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The biocompatibility of two different titanium alloys, Ti-6Al-4V ELI and Ti-5Al-2, 5Fe, and pure titanium were evaluated. The results were as follows: 1) Titanium alloys were implanted into the dorsal subcutaneous tissues of the Hartley guinea-pig for 12 weeks, immersed in calf serum or in Ringer's solution for 8 weeks. The surface changes of the titanium alloys were observed by SEM and the chemical composition was analyzed by XMA. No evident surface changes were found. 2) Three hundred mg, 200 mg and 100 mg of the powders of the tested materials were immersed in 2ml of Eagle's MEM, incubated for 1-7 days, 8-21 days and 22-70 days at 37 C degrees. The amount of metallic elements dissolved in the solutions was measured by ICP and AAS. The detected corrosion rates of V and Al contained in the solution, in which Ti-6Al-4V ELI 100 mg was immersed for 1-7 days, were 194.3 +/- 17.6 and 73.0 +/- 28, 1 pg/mg alloy/day, respectively. V was released more than Al. The amount of Ti was below the detectable limit. The solution Ti-5Al-2.5 Fe 100 mg immersed for 1-7 days contained 31.9 +/- 34.4 pg/mg alloy/day Fe and 25.7 +/- 6.3 pg/mg alloy/day Al. Only in the solution 300 mg immersed for 1-7 days was Ti detected at 1.4 pg/mg alloy/day. 3) By the bacterial mutation assay of Salmonella typhimurium TA 98, Salmonella typhimurium TA 100 and Escherichia coli WP2 uvrA, the solutions, in which the tested materials were immersed, were not found to be mutagenic. 4) By the UDS assay, the grain counts on autoradiography with the solutions, in which the tested materials were immersed, were not greater than the negative control. The results suggest an excellent corrosion resistance of the titanium alloys. Mutagenicity was negative by these mutation assays, indicating that the tested alloys and pure titanium are safe for humans and animals.

Study on biocompatibility of titanium alloys.