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Comment: TOBA-748 CT Revisions

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Dataset wrap
Rowcaps
Rows 1-2:

Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records,

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-366
since both GLP types apply for this  study. 

Row 8:Shows that the applicant's study reference ID is not applicable.
Rows 9-12:Show that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID=1). The study director is associated with the test facility.
Rows 14-16:

Show that TSGRPID (TSGRPID=4) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).  

Jira
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-56

Rows 19, 25:

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-367

Show that this study includes 2 different species of bacteria.
Rows 18-23:Show that TSGRPID (TSGRPID = 2) has been used to link the information for 1 species (salmonella) with 4 different strains and the cell line that are tested in this  study.
Rows 25-26:

Show that TSGRPID (TSGRPID = 3) has been used to link the information for 1 species (E. coli) with the strain and cell line that is tested in this study.

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-665

Dataset2
Row

STUDYID

GNTXAID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

18325064AmesTS1
GLPTYPGood Laboratory Practice TypeFDA
28325064AmesTS2
GLPTYPGood Laboratory Practice TypeOECD
38325064AmesTS1
STSTDTCStudy Start Date2015-07-29
48325064AmesTS1
STITLEStudy Title

The Bacterial Reverse Mutation Test, Study 8325064-1


58325064AmesTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
68325064AmesTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
78325064AmesTS1
SAPPLCNTAPPLCNTApplicant OrganizationExample Applicant Inc.
88325064AmesTS1
SPREFIDAPREFIDApplicant's Study Reference ID
NOT APPLICABLE
98325064AmesTS11TSTFNAMTest Facility NameExample Tox Lab Name
108325064AmesTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
118325064AmesTS11TFCNTRYTest Facility CountryUSA
128325064AmesTS11STDIRStudy DirectorDr. R. Smith
138325064AmesTS1
GLPFLGLP FlagN
148325064AmesTS14TSTGDNAMTesting Guideline NameTest NO. 471
158325064AmesTS14TSTGDORGTesting Guideline OrganizationOECD
168325064AmesTS14TSTGDVERTesting Guideline Version2020-06-29
178325064AmesTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
188325064AmesTS1
SSSTYPStudy Sub TypeBACTERIAL REVERSE MUTATION TEST
198325064AmesTS12

SPECIES

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-484

Species

SALMONELLA TYPHIMURIUM

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-123


208325064AmesTS12STRAINStrain/SubstrainTA98
218325064AmesTS12STRAINStrain/SubstrainTA100
228325064AmesTS12STRAINStrain/SubstrainTA1535
238325064AmesTS12STRAINStrain/SubstrainTA1537
248325064AmesTS12CELLLNCell Line

258325064AmesTS13SPECIESSpecies

Escherichia coli

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-482


268325064AmesTS13STRAINStrain/SubstrainWP2 uvrA pKM101
278325064AmesTS13CELLLNCell Line

...

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 DUREFIDSMKRGM. DUREFID 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 DUREFID 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

2TRTDMINIVTDMINIn vitro Treatment Duration Minimum71.5
38325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM3TRTDTRGIVTDTRGIn vitro Treatment Duration Target72
48325064AmesTXSetSTMSALMONELLA TYPHIMURIUM4TRTDMAXIVTDMAXIn vitro Treatment Duration Maximum72.5
58325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

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

SetSTM

SALMONELLA TYPHIMURIUM7INCBTMPUIncubation Temperature UnitC
88325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

8HUMIDATMRHPAtmospheric Relative Humidity Percent50
98325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM9ATMCO2ATMCO2PAtmospheric 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 TYPHIMURIUM14DUREFIDSMKRGMSmoke Smoking RegimenNON-INTENSE REGIMEN
158325064AmesTXSetAA-TA98-C015PSETCDParent Set CodeSetSTM
168325064AmesTXSetAA-TA98-C015STRAINStrain/SubstrainTA98
178325064AmesTX

