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This example Trial Set (TX) dataset shows information about the test conditions for SetA and SetR in this study. For brevity, the dataset does not show information for SetF, SetG, or any other sets. A fully formed TX dataset for this example study would include information about the test conditions for all sets.
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-454 |
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Rows 1-14: | Show trial set SetSTM, with trial set parameters and trial set values that comprise the test conditions for all data for the species S. typhimurium. | Rows 15, 24, 33, 42: | Show that SetA, SetF, SetG, and SetR each have a parent set code of SetSTM. As a child set of SetSTM, each of these sets inherit the test conditions of SetSTM. | Rows 16-23: | Show trial set parameters and trial set values that comprise the test conditions for the set SetA. SetA is the data for the vehicle control (i.e., Strain of TA98, vehicle control with concentration value of 0). SetA is associated with the first row, labeled "SetA", in the report table for example study 8325064. | Rows 25-32: | Show trial set parameters and trial set values that comprise the test conditions for the set SetF. SetF is the data for the strain of TA98 with a concentration value of 500 µg/plate. SetF is associated with the sixth row, labeled "SetF", in the report table for example study 8325064. | Rows 33-41: | Show trial set parameters and trial set values that comprise the test conditions for the set SetG. SetG is the data for the strain of TA98 with a concentration value of 1600 µg/plate. SetG is associated with the seventh row, labeled "SetG", in the report table for example study 8325064. | Rows 42-50: | Show trial set parameters and trial set values that comprise the test conditions for the set SetR. SetR is the data for the strain of TA100, positive control with a concentration value of 2 µg/plate. SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064. | Row 10: | SPTOBID (Applicant-Defined Tobacco Product ID) is used to uniquely identify the tobacco product. The value of SPTOBID, in this case CIG01a, matches the value for SPTOBID in all the TOPARMCD-TOVAL pairs in the Tobacco Product Identifiers and Descriptors (TO) dataset example in Section 3.1.2, Product Design Parameters and Conformance Testing, Example 1. The TOPARMCD-TOVAL pairs identify this unique product, CIG01a. The TO domain is described in Section 2.8.8.1, Tobacco Product Identifiers and Descriptors (TO). | Row 13: | SPDEVID is the applicant-defined device identifier that is used to uniquely identify the device in the Unique Device Identification (DI) dataset (see also Section 2.8.9.7, SEND Device Identifiers (DI)). The value of SPDEVID, in this case PUFFMASTER3K, matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. This is shown in the DI dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 1. | Row 14: | Shows a value for DUREFID. DUREFID serves as a link to the Device-In Use Properties (DU) domain (see also Section 2.8.9.8, SEND Device-In-Use (DU)), where a matching value of DUREFID indicates parameters of the smoking regimen performed by the smoking machine, as in the DU dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 2. |
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Dataset2 |
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Row | STUDYID | GNTXAID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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1 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | | SPECIES | Species | SALMONELLA TYPHIMURIUM | 2 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | 2 | TRTDMIN | In vitro Treatment Duration Minimum | 71.5 | 3 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | 3 | TRTDTRG | In vitro Treatment Duration Target | 72 | 4 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | 4 | TRTDMAX | In vitro Treatment Duration Maximum | 72.5 | 5 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | 5 | TRTDU | In vitro Treatment Duration Unit | HOURS | 6 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | 6 | INCBTMP | Incubation Temperature | 37 | 7 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | 7 | INCBTMPU | Incubation Temperature Unit | C | 8 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | 8 | HUMID | Atmospheric Relative Humidity Percent | 50 | 9 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | 9 | ATMCO2 | Atmospheric CO2 Percent | 5 | 10 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | 10 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | 11 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | 11 | EXPTYP | | Submerged | 12 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | 12 | SAMTYP | Sample Type | Total Particulate Matter in PBS | 13 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | 13 | SPDEVID | Applicant-defined device identifier | PUFFMASTER3K | 14 | 8325064 | Ames | TX | SetSTM | SALMONELLA TYPHIMURIUM | 14 | DUREFID | Smoke Regimen | NON-INTENSE REGIMEN | 15 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 15 | PSETCD | Parent Set Code | SetSTM | 16 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 15 | STRAIN | Strain/Substrain | TA98 | 17 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 16 | METACT | Metabolic Activation | NOT APPLICABLE | 18 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 17 | METACTFL | Y/N presence of metabolic activation | N | 19 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 18 | INTRVN | Name of the intervention article | TA1 | 20 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 19 | ITVTYPE | Type of intervention article | Vehicle Control | 21 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 20 | ITVCONC | Concentration of intervention article | 0 | 22 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 21 | ITVCONCU | Concentration Unit | ug/plate | 23 | 8325064 | Ames | TX | SetA | A-TA98-C0 | 22 | TRTV | Treatment Vehicle | DMSO | 24 | 8325064 | Ames | TX | SetF | F-TA98-C500 |
| PSETCD | Parent Set Code | SetSTM | 25 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 23 | STRAIN | Strain/Substrain | TA98 | 26 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 24 | METACT | Metabolic Activation | NOT APPLICABLE | 27 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 25 | METACTFL | Y/N presence of metabolic activation | N | 28 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 26 | INTRVN | Name of the intervention article | TA1 | 29 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 27 | ITVTYPE | Type of intervention article | Product | 30 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 28 | ITVCONC | Concentration of intervention article | 500 | 31 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 29 | ITVCONCU | Concentration Unit | ug/plate | 32 | 8325064 | Ames | TX | SetF | F-TA98-C500 | 30 | TRTV | Treatment Vehicle | DMSO | 33 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 31 | PSETCD | Parent Set Code | SetSTM | 34 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 31 | STRAIN | Strain/Substrain | TA98 | 35 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 32 | METACT | Metabolic Activation | NOT APPLICABLE | 36 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 33 | METACTFL | Y/N presence of metabolic activation | N | 37 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 34 | INTRVN | Name of the intervention article | TA1 | 38 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 35 | ITVTYPE | Type of intervention article | Product | 39 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 36 | ITVCONC | Concentration of intervention article | 1600 | 40 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 37 | ITVCONCU | Concentration Unit | ug/plate | 41 | 8325064 | Ames | TX | SetG | G-TA98-C1600 | 38 | TRTV | Treatment Vehicle | DMSO | 42 | 8325064 | Ames | TX | SetR | R-TA100-C2 | 39 | PSETCD | Parent Set Code | SetSTM | 43 | 8325064 | Ames | TX | SetR | R-TA100-C2 | 39 | STRAIN | Strain/Substrain | TA100 | 44 | 8325064 | Ames | TX | SetR | R-TA100-C2 | 40 | METACT | Metabolic Activation | NOT APPLICABLE | 45 | 8325064 | Ames | TX | SetR | R-TA100-C2 | 41 | METACTFL | Y/N presence of metabolic activation | N | 46 | 8325064 | Ames | TX | SetR | R-TA100-C2 | 42 | INTRVN | name of the intervention article | NaN3 | 47 | 8325064 | Ames | TX | SetR | R-TA100-C2 | 43 | ITVTYPE | type of intervention article | Positive Control | 48 | 8325064 | Ames | TX | SetR | R-TA100-C2 | 44 | ITVCONC | Concentration of intervention article | 2 | 49 | 8325064 | Ames | TX | SetR | R-TA100-C2 | 45 | ITVCONCU | Concentration Unit | ug/plate | 50 | 8325064 | Ames | TX | SetR | R-TA100-C2 | 46 | TRTV | Treatment Vehicle | DMSO |
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Row 1: | Shows the value of REFID=STM. This REFID refers to the trial set with a SETCD of "SetSTM", as defined in the TX dataset. LEVEL=1 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set. | Rows 1, 2, 8, 12, 16: | Show that the trial set SetSTM is the parent of set codes SetA, SetF, SetG, and SetR. | Row 2: | Shows the value of REFID=A. This REFID refers to the trial set with a SETCD of "SetA", as defined in the TX dataset. LEVEL=2 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set. | Rows 3-7: | Show the values of 5 observational units (1_1 through 1_5) that are within the parent experimental unit, REFID=A. | Row 8: | Shows the value of REFID=F. This REFID refers to the trial set with a SETCD of "SetF", as defined in the TX dataset. LEVEL=2 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set. | Rows 9-11: | Show the values of 3 observational units (6_1 through 6_3) that are within the parent experimental unit, REFID=F. | Row 12: | Shows the value of REFID=G. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=2 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set. | Rows 13-15: | Show the values of 3 observational units (7_1 through 7_3) that are within the parent experimental unit, REFID=G. | Row 16: | Shows the value of REFID=R. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=2 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set. | Rows 17-19: | Show the values of 3 observational units (18_1 through 18_3) that are within the parent experimental unit, REFID=R. |
