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EC number: 200-875-0 | CAS number: 75-50-3
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trimethylamine
- EC Number:
- 200-875-0
- EC Name:
- Trimethylamine
- Cas Number:
- 75-50-3
- Molecular formula:
- C3H9N
- IUPAC Name:
- N,N-dimethylmethanamine
- Details on test material:
- Methylamine, 30.8% in an aqueous solution.
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 induced rat liver S9
- Test concentrations with justification for top dose:
- - without metabolic activation: 0, 39.1, 78.1, 156, 313, 625, and 1250µg/plate. The highest dose caused growth inhibition in all strains.
- with metabolic activation: 0, 39.1, 78.1, 156, 313, 625, and 1250µg/plate. E.coli and TA98 were exposed to 2500 and 5000µg/plate instead of the lowest one or two concentrations. The highest concentration(s) caused growth inhibition in all strains. - Vehicle / solvent:
- water
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: See below
- Details on test system and experimental conditions:
- Ames test
NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: 2
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: background growth inhibition
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The triplicate values for both repeat experiments were highly comparable, and all results obtained with Trimethylamine were in the same range. By contrast, the positive controls led to a significant increase in mutant colonies.
Additionally, the background mutation frequency obtained in this study is identical to the historical negative control data obtained in our internal lab for the same tester strains and to the range of negative control data presented in the supporting study. Consequently, all controls are considered valid.
Any other information on results incl. tables
First trial (-S9)
Dose [µg/plate] | Revertant colonies per plate | |||||||||||||||
TA100 | TA1535 | WP2 uvrA | TA98 | TA1537 | ||||||||||||
Negative control | 122 | 134 | 119 | 9 | 10 | 11 | 21 | 20 | 22 | 20 | 22 | 22 | 7 | 8 | 5 | |
Mean +/- SD | 125 +/-8 | 10 +/-1 | 21 +/-1 | 21 +/-1 | 7 +/-2 | |||||||||||
TMA | 39.1 | 121 | 111 | 120 | 10 | 11 | 15 | 24 | 24 | 26 | 20 | 20 | 21 | 4 | 4 | 4 |
Mean +/- SD | 117 +/-6 | 12 +/-3 | 25 +/-1 | 20+/-1 | 4+/-0 | |||||||||||
78.1 | 113 | 117 | 112 | 14 | 10 | 13 | 24 | 23 | 24 | 29 | 31 | 29 | 9 | 7 | 7 | |
Mean +/- SD | 114+/-3 | 12+/-2 | 24+/-1 | 30+/-1 | 8+/-1 | |||||||||||
156 | 121 | 120 | 124 | 12 | 11 | 10 | 20 | 24 | 20 | 25 | 21 | 26 | 6 | 4 | 4 | |
Mean +/- SD | 122+/-2 | 11+/-1 | 21+/-2 | 24+/-3 | 5+/-1 | |||||||||||
313 | 109 | 114 | 106 | 9 | 10 | 12 | 23 | 21 | 21 | 19 | 22 | 20 | 5 | 6 | 5 | |
Mean +/- SD | 110+/-4 | 10+/-2 | 22+/-1 | 20+/-2 | 5+/-1 | |||||||||||
625 | 116 | 112 | 113 | 10 | 10 | 12 | 28 | 22 | 26 | 24 | 27 | 23 | 5 | 3 | 9 | |
