Effect of a botanical composition, UP446, on respiratory, cardiovascular and central nervous systems in beagle dogs and rats.
Extensive safety evaluation of UP446, a botanical composition comprised of standardized extracts from roots of Scutellaria baicalensis and heartwoods of Acacia catechu, has been reported previously. Here we carried out additional studies to assess the effect of UP446 on respiratory, cardiovascular and central nervous (CNS) systems. A Functional observational battery (FOB) and whole body plethysmography system in rats and implanted telemetry in dogs were utilized to evaluate the potential CNS, respiratory and cardiovascular toxicity, respectively. UP446 was administered orally at dose levels of 800, 2000 and 5000 mg/kg to SpragueDawley rats and at 4 ascending dose levels (0, 250, 500 and 1000 mg/kg) to beagle dogs. No abnormal effects were observed on the cage side, open field, hand held, and sensori-motor observations suggestive of toxicity in respiratory, cardiovascular and central nervous (CNS) systems. Rectal temperatures were comparable for each treatment groups. Similarly, respiratory rate, tidal volume and minute volume were unaffected by any of the treatment groups. No UP446 related changes were observed on blood pressure, heart rate and electrocardiogram in beagle dogs at dose levels of 250, 500 and 1000 mg/kg. Some minor incidental, non-dose correlated changes were observed in the FOB assessment. These data suggest that UP446 has minimal or no pharmaco-toxicological effect on the respiratory, cardiovascular and central nervous systems.
['Yimam|Mesfin|M|', 'Lee|Young Chul|YC|', 'Jia|Qi|Q|']
D000284:Administration, Oral D000818:Animals D001522:Behavior, Animal D002319:Cardiovascular System D002490:Central Nervous System D004285:Dogs D004305:Dose-Response Relationship, Drug D004562:Electrocardiography D006439:Hemodynamics D008297:Male D010936:Plant Extracts D028321:Plant Preparations D010993:Plethysmography, Whole Body D017207:Rats, Sprague-Dawley D012119:Respiration D012137:Respiratory System D018570:Risk Assessment D013686:Telemetry D013997:Time Factors D018675:Toxicity Tests
Central nervous system Scutellaria baicalensis Acacia catechu Cardiovascular system Respiratory system