In vivo and in vitro genotoxicity studies of Semelil (ANGIPARS™)

Semelil is a novel herbal-based compound formulated for treatment of bed sore and diabetic foot ulcer. The objective of the present preclinical study was to assess the mutagenicity and genotoxicity of Semelil in full compliance with the standard guidelines for testing chemicals. The potential genotoxicity of Semelil, as part of the safety evaluation process was assessed in three different in vitro and in vivo tests, including bacterial reverse mutation (Ames test), mammalian bone marrow chromosomal aberration, and rodent dominant lethal assays. Effects of Semelil was clearly negative at different doses in the Ames test. No statistically significant differences were observed between the levels of chromosomal aberrations in bone marrow cells of mice from the experimental and control groups. The rate of post-implantation losses and thus, the number of lethal mutations in germ cells at different stages of spermatogenesis in male mice treated with a single dose of Semelil did not statistically exceed the control rate. While on the basis of these observations, Semelil can be considered genotoxically safe, further investigations using other bio-assays for mutagenicity studies are warranted.