Mutagenicity Study of VigRX Tablets

This is a mutagenicity safety study, designed to determine whether VigRX tablets have the potential to cause genetic mutations in bacterial cells. The standard method used is the Bacterial Reverse Mutation Assay, commonly known as the Ames Test. It is one of the most widely accepted toxicological screening tools for evaluating the genetic safety of a substance before human use.

The study was conducted by Vedic Lifesciences Pvt. Ltd., Preclinical Division, Mumbai, India, on behalf of the sponsor DM Contact Management, Victoria, British Columbia, Canada. It was performed in compliance with OECD Guideline No. 471.

VigRX tablets were tested against five Salmonella typhimurium tester strains: TA98, TA100, TA102, TA1535, and TA1537. This multi-strain approach is standard practice because different strains detect different types of genetic damage. Together, they provide a comprehensive mutagenicity screen.

Testing was conducted both with and without metabolic activation (S9 fraction prepared from Aroclor 1254-induced rat liver). This matters because some compounds are not themselves mutagenic but may become so after being metabolized in the body. Testing both conditions closes that gap.

The test article was dissolved in dimethyl sulphoxide (DMSO) and applied to bacterial plates using the plate incorporation method. Two separate trials were conducted in triplicates, and all data were expressed as mean standard deviation.

The initial cytotoxicity screening informed the working concentration range. The main mutagenicity assay tested VigRX tablets at concentrations up to 1,000 µg/plate.

Positive controls varied by condition. Without metabolic activation: 2-nitrofluorene, sodium azide, 9-aminoacridine, and mitomycin C. With metabolic activation: 2-aminoanthracene. These are all known mutagens, included to confirm the assay was functioning correctly.

At every concentration tested, in both trials and under both conditions (with and without metabolic activation), the mean revertant colony counts for VigRX tablets were comparable to those of the control and solvent control groups. No statistically significant increase in revertant colonies was observed at any concentration tested.

Positive controls performed as expected, demonstrating 3.0 to 23.5 fold increases in revertant colonies under identical conditions, confirming the validity and sensitivity of the assay.

VigRX tablets are non-mutagenic at the highest concentration tested (1,000 µg/plate) in the Bacterial Reverse Mutation Test across all five Salmonella typhimurium strains tested: TA98, TA100, TA102, TA1535, and TA1537.

In plain terms: VigRX tablets showed no evidence of genetic toxicity at any dose tested. This is one of several independent safety studies supporting the product's purity profile.

 

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