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This is an example showing trial design and results data of Study #123 for the determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay

RowSTUDYIDASSAYIDDOMAINARMCDARMTAETORDETCDELEMENT




































1

TAARM01-Prod1Cigarette Smoke Condensate, 10 ug/mL1TREATMTTreatment
9


9SLS-1101

RowSTUDYIDASSAYIDDOMAINETCDELEMENT



TETREATMTTreatment

Red font (CT is coming!, POSITIVE CONTROL, VEHICLE CONTROL, etc.)

ARMCD.      TREATMENT (element).       SETCD

ARM01             TREATMT.                                CS-01. (Cigarette Smoke 10 ug/mL)

ARM01

TA.XPT

TRIAL ARMS

RowSTUDYIDASSAYIDDOMAINARMCDARMTAETORDETCDELEMENT













































1

TAARM01-Prod1Cigarette Smoke Condensate, 10 ug/mL1TREATMTTreatment
2

TAARM02-Prod1Cigarette Smoke Condensate, 50 ug/mL1TREATMTTreatment
3

TAARM03-Prod1Cigarette Smoke Condensate, 75 ug/mL1TREATMTTreatment
4

TA4
1

5

TA5
1

6

TA6
1

7


7
1

8


8
1

9


9SLS-1101

10


ARM10SLS-2001


TE.XPT

TRIAL ELEMENTS

RowSTUDYIDASSAYIDDOMAINETCDELEMENT



TETREATMTTreatment


tx.spt

TRIAL SET

example: Each plate has a separate product

Product, Smoking Regime (e.g. Traditional combustible, ENDS), Smoke Fraction, etc.

https://www.itis.gov/servlet/SingleRpt/SingleRpt?search_topic=TSN&search_value=969610#null

RowSTUDYIDASSAYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1


CS-10Cigarette Smoke Condensate, 10 ug/mL
METACTMetabolic Activation+S9
2


CS-10Cigarette Smoke Condensate, 10 ug/mL
METACTMetabolic Activation-S9













TXCS-10Cigarette Smoke Condensate, 10 ug/mL
ARMCDArm CodeCS-10



TXCS-10Cigarette Smoke Condensate, 10 ug/mL
SPECIESSpeciesSalmonella enterica 



TXCS-10Cigarette Smoke Condensate, 10 ug/mL
STRAINStrain/SubstrainSalmonella enterica enterica



TXCS-10Cigarette Smoke Condensate, 10 ug/mL
PRODUCTProductproduct A



TXCS-10Cigarette Smoke Condensate, 10 ug/mL
REGIMESmoking RegimeTraditional combustible 



TXCS-20Cigarette Smoke Condensate, 50 ug/mL
ARMCDArm CodeCS-20



TXCS-20Cigarette Smoke Condensate, 50 ug/mL
PRODUCTProductproduct A



...








TXLSL-200sodium lauryl sulphate (SLS) positive control, 200 ug/mL
TRTDOSDose Level100



TXLSL-200sodium lauryl sulphate (SLS) positive control, 200 ug/mL
TCNTRLControl TypePOSITIVE CONTROL



TXLSL-200sodium lauryl sulphate (SLS) positive control, 200 ug/mL
CNTLAGControl AgentSODIUM LAURYL SULPHATE



TXLSL-200sodium lauryl sulphate (SLS) positive control, 200 ug/mL
CNTLAGAMTControl Agent amount (levels)110




LSL-200sodium lauryl sulphate (SLS) positive control, 200 ug/mL
CNTLAGUNITControl Agent Unitug/mL
RowSTUDYIDDOMAINENID (Entity ID)ST vs. LTActivation (+S9, -S9)


RUNID (Run-Port Number)SMPID (Sample ID)SMKFID (Smoke Fraction)

REPLCTID

(Replicate Number)

PLATEID (Plate ID)

COLID

(Column number)

ROWID (Row  number)
SETCD (Set Code, TX)RFSTDTCRFENDTCRFXSTDTCRFXENDTCRFCSTDTCRFCENDTCARMCD
1MA99999

EI

1




1-1030001A111A
CS-102008-04-01T06:00

2008-04-28T14:00

2008-04-02T14:002008-04-02T14:042008-04-01T06:002008-04-01T06:003
2MA99999EI2




1-1030001A111B
CS-102008-04-01T06:002008-04-21T14:002008-04-02T20:002008-04-02T20:042008-04-01T06:002008-04-01T06:003

  • Entity ID links to EI domain (usubjid)
  • TEST:  After ST exposure to increasing concentrations of test article in the presence of S9 mix


RowSTUDYIDDOMAINENID (Entity ID) GTSEQGTTESTCDGTTESTGTORRESGTORRESUGTSTRESCGTSTRESNGTSTRESUGTSPEC???GTMETHODGTDTCGTDYGTNOMDYGTELTMGTTPTREF
1ST487-12GT1
MNTIn vitro Micronucleus Assay
ug/mL

ug/mL






2ST487-12GT2
MNTIn vitro Micronucleus Assay
ug/mL

ug/mL






3ST487-12GT3
MNTIn vitro Micronucleus Assay
ug/mL

ug/mL






4ST487-12GT4
MNTIn vitro Micronucleus Assay
ug/mL

ug/mL






5ST487-12GT5
MNTIn vitro Micronucleus Assay
ug/mL

ug/mL






6ST487-12GT6
MNTIn vitro Micronucleus Assay
ug/mL

ug/mL






7ST487-12GT7
MNTIn vitro Micronucleus Assay
ug/mL

ug/mL






8ST487-12GT8
MNTIn vitro Micronucleus Assay
ug/mL

ug/mL






9ST487-12GT9
MNTIn vitro Micronucleus Assay
ug/mL

ug/mL






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