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EC number: 263-174-9 | CAS number: 61791-42-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Aug - 07 Dec 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
- EC Number:
- 263-174-9
- EC Name:
- Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
- Cas Number:
- 61791-42-2
- Molecular formula:
- UVCB
- IUPAC Name:
- Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
- Details on test material:
- - Name of test material (as cited in study report): trade name given; Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
- Physical state: white powder
- Analytical purity: 97.7%
- Lot/batch No.: 524038
- Expiration date of the lot/batch: 10 May 2013
- Storage condition of test material: at room temperature in the dark
Constituent 1
Method
- Target gene:
- his operon
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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Preliminary Toxicity Test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Main test:
Experiment 1: 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Experiment 2: 5, 15, 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: sterile distilled water
- Justification for choice of solvent/vehicle: The test item was insoluble in dimethyl sulphoxide at 50 mg/mL and acetone at 100 mg/mL but was fully soluble in sterile distilled water at 50 mg/mL in solubility checks performed in-house. Sterile distilled water was therefore selected as the vehicle.
Controls
- Untreated negative controls:
- yes
- Remarks:
- sterile distilled water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2- aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Experiment 1: in agar (plate incorporation), Experiment 2: pre-incubation
DURATION
- Preincubation period for bacterial strains: 20 min at 37 °C
- Exposure duration: 48 hrs
NUMBER OF REPLICATIONS: Triplicate plating.
DETERMINATION OF CYTOTOXICITY
- Method: plates were assessed for numbers of revertant colonies and examined for effects on the growth of the bacterial background lawn. - Evaluation criteria:
- There are several criteria for determining a positive result. Any, one, or all of the following can be used to determine the overall result of the study:
1. A dose-related increase in mutant frequency over the dose range tested.
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data.
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit making a definite judgement about test item activity. Results of this type will be reported as equivocal. - Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- visible reduction in the growth of the bacterial background lawns and/or substantial reductions in the revertant colony frequency in Exp. 1 at 5000 µg/plate ± S9 –mix and in Exp. 2 at ≥ 500 µg/plate - S9 mix and at 5000 µg/plate + S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True 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
- Remarks:
- visible reduction in the growth of the bacterial background lawns and/or substantial reductions in the revertant colony frequency in both experiments from 500 µg/plate onwards ± S9 –mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- visible reduction in the growth of the bacterial background lawns and/or substantial reductions in the revertant colony frequency in both experiments from 500 µg/plate onwards ± S9 –mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- visible reduction in the growth of the bacterial background lawns and/or substantial reductions in the revertant colony frequency in Exp. 1 at 5000 µg/plate ± S9 –mix and in Exp. 2 at ≥ 1500 µg/plate ± S9 mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The test item was fully soluble in sterile distilled water at 50 mg/mL.
- Precipitation: No test item precipitate was observed at any of the doses tested in either the presence or absence of S9-mix.
RANGE-FINDING/SCREENING STUDIES:
A preliminary toxicity test with S. typhimurium strain TA100 and E. coli WP2uvrA was carried out to determine the toxicity of the test item. The concentrations tested were 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate. The test item induced toxicity to TA100 from 1500 µg/plate onwards and was non-toxic to WP2uvrA.
COMPARISON WITH HISTORICAL CONTROL DATA:
The number of revertant colonies in the vehicle, untreated and positive controls was within the ranges of the reported history profile of vehicle (combined historical negative and solvent control ranges) and positive control values of the testing facility for the two last calendar years.
Any other information on results incl. tables
Table 1. Preliminary toxicity test (numbers of revertant colonies).
