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

Assumption: Study can have more than one assay type
Assumption: ASSAYID value of ALL means it applies to all assays in the study

Row	STUDYID	ASSAYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	123	ALL	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
11	123	ALL	TS	1		STSTDTC	Study Start Date	2007-12-30
13	123	ALL	TS	1		STITLE	Study Title	Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods
14	123	ALL	TS	1		SNDIGVER	SEND Implementation Guide Version	Tobacco IMPLEMENTATION GUIDE VERSION 1.0
15	123	ALL	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-03-26
17	123	ALL	TS	1		SSPONSOR	Sponsor Organization	Example Sponsor Inc.
18	123	ALL	TS	1		SPREFID	Sponsor's Study Reference ID		NOT APPLICABLE
19	123	ALL	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
20	123	ALL	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
21	123	ALL	TS	1	1	TFCNTRY	Test Facility Country	USA
24	123	ALL	TS	1	1	STDIR	Study Director	Dr. R. Smith
25	123		TS	1		TRT	Investigational Therapy or Treatment	Drug A
26	123		TS	1	2	TRTV	Treatment Vehicle	Saline
27	123		TS	1	2	TRTVDESC	Treatment Vehicle Structured Description	100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W}
28	123	ALL	TS	1		GLPFL	GLP Flag	Y
29	123	MNT	TS	1		ASTD	Assay Standard	OECD Test No. 487
30	123	MNT	TS	1		ASTDV	Assay Standard Version	2016-07-29
31	123	MNT	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
32	123	MNT	TS	1		SSSTYP	Study Sub Type	In Vitro Micronucleus
33	123	MNT	TS	1		SPECIES	Species	Homo Sapiens
34	123	MNT	TS	1		??	Test System?	TK6 Lymphoblastoid Suspension Cells
35	123	NRU	TS	1		ASTD	Assay Standard	NIH Publication No. 07-4519
36	123	NRU	TS	1		ASTDV	Assay Standard Version	2006-11
37	123	NRU	TS	1		SSTYP	Study Type
38	123	NRU	TS	1		SSSTYP	Study Sub Type	In Vitro Neutral Red Uptake
39	123	NRU	TS	1		SPECIES	Species	Homo Sapiens
40	123	NRU	TS	1		??	Test System??	Normal Human Keratinocyte

Treatment Duration will be controlled? During CT definition/revies will need to decide appropriate Treatment duration values; If not, what are best example values to show?

Row	STUDYID	ASSAYID	DOMAIN	SETCD	TXPARMCD	TXPARM	TXVAL
1	123	MNT	TX	A1	METACT	Metabolic Activation	+S9
2	123	MNT	TX	A1	TRTDUR	Treatment Duration	Short Term
3	123	MNT	TX	A1	PRDCONC	Concentration of product	0
4	123	MNT	TX	A1	PRDCONCU	Concentration Unit	ug/ml
5	123	MNT	TX	A1	Product	Product Name
6	123	MNT	TX	A1		Smoking Regime
7	123	MNT	TX	A1		Smoke Fraction
	123	MNT	TX	A2	METACT	Metabolic Activation	+S9
	123	MNT	TX	A2	TRTDUR	Treatment Duration	Short Term
	123	MNT	TX	A2	PRDCONC	Concentration of product	1250
	123	MNT	TX	A2	PRDCONCU	Concentration Unit	ug/ml
	123	MNT	TX	A2	Product	Product Name
	123	MNT	TX	A2		Smoking Regime
	123	MNT	TX	A2		Smoke Fraction


8	123	MNT	TX	B	METACT	Metabolic Activation	-S9
9	123	MNT	TX	B	TRTDUR	Treatment Duration	Short Term
10	123	MNT	TX	B	TRTDUR	Treatment Duration	Long Term (or 2 parm codes, # and unit)
11	123	MNT	TX	B	PRDCONC	Concentration of product	0
12	123	MNT	TX	B	PRDCONCU	Concentration Unit	ug/ml
13	123	MNT	TX	B	Product	Product Name
14	123	MNT	TX	B		Smoking Regime
15	123	MNT	TX	B		Smoke Fraction

8	123	MNT	TX	C	METACT	Metabolic Activation	-S9
9	123	MNT	TX	C	TRTDUR	Treatment Duration	Long Term
10	123	MNT	TX	C	TRTDUR	Treatment Duration	Long Term (or 2 parm codes, # and unit)
11	123	MNT	TX	C	PRDCONC	Concentration of product	0
12	123	MNT	TX	C	PRDCONCU	Concentration Unit	ug/ml
13	123	MNT	TX	C	Product	Product Name
14	123	MNT	TX	C		Smoking Regime
15	123	MNT	TX	C		Smoke Fraction

BLEO & CPA - positive controls?

Row	STUDYID	ASSAYID	DOMAIN	TXCD	GTSEQ	GTTESTCD	GTTEST	GTCELLEV (cells evaluated)	GTORRES	GTORRESU	GTSTRESC	GTSTRESN	GTSTRESU	GTDTC
1	123	MNT	GT	A2	1	RICC		134	15.7	%	15.7	15.7	%	2022-05-25
2	123	MNT	GT	A2	2	RCC		134	13.0	%	13.0	13.0	%	2022-05-25
3	123	MNT	GT	A2	3	RPD		134	7.9	%	7.9	7.9	%	2022-05-25
4	123	MNT	GT	A2	4	MNCELLS	Micronucleated Cells	3266	20	Cells	20	20	Cells	2022-05-25
5	123	MNT	GT	A2	5	MNCELLS	Micronucleated Cells	2190	17	Cells	17	17	Cells	2022-05-25
6	123	MNT	GT	A2	6	MNCELLS	Micronucleated Cells	2758	13	Cells	13	13	Cells	2022-05-25
7	123	MNT	GT	A2	7	MNCELLS	Micronucleated Cells	2714	21	Cells	21	21	Cells	2022-05-25
8	123	MNT	GT	A2	8	AVGREL	Average Relative MN Frequency		0.66	%	0.66	0.66	%	2022-05-25
9	123	MNT	GT	A1	1	RICC		154	0	%	0	0	%	2022-05-25
10	123	MNT	GT	A1	2	RCC		154	0	%	0	0	%	2022-05-25
11	123	MNT	GT	A1	3	RPD		154	0	%	0	0	%	2022-05-25
12	123	MNT	GT	A1	4	MNCELLS	Micronucleated Cells	3266	15	Cells	15	15	Cells	2022-05-25
13	123	MNT	GT	A1	5	MNCELLS	Micronucleated Cells	2190	13	Cells	13	13	Cells	2022-05-25
14	123	MNT	GT	A1	6	MNCELLS	Micronucleated Cells	2758	17	Cells	17	17	Cells	2022-05-25
15	123	MNT	GT	A1	7	MNCELLS	Micronucleated Cells	2714	12	Cells	12	12	Cells	2022-05-25
16	123	MNT	GT	A1	8	AVGREL	Average Relative MN Frequency		0.57	%	0.57	0.57	%	2022-05-25

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??

(also see Gentox notes on how to approach modeling, to apply that here?)

(Do we need this? a single element (treatment)?)

Row	STUDYID	ASSAYID	DOMAIN	ETCD	ELEMENT

(Do we need this? one arm for each trial set?)

Row	STUDYID	ASSAYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT

Row

STUDYID

DOMAIN

ENID (Entity ID)

RICC

RCC

RPD

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

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In vitro Micronucleus Assay