Page History

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

title	Study 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

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*

0.039*

0.012*

0.030*

0.003*

0.057*

0.032*

0.003*

0.050*

0.044*

0.040*

030001

Medium

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

TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	123

TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	123

	GLPFL	GLP Flag	Y
4	123	TS	1		STSTDTC	Study Start Date	2022-05-25

TSTGDNAM	Testing Guideline Name	Publication No. 07-4519
15

4	TSTGDORG	Testing Guideline Organization	NIH
16

Page tree

Versions Compared

Old Version 62

New Version Current

Key


12	123	TX	NRU	NRU_ASSAY	12	SPTOBID	Applicant-defined tobacco identifier	CIG01a
13	123	TX	CSC-50b	CSC-50-blank

	TX	SLS-110	SLS-110	58	ATMRHP	Atmospheric Relative Humidity Percent	90
59	123

1-10	123NRU	2	OBSERVATIONAL SUMMARY
4	123	SLS-110	2-10	123NRU	2	OBSERVATIONAL SUMMARY
5	123