title: Safety Evaluation of Zingiber cassumunar Roxb. Rhizome Extract: Acute and Chronic Toxicity Studies in Rats.
abstract: Zingiber cassumunar Roxb. has been used for traditional medicine, but few studies have described its potential toxicity. In this study, the acute and chronic oral toxicity of Z. cassumunar extract granules were evaluated in Sprague-Dawley rats. The extract at a single dose of 5000 mg/kg body weight did not produce treatment related signs of toxicity or mortality in any of the animals tested during the 14-day observation period. However, a decrease in body weights was observed in treated males (P < 0.05). The weights of lung and kidney of treated females were increased (P < 0.05). Treated males were increased in spleen and epididymis weights (P < 0.05). In repeated dose 270-day oral toxicity study, the administration of the extracts at concentrations of 0.3, 3, 30, 11.25, 112.5, and 1,125 mg/kg body weight/day revealed no-treatment toxicity. Although certain endpoints among those monitored (i.e., organ weight, hematological parameters, and clinical chemistry) exhibited statistically significant effects, none was adverse. Gross and histological observations revealed no toxicity. Our findings suggest that the Z. cassumunar extract granules are well tolerated for both single and chronic administration. The oral no-observed-adverse-effect level (NOAEL) for the extract was 1,125 mg/kg body weight/day for males and females.
authors.affiliation: Faculty of Dentistry, Thammasat University, Rangsit Campus, Paholyothin Road, Klongluang, Pathumthani 12121, Thailand; Medicinal Herb Research Unit for Asthma, Thammasat University, Phaholyothin Road, Klongluang, Pathumthani 12121, Thailand.
authors.forename: Sittichai
authors.initials: S
authors.lastname: Koontongkaew
authors.affiliation: Medicinal Herb Research Unit for Asthma, Thammasat University, Phaholyothin Road, Klongluang, Pathumthani 12121, Thailand; Faculty of Medicine, Thammasat University, Paholyothin Road, Klongluang, Pathumthani 12120, Thailand.
authors.forename: Orapan
authors.initials: O
authors.lastname: Poachanukoon
authors.affiliation: Faculty of Medicine, Thammasat University, Paholyothin Road, Klongluang, Pathumthani 12120, Thailand.
authors.forename: Seewaboon
authors.initials: S
authors.lastname: Sireeratawong
authors.affiliation: Faculty of Dentistry, Thammasat University, Rangsit Campus, Paholyothin Road, Klongluang, Pathumthani 12121, Thailand.
authors.forename: Thaweephol
authors.initials: T
authors.lastname: Dechatiwongse Na Ayudhya
authors.affiliation: Faculty of Medicine, Chiangmai University, Chiangmai 50200, Thailand.
authors.forename: Parirat
authors.initials: P
authors.lastname: Khonsung
authors.affiliation: Faculty of Medicine, Chiangmai University, Chiangmai 50200, Thailand.
authors.forename: Kanjana
authors.initials: K
authors.lastname: Jaijoy
authors.affiliation: Faculty of Pharmaceutical Science, Huachiew Chalermprakiet University, Bangna-Trad Road, Bang Phli, Samut Prakan 10540, Thailand.
authors.forename: Ruedee
authors.initials: R
authors.lastname: Soawakontha
authors.affiliation: Faculty of Pharmacy, Mahidol University, Si Ayutthaya Road, Bangkok 10400, Thailand.
authors.forename: Monraudee
authors.initials: M
authors.lastname: Chanchai