title: Acute and subchronic oral toxicity studies in rats of a hydrolyzed chicken sternal cartilage preparation.
abstract: Two acute and subchronic oral toxicity studies were conducted in rats to evaluate safety of a patented preparation of hydrolyzed chicken sternal cartilage (BioCell Collagen II) containing collagen type II, chondroitin sulfate, and hyaluronic acid. In the acute oral toxicity study, five males and five females of Sprague-Dawley rats were administered a single dose of 5000 mg of the test product per kg 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 study, Sprague-Dawley rats (40 males, 40 females) were divided into four same-sex groups (10 animals/group). Animals in each group were administered daily either 0, 30, 300 or 1000 mg of the test product per kg of body weight for over 90 days. All animals survived and showed no significant changes in their body weights and histopathology. Although some differences were observed between the treated and control animals in several parameters, they were generally not dose-related or considered to be of toxicological significance. In conclusion, the results from the two oral toxicity studies with male and female young adult rats indicated that the test preparation from hydrolyzed chicken sternal cartilage collagen (BioCell Collagen II) was well tolerated at all four doses tested.
authors.affiliation: AIBMR Life Sciences, Inc., Natural and Medical Products Research, 4117 S. Meridian, Puyallup, WA 98373, USA. alex@aibmr.com
authors.forename: A G
authors.initials: AG
authors.lastname: Schauss
authors.forename: D J
authors.initials: DJ
authors.lastname: Merkel
authors.forename: S M
authors.initials: SM
authors.lastname: Glaza
authors.forename: S R
authors.initials: SR
authors.lastname: Sorenson
mesh_terms: D000276:Adjuvants, Immunologic / Q000633:toxicity; D000284:Administration, Oral; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D002356:Cartilage / Q000737:chemistry*; D002645:Chickens; D002809:Chondroitin Sulfates / Q000633:toxicity*; D024043:Collagen Type II / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006820:Hyaluronic Acid / Q000633:toxicity*; D006868:Hydrolysis; D007592:Joint Diseases / Q000188:drug therapy; D008297:Male; D011897:Random Allocation; D051381:Rats; D017207:Rats, Sprague-Dawley; D013249:Sternum; D023382:Toxicity Tests, Acute; D036401:Toxicity Tests, Chronic
chemical_list: D000276:Adjuvants, Immunologic; D024043:Collagen Type II; D006820:Hyaluronic Acid; D002809:Chondroitin Sulfates