This is an example showing the report table, trial design, and results from a study's in vitro bacterial reverse mutation test using 4 different amino acid-requiring strains of S. typhimurium and 1 strain of E. coli to detect point mutations.
This table shows the assay results for study 8325064, test article TA1, and 3 strains of salmonella (TA98, TA100, and TA1535) at varying concentrations. For brevity, the remaining tables (e.g., additional strains, samples prepared without metabolic activation) are not included. For ease of reference in the table below, each row has been labeled in the right-hand margin with the applicant-defined trial set label (e.g., SetA). For brevity, only the four bolded sets are represented in the following example datasets.
This example Trial Summary (TS) dataset, shows many informational fields that provide context at the study level.
Rows 1-2:
Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP types apply for this study.
Row 3:
Shows that this study was conducted as a GLP study.
Rows 4-5:
Show 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.
Row 9:
Shows that the applicant's study reference ID is not applicable.
Rows 10-13:
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 14-16:
Show that TSGRPID (TSGRPID=4) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).
Row 17:
Shows the study type for this study.
Row 18:
Shows that this study includes a Bacterial Reverse Mutation Assay.
Rows 19-27:
Show that TSGRPID (TSGRPID = 2) has been used to link the information for 1 species (salmonella) with the 4 different strains and cell lines that are tested in this study.
Rows 28-30:
Show that TSGRPID (TSGRPID = 3) has been used to link the information for 1 species (E. coli) with the strain and cell line that is tested in this study.
ts.xpt
xx.xpt
Row
STUDYID
DOMAIN
TSSEQ
TSGRPID
TSPARMCD
TSPARM
TSVAL
TSVALNF
1
8325064
TS
1
GLPTYP
Good Laboratory Practice Type
FDA
2
8325064
TS
2
GLPTYP
Good Laboratory Practice Type
OECD
3
8325064
TS
1
GLPFL
GLP Flag
N
4
8325064
TS
1
STSTDTC
Study Start Date
2015-07-29
5
8325064
TS
1
STITLE
Study Title
The Bacterial Reverse Mutation Test, Study 8325064-1
6
8325064
TS
1
SNDIGVER
SEND Implementation Guide Version
TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
7
8325064
TS
1
SNDCTVER
SEND Controlled Terminology Version
SEND Terminology 2021-09-30
8
8325064
TS
1
APPLCNT
Applicant
Example Applicant Inc.
9
8325064
TS
1
APREFID
Applicant's Study Reference ID
NOT APPLICABLE
10
8325064
TS
1
1
TSTFNAM
Test Facility Name
Example Tox Lab Name
11
8325064
TS
1
1
TSTFLOC
Test Facility Location
10 Somewhere Street, Montgomery, AL 10000
12
8325064
TS
1
1
TFCNTRY
Test Facility Country
USA
13
8325064
TS
1
1
STDIR
Study Director
Dr. R. Smith
14
8325064
TS
1
4
TSTGDNAM
Testing Guideline Name
Test NO. 471
15
8325064
TS
1
4
TSTGDORG
Testing Guideline Organization
OECD
16
8325064
TS
1
4
TSTGDVER
Testing Guideline Version
2020-06-29
17
8325064
TS
1
SSTYP
Study Type
GENOTOXICITY IN VITRO
18
8325064
TS
1
GNTXAID
Genetic Toxicology Assay Identifier
AMES
19
8325064
TS
1
2
SPECIES
Species
SALMONELLA TYPHIMURIUM
20
8325064
TS
1
2
STRAIN
Strain/Substrain
TA98
21
8325064
TS
2
2
STRAIN
Strain/Substrain
TA100
22
8325064
TS
3
2
STRAIN
Strain/Substrain
TA1535
23
8325064
TS
4
2
STRAIN
Strain/Substrain
TA1537
24
8325064
TS
1
2
CELLLN
Cell Line
TA 98 hisD3052; rfa-; uvrB-
25
8325064
TS
2
2
CELLLN
Cell Line
TA 100 hisG46; rfa-; uvrB-
26
8325064
TS
3
2
CELLLN
Cell Line
TA 1535 hisG46; rfa-; uvrB-
27
8325064
TS
4
2
CELLLN
Cell Line
TA 1537 hisC3076; rfa-; uvrB-
28
8325064
TS
2
3
SPECIES
Species
ESCHERICHIA COLI
29
8325064
TS
5
3
STRAIN
Strain/Substrain
WP2 uvrA pKM101
30
8325064
TS
5
3
CELLLN
Cell Line
trpE uvrA
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
This example Trial Set (TX) dataset shows information about the test conditions for SetA and SetR in this study. For brevity, the dataset does not show information for SetF, SetG, or any other sets. A fully formed TX dataset for this example study would include information about the test conditions for all sets.
