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EC number: 611-056-6 | CAS number: 538313-26-7
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:
- September 16, 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Only duplicates and no justification for it. Justification of solution stability is not tested adequately. Statistical processing was not performed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Only duplicates plates were used instead of triplicates. Justification of solution stability is not tested adequately. Statistical processing was not performed.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Copper, diammine[5,5'-bi-1H-tetrazolato(2-)-kN1, kN1']
- EC Number:
- 611-056-6
- Cas Number:
- 538313-26-7
- Molecular formula:
- C2H6CuN10
- IUPAC Name:
- Copper, diammine[5,5'-bi-1H-tetrazolato(2-)-kN1, kN1']
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 was prepared from the liver of rats. The S9 was stored below -80°C until use and thawed just before use. S9 mix (1 ml) = 8 μmol MgCl2+33 μmol KCl+5 µmol Glucose-6-phosphate+4 μmol NADPH+4 μmNADH+100 μmol sodiumphosphate buffer (pH 7.4)+0.1 mL S9
- Test concentrations with justification for top dose:
- The final numbers of prepared viable cells are (x 10^9 cells/mL):
TA100: dosage setting test=2.6 and main test=2.6
TA1535: dosage setting test=2.6 and main test=2.5
WP2uvrA: dosage setting test=4.1 and main test=4.0
TA98: dosage setting test=2.6 and main test=2.6
TA1537: dosage setting test=2.5 and main test=2.5 - Vehicle / solvent:
- DMSO (Dimethyl sulfoxide)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide 5AF-2), 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)aminopropylamino]acridine·2HCl (ICR-191), 2-Aminoanthracene (2AA)
- Remarks:
- 2AA was the only one positive controle for all strains with S9 activation.
- Evaluation criteria:
- Cases where the number of reverse mutation colonies had increased by 2× or more the negative control value, and where dosage-dependency or reproducibility were seen in the increase, were treated as positive, and other cases as negative.
- Statistics:
- Statistical processing was not performed.
Results and discussion
Test results
- Key result
- 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 specified
- 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
Test Results Table (Dosage Setting Test)
Test Implementation Period |
20/8/2010~23/8/2010 |
|||||||||||
Presence of Metabolically Active System |
Tested Substance Dose (μg/plate) |
No. of Reverse Mutations (No. of Colonies/Plate) |
||||||||||
Base Substitution Type |
Frame Shift Type |
|||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||||||||
-S9 mix |
Negative Controls |
91 |
7 |
21 |
19 |
13 |
||||||
99 (100) |
8 (8) |
23 (20) |
18 (19) |
14 (11) |
||||||||
110 |
8 |
15 |
20 |
7 |
||||||||
4.88 |
123 |
(116) |
12 |
(11) |
17 |
(22) |
18 |
(16) |
10 |
(11) |
||
108 |
10 |
27 |
13 |
11 |
||||||||
19.5 |
99 |
(110) |
8 |
(8) |
19 |
(20) |
14 |
(13) |
12 |
(12) |
||
121 |
8 |
21 |
11 |
12 |
||||||||
78.1 |
115 |
(106) |
6 |
(9) |
28 |
(23) |
13 |
(11) |
10 |
(7) |
||
97 |
11 |
17 |
8 |
4 |
||||||||
313 |
129 |
(113) |
8 |
(6) |
20 |
(21) |
15 |
(17) |
6 |
(7) |
||
97 |
4 |
22 |
18 |
7 |
||||||||
1250 |
142 |
(128) |
5 |
(6) |
11 |
(11) |
13 |
(14) |
3 |
(6) |
||
114 |
7 |
10 |
14 |
6 |
||||||||
5000 |
154 |
(135) |
4 |
(3) |
12 |
(9) |
13 |
(10) |
6 |
(4) |
||
115 |
2 |
6 |
7 |
2 |
||||||||
+S9 mix |
Negative Controls |
115 |
(102) |
6 |
(9) |
18 |
(22) |
26 |
(23) |
8 |
(12) |
|
108 |
8 |
20 |
23 |
13 |
||||||||
83 |
13 |
27 |
21 |
15 |
||||||||
4.88 |
110 |
(126) |
13 |
(9) |
15 |
(22) |
30 |
(28) |
13 |
(13) |
||
142 |
10 |
28 |
25 |
12 |
||||||||
19.5 |
136 |
(135) |
7 |
(9) |
21 |
(22) |
30 |
(30) |
13 |
(13) |
||
133 |
10 |
23 |
25 |
12 |
||||||||
78.1 |
118 |
(126) |
13 |
(10) |
19 |
(22) |
30 |
(30) |
12 |
(12) |
||
134 |
7 |
25 |
29 |
8 |
||||||||
313 |
104 |
(110) |
11 |
(11) |
15 |
(11) |
11 |
(16) |
12 |
(14) |
||
115 |
11 |
7 |
20 |
16 |
||||||||
1250 |
98 |
(102) |
8 |
(8) |
13 |
(12) |
14 |
(11) |
11 |
(9) |
||
105 |
8 |
10 |
8 |
7 |
||||||||
5000 |
114 |
(135) |
12 |
(12) |
22 |
(19) |
5 |
(8) |
7 |
(7) |
||
156 |
12 |
16 |
11 |
7 |
||||||||
Positive Controls |
Those not requiring S9 mix |