Mean +/- SD | 114+/-2 | 11+/-1 | 25+/-3 | 25+/-2 | 6+/-3 | |||||||||||
1250 | 68* | 64* | 67* | 7* | 10* | 6* | 18* | 16* | 16* | 14* | 15* | 19* | 7* | 6* | 5* | |
Mean +/- SD | 66+/-2 | 8+/-2 | 17+/-1 | 16+/-3 | 6+/-1 | |||||||||||
Positive control | 530 | 506 | 522 | 404 | 413 | 416 | 120 | 128 | 123 | 696 | 661 | 657 | 426 | 413 | 434 | |
Mean +/- SD | 519+/-12 | 411+/-6 | 124+/-4 | 671+/-21 | 424+/-11 | |||||||||||
Second trial (-S9)
Dose [µg/plate] | Revertant colonies per plate | |||||||||||||||
TA100 | TA1535 | WP2 uvrA | TA98 | TA1537 | ||||||||||||
Negative control | 125 | 117 | 109 | 12 | 13 | 15 | 25 | 25 | 20 | 20 | 20 | 19 | 5 | 7 | 5 | |
Mean +/- SD | 117+/-8 | 13+/-2 | 23+/-3 | 20+/-1 | 6+/-1 | |||||||||||
TMA | 39.1 | 123 | 120 | 117 | 13 | 14 | 15 | 22 | 26 | 29 | 19 | 18 | 21 | 11 | 8 | 8 |
Mean +/- SD | 120+/-3 | 14+/-1 | 26+/-4 | 19+/-2 | 9+/-2 | |||||||||||
78.1 | 122 | 126 | 125 | 13 | 12 | 14 | 26 | 21 | 22 | 18 | 20 | 19 | 8 | 6 | 6 | |
Mean +/- SD | 124+/-2 | 13+/-1 | 23+/-3 | 19+/-1 | 7+/-1 | |||||||||||
156 | 127 | 112 | 118 | 17 | 14 | 14 | 25 | 25 | 24 | 24 | 17 | 17 | 6 | 5 | 4 | |
Mean +/- SD | 119+/-8 | 15+/-2 | 25+/-1 | 19+/-4 | 5+/-1 | |||||||||||
313 | 125 | 129 | 135 | 10 | 12 | 10 | 25 | 27 | 26 | 23 | 20 | 22 | 7 | 4 | 6 | |
Mean +/- SD | 130+/-5 | 11+/-1 | 26+/-1 | 22+/-2 | 6+/-2 | |||||||||||
625 | 130 | 145 | 137 | 11 | 12 | 10 | 28 | 26 | 20 | 21 | 21 | 18 | 6 | 5 | 7 | |
Mean +/- SD | 137+/-8 | 11+/-1 | 25+/-4 | 20+/-2 | 6+/-1 | |||||||||||
1250 | 75* | 75* | 71* | 6* | 8* | 8* | 18* | 19* | 20* | 16* | 16* | 12* | 7* | 4* | 5* | |
Mean +/- SD | 74+/-2 | 7+/-1 | 19+/-1 | 15+/-2 | 5+/-2 | |||||||||||
Positive control | 525 | 508 | 480 | 409 | 402 | 427 | 160 | 155 | 159 | 523 | 552 | 553 | 411 | 419 | 419 | |
Mean +/- SD | 504+/-23 | 413+/-13 | 158+/-3 | 543+/-17 | 416+/-5 | |||||||||||
First trial (+S9)
Dose [µg/plate] | Revertant colonies per plate | ||||||||||||||||
TA100 | TA1535 | WP2 uvrA | TA98 | TA1537 | |||||||||||||
Negative control | 128 | 127 | 124 | 12 | 11 | 15 | 27 | 25 | 30 | 30 | 32 | 30 | 11 | 13 | 10 |
| |
Mean +/- SD | 126+/-2 | 13+/-2 | 27+/-3 | 31+/-1 | 11+/-2 | ||||||||||||
TMA | 39.1 | 121 | 116 | 123 | 11 | 12 | 13 | 9 | 13 | 11 |
| ||||||
Mean +/- SD | 120+/-4 | 12+/-1 | 11+/-2 | ||||||||||||||
78.1 | 114 | 120 | 119 | 10 | 11 | 11 | 26 | 32 | 27 | 10 | 12 | 11 |
| ||||
Mean +/- SD | 118+/-3 | 11+/-1 | 28+/-3 | 11+/-1 | |||||||||||||
156 | 118 | 122 | 120 | 11 | 9 | 12 | 28 | 25 | 26 | 29 | 26 | 28 | 10 | 10 | 11 |
| |
Mean +/- SD | 120+/-2 | 11+/-1 | 26+/-2 | 28+/-2 | 10+/-1 | ||||||||||||
313 | 119 | 120 | 119 | 11 | 14 | 10 | 22 | 24 | 22 | 25 | 29 | 27 | 10 | 13 | 9 |
| |
Mean +/- SD | 119+/-1 | 12+/-2 | 23+/-1 | 27+/-2 | 11+/-2 | ||||||||||||
625 | 107 | 105 | 106 | 12* | 9* | 12* | 23 | 24 | 25 | 31 | 26 | 24 | 9* | 7* | 11* |
| |
Mean +/- SD | 106+/-1 | 11+/-2 | 24+/-1 | 27+/-4 | 9+/-2 | ||||||||||||
