Abstract |
The test article was administered orally via gavage as a solution in arachis oil BP at dose levels of 10, 22, and 50 mg/kg body weight. Each of the three dose groups consisted of five Sprague-Dawley CD male rats. An additional group of five female rats was dosed at 10 mg/kg body weight to demonstrate that there was not a marked difference in toxicity between sexes with this test material. The animals were observed for mortality and overt signs of toxicity at 0.5, 1, 2, and 4 hours post-test material administration and sd>sequently once daily for 14 days. Individual body weights were recorded on study days 0, 7, and 14 or at time of death. Surviving animals were terminated on study day 14 and subjected to necropsy. All animals that expired on study were also subjected to a gross pathological examination. All the male animals treated at 50 mg/kg body weight were found dead within one to three days following dosing. Systemic signs of toxicity noted in females treated at 10 mg/kg body weight and males treated at 22 and 50 mg/kg body weight were hunched posture, lethargy, and decreased respiratory rate. Additional pharmacotoxic signs in the 50 mg/kg body weight males were ataxia and labored/noisy respirations. Isolated incidents of systemic toxicity noted in one 50 mg/kg body weight male were ptosis, gasping respirations, and red/brown stains around the eyes and nose. Surviving.animals appeared normal throughout the study or recovered within one to two days following dosing. |