Laboratory Animal and Comparative Medicine ›› 2026, Vol. 46 ›› Issue (5): 660-667.DOI: 10.12300/j.issn.1674-5817.2025.216

• Laboratory Animals for Traditional Chinese Medicine Research • Previous Articles     Next Articles

28-Day Oral Toxicity Study of Ganoderma lucidum Spore Oil in Rats

LI Yangjin, WU Zhenhong, HUANG Zongxiu()()   

  1. Fujian Provincial Key Laboratory of Zoonosis Research (Fujian Center for Disease Control and Prevention), Fuzhou 350001, China
  • Received:2025-12-23 Revised:2026-04-24 Online:2026-10-25 Published:2026-10-16
  • Correspondence to: HUANG Zongxiu

Abstract:

Objective This study aims to conduct a 28-day oral toxicity test to observe the subacute toxic effects of Ganoderma lucidum spore oil in rats, elucidate its impacts on physiological indicators in rats, and provide a scientific basis for the safety evaluation of this substance. Methods Eighty 4-week-old specific pathogen-free (SPF) SD rats were randomly divided into a control group and three dose groups: low-dose (0.83 g/kg), medium-dose (1.67 g/kg), and high-dose (3.33 g/kg), with 10 males and 10 females in each group. The experimental groups were given Ganoderma lucidum spore oil by gavage at the corresponding doses, while the control group was given the same volume of edible corn oil. Administration lasted for 28 consecutive days, during which the rats had free access to food and water. The general condition of the rats was observed, and body weight, food intake, and food utilization rate were measured. After the treatment period, urine was collected from rats in each group for routine urinalysis. Blood samples were collected from the abdominal aorta under anesthesia induced by intraperitoneal administration of Zoletil 50 (5 mg/kg) and xylazine hydrochloride (10 mg/kg) for complete blood count, coagulation testing, and serum biochemical analyses. Gross necropsy was performed in all rats. Organs were excised and weighed, organ coefficients of major organs were calculated, and histopathological examinations of major organs were conducted in the control and high-dose groups. Results During the entire experimental period, all rats in the control and the three dose groups thrived without any mortality. No abnormal behaviors or clinical signs were observed in any of the groups. In the serum biochemistry, a statistically significant increase (P<0.05) in total protein was found in the high-dose female group compared with the control group. However, there was no dose-response relationship, and the values remained within the normal range of historical data in our laboratory; therefore, the increase was considered not biologically significant. Rats in the remaining groups showed no statistically significant differences (all P>0.05) in complete blood count, serum biochemical parameters, coagulation parameters, urinalysis parameters, or organ coefficients compared with the control group. Histopathological examination revealed no significant abnormalities. Conclusion The results indicate that Ganoderma lucidum spore oil does not exhibit significant subacute toxicity in SD rats at the tested dose levels.

Key words: Ganoderma lucidum spore oil, SD rats, Toxicology, Subacute toxicity, Safety

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