BIOACTIVES

Bioactives are naturally occurring components that are known to affect and modulate a wide range of enzymatic routes, contributing significantly to health when they are consumed throughout life as part of the daily diet

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TOXICOLOGICAL STUDIES

Bacterial mutation in S.typhimurium and E.Coli

The bacterial mutation assay was performed in order to assess the compound’s ability to induce gene mutations in S.typhimurium and E.Coli.
The reverse mutation assay was run in bacterial strains already mutant at a locus whose phenotypic effects are easily detected, and, since many chemicals can demonstrate mutagenic activity only after metabolism to some reactive forms, the test was performed in presence and in absence of a rat liver metabolic system (S9 microsomal fraction).

Results

VitaMK7® does not induce reverse mutation in S.typhimurium and E.Coli at doses up to 5,000 µg/ml.


Mutation in L5178YTK +/- mouse lymphoma cell

The assay was done in order to confirm the inability of vitaMK7® to induce mutation in L5178YTK +/- mouse lymphoma cells cultured after in vitro treatment and in absence or presente of a rat liver microsomal system.

Results

The test concluded that vitaMK7® does not induce mutation at concentrations up to 1,000 µg/ml.


Chromosome aberrations in chinese hamster ovary cells (CHO) in vitro

The assay was made in order to demonstrate the inability of vitaMK7® to induce any chromosomal aberration in presence or absence of a S9 liver microsomal fraction.

Results

No chromosomal aberrtions were observed in CHO after in vitro treatment with concentrations of vitaMK7® up to 125 µg/ml.


Single dose oral toxicity

The acute toxicity of vitaMK7® was assessed in rats or both sexes, dosing the product by gavage at 2,000 mg/kg level. No mortality occured at this dose and during the oservation time, and no clinical significant signs were oserved in any animal. Changes in body weight were not relevant and no anomalies were recorded at the autopsy performed after the observation time.

Results

The lack of mortality points out that the maximum tolerated dose is greater than 2,000 mg/kg body weight, a dose about 20 times the one suggested for human use.


28 days repeated dose toxicity in rats

Repeated dose toxicity was investigated for vitaMK7® in rats, after daily oral administration for 28 days and a 15 days recovery period.
The study consisted of 4 group of 5 male and 5 female rats. Control and high dose groups included 5 additional animals per sex which were sacrificed after 2 weeks of recovery.
No toxicologically relevant changes were observed at any of the dose levels investigated.

Results

The No Observed Adverse Effect Level (NOAEL) in this study is considered to be 100 mg/kg/day, which is the highest dose level investigated.


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