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EC number: 211-367-3 | CAS number: 640-67-5
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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: Well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Manganese Oxalate, dihydrate
- IUPAC Name:
- Manganese Oxalate, dihydrate
Constituent 1
Method
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:
- phenobarbital/betanaphthoflavone induced rat liver, S9
- Test concentrations with justification for top dose:
- Pre-experiment/Experiment I and Experiment II: 3; 10; 33; 100; 333; 1000; 2500; 5000 µg/plate
- Vehicle / solvent:
- On the day of the experiment, the test item Manganese oxalate, dihydrate was suspended in DMSO (MERCK, D-64293 Darmstadt; purity > 99 %). The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, NaN3 (TA 1535, TA 100), 4-nitro-o-phenylene-diamine, 4-NOPD (TA 1537, TA 98), methyl methane sulfonate, MMS (WP2 uvrA)
- Remarks:
- Without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 2-AA
- Remarks:
- With metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation test (experiment I) and the pre-incubation test (experiment II)
Experimental Performance
For each strain and dose level including the controls, three plates were used.
The following materials were mixed in a test tube and poured onto the selective agar plates:
100 μL Test solution at each dose level (solvent or reference mutagen solution (positive control)),
500 μL S9 mix (for test with metabolic activation) or S9 mix substitution buffer (for test without metabolic activation),
100 μL Bacteria suspension (cf. test system, pre-culture of the strains),
2000 μL Overlay agar
In the pre-incubation assay 100 μL test solution (solvent or reference mutagen solution (positive control)), 500 μL S9 mix / S9 mix substitution buffer and 100 μL bacterial suspension were mixed in a test tube and shaken at 37 °C for 60 minutes. After pre-incubation 2.0 mL overlay agar (45 °C) was added to each tube. The mixture was poured on selective agar plates.
After solidification the plates were incubated upside down for at least 48 hours at 37 °C in the dark.
Acceptability of the Assay
The Salmonella typhimurium and Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:
- regular background growth in the negative and solvent control
- the spontaneous reversion rates in the negative and solvent control are in the range of our historical data
- the positive control substances should produce a significant increase in mutant colony frequencies - Evaluation criteria:
- Evaluation of Results
A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory
Results and discussion
Test resultsopen allclose all
- 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
- Remarks:
- Tested up to maximum recommended dose of 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Tested up to maximum recommended dose of 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Example:
TEST-SPECIFIC CONFOUNDING FACTORS
The test item precipitated in the test tubes and on the incubated agar plates at 2500 and 5000 µg/plate. The undissolved particles had no influence on the data recording.
COMPARISON WITH HISTORICAL CONTROL DATA:
performed
Results for the negative controls (spontaneous mutation rates) were considered to be acceptable.
All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Summary of Results Pre-Experiment and Experiment I
Study Name: 1360602 |
Study Code: Harlan CCR 1360602 |
Experiment: 1360602 VV Plate |
Date Plated: 11/08/2010 |
Assay Conditions: |
Date Counted: 17/08/2010 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
||||||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
|
Without Activation |
DMSO |
|
|
13 ± 3 |
13 ± 1 |
26 ± 2 |
121 ± 7 |
42 ± 9 |
Untreated |
|
|
14 ± 2 |
14 ± 2 |
30 ± 9 |
108 ± 7 |
47 ± 8 |
|
Manganese |
3 µg |
|
15 ± 1 |
17 ± 3 |
26 ± 7 |
117 ± 15 |
42 ± 9 |
|
oxalate, dihydrate |
10 µg |
|
15 ± 1 |
18 ± 2 |
32 ± 7 |
127 ± 9 |
