This is an example showing trial design and results data of Study #8325064 for the determination of the from the in vitro bacterial reverse mutation test potential of 10 tobacco products in the in vitro Micronucleus Assaytest of Study #8325064.
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.
Plate number
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- red font - indicates potential for CT code lists
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| title | Study 1238325064, Report Table |
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| title | ts.xpt (trial summary, study level parameters) |
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- Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data. What is the best ASSAYID, Species, Test System, GLP?
Row | STUDYID | ASSAYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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1 | 8325064 | Ames | TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
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2 | 8325064 | Ames | TS | 2 |
| GLPTYP | Good Laboratory Practice Type | OECD |
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3 | 8325064 | Ames | TS | 1 |
| STSTDTC | Study Start Date | 2015-07-29 |
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4 | 8325064 | Ames | TS | 1 |
| STITLE | Study Title |
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Determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay
| The Bacterial Reverse Mutation Test, Study 8325064-1 |
| 5 | 8325064 | Ames |
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5 | TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | TOBACCO IMPLEMENTATION GUIDE VERSION 1.0 |
| 6 | 8325064 | Ames | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-09-30 |
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7 | 8325064 | Ames | TS | 1 |
| SSPONSOR | Sponsor Organization | Example Sponsor Inc. |
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8 | 8325064 | Ames | TS | 1 |
| SPREFID | Sponsor's Study Reference ID |
| NOT APPLICABLE |
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9 | 8325064 | Ames | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name |
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10 | 8325064 | Ames | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
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11 | 8325064 | Ames | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
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12 | 8325064 | Ames | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
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13 | 8325064 | Ames | TS | 1 |
| GLPFL | GLP Flag | N |
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14 | 8325064 | Ames | TS | 1 |
| ASTD | Assay Standard | OECD Test No. 471 |
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123| 8325064 | Ames | TS | 1 |
| ASTDV | Assay Standard Version | 2020-06-29 |
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123| Ames | TS | 1 |
| SSTYP | Study Type | GENOTOXICITY IN VITRO |
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123| 8325064 | Ames | TS | 1 |
| SSSTYP | Study Sub Type | Bacterial Reverse Mutation Test |
| 18 | 8325064 |
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123Salmonella (or E Coli)| Salmonella |
| 19 | 8325064 | Ames |
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| STRAIN | Strain | Salmonella typhimurium, |
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20 |
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19123??NRU, MNvit, MLA) or | this would be Tester Strain |
(| for Ames) | TA98 (examples: H292, CHO, TK6.. etc.) |
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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.
- Do we need "plate counted manually"
- How do we handle "toxic, no revertant colonies"?
- Condition of background bacterial lawn? Slight thinning, Very thin??
 Image Added | Row | STUDYID | ASSAYID | DOMAIN | SETCD | | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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| 1 | 8325064 | Ames | TX | SetA (TA98-DMSORow 1) |
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| METACT | Metabolic Activation (should there be two parms? Presence, type)? | None |
| 8325064 | Ames | TX | SetA |
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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 | 8325064 | Ames | TX | SetA |
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| TRTDRTOL | Treatment Duration Tolerance |
| | 4 | 8325064 | Ames | TX | SetA |
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| TRTDURU | Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL) |
| | 5 | 8325064 | Ames | TX | SetA |
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| INTRVN | name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A) | DMSO. (or TA1) | | 6 | 8325064 | Ames | TX | SetA |
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| ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Vehicle Control. (or Product) | | 7 | 8325064 | Ames | TX | SetA |