With (+) or without (-) S9-mix |
Strain |
Dose (µg/plate) |
||||||||||
|
|
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
- |
TA100 |
108 |
113 |
95 |
103 |
98 |
84 |
99 |
77 |
81 |
31 |
15S |
+ |
TA100 |
106 |
120 |
115 |
114 |
120 |
96 |
97 |
88 |
100 |
52 |
19S |
- |
WP2uvrA |
26 |
30 |
29 |
24 |
25 |
26 |
24 |
35 |
25 |
25 |
20 |
+ |
WP2uvrA |
36 |
36 |
31 |
38 |
30 |
18 |
25 |
37 |
34 |
40 |
22 |
S: Sparse bacterial background lawn
Table 2. Spontaneous mutation rates (concurrent negative controls)
Number of revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||
EXPERIMENT 1 (plate incorporation) |
||||
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA 1537 |
81 109 87 (92) |
19 13 13 (15) |
28 27 21 (25) |
13 17 18 (16) |
4 8 10 (7) |
EXPERIMENT 2 (pre-incubation) |
||||
78 96 83 (86) |
16 12 10 (13) |
31 27 37 (32) |
14 20 16 (17) |
13 9 7 (10) |
Table 3. Test results Experiment 1
EXPERIMENT 1 (plate incorporation) Number of revertants (mean ± standard deviation) |
|||||
S9-Mix |
Without |
||||
Test item (µg/plate) |
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA1537 |
Solvent control (water) |
98 93 94 (95 ± 2.6) |
15 15 15 (15 ± 0.0) |
33 19 21 (24 ± 7.6) |
15 17 22 (18 ± 3.6) |
11 11 10 (11 ± 0.6) |
5 |
97 93 93 (94 ± 2.3) |
18 15 15 (16 ± 1.7) |
20 16 25 (20 ± 4.5) |
17 19 17 (18 ± 1.2) |
11 9 6 (9 ± 2.5) |
15 |
98 95 84 (92 ± 7.4) |
12 13 14 (13 ± 1.0) |
27 31 39 (32 ± 6.1) |
19 18 17 (18 ± 1.0) |
8 11 12 (10 ± 2.1) |
50 |
105 99 81 (95 ± 12.5) |
13 12 15 (13 ± 1.5) |
24 29 19 (24 ± 5.0) |
16 16 21 (18 ± 2.9) |
11 12 10 (11 ± 1.0) |
150 |
106 99 92 (99 ± 7.0) |
16 15 6 (12 ± 5.5) |
14 18 19 (17 ± 2.6) |
22 16 16 (18 ± 3.5) |
13 13 5 (10 ± 4.6) |
500 |
56 62 68 (62 ± 6.0) |
8 6 6 (7 ± 1.2) |
18 28 28 (25 ± 5.8) |
19 17 10 (15 ± 4.7) |
10 7 10 (9 ± 1.7) |
1500 |
25 21 30 (25 ± 4.5) |
5 S 5 S 6 S (5 ± 0.6) |
26 24 26 (25 ± 1.2) |
10 16 8 (11 ± 4.2) |
10 S 5 S 7 S (7 ± 2.5) |
5000 |
16 S 13 S 17 S (15 ± 2.1) |
7 S 4 S 4 S (5 ± 1.7) |
21 27 20 (23 ± 3.8) |
2 S 1 S 4 S (2 ± 1.5) |
3 S 5 S 1 S (3 ± 2.0) |
ENNG |
749 547 751 (682 ± 117.2) |
355 372 380 (369 ± 12.8) |
428 514 514 (485 ± 49.7) |
- |
- |
4NQO |
- |
- |
- |
226 206 194 (209 ± 16.2) |
- |
9AA |
- |
- |
- |
- |
155 226 286 (222 ± 65.6) |
|
|||||
S9-Mix |
With |
||||
Test item (µg/plate) |
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA1537 |