43 ± 13 |
|
|
33 µg |
|
15 ± 2 |
17 ± 0 |
32 ± 5 |
124 ± 6 |
41 ± 7 |
|
|
100 µg |
|
13 ± 2 |
15 ± 5 |
30 ± 4 |
130 ± 16 |
43 ± 1 |
|
|
333 µg |
|
14 ± 0 |
22 ± 2 |
23 ± 6 |
131 ± 15 |
40 ± 3 |
|
|
1000 µg |
|
14 ± 2 |
17 ± 4 |
32 ± 4 |
141 ± 23 |
54 ± 9 |
|
|
2500 µg |
|
17 ± 2P |
14 ± 5P |
33 ± 7P |
136 ± 18P |
51 ± 7P |
|
|
5000 µg |
|
12 ± 1P |
15 ± 2P |
31 ± 2P |
138 ± 6P |
55 ± 6P |
|
NaN3 |
10 µg |
|
1610 ± 36 |
|
|
1866 ± 30 |
|
|
4-NOPD |
10 µg |
|
|
|
455 ± 6 |
|
|
|
4-NOPD |
50 µg |
|
|
69 ± 10 |
|
|
|
|
MMS |
3.0 µL |
|
|
|
|
|
870 ± 16 |
|
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
|
25 ± 6 |
21 ± 6 |
46 ± 6 |
132 ± 18 |
59 ± 3 |
Untreated |
|
|
24 ± 7 |
26 ± 4 |
52 ± 4 |
129 ± 5 |
65 ± 6 |
|
Manganese |
3 µg |
|
23 ± 3 |
23 ± 4 |
41 ± 4 |
139 ± 16 |
66 ± 8 |
|
oxalate, dihydrate |
10 µg |
|
24 ± 2 |
25 ± 2 |
52 ± 4 |
142 ± 20 |
59 ± 12 |
|
|
33 µg |
|
22 ± 7 |
23 ± 4 |
43 ± 8 |
147 ± 8 |
61 ± 8 |
|
|
100 µg |
|
22 ± 3 |
26 ± 6 |
43 ± 8 |
138 ± 7 |
64 ± 7 |
|
|
333 µg |
|
23 ± 1 |
26 ± 2 |
46 ± 3 |
147 ± 10 |
60 ± 3 |
|
|
1000 µg |
|
24 ± 3 |
24 ± 7 |
49 ± 7 |
139 ± 24 |
67 ± 4 |
|
|
2500 µg |
|
14 ± 3P |
24 ± 2P |
43 ± 6P |
132 ± 20P |
58 ± 8P |
|
|
5000 µg |
|
14 ± 3P |
15 ± 2P |
47 ± 6P |
148 ± 13P |
66 ± 10P |
|
2-AA |
2.5 µg |
|
358 ± 28 |
355 ± 18 |
2244 ± 179 |
2656 ± 60 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
380 ± 26 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
P |
Precipitate |
Summary of Results Experiment II
Study Name: 1360602 |
Study Code: Harlan CCR 1360602 |
Experiment: 1360602 HV2 Pre |
Date Plated: 12/08/2010 |
Assay Conditions: |
Date Counted: 17/08/2010 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
||||||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
|
Without Activation |
DMSO |
|
|
16 ± 4 |
11 ± 4 |
28 ± 1 |
112 ± 16 |
46 ± 5 |
Untreated |
|
|
16 ± 6 |
13 ± 1 |
28 ± 6 |
111 ± 7 |
40 ± 4 |
|
Manganese |
3 µg |
|
14 ± 3 |
9 ± 3 |
27 ± 1 |
110 ± 1 |
46 ± 2 |
|
oxalate, dihydrate |
10 µg |
|
12 ± 1 |
11 ± 4 |
21 ± 2 |
88 ± 4 |
47 ± 8 |
|
|
33 µg |
|
12 ± 1 |
9 ± 3 |
23 ± 4 |
96 ± 3 |
47 ± 5 |
|
|
100 µg |
|
15 ± 3 |
9 ± 0 |
30 ± 4 |
99 ± 8 |
46 ± 3 |
|
|
333 µg |
|
16 ± 2 |
9 ± 3 |
24 ± 5 |
93 ± 12 |
46 ± 4 |
|
|
1000 µg |
|
13 ± 5 |
9 ± 2 |
26 ± 4 |
106 ± 8 |
56 ± 2 |
|
|
2500 µg |
|
13 ± 3P |
10 ± 4P |
29 ± 3P |
109 ± 9P |
53 ± 3P |
|
|
5000 µg |
|
10 ± 1P M |
9 ± 3P M |
30 ± 3P |
113 ± 10P |
50 ± 13P |
|
NaN3 |
10 µg |
|
1451 ± 26 |
|
|
1549 ± 82 |
|
|
4-NOPD |
10 µg |
|
|
|
397 ± 48 |
|
|
|
4-NOPD |
50 µg |
|
|
81 ± 6 |
|
|
|
|
MMS |
3.0 µL |
|
|
|
|
|
278 ± 6 |
|
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
|
21 ± 1 |
18 ± 4 |
40 ± 3 |
121 ± 15 |
55 ± 3 |
Untreated |
|
|
27 ± 5 |
24 ± 3 |
40 ± 12 |
138 ± 19 |
53 ± 9 |
|
Manganese |
3 µg |
|
19 ± 3 |
18 ± 3 |
41 ± 4 |
118 ± 11 |
61 ± 9 |
|
oxalate, dihydrate |
10 µg |
|
25 ± 11 |
20 ± 4 |
40 ± 5 |
117 ± 9 |
59 ± 7 |
|
|
33 µg |
|
22 ± 4 |
15 ± 2 |
44 ± 6 |
118 ± 20 |
54 ± 5 |
|
|
100 µg |
|
27 ± 1 |
19 ± 3 |
38 ± 5 |
116 ± 3 |
55 ± 5 |
|
|
333 µg |
|
19 ± 3 |
20 ± 3 |
52 ± 3 |
112 ± 4 |
49 ± 6 |
|
|
1000 µg |
|
21 ± 2 |
19 ± 2 |
39 ± 9 |
118 ± 8 |
59 ± 6 |
|
|
2500 µg |
|
16 ± 2P |
15 ± 1P |
38 ± 8P |
124 ± 4P |
67 ± 5P |
|
|
5000 µg |
|
16 ± 6P M |
14 ± 4P |
38 ± 7P |
108 ± 16P |
55 ± 8P |
|
2-AA |
2.5 µg |
|
287 ± 12 |
185 ± 11 |
1702 ± 46 |
1668 ± 86 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
390 ± 30 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
P M |
Precipitate Manual count |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. - Executive summary:
The test item Manganese oxalate, dihydrate was assessed for its potential to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations:
3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in both experiments.
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Manganese oxalate, dihydrate at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
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