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 1-22:
Show trial set parameters and trial set values that are the test conditions specific to set SetA which is the vehicle control (i.e., Strain of TA98, vehicle control with concentration value of 0). SetA is associated with the first row, labeled "SetA", in the report table for example study 8325064.
Rows 23-44:
Show trial set parameters and trial set values that comprise the test conditions for the set SetF which is the strain of TA98 with a concentration value of 500 µg/plate. SetF is associated with the sixth row, labeled "SetF", in the report table for example study 8325064.
Rows 45-66:
Show trial set parameters and trial set values that comprise the test conditions for the set SetG which is the strain of TA98 with a concentration value of 1600 µg/plate. SetG is associated with the seventh row, labeled "SetG", in the report table for example study 8325064.
Rows 67-88:
Show trial set parameters and trial set values that comprise the test conditions for the set SetR which is the strain of TA100, positive control with a concentration value of 2 µg/plate. SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064.
tx.xpt
tx.xpt
Row
STUDYID
DOMAIN
SETCD
SET
TXSEQ
TXPARMCD
TXPARM
TXVAL
1
8325064
TX
SetA
A-TA98-C0
1
SPECIES
Species
SALMONELLA TYPHIMURIUM
2
8325064
TX
SetA
A-TA98-C0
2
IVTDMIN
In vitro Treatment Duration Minimum
71.5
3
8325064
TX
SetA
A-TA98-C0
3
IVTDTRG
In vitro Treatment Duration Target
72
4
8325064
TX
SetA
A-TA98-C0
4
IVTDMAX
In vitro Treatment Duration Maximum
72.5
5
8325064
TX
SetA
A-TA98-C0
5
IVTDU
In vitro Treatment Duration Unit
HOURS
6
8325064
TX
SetA
A-TA98-C0
6
INCBTMP
Incubation Temperature
37
7
8325064
TX
SetA
A-TA98-C0
7
INCBTMPU
Incubation Temperature Unit
C
8
8325064
TX
SetA
A-TA98-C0
8
ATMRHP
Atmospheric Relative Humidity Percent
50
9
8325064
TX
SetA
A-TA98-C0
9
ATMCO2P
Atmospheric CO2 Percent
5
10
8325064
TX
SetA
A-TA98-C0
10
SPTOBID
Applicant-defined tobacco identifier
CIG01a
11
8325064
TX
SetA
A-TA98-C0
11
EXPTYP
Exposure Type
Submerged
12
8325064
TX
SetA
A-TA98-C0
12
SAMTYP
Sample Type
Total Particulate Matter in PBS
13
8325064
TX
SetA
A-TA98-C0
13
APDEVID
Applicant-defined device identifier
PUFFMASTER3K
14
8325064
TX
SetA
A-TA98-C0
14
SMKRGM
Smoking Regimen
NON-INTENSE REGIMEN
15
8325064
TX
SetA
A-TA98-C0
15
STRAIN
Strain/Substrain
TA98
16
8325064
TX
SetA
A-TA98-C0
16
MTACTIND
Metabolic Activating Agent Name
NOT APPLICABLE
17
8325064
TX
SetA
A-TA98-C0
17
METACTFL
Presence of Metabolic Activation Flag
N
18
8325064
TX
SetA
A-TA98-C0
18
ITVNAM
Intervention Article Name
DMSO
19
8325064
TX
SetA
A-TA98-C0
19
ITVTYPE
Intervention Article Type
VEHICLE
20
8325064
TX
SetA
A-TA98-C0
20
ITVCONC
Intervention Article Concentration
100
21
8325064
TX
SetA
A-TA98-C0
21
ITVCONCU
Intervention Article Concentration Unit
%
22
8325064
TX
