Declines in semen parameters contribute to male infertility. The Tinh Ky (TK) soft pill is a traditional polyherbal formulation composed of the roots or rhizomes of Astragalus membranaceus, Polygonatum kingianum, Curculigo orchioides and the whole plant of Cynomorium songaricum, traditionally used for the management of male infertility. This study evaluated the genotoxic and reproductive safety of TK in Swiss albino mice. For the genotoxicity assessment, animals were randomly assigned to control, low-dose and high-dose groups (n = 10 per group). The Tinh Ky soft pill was administered orally at a low dose (6.8 g/kg/day) or a high dose (20.4 g/kg/day) for 28 days. For the reproductive safety assessment, male Swiss mice were allocated into three groups (n = 11 per group) and received the same oral doses for 30 days before mating with untreated female mice. Chromosomal analysis revealed no statistically significant differences in numerical or structural abnormalities between the treated and control groups (p > 0.05). Pregnancy rates were 48.48 % to 54.55 % in the parental (P) generation and 58.62 % to 63.33 % in the first filial (F1) generation. Mean corpora lutea counts were 11–13 per dam, fetal viability was 96.46 % to 97.87 %, embryo loss was 2.13 % to 3.54 % and F1 litter size was 11–12 pups per litter. None of these parameters differed significantly between the treated and control groups in either the P or F1 generation (p > 0.05). The Tinh Ky soft pill was not associated with adverse genotoxic or male-mediated reproductive effects in Swiss albino mice, providing preliminary preclinical safety evidence supporting further investigation of its traditional use.
