Preclinical toxicological evaluation of 7-methoxy-3-Phenyl-4H-Chromen-4-one: Acute and sub-acute oral toxicity with...

Preclinical toxicity assessment is a critical step in drug development, despite advances in in vitro screening, these models remain insufficient to predict complex systemic toxicity, necessitating in vivo evaluation for novel compounds. 7-Methoxy-3-Phenyl-4H-Chromen-4-one, a structurally relevant chromen derivative, lacks prior in vivo toxicological data despite its potential biological activity.

Acute and sub-acute oral toxicity studies were conducted in in female Wistar albino rats following OECD guidelines. Acute toxicity was assessed using single-dose administration, while sub-acute toxicity involved repeated dosing over 28 days at graded dose levels. Safety evaluation included clinical observations, body weight, hematological and biochemical parameters, cardiac biomarkers and histopathological examination of major organs.

Acute exposure did not produce significant systemic toxicity. Sub-acute administration at lower doses maintained normal physiological and biochemical profiles, whereas higher doses induced dose-dependent alterations in hepatic, renal and cardiac biomarkers along with histopathological changes.

The compound demonstrates a defined safety margin, with a no observed adverse effect level (NOAEL) of 50 mg/kg and lowest observed adverse effect level (LOAEL) of 300 mg/kg. This study was specifically designed to address a critical gap in safety evaluation, providing essential in vivo toxicological data to support future pharmacological and translational investigations.