Skip to main content

Table 14 Mutagenicity data, 24 h exposure, without 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

78

2

122.97

2.50

3.07

N/A

NC2

64

2

108.83

3.03

3.30

N/A

PC

130

90

655.71

40.91

268.25

Mutagenic

4SEAL® 1

64

2

108.83

3.03

3.30

Not Mutagenic

4SEAL® 2

58

3

98.34

4.92

4.84

Not Mutagenic

  1. PC positive control, NC negative control