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The following shows the tabulated data as shown in the report for this study: 

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)

Run-Port Number

Sample ID

Smoke Fraction

Replicate Number

Plate Number

Well Number

Relative Assay Plate Absorbance Readings

Cigarette Smoke Condensate (µg/mL)

SLS (µg/mL)

10

50

75

100

120

140

160

200

110

200

1-1

030001

A

1

1

1

100

83.0

56.7

29.5

13.0

8.57

4.44

1.76

13.7

0.547

1-1

030001

A

1

1

2

107

77.7

65.7

30.2

15.6

9.79

5.41

2.49

8.09

0.791

1-1

030001

A

1

1

3

98.6

77.4

57.7

35.8

8.09

7.36

3.22

0.791

6.38

0.061

1-1

030001

A

1

1

4

94.9

81.5

38.2

31.2

7.60

5.17

3.22

0.791

5.17

0.304

1-1

030001

A

1

1

5

111

78.1

64.5

32.9

8.82

5.90

2.74

1.28

10.3

0.547

1-1

030001

A

1

1

6

96.6

76.2

48.0

26.8

7.84

4.20

2.74

1.52

8.09

4.93

1-1

030001

A

1

1

7

105

77.9

58.2

28.3

8.09

4.68

1.76

0.547

8.57

1.76

1-1

030001

A

1

1

8

95.2

74.0

47.2

24.4

8.57

3.71

3.47

0.304

11.2

0.791

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

1-1

030001

A

1

2

1

93.4

74.0

56.0

35.1

11.8

8.70

5.10

1.98

5.34

1.02

1-1

030001

A

1

2

2

102

75.2

53.3

35.1

11.8

7.74

5.58

3.66

5.34

1.02

1-1

030001

A

1

2

3

107

79.0

55.0

26.5

10.1

6.06

3.66

1.74

7.02

0.780

1-1

030001

A

1

2

4

104

80.2

55.3

29.8

8.94

3.90

3.66

1.50

6.30

0.780

1-1

030001

A

1

2

5

101

75.7

54.1

26.7

4.86

4.38

1.26

1.02

6.30

1.02

1-1

030001

A

1

2

6

110

85.7

67.7

26.0

5.34

4.62

3.42

1.50

6.30

0.540

1-1

030001

A

1

2

7

104

77.8

64.9

27.7

8.22

3.18

2.46

1.02

6.30

0.780

1-1

030001

A

1

2

8

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

Image Removed

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)

Run-Port Number

Sample ID

Smoke Fraction

Replicate Number

Plate Number

Well Number

Relative Assay Plate Absorbance Readings

Cigarette Smoke Condensate (µg/mL)

SLS (µg/mL)

10

50

75

100

120

140

160

200

110

200

1-1

030001

A

1

1

1

100

83.0

56.7

29.5

13.0

8.57

4.44

1.76

13.7

0.547

1-1

030001

A

1

1

2

107

77.7

65.7

30.2

15.6

9.79

5.41

2.49

8.09

0.791

1-1

030001

A

1

1

3

98.6

77.4

57.7

35.8

8.09

7.36

3.22

0.791

6.38

0.061

1-1

030001

A

1

1

4

94.9

81.5

38.2

31.2

7.60

5.17

3.22

0.791

5.17

0.304

1-1

030001

A

1

1

5

111

78.1

64.5

32.9

8.82

5.90

2.74

1.28

10.3

0.547

1-1

030001

A

1

1

6

96.6

76.2

48.0

26.8

7.84

4.20

2.74

1.52

8.09

4.93

1-1

030001

A

1

1

7

105

77.9

58.2

28.3

8.09

4.68

1.76

0.547

8.57

1.76

1-1

030001

A

1

1

8

95.2

74.0

47.2

24.4

8.57

3.71

3.47

0.304

11.2

0.791

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

1-1

030001

A

1

2

1

93.4

74.0

56.0

35.1

11.8

8.70

5.10

1.98

5.34

1.02

1-1

030001

A

1

2

2

102

75.2

53.3

35.1

11.8

7.74

5.58

3.66

5.34

1.02

1-1

030001

A

1

2

3

107

79.0

55.0

26.5

10.1

6.06

3.66

1.74

7.02

0.780

1-1

030001

A

1

2

4

104

80.2

55.3

29.8

8.94

3.90

3.66

1.50

6.30

0.780

1-1

030001

A

1

2

5

101

75.7

54.1

26.7

4.86

4.38

1.26

1.02

6.30

1.02

1-1

030001

A

1

2

6

110

85.7

67.7

26.0

5.34

4.62

3.42

1.50

6.30

0.540

1-1

030001

A

1

2

7

104

77.8

64.9

27.7

8.22

3.18

2.46

1.02

6.30

0.780

1-1

030001

A

1

2

8

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

...

Expand
titlets.xpt (trial summary, study level parameters)
  • Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data. 
  • Assumption: A Trial (study) can have more than one assay type
  • Assumption: ASSAYID value of ALL indicates that it applies to all assays in the study
  • BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?
  • Where is TK6 cell type?  is this test system (see below)
    • needs to be allowed to vary down to the well level / result level
  • For the items highlighted in orange - what is the lowest level where this could vary?  e.g. at the level of a well in a 96-well plate, or a slide vs. assay level vs. product level
    • Smoke Regime needs to be allowed to vary down to the well level / result level
    • run - also at result level 
    • port - (smoking product on the machine, you assign a run number or port-number for multiple replicates depending on linear vs. rotary machines; machine bias), needs to be allowed to vary down to the well level / result level)
    • replicate - (e.g., multiple samples from one vial), could be a replicate per exposure (e.g., 3 plates, multiple analyses for exposure)
    • sample ID - typically a unique number assigned (at CRO) or supplied by sponsor - result level
    • Smoke fraction - result level (e.g.tpm particulate vs. gas gvp)

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123

ALL

TS1
GLPTYPGood Laboratory Practice TypeFDA
2123

ALL

TS2
GLPTYPGood Laboratory Practice TypeOECD
3123ALLTS1
STSTDTCStudy Start Date2022-05-25
4123ALLTS1
STITLEStudy Title

Determination of the in vitro genotoxicity potential of 10 tobacco products in both the in vitro Micronucleus Assay and the in vitro Neutral Red Uptake


5123ALLTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6123

ALL

TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7123ALLTS1
SSPONSORSponsor OrganizationExample Sponsor Inc.
8123ALLTS1
SPREFIDSponsor's Study Reference ID
NOT APPLICABLE
9123ALLTS11TSTFNAMTest Facility NameExample Tox Lab Name
10123

ALL

TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11123ALLTS11TFCNTRYTest Facility CountryUSA
...123ALLTS11STDIRStudy DirectorDr. R. Smith

123ALLTS1
GLPFLGLP FlagY

123MNvitTS1
ASTDAssay StandardOECD Test No. 487 

123MNvitTS1
ASTDVAssay Standard Version2016-07-29

123MNvitTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO

123MNvitTS1
SSSTYPStudy Sub TypeIn Vitro Micronucleus

123MNvitTS1
SPECIESSpeciesHomo Sapiens

123MNvitTS1
??Test System?TK6 Lymphoblastoid Suspension Cells

123NRUTS1
ASTDAssay StandardNIH Publication No. 07-4519

123NRUTS1
ASTDVAssay Standard Version2006-11

123NRUTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO

123NRUTS1
SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake

123NRUTS1
SPECIESSpeciesSalmonella enterica 

123NRUTS1
??Test System??Normal Human Keratinocyte

...