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| Row | STUDYID | GNTXAID | SETCD | REFID | PARENT | LEVEL | LVLDESC |
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1 | 8325064 | Ames | SetSTM | STM |
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2 | 8325064 | Ames | SetA | A | STM | 2 | EXPERIMENTAL UNIT/TRIAL SET |
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3 | 8325064 | Ames | SetA | 1_1 | A | 3 | OBSERVATIONAL UNIT |
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4 | 8325064 | Ames | SetA | 1_2 | A | 3 | OBSERVATIONAL UNIT |
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5 | 8325064 | Ames | SetA | 1_3 | A | 3 | OBSERVATIONAL UNIT |
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6 | 8325064 | Ames | SetA | 1_4 | A | 3 | OBSERVATIONAL UNIT |
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7 | 8325064 | Ames | SetA | 1_5 | A | 3 | OBSERVATIONAL UNIT |
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8 | 8325064 | Ames | SetF | F | STM | 2 | EXPERIMENTAL UNIT/TRIAL SET |
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9 | 8325064 | Ames | SetF | 6_1 | F | 3 | OBSERVATIONAL UNIT |
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10 | 8325064 | Ames | SetF | 6_2 | F | 3 | OBSERVATIONAL UNIT |
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11 | 8325064 | Ames | SetF | 6_3 | F | 3 | OBSERVATIONAL UNIT |
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12 | 8325064 | Ames | SetG | G | STM | 2 | EXPERIMENTAL UNIT/TRIAL SET |
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13 | 8325064 | Ames | SetG | 7_1 | G | 3 | OBSERVATIONAL UNIT |
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14 | 8325064 | Ames | SetG | 7_2 | G | 3 | OBSERVATIONAL UNIT | 15 | 8325064 | Ames | SetG | 7_3 | G | 3 | OBSERVATIONAL UNIT | 16 | 8325064 | Ames | SetG | R | STM | 2 | EXPERIMENTAL UNIT/TRIAL SET | 17 | 8325064 | Ames | SetR | 18_1 | R | 3 | OBSERVATIONAL UNIT | 18 | 8325064 | Ames | SetR | 18_2 | R | 3 | OBSERVATIONAL UNIT | 19 | 8325064 | Ames | SetR | 18_3 | R | 3 | OBSERVATIONAL UNIT |
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Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-454 |
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Rows 1-5: | Show the number of revertant colonies per plate collected for each of 5 observational units, GTREFID=1_1 through 1_5 (see description in the RELREF dataset). | Rows 6, 7: | Show summary values collected (mean, standard deviation) for GTREFID=A that apply to the entire trial set, SetA, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID as shown in the RELREF dataset. | Rows 8-13: | Revertent colonies were counted for each of 3 plates/observational units (GTREFID=6_1 through 6_3) and each value is associated with a record to show a postfix code of "V" (Very thin background bacterial lawn). | Rows 14-16: | Show summary values collected (mean, standard deviation, fold increase) for GTREFID=F that apply to the entire trial set, SetF, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the RELREF dataset. | Rows 17-19: | Show 3 plates/observational units (GTREFID=5_1 through 5_3) where no revertant colonies were counted due to too much cytotoxicity and a postfix code of "T". | Rows 20-22: | Show the number of revertant colonies per plate collected for each of 3 observational units (GTREFID=18_1 through 18_3). | Rows 23-25: | Show summary values collected (mean, standard deviation, fold increase) for GTREFID=R that apply to the entire trial set, SetR, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the RELREF dataset. |
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Row | STUDYID | GNTXAID | DOMAIN | GTSEQ | GTREFID | GTTESTCD | GTTEST | GTORRES | GTORRESU | GTCOLSRT | GTSTRESC | GTSTRESN | GTSTRESU | GTSTAT | GTREASND | GTMETHOD | GTDTC |
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1 | 8325064 | Ames | GT | 1 | 1_1 | RPP | Revertant Colony Numbers Per Plate | 26 | NOT APPLICABLE |
| 26 | 26 | NOT APPLICABLE |
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| INSTRUMENT COUNTED | 2015-08-03 | 2 | 8325064 | Ames | GT | 2 | 1_2 | RPP | Revertant Colony Numbers Per Plate | 35 | NOT APPLICABLE |
| 35 | 35 | NOT APPLICABLE |
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| INSTRUMENT COUNTED | 2015-08-03 | 3 | 8325064 | Ames | GT | 3 | 1_3 | RPP | Revertant Colony Numbers Per Plate | 39 | NOT APPLICABLE |
