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This example shows a report table, trial design, and results data for the in vitro Neutral Red Uptake Cytotoxicity Assay neutral red uptake (NRU) cytotoxicity assay in example study 123.

Expand
titleStudy 123, Sample from Report Table

The following shows the data as it is represented example data for study 123 in a report table for study 123.   This report includes summary statistics (i.e.g. Average, Standard Deviation, Coeff. Var., average, standard deviation, coefficient variation) for each plate and an EC50 value for the entire assay. The grey cells in In the table below, the light grey shading for plate 1 are cells values from wells that do not contain the CHO Hamster cells. NHK cells. The dark grey shading represents the column and row location within the 96-well plate, and in this example the applicant chose to use these column and row locations to assign their REFID values in the RELREF dataset and GT dataset.  

For brevity, the datasets in this example are not comprehensive but are intended to demonstrate a range of proper use. 


Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)




Sample ID

Smoke Regime

Replicate Number

Plate Number

Well Number



Relative Assay Plate Absorbance Readings





Cigarette Smoke Condensate (µg/mL) 

SLS (µg/mL)


EC50 (µg/ml)

0

Well Column:

1

2

3

4

5

6

7

8

9

10

11

12


Well 
Row:

0

10

50

75

100

120

140

160

200

110

200

0



030001

Medium

1

1

1

A

0.046*

0.046*0.039*0.012*0.030*0.003*0.057*0.032*0.003*0.050*0.044*

0.040*



030001

Medium

1

1

2

B

0.048*

107

77.7

65.7

30.2

15.6

9.79

5.41

2.49

8.09

0.791

0.014*



030001

Medium

1

1

3

C

0.005*

98.6

77.4

57.7

35.8

8.09

7.36

3.22

0.791

6.38

0.061

0.050*



030001

Medium

1

1

4

D

0.049*

94.9

81.5

38.2

31.2

7.60

5.17

3.22

0.791

5.17

0.304

0.017*



030001

Medium

1

1

5

E

0.047*

111

78.1

64.5

32.9

8.82

5.90

2.74

1.28

10.3

0.547

0.011*



030001

Medium

1

1

6

F

0.032*

96.6

76.2

48.0

26.8

7.84

4.20

2.74

1.52

8.09

4.93

0.022*



030001

Medium

1

1

7

G

0.044*

105

77.9

58.2

28.3

8.09

4.68

1.76

0.547

8.57

1.76

0.056*



030001

Medium

1

1

8

H

0.056*

0.013*0.040*0.008*0.013*0.002*0.029*0.018*0.006*0.016*0.024*

0.046*


Average


101

78.2

54.5

29.9

9.70

6.17

3.37

1.19

8.94

1.22



Std. Dev.


6

2.9

9.4

3.6

2.95

2.19

1.12

0.72

2.72

1.58



Coeff. Var.


5.8

3.6

17.2

11.9

30.4

35.5

33.1

61.0

30.5

129.9



*media without cells















030001

Medium

1

2

1

A


93.4

74.0

56.0

35.1

11.8

8.70

5.10

1.98

5.34

1.02




030001

Medium

1

2

2

B


102

75.2

53.3

35.1

11.8

7.74

5.58

3.66

5.34

1.02




030001

Medium

1

2

3

C


107

79.0

55.0

26.5

10.1

6.06

3.66

1.74

7.02

0.780




030001

Medium

1

2

4

D


104

80.2

55.3

29.8

8.94

3.90

3.66

1.50

6.30

0.780




030001

Medium

1

2

5

E


101

75.7

54.1

26.7

4.86

4.38

1.26

1.02

6.30

1.02




030001

Medium

1

2

6

F


110

85.7

67.7

26.0

5.34

4.62

3.42

1.50

6.30

0.540




030001

Medium

1

2

7

G


104

77.8

64.9

27.7

8.22

3.18

2.46

1.02

6.30

0.780




030001

Medium

1

2

8

H


103

71.6

58.9

25.5

9.42

4.14

3.90

1.26

4.38

0.780



Average


103

77.4

58.1

29.0

8.82

5.34

3.63

1.71

5.91

0.840



Std. Dev.


5

4.4

5.3

4.0

2.63

1.97

1.37

0.86

0.83

0.170



Coeff. Var.


4.6

5.6

9.2

13.6

29.8

36.9

37.6

50.0

14.1

20.2



EC50 (µg/ml). Effective concentration at 50% cytotoxicity.  (using a specific sigmoidal equation = model).

(could also be EC20 or EC30, EC70, etc.)

