Avivagen Inc. announced that it has completed a series of important safety evaluations of fully oxidized beta-carotene (OxBC), the proprietary and critical active ingredient in the company's highly-regarded OxC-beta™ product line. Results of the Avivagen-initiated toxicology study, conducted following standardized and internationally recognized protocols, provided further evidence of the safety and effectiveness of OxBC and the OxC-beta™product line for use in human and animal applications. Based on previously conducted scientific testing, OxBC and Avivagen's OxC-beta™ product line have achieved self-affirmed GRAS status in the United States and have already secured regulatory approval in a number of other important food and feed markets, including China, Brazil, Philippines, Mexico, Taiwan, New Zealand, Thailand, Vietnam, Australia, and Malaysia.

While there have been zero reports of product-related adverse events from OxBC or OxC-beta™to date, the present toxicology tests were initiated by Avivagen to further reinforce OxBC's applicability as a very safe ingredient in a wide range of products and provide further formal evidence to support continued regulatory approval and adoption in both new jurisdictions and product applications. Toxicology testing consisted of three separate studies, all of which are conducted in animals, typically rats. The first test demonstrated that in rats the maximum tolerated single oral dose of OxBC and the LD50 were 5,000 and 30,079 mg/kg body weight, respectively.

The second test, a 14-day, repeat-dose acute oral toxicity test demonstrated an initial No Observable Adverse Effect.