The following toxicity studies were conducted by Martin Gilman, Ph.D , of Celsis Laboratory Group in New Jersey.
- Study of acute oral toxicity.
- Study of primary dermal irritation.
- Eight week repeated dose dermal toxicity study in rats.
- Eight week repeated dose dermal toxicity study in rabbits.
- Study of delayed contact hypersensitivity modified buehler method.
- Ames salmonella mutagenicity screen.
In all the toxicity studies, there were no side effects and no toxic results. All studies were conducted in compliance with GLP requirements as outlined in 21 CFR parts 58.
In a human clinical trial conducted in 2004 by a Canadian dermatologist, Dr. Howard Yanofsky, there were “no adverse or unexpected drug related adverse events.”
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