The current study described the synthesis and the in vivo acute oral toxicity evaluations in Sprague Dawley rats. The compounds were characterized by elemental analyses, LC-MS, FTIR, (1)H NMR, (13)C NMR and UV-visible spectroscopy. In the acute toxicity study, a single administration of the compounds was performed orally to the rats at the single doses of 2000 mg/kg and they were then monitored for possible side effects, mortality or behavioral changes up to 14 days. The serum level of aspartate (AST), alanine aminotransferases (ALT), alkaline phosphate (ALP), triglyceride, high density lipoprotein (HDL), immunoglobulins (GAM) and the C-reactive proteins did not significantly change. The hematological indices white blood cells (WBC), haematocrit (HCT), red blood cells (RBC), mean corpuscular volume (MCV), mean corpuscular haemoglobin concentration (MCHC), and mean corpuscular hemoglobin (MCH) were within the normal range. The renal function indices examined were also within the reference range. Generally, the compounds exhibited low toxic effects as required for further in vivo therapeutic studies.
The protective role of Tropaelum majus (T.majus) methyl alcohol extract and vitamin E in the case of toxic effect induced by diethyl maleate was evaluated. Forty-two male albino rats were divided into seven groups of six rats each for 15 days. Group 1: normal control group. Group 2: taken daily oral dose of paraffin oil (0.25ml/100g b.wt rat). Group 3: received daily oral dose of vitamin E (100mg/kg b.wt rat). Group 4: taken daily oral dose of 10% of the LD50 of T.majus methyl alcohol extract. Groups 5–7: injected intra-peritoneally with diethyl maleate (5 μl/100g b.wt rat) but groups 6 and 7 received a daily oral dose of either vitamin E or 10% of the LD50 of T.majus methyl alcohol extract 1h prior to diethyl maleate injection. The present results revealed that diethyl maleate induced serum aspartate and alanine aminotransferases enzymes activities decreased in serum, but their activities in the hepatic tissue showed an increase. Glutathione and glucose-6-phosphate dehydrogenase levels showed a decrease, but thiobarbituric acid reactive substances level showed an increase in both serum and liver tissue. Serum and liver proteins decreased in serum and liver tissue. A significant decrease in blood parameters (hemoglobin, hematocrit, as well as red and white blood cells) and serum glucose occurred. Histopathological results showed that diethyl maleate induced a hoop of edema in the hepatic periportal area; while T.majus methyl alcohol extract or vitamin E prior to diethyl maleate injection shift blood and liver toxicity induced by diethyl maleate towards normal values and preserved hepatic lobular architecture. In conclusion, pre-treatment with either T.majus methyl alcohol extract or vitamin E provide protection against blood and liver toxicity induced by diethyl maleate in rats, these results were confirmed by histological examinations.