Ukrain: acute toxicity after intravenous, intramuscular and oral administration in rats

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Drugs Exp Clin Res. 2000;26(5-6):157-61.
Ukrain: acute toxicity after intravenous, intramuscular and oral administration in rats.
Hruby R.
Austrian Research Center, Toxicology, Seibersdorf, Austria.

The acute toxicity of Ukrain (1 g/30 ml) was determined after a single intravenous, intramuscular or oral administration in rats, performed in accordance with Good Laboratory Practice and the relevant European Community directive. Groups of five (male and/or female) Him:OFA rats were treated once with the following doses: intravenous route: 1.0 ml/kg (males and females), 1.7 ml/kg (males and females) and 3.0 ml/kg (females); intramuscular route: 5.0 ml/kg (males and females); oral route: 15.0 ml/kg (females), 27.0 ml/kg (males and females) and 50 ml/kg (females). The animals were kept for up to 14 days afterwards while clinical observations and body weight determinations were made and were then necropsied. An intravenous injection of Ukrain (1 g/30 ml) induced immediate effects (short-term unconsciousness, followed by cardiovascular signs and, later, signs of general malaise), which if not lethal, disappeared in a short time. It was found that the intravenous LD50 was greater than 43 mg active ingredient/kg body weight in the males and 76 mg active ingredient/kg body weight in the females. An intramuscular injection of Ukrain (1 g/30 ml) in the maximum technically feasible dose induced some transient signs of minor clinical importance which did not become life threatening. In both sexes the intramuscular LD50 was greater than 165 mg active ingredient/kg body weight.