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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.
were no overt signs of toxicity and no recorded deaths determined for both males
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.
results clearly demonstrated that AcnEase is not mutagenic in the Ames Assay
when tested directly or following incubation with mircrosomal enzymes.
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 thatAcnEase®treatment does not induce changes in bone marrow chromosomes supporting theposition that the product is not likely to induce mutagenic are carcinogenicchanges in cells.
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.
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.