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
|||||
Dose (μg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
0.5 |
|||||||
No. of Colonies/Plate |
709 |
(705) |
275 |
(269) |
363 |
(373) |
386 |
(386) |
1899 |
(1886) |
||
701 |
262 |
382 |
386 |
1872 |
||||||||
Those requiring S9 mix |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
||||||
Dose (μg/plate) |
1 |
2 |
10 |
0.5 |
2 |
|||||||
No. of Colonies/Plate |
1034 |
(1011) |
261 |
(274) |
502 |
(521) |
341 |
(337) |
428 |
(419) |
||
988 |
286 |
539 |
332 |
409 |
||||||||
Test Results Table (The Test)
Test Implementation Period |
27/8/2010~30/8/2010 |
|||||||||||
Presence of Metabolically Active System |
Tested Substance Dose (μg/plate) |
No. of Reverse Mutations (No. of Colonies/Plate) |
||||||||||
Base Substitution Type |
Frame Shift Type |
|||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||||||||
-S9 mix |
Negative Controls |
99 |
15 |
26 |
27 |
6 |
||||||
104 (104) |
8 (10) |
23 (26) |
15 (20) |
7 (8) |
||||||||
110 |
8 |
28 |
19 |
11 |
||||||||
313 |
115 |
(123) |
7 |
(9) |
21 |
(19) |
19 |
(16) |
10 |
(9) |
||
130 |
11 |
16 |
12 |
7 |
||||||||
625 |
109 |
(110) |
5 |
(8) |
27 |
(20) |
21 |
(13) |
4 |
(12) |
||
133 |
15 |
18 |
13 |
4 |
||||||||
1250 |
126 |
(137) |
14 |
(13) |
21 |
(23) |
14 |
(14) |
5 |
(6) |
||
147 |
12 |
25 |
14 |
7 |
||||||||
2500 |
114 |
(110) |
10 |
(8) |
19 |
(17) |
18 |
(19) |
6 |
(5) |
||
105 |
5 |
14 |
20 |
4 |
||||||||
5000 |
142 |
(132) |
11 |
(13) |
16 |
(14) |
11 |
(10) |
8 |
(5) |
||
122 |
14 |
11 |
9 |
2 |
||||||||
+S9 mi |
Negative Controls |
115 |
(117) |
10 |
(8) |
35 |
(33) |
16 |
(22) |
16 |
(21) |
|
121 |
5 |
28 |
23 |
22 |
||||||||
116 |
8 |
36 |
27 |
25 |
||||||||
313 |
120 |
(108) |
3 |
(8) |
26 |
(21) |
27 |
(27) |
12 |
(16) |
||
96 |
13 |
16 |
27 |
19 |
||||||||
625 |
114 |
(128) |
15 |
(12) |
18 |
(22) |
26 |
(26) |
21 |
(17) |
||
142 |
9 |
25 |
26 |
13 |
||||||||
1250 |
98 |
(110) |
12 |
(14) |
28 |
(25) |
18 |
(19) |
14 |
(17) |
||
122 |
15 |
21 |
19 |
20 |
||||||||
2500 |
153 |
(138) |
6 |
(9) |
19 |
(21) |
25 |
(24) |
5 |
(6) |
||
123 |
11 |
22 |
22 |
6 |
||||||||
5000 |
105 |
(112) |
8 |
(11) |
22 |
(21) |
14 |
(15) |
4 |
(5) |
||
118 |
14 |
19 |
15 |
6 |
||||||||
Positive Controls |
Those not requiring S9 mix |
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
|||||
Dose (μg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
0.5 |
|||||||
No. of Colonies/Plate |
690 |
(687) |
286 |
(265) |
373 |
(380) |
384 |
(393) |
1521 |
(1542) |
||
684 |
244 |
386 |
401 |
1563 |
||||||||
Those requiring S9 mix |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
||||||
Dose (μg/plate) |
1 |
2 |
10 |
0.5 |
2 |
|||||||
No. of Colonies/Plate |
941 |
(1000) |
293 |
(301) |
555 |
(552) |
280 |
(305) |
523 |
(446) |
||
1059 |
308 |
548 |
329 |
368 |
||||||||
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In the test results, the number of reverse mutation colonies was less than 2× that of the negative control value in all tested bacteria strains, regardless of the presence of the S9 mix. It was therefore determined that the mutagenicity was negative.
The number of reverse mutation colonies of the positive control was 2× or more that of the negative control, and the number of reverse mutation colonies of the negative control and positive control were within the range of the historical data. In addition, it was confirmed that the test system was free of contamination, and it was determined that the test was implemented normally.
From the above results, it was determined that CuDABT was free of mutagenicity under the test conditions. - Executive summary:
The ability of CuDABT to induce mutations was investigated using Salmonella typhimurium strains TA100, TA1535, TA98 and TA1537 and Escherichia coli strain WP2uvrA with a pre-incubation method in the presence and absence of a metabolic activation system (S9 mix). As a result, the mutagenicity of the test substance was judged to be negative because the numbers of revertant colonies in the test substance treatment groups were less than two times that in each negative control in all tester strains. Therefore, it is concluded that CuDABT has no ability to induce mutations under the present test conditions.
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