title: Three-month oral repeated administration toxicity study of seed saponins of Thea sinensis L. (Ryokucha saponin) in rats.
abstract: Ryokucha saponin (RSP), which is one of the ingredients of green tea, was administered orally to rats for 3 months at dose levels of 50, 150 and 500 mg/kg/day to assess any toxic effects. As positive control, 1200 mg/kg/day of quillaia saponin (QSP), which contains saponins equivalent in amount to those in 500 mg RSP/kg/day, was administered. The no-effect level of RSP was 50 mg/kg/day and the lowest-observed-effect level of RSP was 150 mg/kg/day for both sexes, so that the true no-effect level of RSP was estimated to be between these dose levels. In addition, it was confirmed that the toxicity of RSP at 500 mg/kg/day was less than that of QSP at 1200 mg/kg/day and RSP was demonstrated to be safer than QSP, which is a permitted food additive.
authors.affiliation: Rohto Pharmaceutical Co., Ltd, Osaka-fu, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Kawaguchi
authors.forename: T
authors.initials: T
authors.lastname: Kato
authors.forename: S
authors.initials: S
authors.lastname: Kamada
authors.forename: A
authors.initials: A
authors.lastname: Yahata
mesh_terms: D000284:Administration, Oral; D000818:Animals; D005260:Female; D005503:Food Additives / Q000633:toxicity; D008297:Male; D051381:Rats; D017208:Rats, Wistar; D012503:Saponins / Q000633:toxicity*; D012639:Seeds; D013662:Tea / Q000633:toxicity*; D013997:Time Factors
chemical_list: D005503:Food Additives; D012503:Saponins; D013662:Tea