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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).
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.
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.
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.
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.