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Table 10 Toxicity data, 4 h exposure, with metabolic activation

From: ISO 10993 biological evaluation of novel hemostatic powder – 4SEAL®

Sample

Number of cells seeded (*10^5)

Number of cells 24 h after treatment (*10^5)

Number of cells 48 h after treatment (*10^5)

Total suspension growth

Relative Suspension Growth (RSG) [%]

Plating Efficiency [%]

Relative Plating Efficiency (RPE) [%]

Relative Total Growth (RTG) [%]

NC1

3

10.23

9.12

15.55

100.00

103.91

100.00

100.00

NC2

3

9.89

9.21

15.18

PC

3

8.67

7.27

10.51

68.37

61.30

59.00

40.33

4SEAL® 1

3

9.78

8.93

14.56

94.73

86.64

92.58

87.70

4SEAL® 2

3

9.83

9.01

14.76

96.07

84.09

89.86

86.32

  1. PC positive control, NC negative control