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Spiramycine is a macrolide antibiotic used for the treatment and prophylaxis of local and systemic bacterial and mycoplasmal infections. It is also an effective drug for the treatment of toxoplasmosis. In order to assay its mutagenic potential in mammalian cells, chromosomal aberrations in both somatic and germ cells and sperm abnormalities were examined in mice after oral treatment (gavage) with spiramycine. Mice were treated subacutely (for 3, 5, 10 consecutive days) with 3 dose levels of spiramycine 104, 208, 416 mg kg-1 b.wt. Spiramycine was found to induce a significant increase in the percentage of chromosomal aberrations in bone-marrow and spermatocyte cells after successive treatments with the doses 208 and 416 mg kg-1 b.wt. This percentage increased with increasing the dose. The effect was more prominent 8 h post treatment with spiramycine compared with that after 24 h. Spiramycine had no significant effect on the mitotic activity in mouse bone-marrow cells compared to the control. For studying sperm abnormalities mice were treated for 5 consecutive days with 104, 208 and 416 mg/kg. Morphological sperm abnormalities increased significantly after treatment with the 2 higher doses of spiramycine. The percentage of abnormal sperms increased with increasing the dose. It reached 3.74±0.60, 6.34±0.66 (p<0.01), 9.28±0.29 (p<0.01) after treatment with the 3 tested doses respectively compared with 3.02±0.50 for the control vehicle. These results show that spiramycine has some clastogenic potential on somatic and germ cells as well as on sperm morphology.

Evaluation of the Genotoxicity of Spiramycine in Male Mice.