title: Toxicity studies of Asahi Kasei PI, purified phosphatidylinositol from soy lecithin.
abstract: Although phosphatidylinositol (PI) is an important component in all plants and animals, there is no toxicity report when purified PI is orally administrated to animals. As a safety evaluation of PI, acute, subchronic and genotoxicity studies were conducted with purified PI from soy lecithin (Asahi Kasei PI). Up to 2,000 mg/kg of Asahi Kasei PI was administrated once orally to male and female rats. There were no deaths or any clinical sign in any group throughout the observation period. Then, Asahi Kasei PI was repeatedly administered orally to male and female rats at daily doses of 100, 300 and 1,000 mg/kg for 13 weeks. Neither death nor any toxicological signs during the administration period and no changes related to the test substance administered were observed in any group with regard to body weight, food consumption, ophthalmoscopy, hematology, blood biochemistry, necropsy, organ weights or histopathology. Based on these results, the no-observed-adverse effect level (NOAEL) of Asahi Kasei PI was considered to be 1,000 mg/kg/day for male and female rats. Genotoxicity evaluation of Asahi Kasei PI was also carried out by the bacterial reverse mutation test (Ames test) and in vitro chromosome aberration test in compliance with the Japanese guidelines on genotoxicity testing of pharmaceuticals, the OECD guidelines for testing chemicals and guidelines for designation of food additives and for revision of standards for use of food additives. The results indicate neither increases of revertant colonies nor chromosome aberration, suggesting that Asahi Kasei PI has high safety in genotoxicity.
authors.affiliation: Department of Toxicology, Panapharm Laboratories Co., Ltd., Kumamoto.
authors.forename: Kumiko
authors.initials: K
authors.lastname: Honda
authors.forename: Teruhiko
authors.initials: T
authors.lastname: Enoshima
authors.forename: Takafumi
authors.initials: T
authors.lastname: Oshikata
authors.forename: Koichi
authors.initials: K
authors.lastname: Kamiya
authors.forename: Masao
authors.initials: M
authors.lastname: Hamamura
authors.forename: Noriko
authors.initials: N
authors.lastname: Yamaguchi
authors.forename: Kaori
authors.initials: K
authors.lastname: Nakamura
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Oguma
authors.forename: Sho
authors.initials: S
authors.lastname: Fujiwara
authors.forename: Michihito
authors.initials: M
authors.lastname: Takabe
authors.forename: Akira
authors.initials: A
authors.lastname: Sono
authors.forename: Tsuneshirou
authors.initials: T
authors.lastname: Kawasaki
authors.forename: Masaaki
authors.initials: M
authors.lastname: Nasu
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Otsubo
authors.forename: Koichi
authors.initials: K
authors.lastname: Wakigawa
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D002478:Cells, Cultured; D002869:Chromosome Aberrations; D019963:Clinical Chemistry Tests; D006224:Cricetinae; D003412:Cricetulus; D004435:Eating / Q000187:drug effects; D005260:Female; D006403:Hematologic Tests; D054709:Lecithins / Q000737:chemistry*; D008297:Male; D009153:Mutagens / Q000145:classification / Q000633:toxicity*; D019055:No-Observed-Adverse-Effect Level; D010716:Phosphatidylinositols / Q000145:classification / Q000633:toxicity*; D010936:Plant Extracts / Q000633:toxicity; D051381:Rats; D017207:Rats, Sprague-Dawley; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D013025:Glycine max / Q000737:chemistry*
chemical_list: D054709:Lecithins; D009153:Mutagens; D010716:Phosphatidylinositols; D010936:Plant Extracts