Study on biocompatibility of titanium alloys.
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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<BR>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.<BR>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 2270 days at 37°C.<BR>The amount of metallic elements dissolved in the solutions was measured by ICP and AAS.<BR>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.<BR>The amount of Ti was below the detectable limit.<BR>The solution Ti-5A1-2.5 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.<BR>3) By the bacterial mutation assay of <I>Salmonella typhimurium</I> TA 98, <I>Salmonella typhimurium</I> TA 100 and <I>Escherichia coli</I> WP2 <I>uvrA-</I>, the solutions, in which the tested materials were immersed, were not found to be mutagenic.<BR>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.<BR>The results suggest an excellent corrosion resistance of the titanium alloys.<BR>Mutagenicity was negative by these mutation assays, indicating that the tested alloys and pure titanium are safe for humans and animals.
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