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| ITVCONC | Concentration of intervention article | 0 (null?) | | 8 | 8325064 | Ames | TX | SetA |
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| ITVCONCU | Concentration Unit | ug/mlplate | | 9 | 8325064 | Ames | TX | SetA |
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| STRAIN | Strain/Substrain | TA98 | | 10 | 8325064 | Ames | TX | SetA |
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| REGIME | Smoking Regime | ISO |
| 8325064 | Ames | TX | SetA |
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| RUN | Assay run number
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| 8325064 | Ames | TX | SetA |
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| PORT | Port ID |
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| 8325064 | Ames | TX | SetA |
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| SMPLID | Sample ID |
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| 8325064 | Ames | TX | SetA |
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| SMKFRC | Smoke Fraction |
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| 8325064 | Ames | TX | SetA |
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| REPNUM | Replicate Number | 1 |
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| 8325064 | Ames | TX | SetA |
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| MEAN | Mean | 33.0 |
| 8325064 | Ames | TX | SetA |
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| STDDEV | Standard Deviation | 5.0 |
| 8325064 | Ames | TX | SetA |
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| FOLDINC | Fold Increase |
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| 8325064 | Ames | TX | P2SetF (row 4) |
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| METACT | Metabolic Activation (should there be two parms? Presence, type)? | +S9 | None |
| 8325064 | Ames | TX | P2SetF |
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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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| 8325064 | Ames | TX | SetF |
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| TRTDRTOL | Treatment Duration Tolerance |
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| 8325064 | Ames | TX | SetF |
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| TRTDURU | Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL) |
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| 8325064 | Ames | TX | SetF |
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| INTRVN | name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A) | 2-Nitrofluorine |
| 8325064 | Ames | TX | SetF |
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| ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Positive Control |
| 8325064 | Ames | TX | SetF |
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| ITVCONC | Concentration of intervention article | 5 |
| 8325064 | Ames | TX | SetF |
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| ITVCONCU | Concentration Unit | ug/plate |
| 8325064 | Ames | TX | SetF |
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| STRAIN | Strain/Substrain | TA98 |
| 8325064 | Ames | TX | SetF |
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| REGIME | Smoking Regime | ISO |
| 8325064 | Ames | TX | SetF |
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| ARTCON | Concentration level of intervention article on plate | 500 |
| 8325064 | Ames | TX | SetF |
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| CONUNIT | Concentration level of intervention article on plate, unit | ug/plate | | ... |
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| 8325064 | Ames | TX | SetI(row 6) |
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| METACT | Metabolic Activation (should there be two parms? Presence, type)? | None |
| 8325064 | Ames | TX | SetI |
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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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| 8325064 | Ames | TX | P2SetI |
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| TRTDRTOL | Treatment Duration Tolerance |
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| 8325064 | Ames | TX | P2SetI |
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| TRTDURU | Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL) | H
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| 8325064 | Ames | TX | P2SetI |
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| INTRVN | name of the intervention article | (Tobacco ProdA, Bleomycin or Cyclophosphamid A) | 2-Nitrofluorine |
| 8325064 | Ames | DMSO TA1 | TX | P2SetI |
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| ITVTYPE | type of intervention article | choices of values: product; negative control; positive control | Positive Control |
| 8325064 | Ames | Product | TX | P2SetI |
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| ITVCONC | Concentration of | i a intervention article | 5 |