SetA
A-TA98-C0
22
TRTV
Treatment Vehicle
DMSO
23
8325064
TX
SetF
F-TA98-C500
23
SPECIES
Species
SALMONELLA TYPHIMURIUM
24
8325064
TX
SetF
F-TA98-C500
24
IVTDMIN
In vitro Treatment Duration Minimum
71.5
25
8325064
TX
SetF
F-TA98-C500
25
IVTDTRG
In vitro Treatment Duration Target
72
26
8325064
TX
SetF
F-TA98-C500
26
IVTDMAX
In vitro Treatment Duration Maximum
72.5
27
8325064
TX
SetF
F-TA98-C500
27
IVTDU
In vitro Treatment Duration Unit
HOURS
28
8325064
TX
SetF
F-TA98-C500
28
INCBTMP
Incubation Temperature
37
29
8325064
TX
SetF
F-TA98-C500
29
INCBTMPU
Incubation Temperature Unit
C
30
8325064
TX
SetF
F-TA98-C500
30
ATMRHP
Atmospheric Relative Humidity Percent
50
31
8325064
TX
SetF
F-TA98-C500
31
ATMCO2P
Atmospheric CO2 Percent
5
32
8325064
TX
SetF
F-TA98-C500
32
SPTOBID
Applicant-defined tobacco identifier
CIG01a
33
8325064
TX
SetF
F-TA98-C500
33
EXPTYP
Exposure Type
Submerged
34
8325064
TX
SetF
F-TA98-C500
34
SAMTYP
Sample Type
Total Particulate Matter in PBS
35
8325064
TX
SetF
F-TA98-C500
35
APDEVID
Applicant-defined device identifier
PUFFMASTER3K
36
8325064
TX
SetF
F-TA98-C500
36
SMKRGM
Smoking Regimen
NON-INTENSE REGIMEN
37
8325064
TX
SetF
F-TA98-C500
37
STRAIN
Strain/Substrain
TA98
38
8325064
TX
SetF
F-TA98-C500
38
MTACTIND
Metabolic Activating Agent Name
NOT APPLICABLE
39
8325064
TX
SetF
F-TA98-C500
39
METACTFL
Presence of Metabolic Activation Flag
N
40
8325064
TX
SetF
F-TA98-C500
40
ITVNAM
Intervention Article Name
TA1
41
8325064
TX
SetF
F-TA98-C500
41
ITVTYPE
Intervention Article Type
PRODUCT
42
8325064
TX
SetF
F-TA98-C500
42
ITVCONC
Intervention Article Concentration
500
43
8325064
TX
SetF
F-TA98-C500
43
ITVCONCU
Intervention Article Concentration Unit
ug/plate
44
8325064
TX
SetF
F-TA98-C500
44
TRTV
Treatment Vehicle
DMSO
45
8325064
TX
SetG
G-TA98-C1600
45
SPECIES
Species
SALMONELLA TYPHIMURIUM
46
8325064
TX
SetG
G-TA98-C1600
46
IVTDMIN
In vitro Treatment Duration Minimum
71.5
47
8325064
TX
SetG
G-TA98-C1600
47
IVTDTRG
In vitro Treatment Duration Target
72
48
8325064
TX
SetG
G-TA98-C1600
48
IVTDMAX
In vitro Treatment Duration Maximum
72.5
49
8325064
TX
SetG
G-TA98-C1600
49
IVTDU
In vitro Treatment Duration Unit
HOURS
50
8325064
TX
SetG
G-TA98-C1600
50
INCBTMP
Incubation Temperature
37
51
8325064
TX
SetG
G-TA98-C1600
51
INCBTMPU
Incubation Temperature Unit
C
52
8325064
TX
SetG
G-TA98-C1600
52
ATMRHP
Atmospheric Relative Humidity Percent
50
53
8325064
TX
SetG
G-TA98-C1600
53
ATMCO2P
Atmospheric CO2 Percent
5
54
8325064
TX
SetG
G-TA98-C1600
54
SPTOBID
Applicant-defined tobacco identifier
CIG01a
55
8325064
TX
SetG
G-TA98-C1600
55
EXPTYP
Exposure Type
Submerged
56
8325064
TX
SetG
G-TA98-C1600
56
SAMTYP
Sample Type
Total Particulate Matter in PBS
57
8325064
TX
SetG
G-TA98-C1600
57
APDEVID
Applicant-defined device identifier
PUFFMASTER3K
58
8325064
TX
SetG
G-TA98-C1600
58
SMKRGM
Smoking Regimen
NON-INTENSE REGIMEN
