It was reported that novel
O, O'-diethyl-(S, S)-ethylenediamine- N, N'-di-2-(3-cyclohexyl) propanoate dihydrochloride (
DE-EDCP) displayed in vitro antiproliferative activity on several human and mouse
cancer cell lines, which was comparable to that of the prototypical anticancer drug
cisplatin. In order to reveal its toxicity profile, acute and repeated-dose toxicity studies were performed in Naval Medical Research Institute (NMRI) Han mice. The intravenous LD50 values of
DE-EDCP were found to be 95.3 and 101.3 mg/kg
body weight in female and male mice, respectively. In the subacute toxicity study,
DE-EDCP was administered intravenously at the doses of 15, 25, and 40 mg/kg/day for a period of 28 days. There were no adverse effects on general condition, growth, feed and water consumption, and hematological parameters. There was a significant increase in
urea and
alanine aminotransferase in female mice and
aspartate aminotransferase and
alkaline phosphatase in both genders in 40 mg/kg/day dose-treated group. The histopathological changes confined to the liver and kidney, but in other organs were not found. Satellite group revealed that changes in the kidney and liver were less pronounced, suggesting their reversibility. Interactions with
DNA could also be of importance for understanding
DE-EDCP toxic side effects. Hyperchromic effect obtained with ultraviolet-visible, suggested electrostatic interactions between
DE-EDCP and
calf thymus DNA. The toxicity testing of
DE-EDCP was conducted to predict human outcomes.