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EC number: 700-526-7 | CAS number: 1333488-95-1
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 guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- methyl (2E)-2-cyano-3-(2,2-difluoro-1,3-benzodioxol-4-yl)prop-2-enoate
- EC Number:
- 700-526-7
- Cas Number:
- 1333488-95-1
- Molecular formula:
- C12H7F2NO4
- IUPAC Name:
- methyl (2E)-2-cyano-3-(2,2-difluoro-1,3-benzodioxol-4-yl)prop-2-enoate
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Characteristics of the strains were checked monthly:
- histidine-auxotrophy
- presence of the rfa character
- deletion of the uvrB gene
- ampicillin resistence (TA 98 and TA 100, containing the R-factor)
- characteristic reversion properties with known mutagens (positive controls)
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- The characteristics of the strain was checked monthly:
- tryptophan-auxotrophy
- absence of the uvrA gene
- characteristic reversion properties with known mutagens (positive controls)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 (rat-liver microsomal fraction)
- Test concentrations with justification for top dose:
- 312.5, 625, 1250, 2500 and 5000 µg/plate (with/without metabolic activation)
- Vehicle / solvent:
- Acetone
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- bidest. water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535 without metabolic activation
Migrated to IUCLID6: 5 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- WP2uvrA without metabolic activation
Migrated to IUCLID6: 2 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 without metabolic activation
Migrated to IUCLID6: 20 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 without metabolic activation
Migrated to IUCLID6: 150 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 2.5 µg/plate
- Remarks:
- TA 100 with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- bidest. water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- TA 1535 with metabolic activation
Migrated to IUCLID6: 400 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 2.5 µg/plate
- Remarks:
- TA 98, TA 1537 with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 50 µg/plate
- Remarks:
- WP2uvrA with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: 2 main experiments, both conducted with plate incorporation method
- Exposure duration: 48 hours at 37 +/- 1.5°C
SELECTION AGENT (mutation assays): test item
NUMBER OF REPLICATIONS: 3
COUNTING: electronic counting with an Artek counter
DETERMINATION OF CYTOTOXICITY
- TA 100 and WP2uvrA with and without metabolic activation at 20.6, 61.7, 185.2, 555.6, 1666.7 and 5000 µg/plate - Evaluation criteria:
- Test is considered acceptable if
- mean colony counts of the control values of strains are within the acceptable ranges
- the results of the positive controls meet the criteria for a positive response (at least a reproducible doubling of the mean number of revertants per plate above that of the negative control at any concentration for one or more of the strains TA 98, TA 1535, TA 1537 and WP2uvrA; a reproducible increase of the mean number of revertants per plate for any concentration above that of the negative control by at least a factor of 1.5 for strain TA 100).
Generally a concentration-related effect should be observable. - Statistics:
