Preclinical animal acute toxicity studies of new developed MRI contrast agent based on gadolinium

Acute toxicity test of new developed MRI contrast agent based on disodium salt of gadopentetic acid complex were carried out on Mus musculus and Sprague Dawley rats according to guidelines of preclinical studies [1]. Groups of six animals each were selected for experiment. Death and clinical symptoms of animals were recorded during 14 days. As a result the maximum tolerated dose (MTD) for female mice is 2.8 mM kg of body weight, male mice - 1.4 mM kg, female rats - 2.8 mM kg, male rats - 5.6 mM kg of body weight. No Observed Adverse Effect Dose (NOAEL) for female mice is 1.4 mM kg, male mice - 0.7 mM kg, male and female rats - 0.7 mM kg. According to experimental data new developed MRI contrast agent based on Gd-DTPA complex is low-toxic.