Research on 90-day subchronic toxicities of the ethanol extract from the cultivated Fritillaria Cirrhosa bulbs by oral administration in Sprague-Dawley rats

Fritillaria Cirrhosa bulbus (BFC) is a Chinese herbal medicine. In the present study, subchronic toxicities of the ethanol extract from cultivated Fritillaria Cirrhosa bulbus (ECBFC) were performed by oral daily administration in Sprague-Dawley rats. The subchronic toxicity test of ECBFC was conducted at doses of 0.34, 0.68, and 2.04 g/kg/day for 90 days (equivalent to the highest human clinical recommend dosage of 25, 50, and 150-fold) with a 4-week satellite group. No mortality or significant changes in behaviors, body weight and food consumption were observed during the experimental and recovery periods. According to the data from ematological analysis, biochemistry, organ coefficient and the results of histopathology, the ECBFC have toxicity to the spleen and liver at the highest (2.04 g/kg), medium (0.68 g/kg) dose and nephrotoxicity at the highest dose. Subchronic oral toxicity of ECBFC in SD rats (90 days) with NOAEL was 0.34 g/kg and LOAEL was 0.68 g/kg. In addition, the toxicity is gender neutral and reversible. The NOAEL value (0.34 g/kg) is 25-fold of the highest human clinical recommend dosage thus the ECBFC could be long-term used as Chinese patent medicine or functional food. [Display omitted] •The ECBFC was first investigated for its subchronic toxicity.•The study consisted of a 90-day administration period and a 4-week recovery period.•The ECBFC had toxicity to the liver, spleen, and kidney in 2.04 and 0.68 g/kg dose.•The NOAEL and LOAEL of ECBFC is 0.34 and 0.68 g/kg.