JTS : Vol. 34 (2009) , No. 3 June 265-280

Toxicity studies of Asahi Kasei PI, purified phosphatidylinositol from soy lecithin

Kumiko Honda¹⁾, Teruhiko Enoshima¹⁾, Takafumi Oshikata¹⁾, Koichi Kamiya¹⁾, Masao Hamamura¹⁾, Noriko Yamaguchi²⁾, Kaori Nakamura²⁾, Yoshihiro Oguma²⁾, Sho Fujiwara²⁾, Michihito Takabe²⁾, Akira Sono²⁾, Tsuneshirou Kawasaki³⁾, Masaaki Nasu³⁾, Kazumasa Otsubo³⁾ and Koichi Wakigawa³⁾

1) Department of Toxicology, Panapharm Laboratories Co., Ltd.
2) Bozo Research Center Inc.
3) Asahi Kasei Pharma Corporation

(Received January 19, 2009)
(Accepted February 26, 2009)

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.

KEY WORDS:

Asahi Kasei PI, Phosphatidylinositol, Rats, Acute toxicity, Subchronic toxicology, Genotoxicity