ATOSSICITA' DEL FOLLIGEN
Folligen Safety Background
Because of the type of questions and comments on Folligen, I am detailing some of the safety studies that we had performed on the product. Any substance that is to be repeatedly applied to the scalp should be exceedingly safe and have independent proof of this safety profiles. The studies were performed at UCSF and the Shanghai Medical University.
1. Patch test
Folligen is applied to the sun under a occlusive plastic barrier for 5 days. Results - No edidence of irritation.
2. LD 50 oral.
Folligen was given to mice at 5ml/Kg. Result: After one week, there was no evidence of toxicity.
3. Acute Skin Irritation test
Folligen was used on guinea pig skin.Result: There was no evidence of erythema or irritation. The index of irritation was 0, and by the criteria of skin irritation degree, a rating of 0-0.4, is classified as a non-irritant.
4. Induced Allergic Test
The human induced allergic test was performed by GB79919-87. Results: Folligen was classified as a non-allergen.
5. Ames Test
Folligen was tested for induction of DNA damage in strains TA97, TA98, TA100 and TA102. Folligen was added with and without the S9 activator system at 10mg/dish, 1 mg/dish, 0.1 mg/dish and 0.01 mg/dish. Results: The Ames test was negative, there was no evidence of DNA damage
6. Test for Bacterial Contamination
Samples of Folligen, 2 months old and 14 months old, were tested for the presence of viable microbes of bacterial or fungal origin. Folligen was placed in microbial growth mediums (liquid BH1B medium and on solid SB agar plates) and incubated 30 degrees centigrade (about the temperature of the scalp) for 72 hours. Result: The was no growth of microorganisms in the systems and Folligen was free of viable microbes.
7. Test for effect on bacterial growth.
Since the scalp has a resident bacterial population, we determined whether Folligen would affect bacterial growth. Microorganisms were grown in culture plates. These were Escherichia coli (ATCC25922), pseudomonas aeruginosa (ATCC9027), staphyloccus aureus (ATCC6538), staphyloccus epidermis (ATCC12228), candida albicans (ATCC18804) and streptococcus faecalis (ATCC29212).
Result: Folligen inhibited the growth of all the microorganisms and was most inhibitory on pseudomonas, staphlococcus, and streptococcus.
Loren Pickart, Ph.D.