This is an example showing trial design, results data, and related datasets (e.g, tobacco description, device identification, smoking regimen) for study #123, test article TA321: In Vitro Mammalian Cell Gene Mutation Test (L5178Y/TK^+/- Mouse Lymphoma Assay).

In this example, the tobacco product is dissolved in a solvent (vehicle is PBS). Some experimental units are treated with a metabolic activation system (S9, using rat liver). There were 6 concentrations of test article used, treating duplicate cultures (A, B). The test article is added to the cell suspension, where the percent suspension growth is measured. Treatment exposure is for 4 hours; then there is a wash process, followed by a 2-day phenotypic expression period. The suspension is then plated onto 3 plates with trifluorothymidine (TFT) and three plates with cloning medium without TFT or cloning efficiency (CE) colonies. After incubation for an additional 10-day mutant selection duration, the total mutant frequency and induced mutant frequency are calculated from the TFT colony plates and the percent relative total growth is calculated from the TFT and CE colony plates based upon percent suspension growth.

Table 1. Initial Definitive Mutagenicity Assay (4-Hour Exposure –S9)

Solvent = PBS A and B are duplicate cultures

****= Cultures treated at other concentrations were not cloned as higher concentrations were available for evaluation

*= Plate contaminated

**= Precipitation

Rows 1-2:	Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP types apply for this example study.
Row 3:	Shows that this study was conducted as a GLP study.
Rows 4-5:	Shows the study start date and study title.
Rows 6-7:	Show the version of SEND Implementation Guide and version of Controlled Terminology used in this study.
Row 8:	Shows the applicant's organization.
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 13-15:	Show that TSGRPID (TSGRPID=2) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).
Row 16:	Shows the study type for this study.
Row 17:	Shows that this study includes a Mammalian Cell Gene Mutation Assay.
Rows 18-19:	Show that TSGRPID (TSGRPID = 3) has been used to link the information for 1 species (Mouse) with the cell line that is tested in this study.

ts.xpt

	STUDYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL
1	123	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	123	TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	123	TS	1		GLPFL	GLP Flag	Y
4	123	TS	1		STSTDTC	Study Start Date	2020-01-01
5	123	TS	1		STITLE	Study Title	Study #123, Test Article TA321: In Vitro Mammalian Cell Gene Mutation Test (L5178Y/TK+/- Mouse Lymphoma Assay)
6	123	TS	1		SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
7	123	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
8	123	TS	1		APPLCNT	Applicant	Example Applicant Inc.
9	123	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
10	123	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
11	123	TS	1	1	TFCNTRY	Test Facility Country	USA
12	123	TS	1	1	STDIR	Study Director	Dr. R. Smith
13	123	TS	1	2	TSTGDNAM	Testing Guideline Name	TEST NO. 490
14	123	TS	1	2	TSTGDORG	Testing Guideline Organization	OECD
15	123	TS	1	2	TSTGDVER	Testing Guideline Version	2016-07-29
16	123	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
17	123	TS	1		GNTXAID	Genetic Toxicology Assay Identifier	MLA
18	123	TS	1	3	SPECIES	Species	Mouse
19	123	TS	1	3	CELLLN	Cell Line	TK+/- -3.7.2C subline of L5178Y cells

TOBA-463 OPEN

This example Trial Set (TX) dataset shows information about the test conditions for all the trial sets (A1, A1CE, A1TFT, A2, A2CE, A2TFT) in this study.

Note that there are three trial set parameters that link to other important datasets: SPTOBID, APDEVID, and SMKRGM.

SPTOBID (Applicant-Defined Tobacco Product ID) is used to uniquely identify the tobacco product. The value of SPTOBID (e.g., CIG01a) matches the value for SPTOBID in all the TOPARMCD-TOVAL pairs in the Tobacco Product Identifiers and Descriptors (TO) dataset example in Section 3.1.2, Product Design Parameters and Conformance Testing, Example 1. The TOPARMCD-TOVAL pairs identify this unique product, CIG01a. The TO domain is described in Section 2.8.8.1, Tobacco Product Identifiers and Descriptors (TO).
The value of APDEVID (e.g., PUFFMASTER3K) matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. SPDEVID is the applicant-defined device identifier that is used to uniquely identify the device in the Unique Device Identification (DI) dataset (see also Section 2.8.9.7, SEND Device Identifiers (DI)). This is shown in the DI dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 1.
SMKRGM serves as a link to the Device-In Use Properties (DU) domain (see also Section 2.8.9.8, SEND Device-In-Use (DU)), where a matching value of SMKRGM indicates parameters of the smoking regimen performed by the smoking machine, as in the DU dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 2.

