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EC number: 937-913-7 | CAS number: -
Toxicological information
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- - no analysis was carried out to determine the homogeneity, concentration or stability of the test item formulation.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of tri-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ-(acetato-O)-di-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese
- EC Number:
- 700-806-9
- Molecular formula:
- C42H87Mn2N6O6 and C36H75Mn2N6O6
- IUPAC Name:
- Reaction mass of tri-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ-(acetato-O)-di-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese
- Reference substance name:
- Reaction mass of tri- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ -(acetato-O)-di- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese
- IUPAC Name:
- Reaction mass of tri- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ -(acetato-O)-di- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese
- Details on test material:
- - Name of test material (as cited in study report): Manganese Octoate/Acetate - MeTACN complex
- Physical state: white solid
- Storage condition of test material: room temperature in the dark under nitrogen
- Lot/batch No.: 16D16603
Constituent 1
Constituent 2
Method
- Target gene:
- S. typhimurium: histidine
E. coli: tryptophan
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate (10% liver S9 in standard co-factors)
- 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 tests: 50, 150, 500, 1500 and 5000 µg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- see below
- Positive controls:
- yes
- Positive control substance:
- other: see below
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- 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
Test Results: Range-Finding Test without Metabolic Activation
| With or without S9 mix | Test substance concentration (µg/plate) | Number of revertants (mean number of colonies/plate and S.D.) | |||||||||
| Base-pair substitution type | Frameshift type | ||||||||||
| TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
| - | 0 | 91 88 81 |
(87)± 5.1 | 16 15 18 |
(16) ± 1.5 |
26 30 38 |
(31) ± 6.1 |
14 18 18 |
(17) ± 2.3 |
14 12 12 |
(13) ± 1.2 |
| - | 50 | 84 81 71 |
(79) ± 6.8 |
20 12 13 |
(15) ± 4.4 |
34 27 39 |
(30) ± 3.6 |
20 15 14 |
(16) ± 3.2 |
13 14 11 |
(13) ± 1.5 |
| - | 150 | 84 87 95 |
(89) ± 5.7 |
14 15 18 |
(16) ± 2.1 |
35 35 27 |
(32) ± 4.6 |
10 18 16 |
(15) ± 4.2 |
13 16 13 |
(14) ± 1.7 |
| - | 500 | 91 74 89 |
(85) ± 9.3 |
13 14 13 |
(13) ± 0.6 |
21 27 35 |
(28) ± 7.0 |
21 14 15 |
(17) ± 3.8 |
13 13 11 |
(12) ± 1.2 |
| - | 1500 | 73 85 92 |
(83) ± 9.6 |
18 19 11 |
(16) ± 4.4 |
30 42 34 |
(35) ± 6.1 |
14 16 14 |
(15) ± 1.2 |
15 13 10 |
(13) ± 2.5 |
| - | 5000 | 102 86 85 |
(91) ± 9.5 |
11 16 19 |
(15) ± 4.0 |
42 30 30 |
(34) ± 6.9 |
19 16 15 |
(17) ± 2.1 |
14 12 13 |
(13) ± 1.0 |
| Positive controls | name | 2AA | 2AA | 2AA | BP | 2AA | |||||
| S9 mix | Concentration (µg/plate) | 3 | 5 | 2 | 0.2 | 80 | |||||
| - | No. colonies/plate | 351 299 288 |
(313) ± 33.7 |
210 223 209 |
(214) ± 7.8 |
517 565 545 |
(542) ± 24.1 |
111 113 98 |
(107) ± 8.1 |
2829 2721 2673 |
(2741) ± 79.9 |
Test Results: Range-Finding Test with Metabolic Activation
| With or without S9 mix | Test substance concentration (µg/plate) | Number of revertants (mean number of colonies/plate and S.D.) | |||||||||
| Base-pair substitution type | Frameshift type | ||||||||||
| TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
| + | 0 | 95 97 101 |
(98) ± 3.1 |
11 14 15 |
(13) ± 2.1 |
32 42 49 |
(41) ± 8.5 |
20 31 20 |
(24) ± 6.4 |
14 7 12 |
(11) ± 3.6 |
| + | 50 | 92 74 88 |
(85) ± 9.5 |
13 11 14 |
(13) ± 1.5 |
48 42 43 |
(44) ± 3.2 |
30 21 22 |
(24) ± 4.9 |
