Biological Safety Evaluation Of The Polypropylene Sutural Lines

Aim: To explore the biocompatibility and safety of polypropylene suture line to provides experimental bases for clinical applications.Methods: According to the standard ISO:10993, we evaluate the biocompatibilities of polypropylene suture line using the cytotoxicity test, sensitization tests, intradermal stimulation test, acute toxicity test, hemolysis test, implantation test, chromosomal aberration test, micronucleus test, Ames test and pyrogen test.Results: (1) Acute toxicity tests showed that polypropylene sutural lines had no acute toxicity. (2) Rats were subcutaneously implanted with polypropylene sutural lines and no distinguished general toxicity signs were observed. Clinical observation, body weight, biochemical indicator in blood, histomorphology tests of rats were all in normal range. (3) Polypropylene suture line had no sensitivity response with the skin of guinea pigs. (4) Intradermal stimulation test showed that polypropylene suture line had no irritant action to the skin of rabbits. (5) Cytotoxic tests showed that relative growth rate of cultured cells day 2 and day 4 with polypropylene suture line were 98% and 80% respectively. Polypropylene suture line had no cytotoxic effects. (6) Chromosomal aberration test showed that polypropylene suture line had no teratogenic actions in human peripheral blood lymphocytes. (7) Micronucleus test showed that polypropylene suture line had no induction effects to the incidence rate of micronuclei of bone marrow polychromatic erythrocytes. (8) Ames tests showed that different doses of the leaching liquor of polypropylene suture line could not induce dose-dependent increase of revertant colonies. Polypropylene sutural lines had no mutagenesis to Salmonella typhimurium. (9) Hemolysis tests showed that the haematolysis rates of polypropylene s suture line were 0.8% and had no obvious hemolytic crisis.Conclusions: These results suggest that polypropylene suture line have favourable biocompatibility.