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Comment: Added TCNTRL parmcd for SETA in TX

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Dataset wrap
Nametx
Rowcaps
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 15-23:

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.

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-666

Rows 24-32:

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.

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-667

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 SMKRGM. SMKRGM 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 SMKRGM 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.

Dataset2

 

RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

1

SPECIESSpeciesSALMONELLA TYPHIMURIUM
28325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

2IVTDMINIn vitro Treatment Duration Minimum71.5
38325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM3IVTDTRGIn vitro Treatment Duration Target72
48325064AmesTXSetSTMSALMONELLA TYPHIMURIUM4IVTDMAXIn vitro Treatment Duration Maximum72.5
58325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

5IVTDUIn vitro Treatment Duration UnitHOURS
68325064AmesTXSetSTMSALMONELLA TYPHIMURIUM6INCBTMPIncubation Temperature37
78325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM7INCBTMPUIncubation Temperature UnitC
88325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

8ATMRHPAtmospheric Relative Humidity Percent50
98325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM9ATMCO2PAtmospheric CO2 Percent5
108325064AmesTXSetSTMSALMONELLA TYPHIMURIUM10SPTOBID

Applicant-defined tobacco identifier

CIG01a
118325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

11EXPTYP

Exposure Type

Submerged
128325064AmesTXSetSTMSALMONELLA TYPHIMURIUM12SAMTYP

Sample Type

Total Particulate Matter in PBS
138325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

13SPDEVIDApplicant-defined device identifierPUFFMASTER3K
148325064AmesTXSetSTMSALMONELLA TYPHIMURIUM14SMKRGMSmoking RegimenNON-INTENSE REGIMEN
158325064AmesTXSetAA-TA98-C015PSETCDParent Set CodeSetSTM
168325064AmesTXSetAA-TA98-C015STRAINStrain/SubstrainTA98
178325064AmesTX

SetA

A-TA98-C016METACTINDMetabolic Activating Agent NameNOT APPLICABLE
188325064AmesTX

SetA

A-TA98-C017METACTFLPresence of Metabolic Activation FlagN
198325064AmesTXSetAA-TA98-C018ITVNAM

Intervention Article Name

TA1
208325064AmesTXSetAA-TA98-C019ITVTYPE

Intervention Article Type

Vehicle Control
218325064AmesTXSetAA-TA98-C020ITVCONCIntervention Article Concentration0
228325064AmesTXSetAA-TA98-C021ITVCONCUIntervention Article Concentration Unitug/plate
238325064AmesTXSetAA-TA98-C0
TCNTRLControl TypeVEHICLE CONTROL
248325064AmesTXSetAA-TA98-C022TRTVTreatment VehicleDMSO
24258325064AmesTXSetF

F-TA98-C500

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-485


PSETCDParent Set CodeSetSTM
25268325064AmesTXSetFF-TA98-C50023STRAINStrain/SubstrainTA98
26278325064AmesTXSetFF-TA98-C50024METACTINDMetabolic Activating Agent NameNOT APPLICABLE
27288325064AmesTXSetFF-TA98-C50025METACTFLPresence of Metabolic Activation FlagN
28298325064AmesTXSetFF-TA98-C50026ITVNAM

Intervention Article Name

TA1
29308325064AmesTXSetFF-TA98-C50027ITVTYPE

Intervention Article Type

Product
30318325064AmesTXSetFF-TA98-C50028ITVCONCIntervention Article Concentration500
31328325064AmesTXSetFF-TA98-C50029ITVCONCUIntervention Article Concentration Unitug/plate
32338325064AmesTXSetFF-TA98-C50030TRTVTreatment VehicleDMSO
33348325064AmesTXSetGG-TA98-C160031PSETCDParent Set CodeSetSTM
34358325064AmesTXSetGG-TA98-C160031STRAINStrain/SubstrainTA98
35368325064AmesTXSetGG-TA98-C160032METACTINDMetabolic Activating Agent NameNOT APPLICABLE
36378325064AmesTXSetGG-TA98-C160033METACTFLPresence of Metabolic Activation FlagN
37388325064AmesTXSetGG-TA98-C160034ITVNAM

Intervention Article Name

TA1
38398325064AmesTXSetGG-TA98-C160035ITVTYPE

Intervention Article Type

Product
39408325064AmesTXSetGG-TA98-C160036ITVCONCIntervention Article Concentration1600
40418325064AmesTXSetGG-TA98-C160037ITVCONCUIntervention Article Concentration Unitug/plate
41428325064AmesTXSetGG-TA98-C160038TRTVTreatment VehicleDMSO
42438325064AmesTX

SetR

R-TA100-C239PSETCDParent Set CodeSetSTM
43448325064AmesTX

SetR

R-TA100-C239STRAINStrain/SubstrainTA100
44458325064AmesTX

SetR

R-TA100-C240METACTINDMetabolic Activating Agent NameNOT APPLICABLE
45468325064AmesTX

SetR

R-TA100-C241METACTFLPresence of Metabolic Activation FlagN
46478325064AmesTX

SetR

R-TA100-C242ITVNAM

Intervention Article Name

NaN3
47488325064AmesTX

SetR

R-TA100-C243ITVTYPE

Intervention Article Type

Positive Control
48498325064AmesTX

SetR

R-TA100-C244ITVCONCIntervention Article Concentration2
49508325064AmesTX

SetR

R-TA100-C245ITVCONCUIntervention Article Concentration Unitug/plate
50518325064AmesTX

SetR

R-TA100-C246TRTVTreatment VehicleDMSO

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