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Comment: TOBA-483

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Dataset wrap
Nametx
Rowcaps
Rows 1-14:Show trial conditions that are common to all trial sets with the species S. typhimurium.  Similar rows are present in each of the trial sets.
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.





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 are the test conditions specific to set SetA which is 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 which is 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 which 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 which 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.
Dataset2

 

Row
STUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1
8325064TXSetAA-TA98-C0
SPECIESSpeciesSALMONELLA TYPHIMURIUM
2
8325064TXSetAA-TA98-C0
IVTDMINIn vitro Treatment Duration Minimum71.5
3
8325064TX

SetA

A-TA98-C0
IVTDTRGIn vitro Treatment Duration Target72
4
8325064TX

SetA

A-TA98-C0
IVTDMAXIn vitro Treatment Duration Maximum72.5
5
8325064TXSetAA-TA98-C0
IVTDUIn vitro Treatment Duration UnitHOURS
6
8325064TXSetAA-TA98-C0
INCBTMPIncubation Temperature37
7
8325064TXSetAA-TA98-C0
INCBTMPUIncubation Temperature UnitC
8
8325064TXSetAA-TA98-C0
ATMRHPAtmospheric Relative Humidity Percent50
9
8325064TXSetAA-TA98-C0
ATMCO2PAtmospheric CO2 Percent5
10
8325064TXSetAA-TA98-C0
SPTOBID

Applicant-defined tobacco identifier

CIG01a
11
8325064TXSetAA-TA98-C0
EXPTYP

Exposure Type

Submerged
12
8325064TX

SetA

A-TA98-C0
SAMTYP

Sample Type

Total Particulate Matter in PBS
13
8325064TX

SetA

A-TA98-C0
SPDEVIDApplicant-defined device identifierPUFFMASTER3K
14
8325064TXSetAA-TA98-C0
SMKRGMSmoking RegimenNON-INTENSE REGIMEN
15158325064TXSetAA-TA98-C015PSETCDParent Set CodeSetSTM
16168325064TXSetAA-TA98-C015STRAINStrain/SubstrainTA98
17178325064TXSetAA-TA98-C016METACTINDMetabolic Activating Agent NameNOT APPLICABLE
18188325064TXSetAA-TA98-C017METACTFLPresence of Metabolic Activation FlagN
19198325064TXSetAA-TA98-C018ITVNAM

Intervention Article Name

DMSO
20208325064TXSetAA-TA98-C019ITVTYPE

Intervention Article Type

VEHICLE
21218325064TXSetAA-TA98-C020ITVCONCIntervention Article Concentration100
22228325064TXSetAA-TA98-C021ITVCONCUIntervention Article Concentration Unit%
23238325064TXSetAA-TA98-C022TRTVTreatment VehicleDMSO
24
8325064TXSetFF-TA98-C500
SPECIESSpeciesSALMONELLA TYPHIMURIUM
25
8325064TXSetFF-TA98-C500
IVTDMINIn vitro Treatment Duration Minimum71.5
26
8325064TXSetFF-TA98-C500
IVTDTRGIn vitro Treatment Duration Target72
27
8325064TXSetFF-TA98-C500
IVTDMAXIn vitro Treatment Duration Maximum72.5
28
8325064TXSetFF-TA98-C500
IVTDUIn vitro Treatment Duration UnitHOURS
29
8325064TXSetFF-TA98-C500
INCBTMPIncubation Temperature37
30
8325064TXSetFF-TA98-C500
INCBTMPUIncubation Temperature UnitC
31
8325064TXSetFF-TA98-C500
ATMRHPAtmospheric Relative Humidity Percent50
32
8325064TXSetFF-TA98-C500
ATMCO2PAtmospheric CO2 Percent5
33
8325064TXSetFF-TA98-C500
SPTOBID

Applicant-defined tobacco identifier

CIG01a
34
8325064TXSetFF-TA98-C500
EXPTYP

Exposure Type

Submerged
35
8325064TXSetFF-TA98-C500
SAMTYP

Sample Type

Total Particulate Matter in PBS
36
8325064TXSetFF-TA98-C500
SPDEVIDApplicant-defined device identifierPUFFMASTER3K
37
8325064TXSetFF-TA98-C500
SMKRGMSmoking RegimenNON-INTENSE REGIMEN
38248325064TXSetF

F-TA98-C500

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

23PSETCDParent Set CodeSetSTM
39258325064TXSetFF-TA98-C50024STRAINStrain/SubstrainTA98
40268325064TXSetFF-TA98-C50025METACTINDMetabolic Activating Agent NameNOT APPLICABLE
41278325064TXSetFF-TA98-C50026METACTFLPresence of Metabolic Activation FlagN
42288325064TXSetFF-TA98-C50027ITVNAM