123

  • Assumption: A Trial (study) can have more than one assay type. (this line will be moved to the ts.xpt assumptions page)

 













123

Dataset wrap
Rowcaps
two Types 8 the sponsor's study reference ID is not applicable 912 that TSGRPID Study Director Test Facility 1824 this example study includes two different species of bacteria and a total of five strains. Show that 2 for one species (Salmonella) with four different strains that are tested in this example study.Show that TSGRPID (TSGRPID = 3) has been used to link the information for one species (Escherichia coli) with the strain that is tested in this example
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: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

Rows 18-22:

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 Neutral Red Uptake Assay.
Rows 19-20:Show that the species is human and the cell line is NHK in this
Rows 23-24:
study.
Dataset2
Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123
NRU
TS1
GLPTYPGood Laboratory Practice TypeFDA
2123
NRU
TS2
GLPTYPGood Laboratory Practice TypeOECD
3123
NRU
TS1
STSTDTCStudy Start

GLPFLGLP FlagY
4123TS1
STSTDTCStudy Start Date2022-05-25
4

5123
NRU
TS1
STITLEStudy Title

Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay

5

6123
NRU
TS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6

7123
NRU
TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7

8123
NRU
TS1
SSPONSOR

APPLCNT
Sponsor Organization
ApplicantExample
Sponsor
Applicant Inc.
8

9123
NRU
TS1
SPREFID

APREFID
Sponsor
Applicant Study Reference ID
NOT APPLICABLE
9
10123
NRU
TS11TSTFNAMTest Facility NameExample Test Lab Name
10

11123
NRU
TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11

12123
NRU
TS11TFCNTRYTest Facility CountryUSA
12

13123
NRU
TS11STDIRStudy DirectorDr. R. Smith
13

14123
NRU
TS1
GLPFL
4
GLP FlagY
TSTGDNAMTesting Guideline NamePublication No. 07-4519
15
14
123
NRU
TS1
ASTDAssay StandardNIH Publication No. 07-4519
4TSTGDORGTesting Guideline OrganizationNIH
16
15
123
NRU
TS1
ASTDV
4TSTGDVERTesting Guideline
Assay Standard
Version2006-11
16

17123
NRU
TS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
17

18123
NRU
TS1
SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake

GNTXAIDGenetic Toxicology Assay IdentifierNRU
19
18
123
NRU
TS1
SPECIESSpecies
Hamster
HUMAN
19

20123
NRU
TS1
TESTSYS

CELLLN
Test System
Cell Line
CHO
NHK
Dataset wrap
Shows the value for STRAIN/SUBSTRAIN is NO STRAIN
Rowcaps
Rows 1-
20
12:Show the test conditions for the set with a short name or SETCD value of NRU. The applicant chose this value to represent test conditions for the entire assay. 
Rows 13-31:Show the test conditions for the set with a short name or SETCD value of CSC-50b.
 
The
sponsor
applicant chose this value to represent plate number 1, well row A, well
number 1
column 3, with a concentration of 50µg/mLof
Cigarette Smoke Condensate
cigarette smoke condensate as shown in the report table for study 123.
Row 17:
  The value for Cell Line (CELLLN) is not applicable because the well is a media-only well, having no
CHO Hamster
NHK cells.
 

Rows

21

32-

40

50:

Show the test conditions for the set with a short name or SETCD value of CSC-50.
 
The
sponsor
applicant chose this value to represent plate number 1, well rows B-G, well column 3 and plate number 2
, with a
, well rows A-H, well column 3. These all have the concentration of 50µg/mLof
Cigarette Smoke Condensate
cigarette smoke condensate as shown in the report table for study 123.
Rows
41
51-
60
69:Show the test conditions for the set with a short name or SETCD value of
CSC
SLS-
50
110.
 
The
sponsor
applicant chose this value to represent
both wells numbered 7 in
plate number 1, well rows B-G, well column 10, and plate number 2,
with a
well rows A-H, well column 10. These all have the concentration of 110µg/mLof
Sodium Laurel Sulfate
sodium laurel sulfate as shown in the report table for study 123.
Dataset2
Row
ROWSTUDYID
ASSAYID
DOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123
NRU
TX
CSC-50b
NRUNRU_ASSAY
CSC-50-blank
1
TRTDMIN
IVTDMINIn vitro Treatment Duration Minimum47.5
2123TXNRU
TXCSC-50bCSC-50-blank