59
8325064
TX
SetG
G-TA98-C1600
59
STRAIN
Strain/Substrain
TA98
60
8325064
TX
SetG
G-TA98-C1600
60
MTACTIND
Metabolic Activating Agent Name
NOT APPLICABLE
61
8325064
TX
SetG
G-TA98-C1600
61
METACTFL
Presence of Metabolic Activation Flag
N
62
8325064
TX
SetG
G-TA98-C1600
62
ITVNAM
Intervention Article Name
TA1
63
8325064
TX
SetG
G-TA98-C1600
63
ITVTYPE
Intervention Article Type
Product
64
8325064
TX
SetG
G-TA98-C1600
64
ITVCONC
Intervention Article Concentration
1600
65
8325064
TX
SetG
G-TA98-C1600
65
ITVCONCU
Intervention Article Concentration Unit
ug/plate
66
8325064
TX
SetG
G-TA98-C1600
66
TRTV
Treatment Vehicle
DMSO
67
8325064
TX
SetR
R-TA100-C2
67
SPECIES
Species
SALMONELLA TYPHIMURIUM
68
8325064
TX
SetR
R-TA100-C2
68
IVTDMIN
In vitro Treatment Duration Minimum
71.5
69
8325064
TX
SetR
R-TA100-C2
69
IVTDTRG
In vitro Treatment Duration Target
72
70
8325064
TX
SetR
R-TA100-C2
70
IVTDMAX
In vitro Treatment Duration Maximum
72.5
71
8325064
TX
SetR
R-TA100-C2
71
IVTDU
In vitro Treatment Duration Unit
HOURS
72
8325064
TX
SetR
R-TA100-C2
72
INCBTMP
Incubation Temperature
37
73
8325064
TX
SetR
R-TA100-C2
73
INCBTMPU
Incubation Temperature Unit
C
74
8325064
TX
SetR
R-TA100-C2
74
ATMRHP
Atmospheric Relative Humidity Percent
50
75
8325064
TX
SetR
R-TA100-C2
75
ATMCO2P
Atmospheric CO2 Percent
5
76
8325064
TX
SetR
R-TA100-C2
76
SPTOBID
Applicant-defined tobacco identifier
CIG01a
77
8325064
TX
SetR
R-TA100-C2
77
EXPTYP
Exposure Type
Submerged
78
8325064
TX
SetR
R-TA100-C2
78
SAMTYP
Sample Type
Total Particulate Matter in PBS
79
8325064
TX
SetR
R-TA100-C2
79
APDEVID
Applicant-defined device identifier
PUFFMASTER3K
80
8325064
TX
SetR
R-TA100-C2
80
SMKRGM
Smoking Regimen
NON-INTENSE REGIMEN
81
8325064
TX
SetR
R-TA100-C2
81
STRAIN
Strain/Substrain
TA100
82
8325064
TX
SetR
R-TA100-C2
82
MTACTIND
Metabolic Activating Agent Name
NOT APPLICABLE
83
8325064
TX
SetR
R-TA100-C2
83
METACTFL
Presence of Metabolic Activation Flag
N
84
8325064
TX
SetR
R-TA100-C2
84
ITVNAM
Intervention Article Name
NaN3
85
8325064
TX
SetR
R-TA100-C2
85
ITVTYPE
Intervention Article Type
Positive Control
86
8325064
TX
SetR
R-TA100-C2
86
ITVCONC
Intervention Article Concentration
2
87
8325064
TX
SetR
R-TA100-C2
87
ITVCONCU
Intervention Article Concentration Unit
ug/plate
88
8325064
TX
SetR
R-TA100-C2
88
TRTV
Treatment Vehicle
DMSO
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
REFID values are defined by the applicant to uniquely identify the observational unit within an experimental unit. In the simplified diagram of an assay procedure (below), the test tube that contains the possible mutagen is an example of an entity that would have a REFID indicating information at the level of trial set. The petri plate created from that test tube and used to count revertant numbers is an example of an entity that would be at an observational level.