Intervention Article Name

TA1
43298325064TXSetFF-TA98-C50028ITVTYPE

Intervention Article Type

PRODUCT
44308325064TXSetFF-TA98-C50029ITVCONCIntervention Article Concentration500
45318325064TXSetFF-TA98-C50030ITVCONCUIntervention Article Concentration Unitug/plate
46328325064TXSetFF-TA98-C50031TRTVTreatment VehicleDMSO
47
8325064TXSetGG-TA98-C1600
SPECIESSpeciesSALMONELLA TYPHIMURIUM
48
8325064TXSetGG-TA98-C1600
IVTDMINIn vitro Treatment Duration Minimum71.5
49
8325064TXSetGG-TA98-C1600
IVTDTRGIn vitro Treatment Duration Target72
50
8325064TXSetGG-TA98-C1600
IVTDMAXIn vitro Treatment Duration Maximum72.5
51
8325064TXSetGG-TA98-C1600
IVTDUIn vitro Treatment Duration UnitHOURS
52
8325064TXSetGG-TA98-C1600
INCBTMPIncubation Temperature37
53
8325064TXSetGG-TA98-C1600
INCBTMPUIncubation Temperature UnitC
54
8325064TXSetGG-TA98-C1600
ATMRHPAtmospheric Relative Humidity Percent50
55
8325064TXSetGG-TA98-C1600
ATMCO2PAtmospheric CO2 Percent5
56
8325064TXSetGG-TA98-C1600
SPTOBID

Applicant-defined tobacco identifier

CIG01a
57
8325064TXSetGG-TA98-C1600
EXPTYP

Exposure Type

Submerged
58
8325064TXSetGG-TA98-C1600
SAMTYP

Sample Type

Total Particulate Matter in PBS
59
8325064TXSetGG-TA98-C1600
SPDEVIDApplicant-defined device identifierPUFFMASTER3K
60
8325064TXSetGG-TA98-C1600
SMKRGMSmoking RegimenNON-INTENSE REGIMEN
61338325064TXSetGG-TA98-C160031PSETCDParent Set CodeSetSTM
62348325064TXSetGG-TA98-C160032STRAINStrain/SubstrainTA98
63358325064TXSetGG-TA98-C160033METACTINDMetabolic Activating Agent NameNOT APPLICABLE
64368325064TXSetGG-TA98-C160034METACTFLPresence of Metabolic Activation FlagN
65378325064TXSetGG-TA98-C160035ITVNAM

Intervention Article Name

TA1
66388325064TXSetGG-TA98-C160036ITVTYPE

Intervention Article Type

Product
67398325064TXSetGG-TA98-C160037ITVCONCIntervention Article Concentration1600
68408325064TXSetGG-TA98-C160038ITVCONCUIntervention Article Concentration Unitug/plate
69418325064TXSetGG-TA98-C160039TRTVTreatment VehicleDMSO
70
8325064TX

SetR

R-TA100-C2
SPECIESSpeciesSALMONELLA TYPHIMURIUM
71
8325064TX

SetR

R-TA100-C2
IVTDMINIn vitro Treatment Duration Minimum71.5
72
8325064TX

SetR

R-TA100-C2
IVTDTRGIn vitro Treatment Duration Target72
73
8325064TX

SetR

R-TA100-C2
IVTDMAXIn vitro Treatment Duration Maximum72.5
74
8325064TX

SetR

R-TA100-C2
IVTDUIn vitro Treatment Duration UnitHOURS
75
8325064TX

SetR

R-TA100-C2
INCBTMPIncubation Temperature37
76
8325064TX

SetR

R-TA100-C2
INCBTMPUIncubation Temperature UnitC
77
8325064TX

SetR

R-TA100-C2
ATMRHPAtmospheric Relative Humidity Percent50
78
8325064TX

SetR

R-TA100-C2
ATMCO2PAtmospheric CO2 Percent5
79
8325064TX

SetR

R-TA100-C2
SPTOBID

Applicant-defined tobacco identifier

CIG01a
80
8325064TX

SetR

R-TA100-C2
EXPTYP

Exposure Type

Submerged
81
8325064TX

SetR

R-TA100-C2
SAMTYP

Sample Type

Total Particulate Matter in PBS
82
8325064TX

SetR

R-TA100-C2
SPDEVIDApplicant-defined device identifierPUFFMASTER3K
83
8325064TX

SetR

R-TA100-C2
SMKRGMSmoking RegimenNON-INTENSE REGIMEN
84428325064TX

SetR

R-TA100-C239PSETCDParent Set CodeSetSTM
85438325064TX

SetR

R-TA100-C240STRAINStrain/SubstrainTA100
86448325064TX

SetR

R-TA100-C241METACTINDMetabolic Activating Agent NameNOT APPLICABLE
87458325064TX

SetR

R-TA100-C242METACTFLPresence of Metabolic Activation FlagN
88468325064TX

SetR

R-TA100-C243ITVNAM

Intervention Article Name

NaN3
89478325064TX

SetR

R-TA100-C244ITVTYPE

Intervention Article Type

Positive Control
90488325064TX

SetR

R-TA100-C245ITVCONCIntervention Article Concentration2
91498325064TX

SetR

R-TA100-C246ITVCONCUIntervention Article Concentration Unitug/plate
92508325064TX

SetR

R-TA100-C247TRTVTreatment VehicleDMSO

...