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EC number: 700-204-6 | CAS number: 1174627-68-9
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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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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:
- methyl (2R)-4-(dimethylcarbamoyl)-2-methylbutanoate; methyl (2S)-4-(dimethylcarbamoyl)-2-methylbutanoate
- EC Number:
- 700-204-6
- Cas Number:
- 1174627-68-9
- Molecular formula:
- C9H17NO3
- IUPAC Name:
- methyl (2R)-4-(dimethylcarbamoyl)-2-methylbutanoate; methyl (2S)-4-(dimethylcarbamoyl)-2-methylbutanoate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): DV-SOLV 1059
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/Beta-Napthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Experiments 1 & 2: 5, 15.81, 50, 158.1, 500, 1581 and 5000; µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO; water
- Justification for choice of solvent/vehicle: Solubility of test material and positive controls
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Salmonella TA 100, TA 1535: without activation
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Salmonella TA 1537: without activation
- Positive control substance:
- other: 4-nitro-1,2-phenylene-diamine (NPD)
- Remarks:
- Salmonella TA 98: without activation
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- E coli: without activation
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- Salmonella all strains, E coli: with activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (experiment 1: plate incorporation); experiment 2: preincubation
DURATION - Preincubation period: 48 hours - Evaluation criteria:
- Criteria for positive result:
- a dose-related increase in the number of revertants and/or
- a reproducible biologically relevant positive result for at least one of the dose groups in at least one strain with or without metabolic activation
An increase is considered biologically relevant if the number of reversions is twice that of controls for S. TA 100, or three times higher for other tested strains.
Results and discussion
Test resultsopen allclose all
- 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 1538
- 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 1537
- 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
- Species / strain:
- E. coli WP2 uvr A
- 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
There were no toxic
effects. Plates incubated with the test item showed normal background
growth up to 5000µg/plate with and without S9 mix in both experiments.
No substantial increase in revertant colony numbers of any of the 5
tester strains was observed following treatment withDV-SOLV
1059at any dose
level, neither in the presence nor absence of metabolic activation (S9
mix). There was also no tendency of higher mutation rates with
increasing concentrations in the range below the generally acknowledged
border of biological relevance.
Appropriate reference mutagens were used as positive controls and these showed a distinct increase of induced revertant colonies.
Results of Gene Mutation Assay: Experiment 1 (Plate incorporation):
Metabolic Activation |
Test Group |
Dose Level (µg/plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
Without Activation |
Untreated |
|
|
7 ± 3 |
3 ± 1 |
21 ± 6 |
90 ± 23 |
31 ± 2 |
DMSO |
|
|
11 ± 5 |
6 ± 2 |
20 ± 6 |
90 ± 20 |
26 ± 4 |
|
Distilled water |
|
|
12 ± 2 |
6 ± 3 |
19 ± 1 |
86 ± 24 |
32 ± 6 |
|
DV-SOLV 1059 |
5 µg |
|
10 ± 1 |
4 ± 2 |
17 ± 6 |
93 ± 14 |
27 ± 6 |
|
|
15.81 µg |
|
7 ± 3 |
8 ± 4 |
28 ± 6 |
87 ± 8 |
30 ± 10 |
|
|
50 µg |
|
11 ± 2 |
5 ± 1 |
18 ± 1 |
104 ± 13 |
33 ± 10 |
|
|
158.1 µg |
|
10 ± 3 |
6 ± 2 |
15 ± 2 |
106 ± 9 |
35 ± 3 |
|
|
500 µg |
|
8 ± 1 |
8 ± 3 |
21 ± 7 |
99 ± 8 |
36 ± 3 |
|
|
1581 µg |
|
8 ± 1 |
7 ± 3 |
19 ± 5 |
93 ± 25 |
29 ± 4 |
|
|
5000 µg |
|
8 ± 3 |
6 ± 2 |
16 ± 5 |
101 ± 10 |
34 ± 4 |
|
NaAZ |
2 µg |
|