Solvent control (water) |
93 99 114 (102 ± 10.8) |
22 27 21 (23 ± 3.2) |
31 40 28 (33 ± 6.2) |
32 21 38 (30 ± 8.6) |
8 12 21 (14 ± 6.7) |
5 |
83 91 79 (84 ± 6.1) |
19 19 13 (17 ± 3.5) |
30 33 38 (34 ± 4.0) |
31 33 29 (31 ± 2.0) |
17 16 10 (14 ± 3.8) |
15 |
85 112 104 (100 ± 13.9) |
14 14 12 (13 ± 1.2) |
39 27 31 (32 ± 6.1) |
19 21 26 (22 ± 3.6) |
11 10 12 (11 ± 1.0) |
50 |
87 108 96 (97 ± 10.5) |
12 17 19 (16 ± 3.6) |
32 31 32 (32 ± 0.6) |
18 32 22 (24 ± 7.2) |
13 11 13 (12 ± 1.2) |
150 |
91 105 83 (93 ± 11.1) |
10 16 8 (11 ± 4.2) |
38 21 38 (32 ± 9.8) |
25 14 29 (23 ± 7.8) |
15 7 11 (11 ± 4.0) |
500 |
95 91 96 (94 ± 2.6) |
13 13 11 (12 ± 1.2) |
35 29 32 (32 ± 3.0) |
15 20 15 (17 ± 2.9) |
6 6 8 (7 ± 1.2) |
1500 |
49 40 68 (52 ± 14.3) |
11 11 8 (10 ± 1.7) |
33 30 39 (34 ± 4.6) |
18 15 20 (18 ± 2.5) |
13 8 8 (10 ± 2.9) |
5000 |
50 S 41 S 37 S (43 ± 6.7) |
11 S 6 S 6 S (8 ± 2.9) |
33 33 25 (30 ± 4.6) |
6 S 3 S 4 S (4 ± 1.5) |
2 S 2 S 2 S (2 ± 0.0) |
2AA |
806 751 876 (811 ± 62.6) |
254 273 286 (271 ± 16.1) |
242 244 223 (236 ± 11.6) |
- |
451 899 517 (622 ± 241.9) |
BP |
- |
- |
- |
213 227 230 (223 ± 9.1) |
- |
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine: 2 µg/plate for WP2uvrA, 3 µg/plate for TA100, 5 µg/plate for TA1535
9AA: 9-Aminoacridine: 80 µg/plate for TA1537
4NQO: 4-Nitroquinoline-1-oxide: 0.2 µg/plate for TA98
2AA: 2-Aminoanthracene: 1 µg/plate for TA100, 2 µg/plate for TA1535 and TA1537, 10 µg/plate for WP2uvrA
BP: Benzo(a)pyrene: 5 µg/plate for TA98
S: Sparse bacterial background lawn
Table 4. Test results Experiment 2
EXPERIMENT 2 (pre-incubation) Number of revertants (mean ± standard deviation) |
|||||
S9-Mix |
Without |
||||
Test item (µg/plate) |
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA1537 |
Solvent control (water) |
86 92 76 (85 ± 8.1) |
13 19 14 (15 ± 3.2) |
20 42 32 (31 ± 11.0) |
22 13 13 (16 ± 5.2) |
11 8 8 (9 ± 1.7) |
5 |
65 90 89 (81 ± 14.2) |
19 9 9 (12 ± 5.8) |
27 28 40 (32 ± 7.2) |
24 9 20 (18 ± 7.8) |
9 9 9 (9 ± 0.0) |
15 |
88 80 93 (87 ± 6.6) |
13 18 12 (14 ± 3.2) |
32 33 30 (32 ± 1.5) |
16 15 13 (15 ± 1.5) |
10 13 8 (10 ± 2.5) |
50 |
82 77 91 (83 ± 7.1) |
6 16 12 (11 ± 5.0) |
32 32 28 (31 ± 2.3) |
13 15 12 (13 ± 1.5) |
8 4 4 (5 ± 2.3) |
150 |
73 72 82 (76 ± 5.5) |
19 18 11 (13 ± 5.7) |
30 27 35 (31± 4.0) |
13 11 10 (11 ± 1.5) |
2 5 4 (4 ± 1.5) |
500 |
54 67 53 (58 ± 7.8) |
8 S 14 S 6 S (9 ± 4.2) |
