Genotoxicity study of bone cement / 中国医疗器械杂志

ABSTRACT

<p><b>OBJECTIVE</b>To investigate the genotoxicity of bone cement.</p><p><b>MATERIAL AND METHODS</b>Test article was mixed of liquid and the powder extract of bone cement. Using bacterial reverse mutation test (Ames test) and mouse lymphoma Assay (MLA) with and without metabolic activation S9. Ames test was performed by the plate incorporation method for its ability to induce reverse mutations in three treatment dosage groups: 25 microl/plate, 50 microl/plate, 100 microl/plate using S. typhimurium TA98, TA100, TA1535, TA1537 and E. coli WP2 uvrA; In MLA, the mutation frequency (MF) and the percentage of small colony mutants (SC%) of L5178 tk(+/-) cells induced by bone cement at final concentration of 0.125%, 0.25% and 0.5% (V/V) were calculated and assayed with +S9/3 h, - S9/3 h, -S9/24 h.</p><p><b>RESULTS</b>Slight precipitations of two dosage group 50 microl/plate and 100 microl/plate were observed after phosphoric acid buffer solution or S9mix added. Growth inhibition effect exists in TA100, TA1535 and WP2 uvrA to varying degrees. Other groups did not cause obvious increases in the mean number of revertant per plate compared with negative control (DMSO). The result of MLA indicated no significant MF or SC% increases (P>0.05) observed comparing with negative control under all test conditions.</p><p><b>CONCLUSIONS</b>The bone cement did not induce reverse mutation at his(-)/trp(-) and there was no obvious damage effect to gene tk(+/-) or chromosome under this study condition.</p>