| 39 | 39 | NOT APPLICABLE |
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| INSTRUMENT COUNTED | 2015-08-03 | 4 | 8325064 | Ames | GT | 4 | 1_4 | RPP | Revertant Colony Numbers Per Plate | 35 | NOT APPLICABLE |
| 35 | 35 | NOT APPLICABLE |
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| INSTRUMENT COUNTED | 2015-08-03 | 5 | 8325064 | Ames | GT | 5 | 1_5 | RPP | Revertant Colony Numbers Per Plate | 30 | NOT APPLICABLE |
| 30 | 30 | NOT APPLICABLE |
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| INSTRUMENT COUNTED | 2015-08-03 | 6 | 8325064 | Ames | GT | 6 | A | RPP | Revertant Colony Numbers Per Plate | 33.0 | NOT APPLICABLE | MEAN | 33.0 | 33.0 | NOT APPLICABLE |
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| 2015-08-03 | 7 | 8325064 | Ames | GT | 7 | A | RPP | Revertant Colony Numbers Per Plate | 5.0 | NOT APPLICABLE | STANDARD DEVIATION | 5.0 | 5.0 | NOT APPLICABLE |
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| 2015-08-03 | 8 | 8325064 | Ames | GT | 1 | 6_1 | RPP | Revertant Colony Numbers Per Plate | 8 | NOT APPLICABLE |
| 8 | 8 | NOT APPLICABLE |
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| MANUALLY COUNTED | 2015-08-03 | 9 | 8325064 | Ames | GT | 2 | 6_1 | CYTOTOX | Cytotoxicity | Very thin background bacterial lawn |
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| 2015-08-03 | 10 | 8325064 | Ames | GT | 3 | 6_2 | RPP | Revertant Colony Numbers Per Plate | 10 | NOT APPLICABLE |
| 10 | 10 | NOT APPLICABLE |
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| MANUALLY COUNTED | 2015-08-03 | 11 | 8325064 | Ames | GT | 4 | 6_2 | CYTOTOX | Cytotoxicity | Very thin background bacterial lawn |
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| 2015-08-03 | 12 | 8325064 | Ames | GT | 5 | 6_3 | RPP | Revertant Colony Numbers Per Plate | 12 | NOT APPLICABLE |
| 12 | 12 | NOT APPLICABLE |
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| MANUALLY COUNTED | 2015-08-03 | 13 | 8325064 | Ames | GT | 6 | 6_3 | CYTOTOX | Cytotoxicity | Very thin background bacterial lawn |
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| V |
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| 2015-08-03 | 14 | 8325064 | Ames | GT | 7 | F | RPPMEAN | Mean Rev Colony Num Per Plate | 10.0 | NOT APPLICABLE | MEAN | 10.0 | 10.0 | NOT APPLICABLE |
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| 2015-08-03 | 15 | 8325064 | Ames | GT | 8 | F | RPPSTDDV | Std Dev Rev Colony Num Per Plate | 2.0 | NOT APPLICABLE | STANDARD DEVIATION | 2.0 | 2.0 | NOT APPLICABLE |
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| 2015-08-03 | 16 | 8325064 | Ames | GT | 9 | F | RPPFLDIC | Fold Increase Rev Colony Num Per Plate | 0.3 | NOT APPLICABLE | FOLD INCREASE | 0.3 | 0.3 | NOT APPLICABLE |
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| 2015-08-03 | 17 | 8325064 | Ames | GT | 1 | 7_1 | CYTOTOX | Cytotoxicity | Toxic No Revertant Colonies |
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| NOT DONE | TOO MUCH CYTOTOXICITY |
| 2015-08-03 | 18 | 8325064 | Ames | GT | 2 | 7_2 | CYTOTOX | Cytotoxicity | Toxic No Revertant Colonies |
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| NOT DONE | TOO MUCH CYTOTOXICITY |
| 2015-08-03 | 19 | 8325064 | Ames | GT | 3 | 7_3 | CYTOTOX | Cytotoxicity | Toxic No Revertant Colonies |
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| T |
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| NOT DONE | TOO MUCH CYTOTOXICITY |
| 2015-08-03 | 20 | 8325064 | Ames | GT | 1 | 18_1 | RPP | Revertant Colony Numbers Per Plate | 812 | NOT APPLICABLE |
| 812 | 812 | NOT APPLICABLE |
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| INSTRUMENT COUNTED | 2015-08-03 | 21 | 8325064 | Ames | GT | 2 | 18_2 | RPP | Revertant Colony Numbers Per Plate | 912 | NOT APPLICABLE |
| 912 | 912 | NOT APPLICABLE |
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| INSTRUMENT COUNTED | 2015-08-03 | 22 | 8325064 | Ames | GT | 3 | 18_3 | RPP | Revertant Colony Numbers Per Plate | 839 | NOT APPLICABLE |
| 839 | 839 | NOT APPLICABLE |
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| INSTRUMENT COUNTED | 2015-08-03 | 23 | 8325064 | Ames | GT | 4 | R | RPPMEAN | Mean Rev Colony Num Per Plate | 854.3 | NOT APPLICABLE | MEAN | 854.3 | 854.3 | NOT APPLICABLE |
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| 2015-08-03 | 24 | 8325064 | Ames | GT | 5 | R | RPPSTDDV | Std Dev Rev Colony Num Per Plate | 51.7 | NOT APPLICABLE | STANDARD DEVIATION | 51.7 | 51.7 | NOT APPLICABLE |
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| 2015-08-03 | 25 | 8325064 | Ames | GT | 6 | R | RPPFLDIC | Fold Increase Rev Colony Num Per Plate | 6.4 | NOT APPLICABLE | FOLD INCREASE | 6.4 | 6.4 | NOT APPLICABLE |
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| 2015-08-03 |
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