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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.

Clewell A.,AIBMR Life Science Inc. | Qureshi I.,AIBMR Life Science Inc. | Endres J.,AIBMR Life Science Inc. | Horvath J.,Pharmaceutical Control and Development Laboratory | And 4 more authors.
Regulatory Toxicology and Pharmacology | Year: 2010

The dietary supplement, 112 Degrees™, was formulated with the goal of supporting sexual functioning in men. Due to rampant problems with drug adulteration for this category of products, a comprehensive screening for active pharmaceutical agents, with an emphasis on drugs prescribed for erectile dysfunction such as type 5 phosphodiesterase (PDE-5) inhibitors, and known unapproved PDE-5 drug analogues, was performed along with preclinical toxicology studies prior to the introduction of this product into the marketplace. 112 Degrees™ was found to be free of all pharmaceutical adulterants tested, and was not mutagenic, clastogenic, or genotoxic as demonstrated by the Ames test, chromosomal aberration assay, and mouse micronucleus assay, respectively. The LD50 in the 14-day acute oral toxicity study was greater than 5000mg/kg, the highest dose tested. © 2009 Elsevier Inc.

Sipka S.,Debrecen University | Beres A.,Pharmaceutical Control and Development Laboratory | Bertok L.,National Research Institute of Radiobiology and Radio Hygiene | Varga T.,Pharmaceutical Control and Development Laboratory | Bruckner G.,University of Kentucky
Innate Immunity | Year: 2015

The observations on the protective effect of bacterial endotoxin in farm-derived cow's milk on childhood asthma and allergy are contradictory. The aim of this study was to determine the endotoxin levels in a'farm-derived whole raw' and 'processed shop' sources of cow's milk, and to test how the temperature and storing conditions might alter their endotoxin concentrations. Milk was collected from farms and shops. The level of endotoxin was measured by micro (gel-clot) Limulus amebocyte lysate test expressed as EU/ml. The concentration ranges of endotoxin were much higher and more widely scattered in the samples of whole raw farm milk than in the processed shop milk. Cold storage or heating increased the endotoxin concentrations in all samples of farm milk, but not in the processed shop milk. These results show that elevated levels of endotoxin in raw farm milk samples can occur from the cowshed or be formed during storage. In processed shop milk, storage does not cause any changes in the amount of endotoxin. Therefore, it is consistent that the handling and storage of raw milk alters the endotoxin concentrations, which may explain previous contradictory findings regarding the beneficial modulating effects on innate immunity toward allergy prevention in early childhood. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

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