Table 8 AMES overall results
From: ISO 10993 biological evaluation of novel hemostatic powder – 4SEAL®
Strain | Mutagenic data points | Overall Result for sample | Solvent control | Positive control | |||
|---|---|---|---|---|---|---|---|
w/o S9 | with S9 | w/o S9 | with S9 | w/o S9 | with S9 | ||
TA98 | No | No | Probably not mutagenic | PASS | PASS | PASS | PASS |
TA100 | No | No | Probably not mutagenic | PASS | PASS | PASS | PASS |
TA1535 | No | Yes | Unclear, needs further evaluation | PASS | PASS | PASS | PASS |
TA1537 | No | No | Probably not mutagenic | PASS | PASS | PASS | PASS |
E. coli uvrA [pKM101] | No | No | Probably not mutagenic | PASS | PASS | PASS | PASS |