Montelukast showed no proof of clastogenic or mutagenic activity in the adhering to assays: the microbial mutagenesis assay, the V-79 mammalian cell mutagenesis assay, the alkaline elution assay in rat hepatocytes, the chromosomal aberration assay in Chinese hamster ovary cells, as well as in the in vivo mouse bone tissue marrow chromosomal aberration assay.
In fertility researches in women rats, montelukast created decreases in fertility and also fecundity indices at an oral dose of 200 mg/kg (approximated direct exposure was about 70 times the AUC for grownups at the maximum recommended daily oral dose). No effects on women fertility or fecundity were observed at a dental dose of 100 mg/kg (estimated direct exposure was roughly 20 times the AUC for grownups at the maximum suggested daily oral dose). Montelukast had no impacts on fertility in male rats at dental dosages up to 800 mg/kg (estimated direct exposure was about 160 times the AUC for adults at the optimum recommended daily dental dosage).
No teratogenicity was noted at dental doses up to 400 mg/kg/day and also 300 mg/kg/day in rabbits and also rats, specifically. These dosages were roughly 100 and also 110 times the max suggested daily oral dosage in adults, respectively, based upon AUCs. Montelukast crosses the placenta following dental application in rats and also bunnies [see Pregnancy (8.