Safety evaluation of DHA-rich Algal Oil from Schizochytrium sp.

The safety of DHA-rich Algal Oil from Schizochytrium sp. containing 40-45 wt% DHA and up to 10 wt% EPA was evaluated by testing for gene mutations, clastogenicity and aneugenicity, and in a subchronic 90-day Sprague-Dawley rat dietary study with in utero exposure, followed by a 4-week recovery phase. The results of all genotoxicity tests were negative. In the 90-day study, DHA-rich Algal Oil was administered at dietary levels of 0.5, 1.5, and 5 wt% along with two control diets: a standard low-fat basal diet and a basal diet supplemented with 5 wt% of concentrated Fish Oil. There were no treatment-related effects of DHA-rich Algal Oil on clinical observations, body weight, food consumption, behavior, hematology, clinical chemistry, coagulation, or urinalysis. Increases in absolute and relative weights of the liver, kidney, spleen and adrenals (adrenals and spleen with histological correlates) were observed in both the Fish Oil- and the high-dose of DHA-rich Algal Oil-treated females and were not considered to be adverse. The no observed adverse effect level (NOAEL) for DHA-rich Algal Oil under the conditions of this study was 5 wt% in the diet, equivalent to an overall average DHA-rich Algal Oil intake of 4260 mg/kg bw/day for male and female rats.

Safety evaluation of Algal Oil from Schizochytrium sp.

The safety of Algal Oil from Schizochytrium sp. was evaluated by testing for gene mutations, clastogenicity and aneugenicity, and in a subchronic 90-day Sprague-Dawley rat dietary study. The results of all genotoxicity tests were negative. The 90-day study involved dietary exposure to 0.5, 1.5, and 5 wt.% of Algal Oil and two control diets: a standard low-fat basal diet and a basal diet supplemented with 5 wt.% menhaden oil (the fish oil control). There were no treatment-related effects of Algal Oil on clinical observations, body weight, food consumption, behavior, hematology, clinical chemistry, coagulation, or urinalysis parameters. Increased mean liver weights and alveolar histiocytosis were observed in both the fish oil control and the high-dose Algal Oil-treated animals and were not considered to be adverse. Algal Oil was bioavailable as demonstrated by the dose-related increase of DHA and EPA levels in tissues and plasma. The no observable adverse effect level (NOAEL) for Algal Oil under the conditions of this study was 5 wt.% in the diet, equivalent to an overall average Algal Oil intake of 3250 mg/kg bw/day for male and female rats. Based on the body surface area, the human equivalent dose is about 30 g Algal Oil/day for a 60 kg adult.

Safety studies on products from whole coffee fruit.

The fruit of the coffee plant, Coffea arabica, has high phenolic antioxidant and phytonutrient content and could be a beneficial food ingredient. However, the fruit has historically been discarded for the favored harvesting of the coffee bean alone. CoffeeBerry products are derived from the whole fruit and include a ground whole powder, a water extract, and a more recently developed water-ethanol extract. The safety of CoffeeBerry products was evaluated in three genotoxicity studies, three short-term oral toxicity studies, and a 90-day dietary toxicity study. Bacterial mutagenicity studies and a micronucleus test using murine peripheral cells demonstrated that none of the three products showed mutagenic or genotoxic potential. In the short-term studies, despite palatability issues, female rats showed a tolerance for whole powder and ethanol extract at doses up to 8800 mg/kg bw/day. Male rats also exhibited palatability issues and tolerated lower doses of approximately 4000 mg/kg bw/day ethanol extract via gavage and approximately 2100 mg/kg bw/day whole powder or water extract in the diet. When fed in the diet to Sprague-Dawley rats for 90 days, ethanol extract showed no adverse effects at dietary concentrations of up to 5% (approximately 3446 and 4087 mg/kg bw/day for male and female rats, respectively).