Rows 1-23:	Show trial set parameters and trial set values that comprise the test conditions for the set A1, both cultures A and B. Set A1 is the data for the product at a concentration of 31.3 ug/mL, with 4-hour exposure, without S9 metabolic activation. Set A1 is associated with the 5^th and 6^th rows of the report table for example study 123.
Rows 24-47:	Show trial set parameters and trial set values that comprise the test conditions for the set A1CE, both cultures A and B. Set A1CE is the data for the product at a concentration of 31.3 ug/mL, with 4-hour exposure, without S9 metabolic activation in cloning efficiency (CE) colonies, in other words in plates with cloning medium without trifluorothymidine (TFT).
Rows 48-74:	Show trial set parameters and trial set values that comprise the test conditions for the set A1TFT, both cultures A and B. Set A1TFT is the data for the product at a concentration of 31.3 ug/mL, with 4-hour exposure, without S9 metabolic activation in plates with cloning medium with trifluorothymidine (TFT).
Rows 75-93:	Show trial set parameters and trial set values that comprise the test conditions for the set A2, both cultures A and B. Set A2 is the data for the product at a concentration of 500 ug/mL, with 4-hour exposure, without S9 metabolic activation. Set A2 is associated with the 13^th and 14^th row of the report table for example study 123.
Rows 94-113:	Show trial set parameters and trial set values that comprise the test conditions for the set A2CE, both cultures A and B. Set A2CE is the data for the product at a concentration of 500 ug/mL, with 4-hour exposure, without S9 metabolic activation in cloning efficiency (CE) colonies, in other words in plates with cloning medium without trifluorothymidine (TFT).
Rows 114-136:	Show trial set parameters and trial set values that comprise the test conditions for the set A2TFT, both cultures A and B. Set A2 is the data for the product at a concentration of 500 ug/mL, with 4-hour exposure, without S9 metabolic activation in plates with cloning medium with trifluorothymidine (TFT).

