 |
6.18 |
2.69 |
3.07 |
9.82 |
6.57 |
|
5000 µg/pl. |
Mean |
111 |
117 |
12 |
14 |
115 |
112 |
264 |
244 |
14 |
14 |
sd |
1.5 |
3.2 |
2.5 |
4.0 |
4.9 |
11.2 |
25.0 |
28.0 |
1.7 |
2.5 |
|
f(I) |
1.02 |
1.01 |
0.92 |
0.82 |
1.17 |
1.06 |
0.87 |
0.79 |
1.27 |
1.17 |
|
2500 µg/pl. |
Mean |
114 |
114 |
15 |
17 |
118 |
123 |
263 |
291 |
14 |
11 |
sd |
4.7 |
5.2 |
3.5 |
3.8 |
23.7 |
10.8 |
39.5 |
47.7 |
4.0 |
2.6 |
|
f(I) |
1.05 |
0.98 |
1.15 |
1.00 |
1.20 |
1.16 |
0.87 |
0.95 |
1.27 |
0.92 |
|
1250 µg/pl. |
Mean |
111 |
127 |
21 |
18 |
95 |
101 |
315 |
273 |
10 |
13 |
sd |
5.7 |
7.6 |
3.1 |
4.6 |
4.9 |
4.9 |
66.0 |
8.3 |
2.5 |
2.6 |
|
f(I) |
1.02 |
1.09 |
1.62 |
1.06 |
0.97 |
0.95 |
1.04 |
0.89 |
0.91 |
1.08 |
|
625 µg/pl. |
Mean |
117 |
123 |
17 |
18 |
110 |
93 |
339 |
316 |
11 |
12 |
sd |
6.8 |
2.6 |
1.7 |
2.1 |
5.8 |
1.2 |
29.5 |
52.9 |
4.0 |
1.5 |
|
f(I) |
1.07 |
1.06 |
1.31 |
1.06 |
1.12 |
0.88 |
1.12 |
1.03 |
1.00 |
1.00 |
|
313 µg/pl. |
Mean |
119 |
128 |
16 |
15 |
101 |
97 |
267 |
283 |
12 |
12 |
sd |
3.2 |
9.0 |
2.6 |
0.6 |
6.4 |
8.6 |
22.0 |
45.0 |
3.1 |
1.5 |
|
f(I) |
1.09 |
1.10 |
1.23 |
0.88 |
1.03 |
0.92 |
0.88 |
0.92 |
1.09 |
1.00 |
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The mutagenic potential of Acetamid was determined with the Bacterial Reverse Mutation Test following OECD 471 and EU B.13/14. The test item did not show mutagenic effects in both experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants (solvent only).
Cytotoxicity of the test item was not detected. The bacterial background lawn was visible and the number of revertants was not significantly decreased.
Therefore it can be stated, that under the test conditions, the test item Acetamid is not mu-tagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA97a, TA98, TA100, TA102 and TA1535. - Executive summary:
The mutagenic potential of Acetamid was determined with the Bacterial Reverse Mutation Test following OECD 471 and EU B.13/14. Two valid experiments were performed.
First Experiment:
Five concentrations of the test item, dissolved in demineralized water (ranging from 50 to 5000 µg/plate) were used. Five genetically changed strains ofSalmonella typhimurium(TA97a, TA98, TA100, TA102 (genetically manipulated) and TA1535) were exposed to the test item both in the presence and in the absence of a metabolic activation system (S9-mix, rat liver S9 induced by Aroclor 1254) for 48 hours, using the plate incorporation method.
None of the concentrations caused a significant increase in the number of revertant colonies in the tested strains. The test item did not show any mutagenic effects in the first experiment.
The test item showed no precipitates on the plates in all tested concentrations.
No signs of toxicity towards the bacteria could be observed.
The sterility control and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range. All positive controls showed mutagenic effects with and without metabolic activation.
Second Experiment:
To verify the results of the first experiment, a second experiment was performed, using five concentrations of the test item (ranging from 313 to 5000 µg/plate) and a modification in study performance (pre-incubation method).
The test item did not show mutagenic effects in the second experiment, either.
The test item showed no precipitates on the plates in all tested concentrations.
No signs of toxicity towards the bacteria could be observed.
The sterility control and the determination of the titre didn’t show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range. All positive controls showed mutagenic effects with and without metabolic activation.
Under the conditions of the test, the test item did not show mutagenic effects towardsSalmonella typhimurium,strainsTA97a, TA98, TA100, TA102 and TA1535.
Therefore, no concentration-effect relationship could be determined.
The test itemAcetamidis considered as “not mutagenic under the conditions of the test”.
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