| 8325064 | Ames | 1250 | TX | P2SetI |
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| ITVCONCU | Concentration Unit | ug/ | mlplate |
| 8325064 | Ames | TX | P2SetI |
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| STRAIN | Strain/Substrain | | TA98 |
| 8325064 | Ames | WP2 uvrA pKM10 1 | TX | P2SetI |
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| REGIME | Smoking Regime | TX | P2 | RUN | Assay run number | 1 | TX | P2 | PORT | Port ID | TX | P2 | SMPLID | Sample ID | TX | P2 | SMKFRC | Smoke Fraction | TX | P2 | REPNUM | | ISO | | ... |
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| 8325064 | Ames | TX | SetR (Row 18) |
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| METACT | Metabolic Activation (should there be two parms? Presence, type)? | None |
| 8325064 | Ames | TX | SetR |
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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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| 8325064 | Ames | TX | SetR |
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| TRTDRTOL | Treatment Duration Tolerance |
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| 8325064 | Ames | TX | SetR |
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| TRTDURU | Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL) |
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| 8325064 | Ames | TX | SetR |
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| INTRVN | name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A) | 4-Nitroquinoline-1-oxide |
| 8325064 | Ames | TX | SetR |
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| ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Positive Control |
| 8325064 | Ames | TX | SetR |
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| ITVCONC | Concentration of intervention article | 2 |
| 8325064 | Ames | TX | SetR |
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| ITVCONCU | Concentration Unit | ug/plate |
| 8325064 | Ames | TX | SetR |
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| STRAIN | Strain/Substrain | TA98 |
| 8325064 | Ames | TX | SetR |
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| REGIME | Smoking Regime | ISO | | ... | 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 | 8325064 | Ames | GT | SETA (TA98-DMSO) | 1 | 1 | RPP | Revertant Numbers Per Plate |
| 26 |
| 26 | 26 |
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2015-08-03 | | 2 | 8325064 | Ames | GT | SETA (TA98-DMSO)SETA | 2 | 2 | RPP | Revertant Numbers Per Plate |
| 35 |
| 35 | 35 |
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2015-08-03 | | 3 | 8325064 | Ames | GT | SETA (TA98-DMSO)SETA | 3 | 3 | RPP | Revertant Numbers Per Plate |
| 39 |
| 39 | 39 |
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2015-08-03 | | 4 | 8325064 | Ames | GT | SETA (TA98-DMSO)SETA | 4 | 4 | RPP | Revertant Numbers Per Plate |
| 35 |
| 35 | 35 |
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2015-08-03 | | 5 | 8325064 | Ames | GT | SETA (TA98-DMSO)SETA | 5 | 5 | RPP | Revertant Numbers Per Plate |
| 30 |
| 30 | 30 |
| 2015-08-03 | | 6 | 8325064 | Ames | GT | SETA (TA98-DMSO)SETA | ALL | 6 | RPPMEAN | Mean of Revertant Numbers Per Plate |
| 33.0 |
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| | 7 | 8325064 | Ames | GT | SETA (TA98-DMSO)SETA | ALL | 7 | RPPSTDDV | Standard Deviation of Revertant Numbers Per Plate |
| 5.0 |
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| | 8 | 8325064 | Ames | GT | SETA (TA98-DMSO)SETA | ALL | 8 | RPPFLDINC | Fold Increase of Revertant Numbers Per Plate |
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| | 9 | 8325064 | Ames |
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| | 10 | 8325064 | Ames |
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| | 11 | 8325064 | Ames |
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| | 12 | 8325064 | Ames |
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| | 13 | 8325064 | Ames |
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| | 14 | 8325064 | Ames |
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| | 15 | 8325064 | Ames |
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| | 16 | GT | A2 | 9 | RICC | Relative Increase in Cell Count | 15.7 | % | 15.7 | 15.7 | % | 2022-05-25 | 10 | GT | A2 | 10 | RCC | Relative Cell Count | 13.0 | % | 13.0 | 13.0 | % | 2022-05-25 | 11 | GT | A2 | 11 | RPD | Relative Population Doubling | 7.9 | % | 7.9 | 7.9 | % | 2022-05-25 | 12 | GT | A2 | 4 | MNCELLS | Micronucleated Cells | 20 | Cells | 20 | 20 | Cells | 2022-05-25 | 13 | GT | A2 | 5 | MNCELLS | Micronucleated Cells | 17 | Cells | 17 | 17 | Cells | 2022-05-25 | 14 | GT | A2 | 6 | MNCELLS | Micronucleated Cells | 13 | Cells | 13 | 13 | Cells | 2022-05-25 | 15 | GT | A2 | 7 | MNCELLS | Micronucleated Cells | 21 | Cells | 21 | 21 | Cells | 2022-05-25 | 16 | GT | A2 | 8 | AVGREL | Average Relative MN Frequency | 0.66 | % | 0.66 | 0.66 | % | 2022-05-25 |
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