- A statistical analysis was not performed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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:
- not examined
- 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
Experiment 1, with/without metabolic activation
Dose |
Tester strains |
|||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli |
||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Solvent control |
43.7 ± 1.5 |
38.0 ± 1.7 |
166.7 ± 5.8 |
104.0 ± 1.0 |
14.3 ± 4.2 |
10.3 ± 4.5 |
8.0 ± 1.0 |
9.7 ± 3.1 |
32.0 ± 1.7 |
32.0 ± 8.7 |
312.5 µg/plate |
42.3 ± 2.3 |
37.0 ± 7.8 |
118 ± 2.6 |
113.7 ± 2.1 |
17.7 ± 1.5 |
16.3 ± 6.4 |
9.3 ± 3.2 |
8.0 ± 4.4 |
29.0 ± 2.6 |
31.0 ± 6.2 |
625 µg/plate |
37.3 ± 5.5 |
33.3 ± 4.2 |
128.7 ± 10.2 |
93.0 ± 14.4 |
13.7 ± 1.5 |
18.0 ± 1.0 |
5.3 ± 9.3 |
14.3 ± 3.2 |
28.0 ± 1.0 |
27.3 ± 3.5 |
1250 µg/plate |
42.3 ± 6.1 |
39.3 ± 4.2 |
126.0 ± 12.8 |
94.3 ± 6.7 |
14.0 ± 3.5 |
11.3 ± 3.5 |
9.3 ± 3.2 |
8.7 ± 4.5 |
22.0 ± 8.2 |
33.3 ± 6.5 |
2500 µg/plate |
24.3 ± 4.9 |
31.7 ± 6.5 |
119.3 ± 8.5 |
85.0 ± 4.0 |
15.3 ± 6.0 |
16.3 ± 3.8 |
5.0 ± 1.7 |
10.7 ± 1.5 |
19.3 ± 4.0 |
20.0 ± 3.0 |
5000 µg/plate |
13.3 ± 5.1 |
29.7 ± 4.2 |
104.3 ± 10.1 |
73.3 ± 17.9 |
6.0 ± 2.6 |
15.7 ± 2.1 |
2.7 ± 2.1 |
9.0 ± 1.7 |
16.7 ± 2.5 |
21.3 ± 1.2 |
Positive control |
1370.0 ± 210.8 |
1611.3 ± 115.3 |
1409.0 ± 72.9 |
1094.0 ± 182.8 |
989.0 ± 94.4 |
485.3 ± 73.5 |
1554.7 ± 372.0 |
139.7 ± 17.0 |
1044.3 ± 104.7 |
1083.7 ± 98.8 |
all numbers as revertants/plate (mean values)
-S9: without metabolic activation
+S9: with metabolic activation
Experiment 2, with/without metabolic activation
Dose |
Tester strains |
|||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli |
||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Solvent control |
19.0 ± 4.4 |
43.7 ± 10.0 |
157.3 ± 14.6 |
139.7 ± 13.4 |
10.0 ± 2.6 |
14.7 ± 3.2 |
10.0 ± 2.6 |
10.0 ± 1.7 |
24.3 ± 5.5 |
15.3 ± 2.5 |
312.5 µg/plate |
24.0 ± 2.6 |
37.0 ± 6.6 |
113.3 ± 9.3 |
134.0 ± 19.9 |
12.0 ± 3.5 |
14.7 ± 1.2 |
8.0 ± 2.0 |
9.3 ± 4.5 |
23.3 ± 2.9 |
24.7 ± 4.0 |
625 µg/plate |
18.7 ± 2.1 |
32.0 ± 5.0 |
114.0 ± 8.5 |
128.0 ± 7.0 |
12.3 ± 0.6 |
15.0 ± 2.6 |
6.0 ± 1.7 |
7.7 ± 2.1 |
15.3 ± 4.7 |
21.3 ± 6.4 |
1250 µg/plate |
14.7 ± 4.2 |
28.0 ± 4.4 |
116.3 ± 20.6 |
128.7 ± 13.1 |
17.0 ± 2.6 |
19.0 ± 2.6 |
6.3 ± 2.1 |
12.0 ± 1.0 |
12.3 ± 3.5 |
20.3 ± 1.5 |
2500 µg/plate |
17.0 ± 2.6 |
23.7 ± 5.1 |
113.3 ± 4.5 |
132.3 ± 4.0 |
16.7 ± 3.2 |
14.7 ± 2.9 |
3.0 ± 1.7 |
8.3 ± 3.8 |
11.3 ± 7.0 |
18.7 ± 4.9 |
5000 µg/plate |
14.3 ± 5.8 |
23.0 ± 6.1 |
128.7 ± 11.7 |
133.0 ± 6.1 |
12.3 ± 5.5 |
12.0 ± 5.2 |
2.3 ± 2.1 |
6.3 ± 2.3 |
9.7 ± 2.5 |
16.7 ± 4.9 |
Positive control |
1417.0 ± 54.3 |
1948.0 ± 270.0 |
1294.0 ± 41.2 |
2034.3 ± 184.0 |
997.3 ± 18.9 |
502.0 ± 54.7 |
2297.3 ± 291.5 |
242.0 ± 47.4 |
664.3 ± 40.5 |
751.7 ± 100.4 |
all numbers as revertants/plate (mean values)
-S9: without metabolic activation
+S9: with metabolic activation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation all tester strains
negative with metabolic activation all tester strains
Under conditions tested, the test item did not induce gene mutations by base pair changes or frame-shifts in the genome of the tester strains used.
Thus, the test item is considered non-mutagenic in this bacterial reverse mutation assay.
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