Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of lincomycin has not been evaluated.
Lincomycin was not found to be mutagenic in the Ames Salmonella reversion assay or the V79 Chinese hamster lung cells at the HGPRT locus. It did not induce DNA strand breaks in V79 Chinese hamster lung cells as measured by alkaline elution or chromosomal abnormalities in cultured human lymphocytes. In vivo, lincomycin was negative in both the rat and mouse micronucleus assays and it did not induce sex-linked recessive lethal mutations in the offspring of male Drosophila. However, lincomycin did cause unscheduled DNA syntheses in freshly isolated rat hepatocytes.
Impairment of fertility was not observed in male or female rats given oral 300 mg/kg doses of lincomycin (0.36 times the highest recommended human dose based on mg/m2).
Pregnancy Category C
There are no studies on the teratogenic potential of lincomycin in animals or adequate and well-controlled studies of pregnant women.
Reproduction studies have been performed in rats using oral doses of lincomycin up to 1000 mg/kg (1.2 times the maximum daily human dose based on mg/m2) and have revealed no adverse effects on survival of offspring from birth to weaning.