2

TRTDTRG
NRU_ASSAY2IVTDTRGIn vitro Treatment Duration Target48
3123
NRU
TX
CSC-50b
NRUNRU_ASSAY
CSC-50-blank
3
TRTDMAX
IVTDMAXIn vitro Treatment Duration Maximum48.5
4123
NRU
TX
CSC-50b
NRUNRU_ASSAY
CSC-50-blank
4
TRTDU
IVTDUIn vitro Treatment Duration UnitHOURS
5123
NRU
TX
CSC-50b
NRUNRU_ASSAY
CSC-50-blank
5INCBTMPIncubation Temperature37
6123TXNRU
TXCSC-50bCSC-50-blank6INCBTMPU
NRU_ASSAY6INCBTMPUIncubation Temperature UnitC
7123
NRU
TX
CSC-50b
NRUNRU_ASSAY
CSC-50-blank
7
WAVELGTHSpectrophotometer  WAVELENGTH IN NANOMETERS
SWAVENMSpectrophotometer Wavelength540
8123
NRU
TX
CSC-50b
NRUNRU_ASSAY
CSC-50-blank
8
HUMID
ATMRHPAtmospheric Relative
Humidity 
Humidity Percent90
9123
NRU
TX
CSC-50b
NRUNRU_ASSAY
CSC-50-blank
9
ATMCO2
ATMCO2PAtmospheric CO2 Percent5
10123TXNRU
TXCSC-50bCSC-50-blank10SPTOBID

Sponsor defined tobacco identifier

NRU_ASSAY10SPDEVIDapplicant defined device identifierPUFFMASTER3k
CIG01a
11123
NRU
TX
CSC-50b
NRUNRU_ASSAY
CSC-50-blank
11
EXPTYP
SMKRGM

Exposure Type

Smoking RegimenMEDIUM INTENSITY REGIMEN
Air Liquid Interface
12123
NRU
TX
CSC-50b
NRUNRU_ASSAY
CSC-50-blank
12
SAMTYPSample Type
SPTOBID

Applicant-defined tobacco identifier

CIG01a
Whole Smoke Conditioned Media
13123
NRU
TXCSC-50bCSC-50-blank13
INTRVNName of the Intervention Article
IVTDMINIn vitro Treatment Duration Minimum47.5
Tobacco ProdA
14123
NRU
TXCSC-50bCSC-50-blank14
ITVTYPEtype of intervention article
IVTDTRGIn vitro Treatment Duration Target48
PRODUCT
15123
NRU
TXCSC-50bCSC-50-blank15
ITVCONCintervention concentration
IVTDMAXIn vitro Treatment Duration Maximum48.5
50
16123
NRU
TXCSC-50bCSC-50-blank16
ITVCONCUintervention unit
IVTDUIn vitro Treatment Duration UnitHOURS
ug/ml
17123
NRU
TXCSC-50bCSC-50-blank17
STRAINStrain/SubstrainNO STRAIN
INCBTMPIncubation Temperature37
18123
NRU
TXCSC-50bCSC-50-blank18
SPDEVIDSponsor defined device identifier
INCBTMPUIncubation Temperature UnitC
PUFFMASTER3k
19123
NRU
TXCSC-50bCSC-50-blank19
DUREFID
SWAVENM
Smoking RegimeMedium Intensity Regimen
Spectrophotometer Wavelength540
20123
NRU
TXCSC-50bCSC-50-blank20
SPTOBID

Sponsor defined tobacco identifier

ATMRHPAtmospheric Relative Humidity Percent90
CIG01a
21123
NRU
TXCSC-
50
50bCSC-50-blank
147.
21
TRTDMINTreatment Duration Minimum
ATMCO2PAtmospheric CO2 Percent
5
22123
NRU
TXCSC-
50
50bCSC-50-blank
2
22
TRTDTRGTreatment Duration Target
SPDEVIDapplicant defined device identifierPUFFMASTER3k
48
23123
NRU
TXCSC-
50
50bCSC-50-blank
3
23
TRTDMAXTreatment Duration Maximum
SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
48.5
24123
NRU
TXCSC-
50
50bCSC-50-blank
4
24
TRTDUTreatment Duration Unit
SPTOBID

Applicant-defined tobacco identifier

CIG01a
HOURS
25123
NRU
TXCSC-
50
50bCSC-50-blank
5
25
INCBTMP
EXPTYP
Incubation Temperature

Exposure Type

Air Liquid Interface
37
26123
NRU
TXCSC-
50
50bCSC-50-blank
6
26
INCBTMPUIncubation Temperature Unit
SAMTYPSample TypeWhole Smoke Conditioned Media
C
27123
NRU
TXCSC-
50
50bCSC-50-blank
7
27
WAVELGTHSpectrophotometer  WAVELENGTH IN NANOMETERS
ITVNAMName of the Intervention ArticleTobacco ProdA
540
28123
NRU
TXCSC-
50
50bCSC-50-blank
8
28
HUMIDAtmospheric Relative Humidity  Percent
ITVTYPEIntervention Article TypePRODUCT
90
29123
NRU
TXCSC-
50
50bCSC-50-blank
9
29
ATMCO2Atmospheric CO2 Percent
ITVCONC

Intervention Article Concentration

50
5
30123
NRU
TXCSC-
50
50bCSC-50-blank
10
30
SPTOBID

Sponsor defined tobacco identifier

ITVCONCUIntervention Article Concentration Unitug/ml
CIG01a
31123
NRU
TXCSC-
50
50bCSC-50-blank
11
31
EXPTYP
CELLLN

