Investigation of the Mutagenic Potential of Immunomodulator Arglabin Native in Tablets in the Ames Test

The mandatory preclinical safety evaluation is an essential prerequisite to obtain the qualitative and effective medicines. Due to the fact that drugs may reveal genotoxic properties, the investigation of their mutagenic activity is an obligatory part of the preclinical drug safety program. The aim of the research is to study mutagenic properties of a new original immunomodulator Arglabin native in tablets in the induced test of gene mutations (the Ames test) on Salmonella typhimurium strains. Materials and methods: Four strains of S. typhimurium TA98, TA100, TA1535, and TA1537 were used to assess the mutagenicity in the Ames test. Results and conclusions: No statistically reliable dose-dependent increase in the number of revertant colonies of Salmonella typhimurium has been observed in the presence of the given drug within the investigated dose ranges from 5.0 to 100.0 μg/mL for strains TA100 and TA1535, and from 5.0 to 250 μg/mL for strains TA98 and TA1537 against the baseline of spantaneous mutations. Arglabin native in tablets does not reveal a mutagenic activity within the studied dose ranges on Salmonella typhimurium strains TA98, TA100, TA1535, TA1537.