Comprehensive toxicological safety assessment of Trichosanthes kirilowii seeds as a candidate for new food resource

Semen Trichosanthis (ST), derived from Trichosanthes kirilowii seeds, has been traditionally used in ancient China to clear heat, resolve phlegm, moisten lungs, and relieve cough. Despite its therapeutic potential, systematic safety data remain limited. This study conducted comprehensive toxicological evaluations through genetic toxicity tests (Ames test, mammalian erythrocyte micronucleus test, mouse spermatocyte chromosome aberration assay), acute (14-day), subchronic (90-day), and teratogenicity assessments. Genetic toxicity tests demonstrated no mutagenicity at doses ≤ 10 g·kg⁻¹ BW. Acute oral administration in institute of cancer research (ICR) mice revealed no mortality or toxicity (LD₅₀ > 20 g·kg⁻¹ BW). Subchronic exposure in Sprague Dawley (SD) rats (5 g·kg⁻¹ BW) showed no adverse effects, establishing a NOAEL ≥ 5 g·kg⁻¹ BW. Teratogenicity studies in pregnant rats (5 g·kg⁻¹ BW) confirmed normal maternal, embryonic, and fetal development without skeletal/visceral abnormalities. Collectively, ST exhibited no detectable genotoxic, acute, subchronic, or teratogenic risks under tested conditions. These findings validate the safety profile of ST for clinical and nutraceutical applications, providing critical data to support its development as a novel food resource. This systematic assessment addresses existing safety knowledge gaps and offers a scientific basis for regulatory decision-making.