SetA

A-TA98-C016METACTMETACTINDMetabolic ActivationActivating Agent NameNOT APPLICABLE
188325064AmesTX

SetA

A-TA98-C017METACTFLY/N presence of metabolic activationPresence of Metabolic Activation FlagN
198325064AmesTXSetAA-TA98-C018INTRVNITVNAM

Intervention Article Name of the intervention article

TA1
208325064AmesTXSetAA-TA98-C019ITVTYPE

Intervention Article Type of intervention article

Vehicle Control
218325064AmesTXSetAA-TA98-C020ITVCONCIntervention Article Concentration of intervention article0
228325064AmesTXSetAA-TA98-C021ITVCONCUIntervention Article Concentration Unitug/plate
238325064AmesTXSetAA-TA98-C022TRTVTreatment VehicleDMSO
248325064AmesTXSetF

F-TA98-C500

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


PSETCDParent Set CodeSetSTM
258325064AmesTXSetFF-TA98-C50023STRAINStrain/SubstrainTA98
268325064AmesTXSetFF-TA98-C50024METACTMETACTINDMetabolic ActivationActivating Agent NameNOT APPLICABLE
278325064AmesTXSetFF-TA98-C50025METACTFLY/N presence of metabolic activationPresence of Metabolic Activation FlagN
288325064AmesTXSetFF-TA98-C50026INTRVNITVNAM

Intervention Article Name of the intervention article

TA1
298325064AmesTXSetFF-TA98-C50027ITVTYPE

Intervention Article Type of intervention article

Product
308325064AmesTXSetFF-TA98-C50028ITVCONCIntervention Article Concentration of intervention article500
318325064AmesTXSetFF-TA98-C50029ITVCONCUIntervention Article Concentration Unitug/plate
328325064AmesTXSetFF-TA98-C50030TRTVTreatment VehicleDMSO
338325064AmesTXSetGG-TA98-C160031PSETCDParent Set CodeSetSTM
348325064AmesTXSetGG-TA98-C160031STRAINStrain/SubstrainTA98
358325064AmesTXSetGG-TA98-C160032METACTMETACTINDMetabolic ActivationActivating Agent NameNOT APPLICABLE
368325064AmesTXSetGG-TA98-C160033METACTFLY/N presence of metabolic activationPresence of Metabolic Activation FlagN
378325064AmesTXSetGG-TA98-C160034INTRVNITVNAM

Intervention Article Name of the intervention article

TA1
388325064AmesTXSetGG-TA98-C160035ITVTYPE

Intervention Article Type of intervention article

Product
398325064AmesTXSetGG-TA98-C160036ITVCONCIntervention Article Concentration of intervention article1600
408325064AmesTXSetGG-TA98-C160037ITVCONCUIntervention Article Concentration Unitug/plate
418325064AmesTXSetGG-TA98-C160038TRTVTreatment VehicleDMSO
428325064AmesTX

SetR

R-TA100-C239PSETCDParent Set CodeSetSTM
438325064AmesTX

SetR

R-TA100-C239STRAINStrain/SubstrainTA100
448325064AmesTX

SetR

R-TA100-C240METACTMETACTINDMetabolic ActivationActivating Agent NameNOT APPLICABLE
458325064AmesTX

SetR

R-TA100-C241METACTFLY/N presence of metabolic activationPresence of Metabolic Activation FlagN
468325064AmesTX

SetR

R-TA100-C242INTRVNITVNAM

Intervention Article Namename of the intervention article

NaN3
478325064AmesTX

SetR

R-TA100-C243ITVTYPE

type of intervention articleIntervention Article Type

Positive Control
488325064AmesTX

SetR

R-TA100-C244ITVCONCIntervention Article Concentration of intervention article2
498325064AmesTX

SetR

R-TA100-C245ITVCONCUIntervention Article Concentration Unitug/plate
508325064AmesTX

SetR

R-TA100-C246TRTVTreatment VehicleDMSO

...