Row	STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	TX	A1	4_-S9_C31.3	1	MTACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
2	123	TX	A1	4_-S9_C31.3	2	METACTFL	Presence of Metabolic Activation Flag	N
3	123	TX	A1	4_-S9_C31.3	3	IVTDMIN	In vitro Treatment Duration Minimum	3
4	123	TX	A1	4_-S9_C31.3	4	IVTDTRG	In vitro Treatment Duration Target	3.5
5	123	TX	A1	4_-S9_C31.3	5	IVTDMAX	In vitro Treatment Duration Maximum	4
6	123	TX	A1	4_-S9_C31.3	6	IVTDU	In vitro Treatment Duration Unit	HOURS
7	123	TX	A1	4_-S9_C31.3	7	PHNXPDUR	In vitro Phenotypic Expression Duration	2
8	123	TX	A1	4_-S9_C31.3	8	PHNXPDU	In vitro Phenotypic Expression Duration Unit	DAYS
9	123	TX	A1	4_-S9_C31.3	9	MUTNDUR	In vitro Mutant Selection Duration	10
10	123	TX	A1	4_-S9_C31.3	10	MUTNDU	In vitro Mutant Selection Duration Unit	DAYS
11	123	TX	A1	4_-S9_C31.3	11	INCBTMP	Incubation Temperature	37
12	123	TX	A1	4_-S9_C31.3	12	INCBTMPU	Incubation Temperature Unit	C
13	123	TX	A1	4_-S9_C31.3	13	ATMRPH	Atmospheric Relative Humidity Percent	50
14	123	TX	A1	4_-S9_C31.3	14	ATMCO2P	Atmospheric CO2 Percent	5
15	123	TX	A1	4_-S9_C31.3	15	SPTOBID	Applicant defined tobacco identifier	CIG01a
16	123	TX	A1	4_-S9_C31.3	16	EXPTYP	Exposure Type	SUBMERGED
17	123	TX	A1	4_-S9_C31.3	17	SAMTYP	Sample Type	TOTAL PARTICULATE MATTER IN PBS
18	123	TX	A1	4_-S9_C31.3	18	ITVNAM	Intervention Article Name	Tobacco ProdA
19	123	TX	A1	4_-S9_C31.3	19	ITVTYPE	Intervention Article Type	PRODUCT
20	123	TX	A1	4_-S9_C31.3	20	ITVCONC	Intervention Article Concentration	31.3
21	123	TX	A1	4_-S9_C31.3	21	ITVCONCU	Intervention Article Concentration Unit	ug/mL
22	123	TX	A1	4_-S9_C31.3	22	SPDEVID	Applicant defined device identifier	PUFFMASTER3K
23	123	TX	A1	4_-S9_C31.3	23	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
24	123	TX	A1CE	4_-S9_C31.3_CE	24	MTACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
25	123	TX	A1CE	4_-S9_C31.3_CE	25	METACTFL	Presence of Metabolic Activation Flag	N
26	123	TX	A1CE	4_-S9_C31.3_CE	26	IVTDMIN	In vitro Treatment Duration Minimum	3
27	123	TX	A1CE	4_-S9_C31.3_CE	27	IVTDTRG	In vitro Treatment Duration Target	3.5
28	123	TX	A1CE	4_-S9_C31.3_CE	28	IVTDMAX	In vitro Treatment Duration Maximum	4
29	123	TX	A1CE	4_-S9_C31.3_CE	29	IVTDU	In vitro Treatment Duration Unit	HOURS
30	123	TX	A1CE	4_-S9_C31.3_CE	30	PHNXPDUR	In vitro Phenotypic Expression Duration	2
31	123	TX	A1CE	4_-S9_C31.3_CE	31	PHNXPDU	In vitro Phenotypic Expression Duration Unit	DAYS
32	123	TX	A1CE	4_-S9_C31.3_CE	32	MUTNDUR	In vitro Mutant Selection Duration	10
33	123	TX	A1CE	4_-S9_C31.3_CE	33	MUTNDU	In vitro Mutant Selection Duration Unit	DAYS
34	123	TX	A1CE	4_-S9_C31.3_CE	34	INCBTMP	Incubation Temperature	37
35	123	TX	A1CE	4_-S9_C31.3_CE	35	INCBTMPU	Incubation Temperature Unit	C
36	123	TX	A1CE	4_-S9_C31.3_CE	36	ATMRPH	Atmospheric Relative Humidity Percent	50
37	123	TX	A1CE	4_-S9_C31.3_CE	37	ATMCO2P	Atmospheric CO2 Percent	5
38	123	TX	A1CE	4_-S9_C31.3_CE	38	SPTOBID	Applicant defined tobacco identifier	CIG01a
39	123	TX	A1CE	4_-S9_C31.3_CE	39	EXPTYP	Exposure Type	SUBMERGED
40	123	TX	A1CE	4_-S9_C31.3_CE	40	SAMTYP	Sample Type	TOTAL PARTICULATE MATTER IN PBS
41	123	TX	A1CE	4_-S9_C31.3_CE	41	ITVNAM	Intervention Article Name	Tobacco ProdA
42	123	TX	A1CE	4_-S9_C31.3_CE	42	ITVTYPE	Intervention Article Type	PRODUCT
43	123	TX	A1CE	4_-S9_C31.3_CE	43	ITVCONC	Intervention Article Concentration	31.3
44	123	TX	A1CE	4_-S9_C31.3_CE	44	ITVCONCU	Intervention Article Concentration Unit	ug/mL
45	123	TX	A1CE	4_-S9_C31.3_CE	45	SPDEVID	Applicant defined device identifier	PUFFMASTER3K
46	123	TX	A1CE	4_-S9_C31.3_CE	46	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
47	123	TX	A1CE	4_-S9_C31.3_CE	47	SELAPIND	Selective Agent Present Indicator	N
48	123	TX	A1TFT	4_-S9_C31.3_TFT	48	MTACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
49	123	TX	A1TFT	4_-S9_C31.3_TFT	49	METACTFL	Presence of Metabolic Activation Flag	N
50	123	TX	A1TFT	4_-S9_C31.3_TFT	50	IVTDMIN	In vitro Treatment Duration Minimum	3
51	123	TX	A1TFT	4_-S9_C31.3_TFT	51	IVTDTRG	In vitro Treatment Duration Target	3.5
52	123	TX	A1TFT	4_-S9_C31.3_TFT	52	IVTDMAX	In vitro Treatment Duration Maximum	4
53	123	TX	A1TFT	4_-S9_C31.3_TFT	53	IVTDU	In vitro Treatment Duration Unit	HOURS
54	123	TX	A1TFT	4_-S9_C31.3_TFT	54	PHNXPDUR	In vitro Phenotypic Expression Duration	2
55	123	TX	A1TFT	4_-S9_C31.3_TFT	55	PHNXPDU	In vitro Phenotypic Expression Duration Unit	DAYS
56	123	TX	A1TFT	4_-S9_C31.3_TFT	56	MUTNDUR	In vitro Mutant Selection Duration	10
57	123	TX	A1TFT	4_-S9_C31.3_TFT	57	MUTNDU	In vitro Mutant Selection Duration Unit	DAYS
58	123	TX	A1TFT	4_-S9_C31.3_TFT	58	INCBTMP	Incubation Temperature	37
59	123	TX	A1TFT	4_-S9_C31.3_TFT	59	INCBTMPU	Incubation Temperature Unit	C
60	123	TX	A1TFT	4_-S9_C31.3_TFT	60	ATMRPH	Atmospheric Relative Humidity Percent	50
61	123	TX	A1TFT	4_-S9_C31.3_TFT	61	ATMCO2P	Atmospheric CO2 Percent	5
62	123	TX	A1TFT	4_-S9_C31.3_TFT	62	SPTOBID	Applicant defined tobacco identifier	CIG01a
63	123	TX	A1TFT	4_-S9_C31.3_TFT	63	EXPTYP	Exposure Type	SUBMERGED
64	123	TX	A1TFT	4_-S9_C31.3_TFT	64	SAMTYP	Sample Type	TOTAL PARTICULATE MATTER IN PBS
65	123	TX	A1TFT	4_-S9_C31.3_TFT	65	ITVNAM	Intervention Article Name	Tobacco ProdA
66	123	TX	A1TFT	4_-S9_C31.3_TFT	66	ITVTYPE	Intervention Article Type	PRODUCT
67	123	TX	A1TFT	4_-S9_C31.3_TFT	67	ITVCONC	Intervention Article Concentration	31.3
68	123	TX	A1TFT	4_-S9_C31.3_TFT	68	ITVCONCU	Intervention Article Concentration Unit	ug/mL
