Abstract

The paper presents the results of a study on the possibility of toxic effects developing in contact with the antitumor drug – lysomustine - to assess the health risk in the manufacture of the finished dosage form and its use. The work was performed on 40 outbred rats, 40 guinea pigs and 114 outbred mice. The experimental study has showed that lysomustine does not irritate intact skin, is not a potential allergen, has no skin-resorptive effect, does not cause reproductive disorders. The drug reveales mutagenic properties inherent in many cytostatics, representatives of the class of N-nitrosoalkylureas. The research results allow to conclude that the presence of the drug in the air of industrial premises and on the skin of workers in its manufacture and use of the finished dosage form is unacceptable.

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