Single and 90-day repeated oral dose toxicity studies of fermented Rhus verniciflua stem bark extract in Sprague–Dawley rats

• Published in: Food and chemical toxicology 2013-05, Vol.55, p.617-626
• Main Authors: Shin, Seo-Ho, Koo, Kyo-Hwan, Bae, Jin-Sook, Cha, Seung-Bum, Kang, In-Soo, Kang, Min-Soo, Kim, Hak-Soo, Heo, Hyun-Suk, Park, Min-Su, Gil, Gi-Hyun, Lee, Joo-Young, Kim, Kap-Ho, Li, Yinghua, Lee, Hyun-Kul, Song, Si-Whan, Choi, Han-Seok, Kang, Boo-Hyon, Kim, Jong-Choon
• Format: Article
• Language: English
• Subjects: Acute toxicity; Administration, Oral; adverse effects; Animals; bark; Biological and medical sciences; blood serum; Body Weight - drug effects; Dose-Response Relationship, Drug; Drinking Behavior - drug effects; Feeding Behavior - drug effects; Female; Fermentation; Fermented Rhus verniciflua stem bark extract; hematology; histopathology; lethal dose; Male; Medical sciences; necropsy; no observed adverse effect level; oral administration; Phenolic compounds; Plant Bark - chemistry; Plant Extracts - administration & dosage; Plant Extracts - toxicity; Rats; Rats, Sprague-Dawley; Rhus; Rhus - chemistry; Subchronic toxicity; tissue weight; toxicity testing; Toxicodendron vernicifluum; Toxicology; urinalysis; Urushiol
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2013.01.043

► Toxic effects of fermented Rhus verniciflua stem bark extract were investigated. ► No dead animals and toxic changes were observed in the single dose toxicity study. ► No treatment-related changes were observed in the repeated dose toxicity study. ► The approximate lethal dose of the extract was >10,000mg/kg in rats. ► The oral NOAEL of the extract was >5000mg/kg/day in rats of both genders. Fermented Rhus verniciflua stem bark (FRVSB) extract, an urushiol-free extract of Rhus verniciflua Stokes (RVS) fermented with Fomitella fraxinea, has various biological activities. The present study was carried out to investigate the potential toxicity of the FRVSB extract following single and repeated oral administration to Sprague–Dawley rats. In the single dose toxicity study, the FRVSB extract was administered orally to male and female rats at single doses of 0, 2500, 5000, and 10,000mg/kg. No animals died and no toxic changes were observed in clinical signs, body weight, and necropsy findings during the 15-day period following administration. In the repeated dose toxicity study, the FRVSB extract was administered orally to male and female rats for 90days at doses of 0, 556, 1667, and 5000mg/kg/day. There were no treatment-related adverse effects in clinical signs, body weight, food and water consumption, ophthalmic examination, urinalysis, hematology, serum biochemistry, necropsy findings, organ weight, and histopathology at any dose tested. The approximate lethal dose of the FRVSB extract was >10,000mg/kg in both genders, the oral no-observed-adverse-effect level of the FRVSB extract was >5000mg/kg/day in both genders, and no target organs were identified.