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Safety assessment of non-animal chondroitin sulfate sodium: Subchronic study in rats, genotoxicity tests and human bioavailability

Author:
Miraglia, Niccolò, Bianchi, Davide, Trentin, Antonella, Volpi, Nicola, Soni, Madhu G.
Source:
Food and chemical toxicology 2016 v.93 pp. 89-101
ISSN:
0278-6915
Subject:
absorption, adverse effects, amino sugars, bioavailability, body weight changes, bovine spongiform encephalopathy, chondroitin sulfate, chromosome aberrations, dietary supplements, feed intake, genotoxicity, glucuronic acid, humans, microscopy, mortality, mutagenicity, no observed adverse effect level, pharmacokinetics, polymers, rats, safety assessment, sodium sulfate, subchronic toxicity, toxicology, urinalysis
Abstract:
Chondroitin sulfate, an amino sugar polymer made of glucuronic acid and N-acetyl-galactosamine, is used in dietary supplements to promote joint health. Commonly used chondroitin sulfate is of animal origin and can pose potential safety problems including bovine spongiform encephalopathy (BSE). The objective of the present study was to investigate potential adverse effects, if any, of microbial derived chondroitin sulfate sodium (CSS) in subchronic toxicity, genotoxicity and bioavailability studies. In the toxicity study, Sprague Dawley rats (10/sex/group) were gavaged with CSS at dose levels of 0, 250, 500 and 1000 mg/kg body weight (bw)/day for 90-days. No mortality or significant changes in clinical signs, body weights, body weight gain or feed consumption were noted. Similarly, no toxicologically relevant treatment-related changes in hematological, clinical chemistry, urinalysis and organ weights were noted. Macroscopic and microscopic examinations did not reveal treatment-related abnormalities. In vitro mutagenic and clastogenic potentials as evaluated by Ames assay, chromosomal aberration test and micronucleus assay did not reveal genotoxicity of CSS. In pharmacokinetic study in human, CSS showed higher absorption as compared to chondroitin sulfate of animal origin. The results of subchronic toxicity study supports the no-observed-adverse-effect level (NOAEL) for CSS as 1000 mg/kg bw/day, the highest dose tested.
Agid:
5257906