90‐Day Subchronic Toxicological Evaluation of a Zylaria in Sprague Dawley Rats

Objective Zylaria comprises a blend of botanical components, including Xylaria Nigripes (mycelium), Cuscuta Chinensis (seed) and Panax Notoginseng (root). This study aimed to evaluate the potential toxicity of Zylaria when administered orally (via gavage) to Sprague Dawley (SD) rats for 90 days continuously and examine any delayed toxicity after a minimum recovery period of 28 days post‐treatment cessation. Methods One hundred SD rats of both sexes were divided into six study groups: four main groups with 10 rats of each sex receiving different doses of Zylaria (0, 1000, 2750 and 4500 mg/kg body weight per day) and two recovery groups with five rats of each sex receiving either the vehicle control (Milli‐Q water) or high‐dose Zylaria. Throughout the study, animals were monitored daily for general behaviour, body weight fluctuations and clinical signs. Upon completion of the treatment period, haematological, coagulation, clinical chemistry, thyroid hormone analyses and histopathological examination of organs were conducted. Results Oral administration of Zylaria at tested concentrations did not induce any adverse events on general health, body weight, relative organ weights, or haematological, coagulation, clinical chemistry, and thyroid hormone parameters. Histopathological examination demonstrated no significant structural alterations in organs, even in animals treated with high doses of Zylaria. No test item–related effects were observed during the 28‐day recovery period after cessation of the treatment. Conclusion The study concluded that Zylaria treatment for 90 days does not lead to toxicity, even at doses up to 4500 mg/kg bw/day, indicating its safety for use.