69	123	TX	A1TFT	4_-S9_C31.3_TFT	69	SPDEVID	Applicant defined device identifier	PUFFMASTER3K
70	123	TX	A1TFT	4_-S9_C31.3_TFT	70	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
71	123	TX	A1TFT	4_-S9_C31.3_TFT	71	SELAPIND	Selective Agent Present Indicator	Y
72	123	TX	A1TFT	4_-S9_C31.3_TFT	72	SELANAM	Selective Agent Name	Trifluorothymidine
73	123	TX	A1TFT	4_-S9_C31.3_TFT	73	SELCONC	Selective Agent Concentration	5
74	123	TX	A1TFT	4_-S9_C31.3_TFT	74	SELCONCU	Selective Agent Concentration Unit	ug/mL
75	123	TX	A2	4_-S9_C500	75	MTACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
76	123	TX	A2	4_-S9_C500	76	METACTFL	Presence of Metabolic Activation Flag	N
77	123	TX	A2	4_-S9_C500	77	IVTDMIN	In vitro Treatment Duration Minimum	3
78	123	TX	A2	4_-S9_C500	78	IVTDTRG	In vitro Treatment Duration Target	3.5
79	123	TX	A2	4_-S9_C500	79	IVTDMAX	In vitro Treatment Duration Maximum	4
80	123	TX	A2	4_-S9_C500	80	IVTDU	In vitro Treatment Duration Unit	HOURS
81	123	TX	A2	4_-S9_C500	81	INCBTMP	Incubation Temperature	37
82	123	TX	A2	4_-S9_C500	82	INCBTMPU	Incubation Temperature Unit	C
83	123	TX	A2	4_-S9_C500	83	ATMHRP	Atmospheric Relative Humidity Percent	50
84	123	TX	A2	4_-S9_C500	84	ATMCO2P	Atmospheric CO2 Percent	5
85	123	TX	A2	4_-S9_C500	85	SPTOBID	Applicant-defined tobacco identifier	CIG01a
86	123	TX	A2	4_-S9_C500	86	EXPTYP	Exposure Type	SUBMERGED
87	123	TX	A2	4_-S9_C500	87	SAMTYP	Sample Type	TOTAL PARTICULATE MATTER IN PBS
88	123	TX	A2	4_-S9_C500	88	ITVNAM	Intervention Article Name	Tobacco ProdA
89	123	TX	A2	4_-S9_C500	89	ITVTYPE	Intervention Article Type	PRODUCT
90	123	TX	A2	4_-S9_C500	90	ITVCONC	Intervention Article Concentration	500
91	123	TX	A2	4_-S9_C500	91	ITVCONCU	Intervention Article Concentration Unit	ug/mL
92	123	TX	A2	4_-S9_C500	92	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
93	123	TX	A2	4_-S9_C500	93	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
94	123	TX	A2CE	4_-S9_C500_CE	94	MTACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
95	123	TX	A2CE	4_-S9_C500_CE	95	METACTFL	Presence of Metabolic Activation Flag	N
96	123	TX	A2CE	4_-S9_C500_CE	96	IVTDMIN	In vitro Treatment Duration Minimum	3
97	123	TX	A2CE	4_-S9_C500_CE	97	IVTDTRG	In vitro Treatment Duration Target	3.5
98	123	TX	A2CE	4_-S9_C500_CE	98	IVTDMAX	In vitro Treatment Duration Maximum	4
99	123	TX	A2CE	4_-S9_C500_CE	99	IVTDU	In vitro Treatment Duration Unit	HOURS
100	123	TX	A2CE	4_-S9_C500_CE	100	INCBTMP	Incubation Temperature	37
101	123	TX	A2CE	4_-S9_C500_CE	101	INCBTMPU	Incubation Temperature Unit	C
102	123	TX	A2CE	4_-S9_C500_CE	102	ATMHRP	Atmospheric Relative Humidity Percent	50
103	123	TX	A2CE	4_-S9_C500_CE	103	ATMCO2P	Atmospheric CO2 Percent	5
104	123	TX	A2CE	4_-S9_C500_CE	104	SPTOBID	Applicant-defined tobacco identifier	CIG01a
105	123	TX	A2CE	4_-S9_C500_CE	105	EXPTYP	Exposure Type	SUBMERGED
106	123	TX	A2CE	4_-S9_C500_CE	106	SAMTYP	Sample Type	TOTAL PARTICULATE MATTER IN PBS
107	123	TX	A2CE	4_-S9_C500_CE	107	ITVNAM	Intervention Article Name	Tobacco ProdA
108	123	TX	A2CE	4_-S9_C500_CE	108	ITVTYPE	Intervention Article Type	PRODUCT
109	123	TX	A2CE	4_-S9_C500_CE	109	ITVCONC	Intervention Article Concentration	500
110	123	TX	A2CE	4_-S9_C500_CE	110	ITVCONCU	Intervention Article Concentration Unit	ug/mL
111	123	TX	A2CE	4_-S9_C500_CE	111	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
112	123	TX	A2CE	4_-S9_C500_CE	112	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
113	123	TX	A2CE	4_-S9_C500_CE	113	SELAPIND	Selective Agent Present Indicator	N
114	123	TX	A2TFT	4_-S9_C500_TFT	114	MTACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
115	123	TX	A2TFT	4_-S9_C500_TFT	115	METACTFL	Presence of Metabolic Activation Flag	N
116	123	TX	A2TFT	4_-S9_C500_TFT	116	IVTDMIN	In vitro Treatment Duration Minimum	3
117	123	TX	A2TFT	4_-S9_C500_TFT	117	IVTDTRG	In vitro Treatment Duration Target	3.5
118	123	TX	A2TFT	4_-S9_C500_TFT	118	IVTDMAX	In vitro Treatment Duration Maximum	4
119	123	TX	A2TFT	4_-S9_C500_TFT	119	IVTDU	In vitro Treatment Duration Unit	HOURS
120	123	TX	A2TFT	4_-S9_C500_TFT	120	INCBTMP	Incubation Temperature	37
121	123	TX	A2TFT	4_-S9_C500_TFT	121	INCBTMPU	Incubation Temperature Unit	C
122	123	TX	A2TFT	4_-S9_C500_TFT	122	ATMHRP	Atmospheric Relative Humidity Percent	50
123	123	TX	A2TFT	4_-S9_C500_TFT	123	ATMCO2P	Atmospheric CO2 Percent	5
124	123	TX	A2TFT	4_-S9_C500_TFT	124	SPTOBID	Applicant-defined tobacco identifier	CIG01a
125	123	TX	A2TFT	4_-S9_C500_TFT	125	EXPTYP	Exposure Type	SUBMERGED
126	123	TX	A2TFT	4_-S9_C500_TFT	126	SAMTYP	Sample Type	TOTAL PARTICULATE MATTER IN PBS
127	123	TX	A2TFT	4_-S9_C500_TFT	127	ITVNAM	Intervention Article Name	Tobacco ProdA
128	123	TX	A2TFT	4_-S9_C500_TFT	128	ITVTYPE	Intervention Article Type	PRODUCT
129	123	TX	A2TFT	4_-S9_C500_TFT	129	ITVCONC	Intervention Article Concentration	500
130	123	TX	A2TFT	4_-S9_C500_TFT	130	ITVCONCU	Intervention Article Concentration Unit	ug/mL
131	123	TX	A2TFT	4_-S9_C500_TFT	131	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
132	123	TX	A2TFT	4_-S9_C500_TFT	132	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
133	123	TX	A2TFT	4_-S9_C500_TFT	133	SELAPIND	Selective Agent Present Indicator	Y
134	123	TX	A2TFT	4_-S9_C500_TFT	134	SELANAM	Selective Agent Name	Trifluorothymidine
135	123	TX	A2TFT	4_-S9_C500_TFT	135	SELCONC	Selective Agent Concentration	5
136	123	TX	A2TFT	4_-S9_C500_TFT	136	SELCONCU	Selective Agent Concentration Unit	ug/mL

