13-week oral repeated administration toxicity study of bovine lactoferrin in rats

Bovine lactoferrin (LF), which is an iron-binding glycoprotein in milk, was administered orally to groups of 12 males and 12 female rats at dose level s of 200, 600 and 2000 mg/kg/day once daily for 13 weeks and its toxicity o n repeated administration was examined. Throughout the administration perio d, there were no deaths caused by administration of the test compound, nor were there any adverse effects noted in the general condition of the animal s. The study findings concerning body weight and food consumption, ophthalm ology, urinalysis including water consumption, haematology, blood chemistry , necropsy, organ weights and histopathology revealed that there were no ap parent changes due to administration of LF. Therefore, the level of LF at w hich no adverse effect was observed was considered to be 2000 mg/kg/day for both sexes. (C) 2000 Elsevier Science Ltd. All rights reserved.