1250 | 110 | 104* | 97* | 8* | 9* | 8* | 33 | 33 | 37 | 31* | 31* | 29* | 14* | 18* | 10* |
| |
Mean +/- SD | 104+/-7 | 8+/-1 | 34+/-2 | 30+/-1 | 14+/-4 | ||||||||||||
2500 | 19* | 18* | 22* | 6* | 10* | 9Ü |
| ||||||||||
Mean +/- SD | 20+/-2 | 8+/-2 | |||||||||||||||
5000 | 5* | 9* | 11* | 0* | 0* | 0* |
| ||||||||||
Mean +/- SD | 8+/-3 | 0+/-0 | |||||||||||||||
Positive control | 758 | 753 | 761 | 286 | 302 | 300 | 808 | 772 | 798 | 270 | 298 | 284 | 158 | 162 | 172 |
| |
Mean +/- SD | 757+/-4 | 296+/-9 | 793+/-19 | 284+/-14 | 164+/-7 | ||||||||||||
Second trial (+S9)
Dose [µg/plate] | Revertant colonies per plate | |||||||||||||||
TA100 | TA1535 | WP2 uvrA | TA98 | TA1537 | ||||||||||||
Negative control | 118 | 125 | 122 | 16 | 15 | 16 | 27 | 29 | 30 | 25 | 30 | 24 | 10 | 15 | 10 | |
Mean +/- SD | 122+/-4 | 16+/-1 | 29+/-2 | 26+/-3 | 12+/-3 | |||||||||||
TMA | 39.1 | 120 | 121 | 123 | 11 | 12 | 14 | 8 | 11 | 13 | ||||||
Mean +/- SD | 121+/-2 | 12+/-2 | 11+/-3 | |||||||||||||
78.1 | 124 | 121 | 107 | 17 | 12 | 12 | 30 | 25 | 26 | 11 | 14 | 13 | ||||
Mean +/- SD | 117+/-9 | 14+/-3 | 27+/-3 | 13+/-2 | ||||||||||||
156 | 117 | 129 | 129 | 13 | 10 | 13 | 23 | 26 | 28 | 31 | 28 | 28 | 14 | 10 | 13 | |
Mean +/- SD | 125+/-7 | 12+/-2 | 26+/-3 | 29+/-2 | 12+/-2 | |||||||||||
313 | 125 | 120 | 126 | 13 | 10 | 13 | 29 | 30 | 31 | 26 | 28 | 27 | 13 | 14 | 12 | |
Mean +/- SD | 124+/-3 | 12+/-2 | 30+/-1 | 27+/-1 | 13+/-1 | |||||||||||
625 | 123 | 109 | 111 | 15* | 12* | 13* | 22 | 24 | 25 | 32 | 28 | 28 | 11* | 13* | 10* | |
Mean +/- SD | 114+/-8 | 13+/-2 | 24+/-2 | 29+/-2 | 11+/-2 | |||||||||||
1250 | 112* | 114* | 114* | 9* | 7* | 8* | 30 | 25 | 30 | 17* | 22* | 18* | 12* | 9* | 12* | |
Mean +/- SD | 113+/-1 | 8+/-1 | 28+/-3 | 19+/-3 | 11+/-2 | |||||||||||
2500 | 19* | 20* | 21* | 0* | 0* | 0* | ||||||||||
Mean +/- SD | 20+/-1 | 0+/-0 | ||||||||||||||
5000 | 0* | 0* | 0* | 0* | 0* | 0* | ||||||||||
Mean +/- SD | 0+/-0 | 0+/-0 | ||||||||||||||
Positive control | 759 | 776 | 742 | 286 | 290 | 252 | 602 | 609 | 623 | 362 | 368 | 383 | 140 | 148 | 150 | |
Mean +/- SD | 759+/-17 | 276+/-21 | 611+/-11 | 371+/-11 | 146+/-5 | |||||||||||
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
Trimethylamine showed no gene mutation effects to S.typhimurium strains TA98, TA100, TA1535, and TA1537 and E.coli strain WP2 uvr A. - Executive summary:
Gene mutation properties of trimethylamine was investigated in a bacterial reverse mutation assay (Ames test). This test was performed according to the OECD guideline 471 with Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 as well as with Escherichia coli strain WP2 uvr A. The concentrations of the test substance ranged from 0 to 5000 µg and the test result was negative according to all strains, with and without metablic activation.
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