The applicant chose to define the REFID values to indicate the Duration of Exposure, the existence of S9 metabolic activation, the concentration of intervention article, and the presence of selective agent, such that a duration of 4 hours without S9 activation at a concentration of 31.3 ug/mL in the presence of TFT as the selective agent would be indicated as a REFID of 4_-S9_C31.3_TFT.

Row 1:	Shows the REFID for 4_-S9_C31.3_B_OS which has a LVLDESC of observational summary, where the study has recorded data for summary statistics based upon all CE and TFT plates as well as percent suspension growth at the concentration of 31.3 ug/mL (based upon the descendants of 4_-S9_C31.3_B_OS).
Row 2:	Shows the REFID for the experimental unit 4_-S9_C31.3_B (i.e., the suspension where the test article was added under test conditions described in set A1, at a concentration of 31.3 ug/mL) and that the percent suspension growth was measured for the 4-hour exposure without S9 metabolic activation.
Row 3:	Shows the REFID for the trial set that represents the suspension without TFT. This REFID is the identifier for results attributed to all 3 CE colony plates (e.g., mean).
Rows 4-6:	Show the REFIDs for the observational units (i.e., the identifiers for the plates where the suspension without TFT was added; thus, the CE colonies).
Row 7:	Shows the REFID for the trial set that represents the suspension with TFT. This REFID is the identifier for results attributed to all 3 TFT colony plates.
Rows 8-10:	Show the REFIDs for the observational units (i.e., the identifiers for the plates where the suspension with TFT was added; thus, the TFT colonies).
Row 11:	Shows the REFID for 4_-S9_C500_B_OS which has a LVLDESC of observational summary, where the study has recorded data for summary statistics based upon all CE and TFT plates as well as percent suspension growth at the concentration of 500 ug/mL (based upon the descendants of 4_-S9_C500_B_OS).
Row 12:	Shows the REFID for the experimental unit (i.e., the suspension where the test article was added under test conditions described in set A2, at a concentration of 500 ug/mL) and that the percent suspension growth was measured for the 4-hour exposure without S9 metabolic activation.
Row 13:	Shows the REFID for the trial set that represents the suspension without TFT. This REFID is the identifier for results attributed to all 3 CE colony plates.
Rows 14-16:	Show the REFIDs for the observational units (i.e., the identifiers for the plates where the suspension was added without TFT; thus, the CE colonies).
Row 17:	Shows the REFID for the trial set that represents the suspension with TFT. This REFID is the identifier for results attributed to all 3 TFT colony plates.
Rows 18-20:	Show the REFIDs for the observational units (i.e., the identifiers for the plates where the suspension was added with TFT; thus, the TFT colonies).

