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Comment: TOBA-366, TOBA-454

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Dataset wrap
Rowcaps

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

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

Row 18:

Shows that this study includes a Bacterial Reverse Mutation assessment.
Rows 19-23: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 25-27:

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

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

18325064TS1
GLPTYPGood Laboratory Practice TypeFDA
28325064TS2
GLPTYPGood Laboratory Practice TypeOECD
38325064TS1
STSTDTCStudy Start Date2015-07-29
48325064TS1
STITLEStudy Title

The Bacterial Reverse Mutation Test, Study 8325064-1


58325064TS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
68325064TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
78325064TS1
APPLCNTApplicant OrganizationExample Applicant Inc.
88325064TS1
APREFIDApplicant's Study Reference ID
NOT APPLICABLE
98325064TS11TSTFNAMTest Facility NameExample Tox Lab Name
108325064TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
118325064TS11TFCNTRYTest Facility CountryUSA
128325064TS11STDIRStudy DirectorDr. R. Smith
138325064TS1
GLPFLGLP FlagN
148325064TS14TSTGDNAMTesting Guideline NameTest NO. 471
158325064TS14TSTGDORGTesting Guideline OrganizationOECD
168325064TS14TSTGDVERTesting Guideline Version2020-06-29
178325064TS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
188325064TS1

GNTXAID

Genetic Toxicology Assay Identifier

AMES


198325064TS12

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


208325064TS12STRAINStrain/SubstrainTA98
218325064TS22STRAINStrain/SubstrainTA100
228325064TS32STRAINStrain/SubstrainTA1535
238325064TS42STRAINStrain/SubstrainTA1537
248325064TS12CELLLNCell LineTA 98 hisD3052; rfa-; uvrB-
258325064TS22CELLLNCell LineTA 100 hisG46; rfa-; uvrB-
268325064TS32CELLLNCell LineTA 1535 hisG46; rfa-; uvrB-
278325064TS42CELLLNCell LineTA 1537 hisC3076; rfa-; uvrB-
288325064TS123SPECIESSpecies

ESCHERICHIA COLI

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


298325064TS53STRAINStrain/SubstrainWP2 uvrA pKM101
308325064TS253CELLLNCell LinetrpE uvrA

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Dataset wrap
Namegt
Rowcaps
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=7_1 through 7_3) where no revertant colonies were counted due to too much cytotoxicity and a postfix code of "T". 

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
columnIdsissuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution
columnskey,summary,type,created,updated,due,assignee,reporter,priority,status,resolution
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-668

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. 
Dataset2
RowSTUDYIDDOMAINGTSEQGTREFIDGTTESTCDGTTESTGTORRESGTORRESUGTCOLSRTGTSTRESCGTSTRESNGTSTRESUGTSTATGTREASNDGTMETHODGTDTC
18325064GT11_1RPPRevertant Colony Numbers Per Plate26NOT APPLICABLE
2626

NOT APPLICABLE

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-487



INSTRUMENT COUNTED

2015-08-03
28325064GT21_2RPPRevertant Colony Numbers Per Plate35NOT APPLICABLE
3535NOT APPLICABLE

INSTRUMENT COUNTED2015-08-03
38325064GT31_3RPPRevertant Colony Numbers Per Plate39NOT APPLICABLE
3939NOT APPLICABLE

INSTRUMENT COUNTED2015-08-03
48325064GT41_4RPPRevertant Colony Numbers Per Plate35NOT APPLICABLE
3535NOT APPLICABLE

INSTRUMENT COUNTED

2015-08-03
58325064GT51_5RPPRevertant Colony Numbers Per Plate30NOT APPLICABLE
3030NOT APPLICABLE

INSTRUMENT COUNTED2015-08-03
68325064GT6ARPPRevertant Colony Numbers Per Plate33.0NOT APPLICABLEMEAN33.033.0NOT APPLICABLE


2015-08-03
78325064GT7ARPPRevertant Colony Numbers Per Plate5.0NOT APPLICABLESTANDARD DEVIATION5.05.0NOT APPLICABLE


2015-08-03
88325064GT186_1RPPRevertant Colony Numbers Per Plate8NOT APPLICABLE
88NOT APPLICABLE

MANUALLY COUNTED2015-08-03
98325064GT296_1CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
108325064GT3106_2RPPRevertant Colony Numbers Per Plate10NOT APPLICABLE
1010NOT APPLICABLE

MANUALLY COUNTED2015-08-03
118325064GT4116_2CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
128325064GT5126_3RPPRevertant Colony Numbers Per Plate12NOT APPLICABLE
1212NOT APPLICABLE

MANUALLY COUNTED2015-08-03
138325064GT6136_3CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
148325064GT714FRPPMEANMean Rev Colony Num Per Plate

10.0

NOT APPLICABLEMEAN

10.0

10.0

NOT APPLICABLE


2015-08-03
158325064GT815FRPPSTDDVStd Dev Rev Colony Num Per Plate2.0NOT APPLICABLESTANDARD DEVIATION2.02.0NOT APPLICABLE


2015-08-03
168325064GT916FRPPFLDICFold Increase Rev Colony Num Per Plate0.3NOT APPLICABLEFOLD INCREASE0.30.3NOT APPLICABLE


2015-08-03
178325064GT1177_1CYTOTOXCytotoxicity

Toxic No Revertant Colonies



T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
188325064GT2187_2CYTOTOXCytotoxicityToxic No Revertant Colonies

T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
198325064GT3197_3CYTOTOXCytotoxicityToxic No Revertant Colonies

T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
208325064GT12018_1RPPRevertant Colony Numbers Per Plate

812

NOT APPLICABLE


812

812

NOT APPLICABLE

INSTRUMENT COUNTED

2015-08-03
218325064GT22118_2RPPRevertant Colony Numbers Per Plate

912

NOT APPLICABLE


912

912

NOT APPLICABLE

INSTRUMENT COUNTED2015-08-03
228325064GT32218_3RPPRevertant Colony Numbers Per Plate

839

NOT APPLICABLE


839

839

NOT APPLICABLE

INSTRUMENT COUNTED2015-08-03
238325064GT423RRPPMEANMean Rev Colony Num Per Plate854.3NOT APPLICABLEMEAN854.3854.3NOT APPLICABLE


2015-08-03
248325064GT524RRPPSTDDVStd Dev Rev Colony Num Per Plate51.7NOT APPLICABLESTANDARD DEVIATION51.751.7NOT APPLICABLE


2015-08-03
258325064GT625RRPPFLDICFold Increase Rev Colony Num Per Plate6.4NOT APPLICABLEFOLD INCREASE6.46.4NOT APPLICABLE


2015-08-03

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