In vitro Micronucleus Assay

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

Row	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	TS	1		SSTYP	Study Type	REPEAT DOSE TOXICITY
2	TS	1		SPECIES	Species	RAT
3	TS	1		STRAIN	Strain/Substrain	FISCHER 344
4	TS	1		SPLRNAM	Test Subject Supplier	HARLAN
5	TS	1		SDESIGN	Study Design	CROSSOVER
6	TS	1		ROUTE	Route of Administration	ORAL
7	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
8	TS	1		EXPSTDTC	Experimental Start Date	2008-01-01
9	TS	1		EXPENDTC	Experimental End Date	2008-03-07
10	TS	1		TRMSAC	Time to Terminal Sacrifice	P42D
11	TS	1		STSTDTC	Study Start Date	2007-12-30
12	TS	1		DOSDUR	Dosing Duration	P42D
13	TS	1		STITLE	Study Title	Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods
14	TS	1		SNDIGVER	SEND Implementation Guide Version	SEND IMPLEMENTATION GUIDE VERSION 3.2
15	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-03-26
16	TS	1		STCAT	Study Category	TOX
17	TS	1		SSPONSOR	Sponsor Organization	Example Sponsor Inc.
18	TS	1		SPREFID	Sponsor's Study Reference ID		NOT APPLICABLE
19	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
20	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
21	TS	1	1	TFCNTRY	Test Facility Country	USA
22	TS	1		AGETXT	Age Text	6-8
23	TS	1		AGEU	Age Unit	WEEKS
24	TS	1	1	STDIR	Study Director	Dr. R. Smith
25	TS	1		TRT	Investigational Therapy or Treatment	Drug A
26	TS	1	2	TRTV	Treatment Vehicle	Saline
27	TS	1	2	TRTVDESC	Treatment Vehicle Structured Description	100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W}
28	TS	1		GLPFL	GLP Flag	Y
29	TS	1		TRTCAS	Primary Treatment CAS Registry Number		TEMPORARILY UNAVAILABLE

Row	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	TS	1		SSTYP	Study Type	REPEAT DOSE TOXICITY
2	TS	1		SPECIES	Species	RAT
3	TS	1		STRAIN	Strain/Substrain	FISCHER 344
4	TS	1		SPLRNAM	Test Subject Supplier	HARLAN
5	TS	1		SDESIGN	Study Design	CROSSOVER
6	TS	1		ROUTE	Route of Administration	ORAL
7	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
8	TS	1		EXPSTDTC	Experimental Start Date	2008-01-01
9	TS	1		EXPENDTC	Experimental End Date	2008-03-07
10	TS	1		TRMSAC	Time to Terminal Sacrifice	P42D
11	TS	1		STSTDTC	Study Start Date	2007-12-30
12	TS	1		DOSDUR	Dosing Duration	P42D
13	TS	1		STITLE	Study Title	Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods
14	TS	1		SNDIGVER	SEND Implementation Guide Version	SEND IMPLEMENTATION GUIDE VERSION 3.2
15	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-03-26
16	TS	1		STCAT	Study Category	TOX
17	TS	1		SSPONSOR	Sponsor Organization	Example Sponsor Inc.
18	TS	1		SPREFID	Sponsor's Study Reference ID		NOT APPLICABLE
19	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
20	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
21	TS	1	1	TFCNTRY	Test Facility Country	USA
22	TS	1		AGETXT	Age Text	6-8
23	TS	1		AGEU	Age Unit	WEEKS
24	TS	1	1	STDIR	Study Director	Dr. R. Smith
25	TS	1		TRT	Investigational Therapy or Treatment	Drug A
26	TS	1	2	TRTV	Treatment Vehicle	Saline
27	TS	1	2	TRTVDESC	Treatment Vehicle Structured Description	100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W}
28	TS	1		GLPFL	GLP Flag	Y
29	TS	1		TRTCAS	Primary Treatment CAS Registry Number		TEMPORARILY UNAVAILABLE

Row	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT




1	TA	ARM01-Prod1	Cigarette Smoke Condensate, 10 ug/mL	1	TREATMT	Treatment
9		9	SLS-110	1

Row	STUDYID	ASSAYID	DOMAIN	ETCD	ELEMENT
			TE	TREATMT	Treatment

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

Row	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT





1	TA	ARM01-Prod1	Cigarette Smoke Condensate, 10 ug/mL	1	TREATMT	Treatment
2	TA	ARM02-Prod1	Cigarette Smoke Condensate, 50 ug/mL	1	TREATMT	Treatment
3	TA	ARM03-Prod1	Cigarette Smoke Condensate, 75 ug/mL	1	TREATMT	Treatment
4	TA	4		1
5	TA	5		1
6	TA	6		1
7		7		1
8		8		1
9		9	SLS-110	1
10		ARM10	SLS-200	1

TE.XPT

TRIAL ELEMENTS

Row	STUDYID	ASSAYID	DOMAIN	ETCD	ELEMENT
			TE	TREATMT	Treatment

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

One study (Original sample of TK6 cells); (6 rows in GT)

Assay (MNT) (ran on 10 tobacco products)
3 assay/test conditions;
Treatment duration (2: ST, LT);
Presence of metabolic activation (2: presence, type)

Concentrations of product (6 of these: 0, x, y, z,..., +CNTL);
CytoTox % (3 different percentages from testing 1 portion of the original sample)
4 MN counts conducted (on 4 different portions of original sample?)

EID (5 of these, Count1 - Count4 and Cytotox): with many TX Parm codes

Cytotox: RICC, RIC, RPD, #cells

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET	TXPARMCD	TXPARM	TXVAL
1	123	1	TX			METACT	Metabolic Activation	+S9
2						METACT	Metabolic Activation	-S9
						TRTDUR	Treatment Duration	Short Term
						TRTDUR	Treatment Duration	Long Term (or 2 parm codes, # and unit)
						PRDCONC	Concentration of product	0
						PRDCONCU	Concentration Unit	ug/ml
						Product	Product Name
							Smoking Regime
							Smoke Fraction

			TX	CS-10	Cigarette Smoke Condensate, 10 ug/mL	ARMCD	Arm Code	CS-10
			TX	CS-10	Cigarette Smoke Condensate, 10 ug/mL	SPECIES	Species	Salmonella enterica
			TX	CS-10	Cigarette Smoke Condensate, 10 ug/mL	STRAIN	Strain/Substrain	Salmonella enterica enterica
			TX	CS-10	Cigarette Smoke Condensate, 10 ug/mL	PRODUCT	Product	product A
			TX	CS-10	Cigarette Smoke Condensate, 10 ug/mL	REGIME	Smoking Regime	Traditional combustible
			TX	CS-20	Cigarette Smoke Condensate, 50 ug/mL	ARMCD	Arm Code	CS-20
			TX	CS-20	Cigarette Smoke Condensate, 50 ug/mL	PRODUCT	Product	product A
			...
			TX	LSL-200	sodium lauryl sulphate (SLS) positive control, 200 ug/mL	TRTDOS	Dose Level	100
			TX	LSL-200	sodium lauryl sulphate (SLS) positive control, 200 ug/mL	TCNTRL	Control Type	POSITIVE CONTROL
			TX	LSL-200	sodium lauryl sulphate (SLS) positive control, 200 ug/mL	CNTLAG	Control Agent	SODIUM LAURYL SULPHATE
			TX	LSL-200	sodium lauryl sulphate (SLS) positive control, 200 ug/mL	CNTLAGAMT	Control Agent amount (levels)	110
				LSL-200	sodium lauryl sulphate (SLS) positive control, 200 ug/mL	CNTLAGUNIT	Control Agent Unit	ug/mL

Row	STUDYID	DOMAIN	ENID (Entity ID)	Sum of cell ev.	Cells with MN	SMKFID (Smoke Fraction)	REPLCTID (Replicate Number)	PLATEID (Plate ID)	COLID (Column number)	ROWID (Row number)	SETCD (Set Code, TX)	RFSTDTC	RFENDTC	RFXSTDTC	RFXENDTC	RFCSTDTC	RFCENDTC	ARMCD
1	MA99999	GT			030001	A	1	1	1	A	CS-10	2008-04-01T06:00	2008-04-28T14:00	2008-04-02T14:00	2008-04-02T14:04	2008-04-01T06:00	2008-04-01T06:00	3
2	MA99999	GT	1	1-1	030001	A	1	1	1	B	CS-10	2008-04-01T06:00	2008-04-21T14:00	2008-04-02T20:00	2008-04-02T20:04	2008-04-01T06:00	2008-04-01T06:00	3
			2
			3
			4

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

Row	STUDYID	DOMAIN	GTTESTCD	GTTEST	GTORRESU	GTSTRESU	GTDTC
1	ST487-12	GT	RICC		ug/mL	ug/mL	25-05-2022
2	ST487-12	GT	RCC		ug/mL	ug/mL
3	ST487-12	GT	RPD		ug/mL	ug/mL
4	ST487-12	GT	CELLS	Sum of cells evaluated	ug/mL	ug/mL
5	ST487-12	GT	MNNUM	Cells with Micronuclei	ug/mL	ug/mL
6	ST487-12	GT	MNT	In vitro Micronucleus Assay	ug/mL	ug/mL
7	ST487-12	GT	MNT	In vitro Micronucleus Assay	ug/mL	ug/mL
8	ST487-12	GT	MNT	In vitro Micronucleus Assay	ug/mL	ug/mL
9	ST487-12	GT	MNT	In vitro Micronucleus Assay	ug/mL	ug/mL

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In vitro Micronucleus Assay