Int J Toxicol. 2026 Jul 21:10915818261469132. doi: 10.1177/10915818261469132. Online ahead of print.
ABSTRACT
Diosgenin, derived from Dioscorea alata, is a well-known traditional medicinal compound with therapeutic potential against various conditions, including cancer and cardiovascular diseases. This study aimed to synthesize diosgenin polyethylene glycol succinate (DPGS) from diosgenin and evaluate its acute and chronic toxicity in rats. DPGS was designed as a novel amphiphilic excipient for universal solubilization, improving drug delivery and therapeutic performance. The acute toxicity assessment involved administering DPGS to female Albino-Wistar rats, while the chronic toxicity study was conducted over 90 days in both male and female Albino-Wistar rats at doses of 0 (control), 500, 1000, and 2000 mg/kg body weight/day. Additionally, recovery groups from the control and high-dose categories were observed for another 28 days. In the acute toxicity study, no clinical toxicity or mortality was observed at the highest dose of 2000 mg/kg body weight/day. Similarly, in the 90-day chronic study, no mortality or significant treatment-related effects were detected across all dose groups in either sex, based on histopathological, hematological, and clinical chemistry evaluations. These findings suggest that the oral no-observed-adverse-effect level (NOAEL) of DPGS in Albino-Wistar rats is greater than 2000 mg/kg body weight/day. The results support the safety profile of DPGS and its potential application as an excipient in drug formulation and delivery systems.
PMID:42480106 | DOI:10.1177/10915818261469132