Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2592473 | Regulatory Toxicology and Pharmacology | 2010 | 7 Pages |
Abstract
The dietary supplement, 112 Degreesâ¢, 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 LD50 in the 14-day acute oral toxicity study was greater than 5000 mg/kg, the highest dose tested.
Keywords
LD50cGMPGAPDHPDESOPEuterpe oleraceaAPImRNAPDAOECDLSDFBSTribulus terrestrisbDNADMEMButea superbaPBSFDA3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromideDMSOMTTv/vphoto diode arrayAçaíChromosomal aberrationSafetyanalysis of varianceANOVAcurrent Good Manufacturing PracticesPanax ginsengvolume per volumeleast significant differenceDimethyl sulfoxidemessenger ribonucleic acidstandard operating procedureFood and Drug AdministrationOrganization for Economic Cooperation and Developmentfetal bovine serumToxicologyAlternative medicineMass spectrometrySexual functioningPhosphate buffered salinePhosphodiesteraseDulbecco’s modified eagle’s mediumActive Pharmaceutical IngredientMicronucleushigh performance liquid chromatographyHPLCglyceraldehyde-3-phosphate dehydrogenase
Related Topics
Life Sciences
Environmental Science
Health, Toxicology and Mutagenesis
Authors
A. Clewell, I. Qureshi, J. Endres, J. Horváth, I. Financsek, J. Neal-Kababick, K. Jade, A.G. Schauss,