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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:
2012

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

Constituent 1
Chemical structure
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
Constituent 2
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

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