Toxicological evaluation of a dietary supplement formulated for male sexual health prior to market release
| Autor: | J. Neal-Kababick, I. Financsek, K.A. Jade, J. Horváth, John R. Endres, Alexander G. Schauss, Amy E. Clewell, I. Qureshi |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Drug
Male Salmonella typhimurium media_common.quotation_subject Sexual Behavior Drug Evaluation Preclinical CHO Cells Pharmacology Toxicology medicine.disease_cause Median lethal dose Ames test Lethal Dose 50 Rats Sprague-Dawley Clastogen Mice Cricetulus Cricetinae medicine Animals Humans Toxicity Tests Chronic Micronuclei Chromosome-Defective media_common Mice Inbred BALB C Micronucleus Tests Dose-Response Relationship Drug business.industry Drug Adulteration General Medicine medicine.disease Rats Erectile dysfunction Consumer Product Safety Micronucleus test Dietary Supplements Mutation Female business Drug Contamination Genotoxicity |
| Zdroj: | Regulatory toxicology and pharmacology : RTP. 57(1) |
| ISSN: | 1096-0295 |
| Popis: | The dietary supplement, 112 Degrees, was formulated with the goal of supporting sexual functioning in men. Due to rampant problems with drug adulteration for this category of products, a comprehensive screening for active pharmaceutical agents, with an emphasis on drugs prescribed for erectile dysfunction such as type 5 phosphodiesterase (PDE-5) inhibitors, and known unapproved PDE-5 drug analogues, was performed along with preclinical toxicology studies prior to the introduction of this product into the marketplace. 112 Degrees was found to be free of all pharmaceutical adulterants tested, and was not mutagenic, clastogenic, or genotoxic as demonstrated by the Ames test, chromosomal aberration assay, and mouse micronucleus assay, respectively. The LD(50) in the 14-day acute oral toxicity study was greater than 5000 mg/kg, the highest dose tested. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect