Pre-clinical in vitro and in vivo safety evaluation of bovine whey derived osteopontin, Lacprodan® OPN-10.

Abstract Lacprodan® OPN-10 is a proprietary whey-based protein product that contains bovine-derived osteopontin (OPN), found in human milk and other bodily tissues. In vitro genotoxicity tests conducted according to accepted guidelines at up to 5000 μg/plate OPN failed to induce genetic mutations in Salmonella typhimurium strains and Escherichia coli strain and did not induce chromosomal aberrations or cytotoxicity in human lymphocytes. Administration of an acute dose of Lacprodan® OPN-10 (2300 mg/kg body weight) to male and female mice did not induce chromosomal damage or mitotic apparatus damage to erythroblasts from bone marrow. Lacprodan® OPN-10 was evaluated in a 13-week oral toxicity study in which rats were fed diets containing 0.5%, 1.0% and 2.0% Lacprodan® OPN-10. No test-article-related clinical observations or toxicological effects on body or organ weights, food consumption, ophthalmic effects, locomotor activity, hematology, clinical chemistry, urinalysis, or pathology were identified. In a teratogenicity study, administration of Lacprodan® OPN-10 up to 2500 mg/kg bw/day via gavage to pregnant rats had no effect on dams or pups. The No Observed Adverse Effect Level (NOAEL) for Lacprodan® OPN-10 in the 13-week toxicity study was 2.0% of the diet (equivalent to 1208 mg/kg bw/day in male rats and 1272 mg/kg bw/day in female rats).