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relref.xpt

Row	STUDYID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	123	A1	4_-S9_C31.3_B_OS		1	OBSERVATIONAL SUMMARY
2	123	A1	4_-S9_C31.3_B	4_-S9_C31.3_B_OS	2	EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
3	123	A1CE	4_-S9_C31.3_B_CE	4_-S9_C31.3_B	3	TRIAL SET/OBSERVATIONAL SUMMARY
4	123	A1CE	4_-S9_C31.3_B_CE_1	4_-S9_C31.3_B_CE	4	OBSERVATIONAL UNIT
5	123	A1CE	4_-S9_C31.3_B_CE_2	4_-S9_C31.3_B_CE	4	OBSERVATIONAL UNIT
6	123	A1CE	4_-S9_C31.3_B_CE_3	4_-S9_C31.3_B_CE	4	OBSERVATIONAL UNIT
7	123	A1TFT	4_-S9_C31.3_B_TFT	4_-S9_C31.3_B	3	TRIAL SET/OBSERVATIONAL SUMMARY
8	123	A1TFT	4_-S9_C31.3_B_TFT_1	4_-S9_C31.3_B_TFT	4	OBSERVATIONAL UNIT
9	123	A1TFT	4_-S9_C31.3_B_TFT_2	4_-S9_C31.3_B_TFT	4	OBSERVATIONAL UNIT
10	123	A1TFT	4_-S9_C31.3_B_TFT_3	4_-S9_C31.3_B_TFT	4	OBSERVATIONAL UNIT
11	123	A2	4_-S9_C500_B_OS		1	OBSERVATIONAL SUMMARY
12	123	A2	4_-S9_C500_B	4_-S9_C500_B_OS	2	EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
13	123	A2CE	4_-S9_C500_B_CE	4_-S9_C500_B	3	TRIAL SET/OBSERVATIONAL UNIT
14	123	A2CE	4_-S9_C500_B_CE_1	4_-S9_C500_B_CE	4	OBSERVATIONAL UNIT
15	123	A2CE	4_-S9_C500_B_CE_2	4_-S9_C500_B_CE	4	OBSERVATIONAL UNIT
16	123	A2CE	4_-S9_C500_B_CE_3	4_-S9_C500_B_CE	4	OBSERVATIONAL UNIT
17	123	A2TFT	4_-S9_C500_B_TFT	4_-S9_C500_B	3	TRIAL SET/OBSERVATIONAL UNIT
18	123	A2TFT	4_-S9_C500_B_TFT_1	4_-S9_C500_B_TFT	4	OBSERVATIONAL UNIT
19	123	A2TFT	4_-S9_C500_B_TFT_2	4_-S9_C500_B_TFT	4	OBSERVATIONAL UNIT
20	123	A2TFT	4_-S9_C500_B_TFT_3	4_-S9_C500_B_TFT	4	OBSERVATIONAL UNIT

