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Budapest, Hungary

Schauss A.G.,Meridian Life Sciences, Inc. | Clewell A.,Meridian Life Sciences, Inc. | Balogh L.,National Fjc Research Institute For Radiobiology And Radiohygiene | Szakonyi I.P.,Toxi Coop | And 6 more authors.
Toxicology | Year: 2010

The safety of an açai (Euterpe oleracea Mart.) pulp enriched fruit and berry juice, MonaVie Active®, fortified with the functional ingredient, glucosamine, was studied. The beverage was found not to be mutagenic, clastogenic, cytotoxic, or genotoxic, as determined by the bacterial reverse mutation assay, chromosomal aberration assay, mouse micronucleus assay, and mammalian cell gene mutation (L5178Y) assay. The single dose LD50 based on a 14-day acute oral toxicity study is greater than 20,000mg/kgbw, the highest dose tested. In a repeat dose 90-day oral subchronic toxicity study by gavage, 220 animals were randomly assigned to a control group, an untreated group, or one of three experimental groups (10, 20 and 40g/kgbw). No treatment-related significant changes in body weight, food and water consumption, ophthalmology, organ weights, urinanalysis, hematological and clinical chemistry, or gross pathology, were observed in surviving animals compared to the control groups. Three animals died midway through the observation period (male, 20g/kgbw/day; male 40g/kgbw/day; and, female, 10g/kgbw/day). These animals died without preceding clinical symptoms, histopathological lesions, or evidence of injury to tissue or organs except for signs of suffocation/aspiration congestion, which was concluded to be due to problems with the gavage administration of the fluid test article, and not due to the test article itself. The NOEAL was determined to be 40g/kgbw/day for male and female rats, which was the highest dose tested. Phylloquinone (vitamin K1) content averaged 21.7μg/100g, comparable to amounts found in iceberg lettuce. In conclusion, the results provide additional experimental evidence that MonaVie Active® juice is non-toxic. © 2010 Elsevier Ireland Ltd.

Schauss A.G.,AIBMR Life Science Inc. | Vertesi A.,Toxi Coop | Endres J.R.,AIBMR Life Science Inc. | Hirka G.,Toxi Coop | And 3 more authors.
Toxicology | Year: 2010

The dietary antioxidant l-(+)-ergothioneine was tested for its potential mutagenic activity using the bacterial reverse mutation assay. The experiments were carried out using histidine-requiring auxotrophic strains of Salmonella typhimurium (Salmonella typhimurium TA98, TA100, TA1535 and TA1537), and the tryptophan-requiring auxotrophic strain of Escherichia coli (Escherichia coli WP2 uvrA) in the presence and absence of a post-mitochondrial supernatant (S9) prepared from livers of phenobarbital/β-naphthoflavone-induced rats. The revertant colony numbers of vehicle control plates with and without S9 Mix were within the corresponding historical control data ranges. The reference mutagen treatments (positive controls) showed the expected, biologically relevant increases in induced revertant colonies in all experimental phases in all tester strains. No biologically relevant increases were observed in revertant colony numbers of any of the five test strains following treatment with l-(+)-ergothioneine at any concentration level, either in the presence or absence of metabolic activation (S9 Mix) in the performed experiments. On the basis of the data reported, it can be concluded that l-(+)-ergothioneine did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Thus l-(+)-ergothioneine has no mutagenic activity on the applied bacteria tester strains under the test conditions used in this study. Research is continuing to define the role of l-(+)-ergothioneine in disease pathophysiology. Further studies on its safety are suggested. © 2010 Elsevier Ireland Ltd.

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