Abstract:

OBJECTIVE: To explore the genetic toxicity of cetirizine amidine sodium and to evaluate whether cetirizine amidine sodium would change the genetic material in the body. Providing necessary experimental data for its development and application as a new drug. METHODS：Three tests were used to study the genetic toxicity of cetirizine amidine sodium： bone marrow cell micronucleus test，in vitro mammalian cells chromosome aberration test and salmonella typhimurium typhimurium mammals microsomal enzyme test (Ames test). RESULTS：The rates of micronucleus in each dose group and negative control group showed no significant difference (P>0.05). Cell chromosome aberration frequency in each group and in negative control group revealed no significant difference. Comparing with the solvent control group，the number of revertant colonies of TA97，TA98，TA100，TA102 strains did not increase twice or more times. CONCLUSION： Under this experimental condition，cetirizine amidine sodium did not demonstrate any genetic toxicity.

Key words: cetirizine amidine sodium, cephalosporin, genetic toxicity, safety evaluation