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For ease of reviewing the results in the Genetic Toxicology In Vitro Test Results (GT) dataset, two rows of the sample report for study 123 (the sixth row and the fourteenth row) are repeated in the graphic excerpt below, with labels corresponding to their test codes and tests in the GT domain:

Row 6:

Row 14:

*= Plate contaminated

Row 1:	Shows results for the experimental unit A1 as shown in row 6 of Table 1, concentration 31.3, in the sample report for study 123 . The GTREFID aligns with the REFID for SETCD=A1 in the RELREF dataset, matching the test conditions of A1 in the TX dataset.
Rows 2-4:	Show results for each of three observational units within the trial set A1CE as shown in the three plates numbered 1, 2, and 3 under "CE Colonies, Plate Counts" on row 6 of Table 1 in the sample report for study 123. The GTREFIDs align with the REFID for SETCD=A1CE in the RELREF dataset, matching the test conditions of trial set A1CE in the TX dataset. From the A1CE entries in the TX dataset, you see there is no selective agent present on these plates.
Row 5:	Shows the result for 4_-S9_C31.3_B_CE. Looking at the RELREF dataset, this REFID aligns with the SETCD A1CE in the TX dataset where the parameter codes indicate a suspension without TFT. This result (i.e., mean) is an observational summary attributed to all 3 CE colony plates because they are children of 4_-S9_C31.3_B_CE.
Rows 6-8:	Show results for each of three observational units within the trial set A1TFT as shown in the three plates numbered 1, 2, and 3 under "TFT Colonies, Plate Counts" on row 6 of Table 1 in the sample report for study 123. The GTREFIDs align with the REFID for SETCD=A1TFT in the RELREF dataset, matching the test conditions of trial set A1TFT in the TX dataset. From the A1TFT entries in the TX dataset, you see the selective agent Trifluorothymidine is present on these plates in a concentration of 5 ug/mL.
Rows 9-11:	Show results for the trial set A1TFT that represents the suspension with a 31.3 ug/mL of intervention article and with TFT. These results (i.e., mean, mutant frequency) are attributed to all 3 TFT colony plates. GTCOLSRT is populated with MEAN to distinguish this test from the Colony Numbers Per Plate of the individual plates.
Row 12:	Shows results for 4_-S9_C31.3_B_OS. Looking at the RELREF dataset, this REFID aligns with the SETCD A1 in the TX dataset where the parameter codes indicate a dose concentration of 31.3 ug/mL. This result (i.e., relative total growth) is an observational summary attributed to all plates in the sixth row of the sample report table (the descendants of 4_-S9_C31.3_B_OS).
Row 13:	Shows results for experimental unit A2 as shown in row 14 of Table 1, concentration 500, in the sample report for study 123. The GTREFID aligns with the REFID for SETCD=A2 in the RELREF dataset, matching the test conditions of trial set A2 in the TX dataset.
Rows 14-16:	Show results for each of three observational units within the trial set A2CE as shown in the three plates numbered 1, 2, and 3 under "CE Colonies, Plate Counts" on row 14 of Table 1 in the sample report for study 123. The GTREFID aligns with the REFID for SETCD=A2CE in the RELREF dataset, matching the test conditions of trial set A2CE in the TX dataset. From the A2CE entries in the TX dataset, you see there is no selective agent present on these plates.
Row 17:	Shows the result for 4_-S9_C500_B_CE. Looking at the RELREF dataset, this REFID aligns with the SETCD A2CE in the TX dataset where the parameter codes indicate a suspension with 500 ug/mL of intervention article but without TFT. This result (i.e., mean) is an observational summary attributed to all 3 CE colony plates because they are children of 4_-S9_C500_B_CE.
Rows 18-20:	Show results for each of three observational units within the trial set A2TFT as shown in the three plates numbered 1, 2, and 3 under "TFT Colonies, Plate Counts" on row 14 of Table 1 in the sample report for study 123. The GTREFID aligns with the REFID for SETCD=A2TFT in the RELREF dataset, matching the test conditions of trial set A2TFT in the TX dataset. From the A2TFT entries in the TX dataset, you see the selective agent Trifluorothymidine is present on these plates in a concentration of 5 ug/mL.
Rows 21-23:	Show results for the trial set A2TFT that represents the suspension with a 500 ug/mL of intervention article and with TFT. These results (i.e., mean, mutant frequency) are attributed to all 3 TFT colony plates. GTCOLSRT is populated with MEAN to distinguish this test from the Colony Numbers Per Plate of the individual plates.
Row 24:	Shows results for 4_-S9_C500_B_CE_OS. Looking at the RELREF dataset, this REFID aligns with the SETCD A2 in the TX dataset where the parameter codes indicate a dose concentration of 500 ug/mL. This result (i.e., relative total growth) is an observational summary attributed to all plates in the fourteenth row of the sample report table (the descendants of 4_-S9_C500_B_CE_OS).