This picture does not depict the more complicated procedures, trial sets, or observational units for the example study. For study 8325064, the applicant chose to define the REFIDs at the trial set level with a single character (e.g., A, F, G, R) and chose to define REFIDs at the observational level based on the location of each tube in 1 of multiple exposure/incubation plates (e.g, 6_1 for plate 6, position 1).
Row 1:
Shows the value of REFID=A. This REFID refers to the trial set with a SETCD of "SetA", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, DMSO.
Rows 2-6:
Show the values of 5 observational units (1_1 through 1_5) that are within the parent experimental unit, REFID=A.
Row 7:
Shows the value of REFID=F. This REFID refers to the trial set with a SETCD of "SetF", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, TA1.
Rows 8-10:
Show the values of 3 observational units (6_1 through 6_3) that are within the parent experimental unit, REFID=F.
Row 11:
Shows the value of REFID=G. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, TA1.
Rows 12-14:
Show the values of 3 observational units (7_1 through 7_3) that are within the parent experimental unit, REFID=G.
Row 15:
Shows the value of REFID=R. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, NaN3.
Rows 16-18:
Show the values of 3 observational units (18_1 through 18_3) that are within the parent experimental unit, REFID=R.
$titleHtml
relref.xpt
Row
STUDYID
SETCD
REFID
PARENT
LEVEL
LVLDESC
1
8325064
SetA
A
1
EXPERIMENTAL UNIT/TRIAL SET
2
8325064
SetA
1_1
A
2
OBSERVATIONAL UNIT
3
8325064
SetA
1_2
A
2
OBSERVATIONAL UNIT
4
8325064
SetA
1_3
A
2
OBSERVATIONAL UNIT
5
8325064
SetA
1_4
A
2
OBSERVATIONAL UNIT
6
8325064
SetA
1_5
A
2
OBSERVATIONAL UNIT
7
8325064
SetF
F
1
EXPERIMENTAL UNIT/TRIAL SET
8
8325064
SetF
6_1
F
2
OBSERVATIONAL UNIT
9
8325064
SetF
6_2
F
2
OBSERVATIONAL UNIT
10
8325064
SetF
6_3
F
2
OBSERVATIONAL UNIT
11
8325064
SetG
G
1
EXPERIMENTAL UNIT/TRIAL SET
12
8325064
SetG
7_1
G
2
OBSERVATIONAL UNIT
13
8325064
SetG
7_2
G
2
OBSERVATIONAL UNIT
14
8325064
SetG
7_3
G
2
OBSERVATIONAL UNIT
15
8325064
SetR
R
1
EXPERIMENTAL UNIT/TRIAL SET
16
8325064
SetR
18_1
R
2
OBSERVATIONAL UNIT
17
8325064
SetR
18_2
R
2
OBSERVATIONAL UNIT
18
8325064
SetR
18_3
R
2
OBSERVATIONAL UNIT
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Rows 1-5:
Show the number of revertant colonies per plate collected for each of 5 observational units, GTREFID=1_1 through 1_5 (see description in the RELREF dataset).
Rows 6, 7:
Show summary values collected (mean, standard deviation) for GTREFID=A that apply to the entire trial set, SetA, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID as shown in the RELREF dataset.
Rows 8-13:
Revertent colonies were counted for each of 3 plates/observational units (GTREFID=6_1 through 6_3) and each value is associated with a record to show a postfix code of "V" (Very thin background bacterial lawn).
Rows 14-16:
Show summary values collected (mean, standard deviation, fold increase) for GTREFID=F that apply to the entire trial set, SetF, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the RELREF dataset.
Rows 17-19:
Show 3 plates/observational units (GTREFID=7_1 through 7_3) where no revertant colonies were counted due to too much cytotoxicity and a postfix code of "T". TOBA-668
- Jira project doesn't exist or you don't have permission to view it.
Rows 20-22:
Show the number of revertant colonies per plate collected for each of 3 observational units (GTREFID=18_1 through 18_3).
Rows 23-25:
Show summary values collected (mean, standard deviation, fold increase) for GTREFID=R that apply to the entire trial set, SetR, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the RELREF dataset.