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This is an example showing trial design and results from the in vitro bacterial reverse mutation test of Study #8325064. 

The bacterial reverse mutation test uses amino acid-requiring strains of Salmonella typhimurium (S. typhimurium) and Escherichia coli (E. coli) to detect point mutations, which involve substitution, addition or deletion of one or a few DNA base pairs. The principle of this bacterial reverse mutation test is that it detects chemicals that induce mutations which revert mutations present in the tester strains and restore the functional capability of the bacteria to synthesize an essential amino acid. The revertant bacteria are detected by their ability to grow in the absence of the amino acid required by the parent tester strain.



  • red font - indicates potential for CT code lists
  • green font - links to other domains
  • purple font - to be discussed

  • Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data. 

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1

8325064AmesTS1
GLPTYPGood Laboratory Practice TypeFDA

2

8325064AmesTS2
GLPTYPGood Laboratory Practice TypeOECD

3

8325064AmesTS1
STSTDTCStudy Start Date2015-07-29

4

8325064AmesTS1
STITLEStudy Title

The Bacterial Reverse Mutation Test, Study 8325064-1


5

8325064AmesTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0

6

8325064AmesTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30

7

8325064AmesTS1
SSPONSORSponsor OrganizationExample Sponsor Inc.

8

8325064AmesTS1
SPREFIDSponsor's Study Reference ID
NOT APPLICABLE

9

8325064AmesTS11TSTFNAMTest Facility NameExample Tox Lab Name

10

8325064AmesTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000

11

8325064AmesTS11TFCNTRYTest Facility CountryUSA

12

8325064AmesTS11STDIRStudy DirectorDr. R. Smith

13

8325064AmesTS1
GLPFLGLP FlagN

14

8325064AmesTS1
ASTDAssay StandardOECD Test No. 471 

15

8325064AmesTS1
ASTDVAssay Standard Version2020-06-29

16

8325064AmesTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO

17

8325064AmesTS1
SSSTYPStudy Sub TypeBacterial Reverse Mutation Test

18

8325064AmesTS1
SPECIESSpeciesSalmonella 

19

8325064Ames


STRAINStrainSalmonella typhimurium, 

20

8325064AmesTS1
CELLLNCell Line (this would be Tester Strain for Ames)

TA98

(examples: H292, CHO, TK6.. etc.)


  • During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled;  For now, we just include good example values based on our experience
  • Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
  • Do we need "plate counted manually"
  • How do we handle "toxic, no revertant colonies"?
  • Condition of background bacterial lawn?  Slight thinning, Very thin? - refer to SEND team's marked-up table.
  • When "-" in Mean, Std Dev, Fold Inc - refer to SEND team's marked-up table (GTSTAT = NOT DONE; variety of REASND)

                         

RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it)
TXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetA (Row 1)



METACTMetabolic Activation  (should there be two parms? Presence, type)?None

8325064AmesTXSetA

TRTDRTRGTreatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)
38325064AmesTXSetA

TRTDRTOLTreatment Duration Tolerance
48325064AmesTXSetA

TRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
58325064AmesTXSetA

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

DMSO. (or TA1)
68325064AmesTXSetA

ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Vehicle Control. (or Product)
78325064AmesTXSetA

ITVCONCConcentration of intervention article0 (null?)
88325064AmesTXSetA

ITVCONCUConcentration Unitug/plate
98325064AmesTXSetA

STRAINStrain/SubstrainTA98
108325064AmesTXSetA

REGIMESmoking RegimeISO

8325064AmesTXSetA

RUN

Assay run number

1


8325064AmesTXSetA

PORTPort ID

8325064AmesTXSetA

SMPLIDSample ID

8325064AmesTXSetA

SMKFRCSmoke Fraction

8325064AmesTXSetA

REPNUMReplicate Number1

8325064AmesTXSetA

MEANMean33.0

8325064AmesTXSetA

STDDEVStandard Deviation5.0

8325064AmesTXSetA

FOLDINCFold Increase
...









8325064AmesTX

SetF

(row 4)



METACTMetabolic Activation  (should there be two parms? Presence, type)?None

8325064AmesTX

SetF



TRTDRTRGTreatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)

8325064AmesTXSetF

TRTDRTOLTreatment Duration Tolerance

8325064AmesTXSetF

TRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)

8325064AmesTXSetF

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

2-Nitrofluorine

8325064AmesTXSetF

ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Positive Control

8325064AmesTXSetF

ITVCONCConcentration of intervention article5

8325064AmesTXSetF

ITVCONCUConcentration Unitug/plate

8325064AmesTXSetF

STRAINStrain/SubstrainTA98

8325064AmesTXSetF

REGIMESmoking RegimeISO

8325064AmesTXSetF

ARTCONConcentration level of intervention article on plate500

8325064AmesTXSetF

CONUNITConcentration level of intervention article on plate, unitug/plate
...









8325064AmesTX

SetI(row 6)



METACTMetabolic Activation  (should there be two parms? Presence, type)?None

8325064AmesTXSetI

TRTDRTRGTreatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)

8325064AmesTXSetI

TRTDRTOLTreatment Duration Tolerance

8325064AmesTXSetI

TRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)

8325064AmesTXSetI

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

2-Nitrofluorine

8325064AmesTXSetI

ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Positive Control

8325064AmesTXSetI

ITVCONCConcentration of intervention article5

8325064AmesTXSetI

ITVCONCUConcentration Unitug/plate

8325064AmesTXSetI

STRAINStrain/SubstrainTA98

8325064AmesTXSetI

REGIMESmoking RegimeISO
...









8325064AmesTX

SetR

(Row 18)



METACTMetabolic Activation  (should there be two parms? Presence, type)?None

8325064AmesTX

SetR



TRTDRTRGTreatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)

8325064AmesTXSetR

TRTDRTOLTreatment Duration Tolerance

8325064AmesTXSetR

TRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)

8325064AmesTXSetR

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

4-Nitroquinoline-1-oxide

8325064AmesTXSetR

ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Positive Control

8325064AmesTXSetR

ITVCONCConcentration of intervention article2

8325064AmesTXSetR

ITVCONCUConcentration Unitug/plate

8325064AmesTXSetR

STRAINStrain/SubstrainTA98

8325064AmesTXSetR

REGIMESmoking RegimeISO
...


















Do we need GTMETHOD?

RowSTUDYIDASSAYIDDOMAINTXSETCDPLTWLIDGTSEQGTTESTCDGTTESTGTCELLEV
(cells evaluated)		GTORRESGTORRESUGTSTRESCGTSTRESNGTSTRESUGTDTC
18325064AmesGTSETA (TA98-DMSO)11RPPRevertant Numbers Per Plate
26
2626

2015-08-03
28325064AmesGTSETA 22RPPRevertant Numbers Per Plate
35
3535

2015-08-03
38325064AmesGTSETA 33RPPRevertant Numbers Per Plate
39
3939

2015-08-03
48325064AmesGTSETA 44RPPRevertant Numbers Per Plate
35
3535

2015-08-03
58325064AmesGTSETA 55RPPRevertant Numbers Per Plate
30
3030
2015-08-03
68325064AmesGTSETA ALL6RPPMEANMean of Revertant Numbers Per Plate
33.0




78325064AmesGTSETA ALL7RPPSTDDVStandard Deviation of Revertant Numbers Per Plate
5.0




88325064AmesGTSETA ALL8RPPFLDINCFold Increase of Revertant Numbers Per Plate






98325064Ames












108325064Ames












118325064Ames












128325064Ames












138325064Ames












148325064Ames












158325064Ames












16














...














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