BioCell Collagen II Safety Confirmed

PUYALLUP, Wash.AIBMR Life Sciences Inc. researchers, led by Axander Schauss, Ph.D., reported two oral tests of chicken sternal cartilage collagen (as BioCell Collagen II®, from BioCell Technologies) showed the joint health ingredient is safe, even at levels well above recommended dosage. Results from the toxicity studies were published in the February issue of Food and Chemical Toxicology journal (45, 2:315-21, 2007).

The investigation involved both acute and subchronic tests on BioCell Collagen II, which contains a minimum 60 percent hydrolyzed collagen type II, 20 percent chondroitin sulfate, and 10 percent hyaluronic acid. In the acute study, five male and five female rats administered a single 5,000 mg dose of BioCell Collagen II per kg of body weight and observed for 14 days. All animals survived and exhibited normal body weight gain throughout the study. Macroscopic necropsy examination conducted on day 15 revealed no gross pathological lesions in any of the animals.

In the subchronic test, 40 male and 40 female rats were divided into four same-sex groups. Animals in each group were administered 0 mg, 30 mg, 300 mg or 1000 mg of collagen per kg of body weight daily for more than 90 days. All subjects survived and showed no significant changes in body weight or histopathology. Researchers noted while there were some observed differences between the treated and control animals in several parameters, these differences were generally not dose-related or considered to be of toxicological significance. Overall, subjects exhibited no toxicity, even at 33 times the recommended dose, as observed by a review of a variety of biomarkers and histopathological examinations.

Researchers concluded results from the two oral toxicity studies with male and female young adult rats indicated BioCell Collagen II was well tolerated at all four doses tested.

BioCell Collagen II is the only dietary ingredient of its kind to undergo the rigors of toxicity testing, said Suhail Ishaq, vice president of BioCell. Consumers can be confident about the safety BioCell Collagen II, and it opens the door to new product development in the functional foods market. With this toxicity study behind us, along with other studies we have commissioned, our next goal is to achieve GRAS certification."