9 11 18 |
(13) ± 4.7 |
| + | 150 | 84 73 87 |
(81) ± 7.4 |
13 12 8 |
(11) ± 2.6 |
34 32 29 |
(32) ± 2.5 |
31 24 31 |
(29) ± 4.0 |
12 12 12 |
(12) ± 0.0 |
| + | 500 | 78 77 81 |
(79) ± 2.1 |
11 11 13 |
(12) ± 1.2 |
32 42 44 |
(39) ± 6.4 |
22 32 24 |
(26) ± 5.3 |
9 13 13 |
(12) ± 2.3 |
| + | 1500 | 77 89 87 |
(84) ± 6.4 |
11 9 10 |
(10) ± 1.0 |
43 52 38 |
(44) ± 7.1 |
23 27 30 |
(27) ± 3.5 |
12 11 12 |
(12) ± 0.6 |
| + | 5000 | 92 107 95 |
(98) ± 7.9 |
16 12 11 |
(13) ± 2.6 |
48 35 48 |
(44) ± 7.5 |
29 24 23 |
(25) ± 3.2 |
13 14 10 |
(12) ± 2.1 |
| Positive controls | name | ENNG | ENNG | ENNG | 4NQO | 9AA | |||||
| S9 mix | Concentration (µg/plate) | 1 | 2 | 10 | 5 | 2 | |||||
| + | No. colonies/plate | 1024 1103 1018 |
(313) ± 33.7 |
217 172 147 |
(214) ± 7.8 |
141 152 135 |
(143) ± 8.6 |
107 115 113 |
(112) ± 4.2 |
129 117 114 |
(120) ± 7.9 |
Test Results: main Test without Metabolic Activation
| With or without S9 mix | Test substance concentration (µg/plate) | Number of revertants (mean number of colonies/plate and S.D.) | |||||||||
| Base-pair substitution type | Frameshift type | ||||||||||
| TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
| - | 0 | 96 95 112 |
(101) ± 9.5 |
20 24 22 |
(22) ± 2.0 |
41 36 35 |
(37) ± 3.2 |
20 21 20 |
(20) ± 0.6 |
16 10 11 |
(12) ± 3.2 |
| - | 50 | 87 110 93 |
(97) ± 11.9 |
16 22 13 |
(17) ± 4.6 |
40 32 36 |
(36) ± 4.0 |
20 21 19 |
(20) ± 1.0 |
14 15 12 |
(14) ± 1.5 |
| - | 150 | 100 84 74 |
(86) ± 13.1 |
21 16 19 |
(19) ± 2.5 |
27 34 34 |
(32) ± 4.0 |
16 22 26 |
(21) ± 5.0 |
10 11 11 |
(11) ± 0.6 |
| - | 500 | 109 119 96 |
(108) ± 11.5 |
20 20 23 |
(21) ± 1.7 |
37 31 40 |
(36) ± 4.6 |
23 16 24 |
(21) ± 4.4 |
8 15 11 |
(11) ± 3.5 |
| - | 1500 | 84 87 96 |
(89) ± 6.2 |
22 23 26 |
(24) ± 2.1 |
36 41 35 |
(37) ± 3.2 |
26 23 23 |
(24) ± 1.7 |
7 8 13 |
(9) ± 3.2 |
| - | 5000 | 98 97 102 |
(99) ± 2.6 |
16 24 21 |
(20) ± 4.0 |
44 41 29 |
(38) ± 7.9 |
23 23 22 |
(23) ± 0.6 |
9 12 9 |
(10) ± 1.7 |
| Positive controls | name | ENNG | ENNG | ENNG | 4NQO | 9AA | |||||
| S9 mix | Concentration (µg/plate) | 3 | 5 | 2 | 0.2 | 80 | |||||
| - | No. colonies/plate | 493 479 528 |
(500) ± 25.2 |
153 189 162 |
(168) ± 18.7 |
581 563 555 |
(566) ± 13.3 |
141 146 125 |
(137) ± 11.0 |
455 451 555 |
(487) ± 58.9 |
Test Results: main Test with Metabolic Activation
| With or without S9 mix | Test substance concentration (µg/plate) | Number of revertants (mean number of colonies/plate and S.D.) | |||||||||
| Base-pair substitution type | Frameshift type | ||||||||||
| TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
| + | 0 | 96 101 97 |
(98) ± 2.6 |
15 10 19 |
(15) ± 4.5 |
40 47 40 |
(42) ± 4.0 |
15 19 15 |
(16) ± 2.3 |
15 11 12 |
(13) ± 2.1 |
| + | 50 | 89 96 107 |
(97) ± 9.1 |
15 10 13 |
(13) ± 2.5 |
46 40 40 |
(42) ± 3.5 |
13 16 13 |
(14) ± 1.7 |
11 13 12 |
(12) ± 1.0 |
| + | 150 | 93 82 100 |
(+92) ± 9.1 |
11 14 15 |
(13) ± 2.1 |
43 44 38 |
(42) ± 3.2 |
20 20 19 |
(20) ± 0.6 |
12 13 14 |
(13) ± 1.0 |
| + | 500 | 77 99 82 |
(86) ± 11.5 |
18 15 12 |
(15) ± 3.0 |
34 40 43 |
(39) ± 4.6 |
13 14 13 |
(13) ± 0.6 |
14 13 10 |
(12) ± 2.1 |
| + | 1500 | 99 97 82 |
(93) ± 9.3 |
12 12 10 |
(11) ± 1.2 |
38 36 43 |
(39) ± 3.6 |
20 12 14 |
(15) ± 4.2 |
13 14 14 |
(14) ± 0.6 |
| + | 5000 | 90 106 108 |
(101) ± 9.9 |
14 15 13 |
(14) ± 1.0 |
40 35 40 |
(38) ± 2.9 |
15 21 16 |
(17) ± 3.2 |
11 13 14 |
(13) ± 1.5 |
| Positive controls | name | 2AA | 2AA | 2AA | BP | 2AA | |||||
| S9 mix | Concentration (µg/plate) | 1 | 2 | 10 | 5 | 2 | |||||
| + | No. colonies/plate | 1198 1114 1237 |
(1183) ± 62.9 |
386 421 397 |
(401) ± 17.9 |
414 407 415 |
(412) ± 4.4 |
184 184 151 |
(173) ± 19.1 |
277 340 159 |
(259) ± 91.9 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The Drycoat substance is not mutagenic
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