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The bacterial reverse mutation test uses amino acid-requiring strains of Salmonella typhimurium (S. typhimurium) and Escherichia coli (E. coli) to detect point mutations, which involve substitution, addition or deletion of one or a few DNA base pairs. The principle of this bacterial reverse mutation test is that it detects chemicals that induce mutations which revert mutations present in the tester strains and restore the functional capability of the bacteria to synthesize an essential amino acid. The revertant bacteria are detected by their ability to grow in the absence of the amino acid required by the parent tester strain.
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- red font - indicates potential for CT code lists
- green font - links to other domains
- purple font - to be discussed
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- During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
- Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
- Where is TK6 cell type? is this test system (see below)
- needs to be allowed to vary down to the well level / result level
| Row | STUDYID | ASSAYID | DOMAIN | SETCD | | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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| 8325064 | Ames | TX | P1 (plate 1SetA (TA98-DMSO) |
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| METACT | Metabolic Activation (should there be two parms? Presence, type)? | None |
| 8325064 | Ames | TX | P1SetA |
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| TRTDRTRG | Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable) |
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| TXP1 |
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| TRTDRTOL | Treatment Duration Tolerance |
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| TXP1 |
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| TRTDURU | Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL) |
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| TXP1 |
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| INTRVN | name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A) | DMSO TA1 |
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| TXP1 |
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| ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Vehicle Control |
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| TXP1 |
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| ITVCONC | Concentration of intervention article | 0 |
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| TXP1 |
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| ITVCONCU | Concentration Unit | ug/ml |
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| TX | P1 |
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| STRAIN | Strain/Substrain | TA98 |
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| TX | P1 |
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| REGIME | Smoking Regime |
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| TX | P1 |
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| RUN | Assay run number | 1 |
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| TX | P1 |
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| PORT | Port ID |
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| TX | P1 |
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| SMPLID | Sample ID |
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| TX | P1 |
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| SMKFRC | Smoke Fraction |
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| TX | P1 |
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| REPNUM | Replicate Number |
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| MEAN |
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| STDDEV |
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| FOLDINC |
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| TX | P2 |
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| METACT | Metabolic Activation (should there be two parms? Presence, type)? | +S9 |
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| TX | P2 |
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| TRTDRTRG | Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable) | 3 |
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| TX | P2 |
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| TRTDRTOL | Treatment Duration Tolerance |
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| TX | P2 |
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| TRTDURU | Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL) | H |
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| TX | P2 |
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| INTRVN | name of the intervention article | DMSO TA1 |
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| TX | P2 |
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| ITVTYPE | type of intervention article | Product |
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| TX | P2 |
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| ITVCONC | Concentration of i a | 1250 |
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| TX | P2 |
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| ITVCONCU | Concentration Unit | ug/ml |
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| TX | P2 |
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| STRAIN | Strain/Substrain | WP2 uvrA pKM10 1 |
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| TX | P2 |
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| REGIME | Smoking Regime |
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| TX | P2 |
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| RUN | Assay run number | 1 |
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| TX | P2 |
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| PORT | Port ID |
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| TX | P2 |
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| SMPLID | Sample ID |
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| TX | P2 |
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| SMKFRC | Smoke Fraction |
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| TX | P2 |
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| REPNUM | Replicate Number |
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| title | gt.xpt (similar to LB) |
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Do we need GTMETHOD? | Row | STUDYID | ASSAYID | DOMAIN | TXSETCD | PLTWLID | GTSEQ | GTTESTCD | GTTEST | GTCELLEV
(cells evaluated) | GTORRES | GTORRESU | GTSTRESC | GTSTRESN | GTSTRESU | GTDTC |
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| 1 |
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| GT |
P1| SETA (TA98-DMSO) | 1 | 1 | RPP | Revertant Numbers Per Plate |
| 26 |
| 26 | 26 |
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2015-08-03 | | 2 |
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| GT |
P1 | 2 | RPP | Revertant Numbers Per Plate |
| 35 |
| 35 | 35 |
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2015-08-03 | | 3 |
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| GT |
P1 | 3 | RPP | Revertant Numbers Per Plate |
| 39 |
| 39 | 39 |
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2015-08-03 | | 4 |
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| GT | SETA (TA98-DMSO) | 4 | 4 | RPP | Revertant Numbers Per Plate |
| 35 |
CellsCells| 35 |
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2015-08-03 | | 5 |
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| GT | SETA (TA98-DMSO) | 5 | 5 | RPP | Revertant Numbers Per Plate |
| 30 |
CellsCells| 30 |
| 2015-08-03 | | 6 |
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| GT | SETA (TA98-DMSO) | ALL | 6 | RPPMEAN | Mean of Revertant Numbers Per Plate |
| 33.0 |
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| GT | SETA (TA98-DMSO) | ALL | 7 | RPPSTDDV | Standard Deviation of Revertant Numbers Per Plate |
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| GT | SETA (TA98-DMSO) | ALL | 8 | RPPFLDINC | Fold Increase of Revertant Numbers Per Plate |
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| GT | A2 |
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| 9 | RICC | Relative Increase in Cell Count |
| 15.7 | % | 15.7 | 15.7 | % | 2022-05-25 | | 10 |
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| GT | A2 |
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| 10 | RCC | Relative Cell Count |
| 13.0 | % | 13.0 | 13.0 | % | 2022-05-25 | | 11 |
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| GT | A2 |
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| 11 | RPD | Relative Population Doubling |
| 7.9 | % | 7.9 | 7.9 | % | 2022-05-25 | | 12 |
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| GT | A2 |
| 4 | MNCELLS | Micronucleated Cells |
| 20 | Cells | 20 | 20 | Cells | 2022-05-25 | | 13 |
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| GT | A2 |
| 5 | MNCELLS | Micronucleated Cells |
| 17 | Cells | 17 | 17 | Cells | 2022-05-25 | | 14 |
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| GT | A2 |
| 6 | MNCELLS | Micronucleated Cells |
| 13 | Cells | 13 | 13 | Cells | 2022-05-25 | | 15 |
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| GT | A2 |
| 7 | MNCELLS | Micronucleated Cells |
| 21 | Cells | 21 | 21 | Cells | 2022-05-25 | | 16 |
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| GT | A2 |
| 8 | AVGREL | Average Relative MN Frequency |
| 0.66 | % | 0.66 | 0.66 | % | 2022-05-25 | | ... |
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