635 ± 129 |
|
|
990 ± 56 |
|
|
2AA |
2 µg |
|
|
|
|
|
|
|
9AA |
50 µg |
|
|
287 ± 23 |
|
|
|
|
NPD |
4 µg |
|
|
|
292 ± 03 |
|
|
|
MMS |
2 µL |
|
|
|
|
|
651 ± 57 |
|
|
|
|
|
|
|
|
|
|
With Activation |
Untreated |
|
|
8 ± 3 |
5 ± 0 |
29 ± 5 |
88 ± 5 |
42 ± 6 |
DMSO |
|
|
8 ± 1 |
8 ± 1 |
20 ± 6 |
95 ± 6 |
37 ± 7 |
|
Distilled water |
|
|
11 ± 5 |
9 ± 1 |
19 ± 1 |
86 ± 7 |
44 ± 16 |
|
DV-SOLV 1059 |
5 µg |
|
10 ± 3 |
8 ± 2 |
26 ± 5 |
84 ± 7 |
37 ± 12 |
|
|
15.81 µg |
|
8 ± 6 |
6 ± 3 |
24 ± 2 |
86 ± 8 |
42 ± 3 |
|
|
50 µg |
|
11 ± 2 |
9 ± 1 |
24 ± 7 |
86 ± 5 |
32 ± 7 |
|
|
158.1 µg |
|
11 ± 2 |
5 ± 2 |
19 ± 3 |
78 ± 1 |
41 ± 5 |
|
|
500 µg |
|
12 ± 2 |
7 ± 2 |
26 ± 11 |
84 ± 5 |
44 ± 2 |
|
|
1581 µg |
|
8 ± 3 |
9 ± 2 |
26 ± 5 |
85 ± 11 |
41 ± 8 |
|
|
5000 µg |
|
9 ± 5 |
10 ± 2 |
27 ± 12 |
72 ± 15 |
38 ± 8 |
|
2-AA |
2 µg |
|
223 ± 10 |
153 ± 19 |
1889 ± 157 |
1937 ± 107 |
|
|
2-AA |
50 µg |
|
|
|
|
|
183 ± 5 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
|
||
NaAZ 2-AA 9AA NPD MMS |
sodium azide 2-aminoanthracene 9-aminoacridine 4-nitro-1,2-phenylene-diamine methyl methane sulfonate |
|
|
Results of Gene Mutation Assay: Experiment 2 (Pre-incubation):
Metabolic Activation |
Test Group |
Dose Level (µg/plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
Without Activation |
Untreated |
|
|
14 ± 5 |
9 ± 2 |
19 ± 5 |
98 ± 3 |
40 ± 4 |
DMSO |
|
|
10 ± 4 |
8 ± 3 |
22 ± 2 |
100 ± 11 |
30 ± 0 |
|
Distilled water |
|
|
16 ± 4 |
6 ± 2 |
19 ± 1 |
105 ± 2 |
38 ± 5 |
|
DV-SOLV 1059 |
5 µg |
|
16 ± 1 |
6 ± 1 |
16 ± 6 |
107 ± 8 |
37 ± 9 |
|
|
15.81 µg |
|
16 ± 1 |
5 ± 1 |
20 ± 4 |
103 ± 6 |
38 ± 9 |
|
|
50 µg |
|
14 ± 3 |
5 ± 1 |
16 ± 4 |
102 ± 10 |
39 ± 7 |
|
|
158.1 µg |
|
17 ± 1 |
9 ± 5 |
12 ± 6 |
98 ± 2 |
46 ± 4 |
|
|
500 µg |
|
15 ± 4 |
6 ± 3 |
13 ± 1 |
101 ± 16 |
36 ± 4 |
|
|
1581 µg |
|
11 ± 1 |
6 ± 3 |
13 ± 1 |
96 ± 21 |
33 ± 6 |
|
|
5000 µg |
|
13 ± 4 |
4 ± 3 |
14 ± 3 |
92 ± 5 |
28 ± 5 |
|
NaAZ |
2 µg |
|
801 ± 39 |
|
|
1087 ± 133 |
|
|
2AA |
2 µg |
|
|
|
|
|
|
|
9AA |
50 µg |
|
|
220 ± 30 |
|
|
|
|
NPD |
4 µg |
|
|
|
230 ± 35 |
|
|
|
MMS |
2 µL |
|
|
|
|
|
803 ± 21 |
|
|
|
|
|
|
|
|
|
|
With Activation |
Untreated |
|
|
18 ± 6 |
2 ± 0 |
30 ± 3 |
115 ± 20 |
43 ± 8 |
DMSO |
|
|
16 ± 4 |
9 ± 1 |
27 ± 6 |
102 ± 3 |
43 ± 8 |
|
Distilled water |
|
|
14 ± 3 |
16 ± 6 |
26 ± 4 |
113 ± 7 |
49 ± 4 |
|
DV-SOLV 1059 |
5 µg |
|
17 ± 2 |
8 ± 4 |
19 ± 6 |
112 ± 6 |
58 ± 9 |
|
|
15.81 µg |
|
16 ± 4 |
12 ± 5 |
25 ± 3 |
105 ± 4 |
49 ± 3 |
|
|
50 µg |
|
13 ± 1 |
9 ± 3 |
24 ± 3 |
100 ± 9 |
54 ± 3 |
|
|
158.1 µg |
|
14 ± 1 |
11 ± 3 |
16 ± 2 |
98 ± 1 |
53 ± 10 |
|
|
500 µg |
|
16 ± 2 |
10 ± 5 |
18 ± 3 |
84 ± 6 |
63 ± 2 |
|
|
1581 µg |
|
17 ± 1 |
7 ± 2 |
22 ± 4 |
91 ± 5 |
58 ± 2 |
|
|
5000 µg |
|
15 ± 4 |
8 ± 3 |
24 ± 3 |
85 ± 12 |
47 ± 5 |
|
2-AA |
2 µg |
|
156 ± 13 |
148 ± 7 |
1677 ± 198 |
1887 ± 201 |
|
|
2-AA |
50 µg |
|
|
|
|
|
188 ± 16 |
|
|
|
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, DV-SOLV 1059 is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay. - Executive summary:
This study was performed to investigate the potential of DV-SOLV 1059 to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and Escherichia coli strain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations of the active ingredient:
Pre-Experiment/Experiment I/Experiment II: 5, 15.81, 50, 158.1, 500, 1581 and 5000 µg/plate
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation in both independent experiments.
No toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), occurred in the test groups with or without metabolic activation.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with DV-SOLV 1059 at any dose level, either in the presence or absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, in the mutagenicity test described and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, DV-SOLV 1059 is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
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