30 26 26 (27 ± 2.3) |
8 6 3 (6 ± 2.5) |
6 S 3 S 16 S (8 ± 6.8) |
1500 |
32 S 12 S 30 S (25 ± 11.0) |
10 S 6 S 7 S (8 ± 2.1) |
19 31 27 (26 ± 6.1) |
8 10 7 (8 ± 1.5) |
3 S 3 S 1 S (2 ± 1.2) |
5000 |
11 S 17 S 21 S (16 ± 5.0) |
1 S 2 S 5 S (3 ± 2.1) |
24 30 26 (27 ± 3.1) |
2 S 1 S 1 S (1 ± 0.6) |
0 V 0 V 0 V (0 ± 0.0) |
ENNG |
787 720 591 (699 ± 99.6) |
878 872 836 (862 ± 22.7) |
445 440 200 (362 ± 140.0) |
- |
- |
4NQO |
- |
- |
- |
112 119 144 (125 ± 16.8) |
- |
9AA |
- |
- |
- |
- |
956 715 835 (835 ± 120.5) |
|
|||||
S9-Mix |
With |
||||
Test item (µg/plate) |
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA1537 |
Solvent control (water) |
108 97 96 (100 ± 6.7) |
18 22 9 (16 ± 6.7) |
19 30 36 (28 ± 8.6) |
20 29 15 (21 ± 7.1) |
13 13 15 (14 ± 1.2) |
5 |
71 87 89 (82 ± 9.9) |
9 8 12 (10 ± 2.1) |
29 36 36 (34 ± 4.0) |
22 17 16 (18 ± 3.2) |
14 16 8 (13 ± 4.2) |
15 |
83 93 76 (84 ± 8.5) |
8 8 11 (9 ± 1.7) |
33 24 32 (30 ± 4.9) |
17 21 28 (22 ± 5.6) |
9 18 13 (13 ± 4.5) |
50 |
85 78 89 (84 ± 5.6) |
11 11 11 (11 ± 0.0) |
29 37 24 (30 ± 6.6) |
22 17 13 (17 ± 4.5) |
13 11 6 (10 ± 3.6) |
150 |
73 64 95 (77 ± 15.9) |
8 12 10 (10 ± 2.0) |
36 22 20 (26 ± 8.7) |
24 18 22 (21 ± 3.1) |
8 5 7 (7 ± 1.5) |
500 |
19 37 19 (25 ± 10.4) |
4 3 8 (5 ± 2.6) |
32 34 31 (32 ± 1.5) |
22 28 9 (20 ± 9.7) |
17 10 11 (13 ± 3.8) |
1500 |
48 21 22 (30 ± 15.3) |
2 S 3 S 4 S (3 ± 1.0) |
29 34 19 (27 ± 7.6) |
16 10 10 (12 ± 3.5) |
7 2 5 (5 ± 2.5) |
5000 |
25 S 10 S 22 S (19 ± 7.9) |
2 S 5 S 2 S (3 ± 1.7) |
20 20 29 (23 ± 5.2) |
7 S 7 S 5 S (6 ± 1.2) |
2 S 3 S 2 S (2 ± 0.6) |
2AA |
957 822 953 (911 ± 76.8) |
162 394 448 (335 ± 152.0) |
197 168 187 (184 ± 14.7) |
- |
345 345 302 (331 ± 24.8) |
BP |
- |
- |
- |
132 137 145 (138 ± 6.6) |
- |
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine: 2 µg/plate for WP2uvrA, 3 µg/plate for TA100, 5 µg/plate for TA1535
9AA: 9-Aminoacridine: 80 µg/plate for TA1537
4NQO: 4-Nitroquinoline-1-oxide: 0.2 µg/plate for TA98
2AA: 2-Aminoanthracene: 1 µg/plate for TA100, 2 µg/plate for TA1535 and TA1537, 10 µg/plate for WP2uvrA
BP: Benzo(a)pyrene: 5 µg/plate for TA98
S: Sparse bacterial background lawn
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: Negative in S. typhimurium strains TA98, TA100, TA1535 and TA1537 and in E. coli strain WP2 uvrA with and without metabolic activation.
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