Safety assessment was based upon physical examinations, abdominal ultrasound, EKG, thoracic X-ray and full clinical chemistry and hematology. Any possible adverse events or side effects were also monitored.
All clinical chemistry and hematology tests following 30 days of treatment were found to be normal. All physical examinations, including abdominal ultrasound, EKG’s and X-Rays were found to be in normal in all ranges following treatment. There was no sign of allergic responses or any form of anaphylactic response. T
Four distinct studies were performed including: a maximal tolerated dose/LD50 experiment in mice, bone marrow micro-nucleus assay for mutagenicity, Ames test, and the mouse sperm cell deformity assay.
In the study on mice the used dose represented approximately 24 to 240 times the standard human dose used in AcnEase. The mice were observed for 2 weeks for all signs and symptoms of toxicity.
There were no overt signs of toxicity and no recorded deaths determined for both males and females.
The use of the Ames test is a standard method used to explore the mutagenic potential of test articles. The experiments are performed on the active ingredients directly and in a second test following incubation with mircrosomal enzymes. The drugs are incubated with the liver microsomes to mimic the effect of liver metabolism on the active ingredients to insure that metabolites of the drug do not possess mutagenic potential. The test is performed in 4 separate bacterial strains.
The results clearly demonstrated that AcnEase is not mutagenic in the Ames Assay when tested directly or following incubation with mircrosomal enzymes.
The purpose of these experiments is to determine if AcnEase will induce chromosomal aberrations, which is an index of mutagenicity and carcinogenicity. 50 Kunming mice (25 males and 25 females) weighing between 35-30 grams were used in this study.The results clearly demonstrated that AcnEase® treatment does not induce changes in bone marrow chromosomes supporting the position that the product is not likely to induce mutagenic are carcinogenic changes in cells.
This assay is performed to determine if AcnEase will induce aberrations in germ cell lines. The experiments were performed in 25 male Kunming mice 25-35 grams in weight.
The results demonstrated no statistically significant difference between the control group and any of the AcnEase tested groups. The results confirmed that AcnEase does not adversely affect germ cell lines.