gt.xpt

xx.xpt

Row	STUDYID	DOMAIN	GTSEQ	GTREFID	GTTESTCD	GTTEST	GTORRES	GTORRESU	GTCOLSRT	GTSTRESC	GTSTRESN	GTSTRESU	GTSPCCND	GTRUNID	GTDTC
1	123	GT	1	4_-S9_C31.3_B	PSG	Percent Suspension Growth	94	%		94	94	%	PRECIPITATED	1	2020-01-01
2	123	GT	2	4_-S9_C31.3_B_CE_1	CPP	Colony Numbers Per Plate	148			148	148			1	2020-01-01
3	123	GT	3	4_-S9_C31.3_B_CE_2	CPP	Colony Numbers Per Plate	140			140	140			1	2020-01-01
4	123	GT	4	4_-S9_C31.3_B_CE_3	CPP	Colony Numbers Per Plate	143			143	143			1	2020-01-01
5	123	GT	5	4_-S9_C31.3_B_CE	CPP	Colony Numbers Per Plate	144		MEAN	144	144			1	2020-01-01
6	123	GT	6	4_-S9_C31.3_B_TFT_1	CPP	Colony Numbers Per Plate	46							1	2020-01-01
7	123	GT	7	4_-S9_C31.3_B_TFT_2	CPP	Colony Numbers Per Plate	59							1	2020-01-01
8	123	GT	8	4_-S9_C31.3_B_TFT_3	CPP	Colony Numbers Per Plate	69							1	2020-01-01
9	123	GT	9	4_-S9_C31.3_B_TFT	CPP	Colony Numbers Per Plate	58		MEAN					1	2020-01-01
10	123	GT	10	4_-S9_C31.3_B_TFT	MF	Mutant Frequency	81	/10^6		81	81	/10^6		1	2020-01-01
11	123	GT	11	4_-S9_C31.3_B_TFT	IMF	Induced Mutant Frequency	8	/10^6		8	8	/10^6		1	2020-01-01
12	123	GT	12	4_-S9_C31.3_B_OS	RTG	Relative Total Growth	74	%		74	74	%		1	2020-01-01
13	123	GT	1	4_-S9_C500_B	PSG	Percent Suspension Growth	103	%		103	103	%		1	2020-01-01
14	123	GT	2	4_-S9_C500_B_CE_1	CPP	Colony Numbers Per Plate	187			187	187			1	2020-01-01
15	123	GT	3	4_-S9_C500_B_CE_2	CPP	Colony Numbers Per Plate	150			150	150			1	2020-01-01
16	123	GT	4	4_-S9_C500_B_CE_3	CPP	Colony Numbers Per Plate							CONTAMINATED	1	2020-01-01
17	123	GT	5	4_-S9_C500_B_CE	CPP	Colony Numbers Per Plate	169		MEAN	169	169			1	2020-01-01
18	123	GT	6	4_-S9_C500_B_TFT_1	CPP	Colony Numbers Per Plate	56			56	56			1	2020-01-01
19	123	GT	7	4_-S9_C500_B_TFT_2	CPP	Colony Numbers Per Plate	66			66	66			1	2020-01-01
20	123	GT	8	4_-S9_C500_B_TFT_3	CPP	Colony Numbers Per Plate	51			51	51			1	2020-01-01
21	123	GT	9	4_-S9_C500_B_TFT	CPP	Colony Numbers Per Plate	58		MEAN	58	58			1	2020-01-01
22	123	GT	10	4_-S9_C500_B_TFT	MF	Mutant Frequency	68	/10^6		68	68	/10^6		1	2020-01-01
23	123	GT	11	4_-S9_C500_B_TFT	IMF	Induced Mutant Frequency	-4	/10^6		-4	-4	/10^6		1	2020-01-01
24	123	GT	12	4_-S9_C500_B_CE_OS	RTG	Relative Total Growth	95	%		95	95	%		1	2020-01-01

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SEND Example.In vitro Mammalian Cell Gene Mutation Assay (MLA)

Table 1. Initial Definitive Mutagenicity Assay (4-Hour Exposure –S9)