Acute and repeated dose (28 days) oral safety studies of phosphatidyl-hydroxytyrosol

Phosphatidyl-hydroxytyrosol, a carrier of hydroxytyrosol under the form of phospholipid with high antioxidant capacity, is being actively studied as a potential ingredient of functional foods and supplements. To support the safety, phosphatidyl-hydroxytyrosol has been examined in an acute and in a 28-day repeated dose oral toxicity studies in rats. Phosphatidyl-hydroxytyrosol administered in a single oral gavage dose of 2000 mg/kg of body weight (bw) resulted in no adverse events or mortality. In addition, phosphatidyl-hydroxytyrosol administered as a daily dose of 2000 mg/kg bw for 28 days by gavage resulted in no adverse events or mortality. No evidence or treatment related toxicity was detected during both studies. Data analysis of body weight gain, food consumption, clinical observations, blood biochemical, haematology, organ weight ratios and histopathological findings did not show significant differences between control and treated groups. It is concluded that phosphatidyl-hydroxytirosol orally administered to rats was safe and that no treatment-related toxicity was detected even at the high doses investigated in both acute (2000 mg/kg bw) and repeated dose (28-day) oral (2000 mg/kg bw) toxicity studies.