Exposure Type

Cell LineNOT APPLICABLE
Air Liquid Interface
32123
NRU
TXCSC-50CSC-50
12
32
SAMTYPSample Type
IVTDMINIn vitro Treatment Duration Minimum47.5
Whole Smoke Conditioned Media
33123
NRU
TXCSC-50CSC-50
13
33
INTRVNName of the Intervention Article
IVTDTRGIn vitro Treatment Duration Target48
Tobacco ProdA
34123
NRU
TXCSC-50CSC-50
14
34
ITVTYPEtype of intervention articlePRODUCT 
IVTDMAXIn vitro Treatment Duration Maximum48.5
35123
NRU
TXCSC-50CSC-50
15
35
ITVCONCintervention concentration
IVTDUIn vitro Treatment Duration UnitHOURS
50
36123
NRU
TXCSC-50CSC-50
16
36
ITVCONCU
INCBTMP
intervention unit
Incubation Temperature37
ug/ml
37123
NRU
TXCSC-50CSC-50
17
37
STRAINStrain/SubstrainCHO
INCBTMPUIncubation Temperature UnitC
38123
NRU
TXCSC-50CSC-50
18
38
SPDEVIDSponsor defined device identifier
SWAVENMSpectrophotometer Wavelength540
PUFFMASTER3k
39123
NRU
TXCSC-50CSC-50
19
39
DUREFIDSmoking Regime
ATMRHPAtmospheric Relative Humidity Percent90
Medium Intensity Regimen
40123
NRU
TXCSC-50CSC-50
20
40
SPTOBID

Sponsor defined tobacco identifier

ATMCO2PAtmospheric CO2 Percent5
CIG01a
41123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
50
1
41
TRTDMINTreatment Duration Minimum
SPDEVIDapplicant defined device identifierPUFFMASTER3k
47.5
42123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
50
2
42
TRTDTRGTreatment Duration Target
SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
48
43123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
50
3
43
TRTDMAXTreatment Duration Maximum
SPTOBID

Applicant-defined tobacco identifier

CIG01a
48.5
44123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
50
4
44
TRTDUTreatment Duration Unit
EXPTYP

Exposure Type

Air Liquid Interface
HOURS
45123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
50
5
45
INCBTMP
SAMTYP
Incubation Temperature
Sample TypeWhole Smoke Conditioned Media
37
46123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
50
6
46
INCBTMPUIncubation Temperature Unit
ITVNAMIntervention Article NameTobacco ProdA
C
47123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
50
7
47
WAVELGTHSpectrophotometer wavelength in nanometers
ITVTYPEIntervention Article TypePRODUCT
540
48123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
50
8
48
HUMIDAtmospheric Relative Humidity  Percent
ITVCONC

Intervention Article Concentration

50
90
49123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
50
9
49
ATMCO2Atmospheric CO2 Percent
ITVCONCUIntervention Article Concentration Unitug/ml
5
50123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
50
10
50
SPTOBID

Sponsor defined tobacco identifier

CELLLNCell LineNHK
CIG01a
51123
NRU
TXSLS-110SLS-110
11
51
EXPTYP

Exposure Type

IVTDMINIn vitro Treatment Duration Minimum47.5
Air Liquid Interface
52123
NRU
TX
TX
SLS-110SLS-110
12
52
SAMTYPSample Type
IVTDTRGIn vitro Treatment Duration Target48
Liquid
53123
NRU
TXSLS-110SLS-110
13
53
INTRVNName of the Intervention Article
IVTDMAXIn vitro Treatment Duration Maximum48.5
Sodium Laurel Sulfate
54123
NRU
TXSLS-110SLS-110
14
54
ITVTYPEtype of intervention article
IVTDUIn vitro Treatment Duration UnitHOURS
POSITIVE CONTROL
55123
NRU
TXSLS-110SLS-110
15
55
ITVCONC
INCBTMP
intervention concentration
Incubation Temperature
200
37
56123
NRU
TXSLS-110SLS-110
16
56
ITVCONCUintervention unit
INCBTMPUIncubation Temperature UnitC
ug/ml
57123
NRU
TXSLS-110SLS-110
17
57
STRAINStrain/Substrain
SWAVENMSpectrophotometer Wavelength540
CHO
58123
NRU
TXSLS-110SLS-110
18
58
SPDEVIDSponsor defined device identifier
ATMRHPAtmospheric Relative Humidity Percent90
PUFFMASTER3k
59123
NRU
TXSLS-110SLS-110
19
59
DUREFIDSmoking Regime
ATMCO2PAtmospheric CO2 Percent5
Medium Intensity Regimen
60123
NRU
TXSLS-110SLS-110
20
60
SPTOBID
SPDEVID
Sponsor
applicant defined
tobacco
device identifierPUFFMASTER3k
CIG01a
61