Skip to main content

Table 13 Mutagenicity data, 4 h exposure, with metabolic activation

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

Sample

Number of large colonies

Number of small colonies

Mutant frequency (*10^-6)

Small colonies [%]

Small colonies mutant frequency (*10^-6)

Mutagenicity

NC1

85

2

128.94

2.30

2.96

N/A

NC2

80

2

111.01

2.44

2.71

N/A

PC

54

88

376.58

61.97

233.38

Mutagenic

4SEAL® 1

77

4

136.72

4.94

6.75

Not Mutagenic

4SEAL® 2

62

6

115.89

8.82

10.23

Not Mutagenic

  1. PC positive control, NC negative control