The study, published recently in the journal Food and Chemical Toxicology , consisted of two oral toxicity studies, with no adverse effects being observed at 33 times the expected human oral intake of hydrolyzed chicken sternal cartilage.
"The affirmation on the safety of BioCell Collagen II reflects a significant advance in today's health food industry," said Suhail Ishaq, Biocell's VP.
"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 that we have commissioned, our next goal is to achieve GRAS certification."
The ingredient, already used in dietary supplement formulations, is reported to be composed of a minimum 60 per cent hydrolyzed collagen type II, 20 per cent chondroitin sulphate, and 10 per cent hyaluronic acid (HA).
The research, funded by BioCell and led by Alex Schauss from AIBMR Life Sciences, consisted of two acute and sub-chronic oral toxicity studies.
The former used 10 Sprague-Dawley rats (five female) and gave them a single dose of 5000 mg per kg body weight and monitored the animals for 14 days.
All animals are reported to have survived and exhibited normal body weight gain.
In the subchronic study, 80 Sprague-Dawley rats (40 females) were divided into four same-sex groups and administered a daily dose of 0, 30, 300 or 1000 mg per kg of body weight for over 90 days.
Again, all animals are reported to have survived with no significant changes in their body weights and histopathology.
"Based on the toxicological parameters of the two studies, our findings suggest that BioCell Collagen II taken orally as a food supplement would be well tolerated and safe in humans when consumed up to the daily recommended dose of 30 mg/kg, or 2100 mg in a 70-kg reference adult male or 1500 mg in a 50-kg reference adult female," wrote the researchers.
"Human clinical studies are needed, however, to test further the safety of the test product during longer than 90-day consumption," they concluded.
Schauss and his collaborators also report that the study makes an important contribution to the literature since, no other published sub-chronic oral toxicity studies on these other supplements containing collagen type II, hyaluronic acid, or chondroitin sulphate have been reported.
"This study also represents the first GLP compliant toxicology study on hydrolyzed chicken sternal cartilage," he added.
Source: Food and Chemical Toxicology Febraury 2007, Volume 45, Issue 2, Pages 315-321 "Acute and subchronic oral toxicity studies in rats of a hydrolyzed chicken sternal cartilage preparation" Authors: A.G. Schauss, D.J. Merkel, S.M. Glaza, S.R. Sorensonet