[Show abstract][Hide abstract] ABSTRACT: Previous research has shown that undenatured type II collagen is effective in the treatment of arthritis. The present study evaluated the broad-spectrum safety of UC-II by a variety of toxicological assays including acute oral, acute dermal, primary dermal irritation, and primary eye irritation toxicity. In addition, genotoxicity studies such as Ames bacterial reverse mutation assay and mouse lymphoma tests, as well as a dose-dependent 90-day sub-chronic toxicity study were conducted. Safety studies indicated that acute oral LD(50) of UC-II was greater than 5000 mg/kg in female Sprague-Dawley rats. No changes in body weight or adverse effects were observed following necropsy. Acute dermal LD(50) of UC-II was determined to be greater than 2000 mg/kg. Primary skin irritation tests conducted on New Zealand Albino rabbits classified UC-II as slightly irritating. Primary eye irritation tests conducted on rabbits indicated that UC-II was moderately irritating to the eye. UC-II did not induce mutagenicity in the bacterial reverse mutation test in five Salmonella typhimurium strains either with or without metabolic activation. Similarly, UC-II did not induce a mutagenic effect in the gene mutation test in mouse lymphoma cells either with or without metabolic activation. A dose-dependent 90-day sub-chronic toxicity study revealed no pathologically significant changes in selected organ weights individually or as percentages of body or brain weights. No significant changes were observed in hematology and clinical chemistry. Therefore, the results from the current study show a broad-spectrum safety profile of UC-II.
[Show abstract][Hide abstract] ABSTRACT: The present study was conducted to examine the safety of a novel plant-based calcium supplement, derived from marine algae and containing high levels of calcium, magnesium, and other bone supporting minerals (commercially known as AlgaeCal (AC)). The present study evaluated the broad-spectrum safety of AC using a variety of toxicological assays including acute oral, acute dermal, primary skin irritation, and primary eye irritation toxicity. Under the conditions of the study, the acute oral LD(50) of AC was found to be greater than 5000 mg/kg body weight in rats, while the single acute dermal LD(50) was greater than 2000 mg/kg body weight. The primary skin irritation index of AC was found to be 0.4 and classified as slightly irritating to the skin. In primary eye irritation studies, the maximum mean total score of AC was observed to be 13.7 and classified as mildly irritating to the eye. Furthermore, another independent set of studies was conducted to obtain preliminary data for the teratogenic effects of AC in pregnant rats likely to arise from repeated gestational exposure, via oral gavage, over a test period of implantation through gestation (gestation days 5-19). Under the conditions of this pilot study, the effect of daily administration of AC by oral gavage at dose levels of 0, 500, 2500, and 5000 mg/kg/day during gestation days 5-19 of a 21-day pregnancy has appeared to result in no adverse toxicological effects to the pregnant rat or its developing offspring. A slight, non-significant increase in the incidence of incomplete sterna ossification (5(th) center) was observed. Under the conditions of the study, a no-observed-adverse effect level (NOAEL) of 5000 mg/kg/day of AC during pregnancy of the rat was observed. Overall, no significant toxicities of AC were observed in these toxicity models. Therefore, the results from the current study demonstrate a broad-spectrum safety profile of AC.
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