Two Tests Ask the Hardest Questions About Safety. VigRX Passed Both.

There are two safety tests pharmaceutical researchers use to ask the most fundamental questions about any new substance entering the body. One asks whether the ingredient can damage DNA. The other asks how much it takes to be acutely toxic. These are not marketing exercises. They are the same tests the drug industry uses.
VigRX tablet blend underwent both.

The Ames Test: Can the Formula Cause Genetic Mutation?

The Ames Test, formally known as the Bacterial Reverse Mutation Test, is a gold-standard genotoxicity assay used globally to screen substances for mutagenic potential. It was conducted at Pharmaceutical Control and Development Laboratory Co., Ltd., an independent laboratory in Budapest, Hungary, under Good Laboratory Practices (GLP) and according to OECD Test Guideline 471.

The test exposed five strains of Salmonella typhimurium bacteria (TA98, TA100, TA1535, TA1537, and WP2 uvrA) to VigRX tablet blend at six dose levels ranging from 50 to 5,000 micrograms per plate. Testing was conducted both with and without metabolic activation (10% S9 liver fraction), which simulates how the body processes substances. A definitive assay and a repeat assay were both performed.

The study gave a negative result to VigRX tablet blend as test article.

In the language of this test, negative is the result you want. It means no revertant colonies were found in numbers exceeding three times the background average at any dose tested, either with or without metabolic activation. There was no dose-related increase over the full range tested. The results of the repeat assay confirmed the findings of the definitive assay.

The study director, Janos Horvath, M.Sc., signed the final report on April 3, 2007. The conclusion was direct: the test article had no mutagenic effect on any strain used in this test.

The Acute Oral Toxicity Study: How Much Is Too Much?

The Acute Oral Toxicity Study was also conducted by Pharmaceutical Control and Development Laboratory Co., Ltd. in Budapest, under GLP and OECD Guideline 423. The study was designed to determine the oral LD50 of VigRX tablet blend.

Male and female Wistar rats received a single oral dose of VigRX tablet blend at either 2,000 mg/kg or 4,000 mg/kg body weight. All animals were observed for 14 days following treatment for clinical signs, body weight changes, and any abnormal behavior or toxicity.

Individual clinical symptom records for all animals in both dose groups showed the same result: symptom-free across the full 0 to 240 minute observation window. Feeding began naturally at approximately 122 to 132 minutes following treatment, indicating normal physiological behavior.

No deaths occurred. No toxic or other clinical symptoms were apparent. Autopsy revealed no treatment-related pathological changes. A slight lag in body weight gain was noted in the high-dose group, attributed to the doubled dosing volume rather than toxicity.

Conclusion from study director Susan Somfai-Relle, M.D.: The single oral LD50 proved to be higher than 4,000 mg/kg in both males and females. This corresponds to more than 260 times the planned human daily dose of VigRX tablet blend as a dietary supplement.

Why These Two Studies Matter for the Consumer

The Ames Test and the Acute Oral Toxicity Study are not efficacy studies. They do not tell you the formula will work. What they tell you is that the formula will not hurt you at the genetic level, will not cause cellular mutation, and is not acutely toxic at doses far beyond what any person would take.

When VigRX references a safety profile, this is where that claim originates. Independent laboratories. Standardized international protocols. Signed study reports. There is no financial interest in the product on the part of the researchers.

Many supplements have never been near either of these tests.

Study References

Bacterial Reverse Mutation (Ames) Test of VigRX Tablet Blend. Study Code PCDL-0703.
Pharmaceutical Control and Development Laboratory Co., Ltd. Budapest, Hungary. 2007.

Acute Oral Toxicity Study of VigRX Tablet Blend. Study Code PCDL-0702.
Pharmaceutical Control and Development Laboratory Co., Ltd. Budapest, Hungary. 2007.

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