Evaluation of genetic and developmental toxicity of surfactin C from Bacillus subtilis BC1212

Surfactin C is a biosurfactant produced by Bacillus subtilis from Korean soybean paste. Surfactin C is known to have several therapeutic effects including anti-inflammatory, fibrinolytic, and thrombolytic activities. However, there is little information concerning its safety. In this study, we evaluated the genetic and developmental toxicity of surfactin C. Bacterial reverse mutation and rodent micronucleus assays were performed to determine its genotoxic potentials. Surfactin C at 0, 125, 250, and 500mg/kg of body weight/day was administered orally to pregnant ICR mice during the period of major organogenesis. There was no genetic toxicity related to surfactin C treatment in in vitro and in vivo systems. In the developmental study, surfactin C did not demonstrate maternal toxicity, fetotoxicity, and teratogenicity, and hence the no observed effect level was concluded 500mg/kg per day in ICR mice.