Preclinical study of reproductive toxicity of a drug based on an aqueous solution of fullerene С<sub>60</sub> for the treatment of food allergies

BACKGROUND: The incidence of food allergy in adults and children is very high. The key approach in the therapy of food allergy can be quality drug selection. New synthetic derivatives of fullerene, a high-tech hydrocarbon, can become such drugs. A unique biocompatible method for obtaining a stable aqueous dispersion of fullerene C60 (ADF-C60) as the main component for drugs for the treatment of allergic diseases has been developed. In this article, reproductive toxicity of the drug ADF-C60, currently in preclinical safety studies, was studied in female white outbred rats. Due to its properties, the ADF-C60 is promising for treatment of food allergy and can presumably be used during pregnancy. AIM: Preclinical study of reproductive toxicity of an ADF-C60 in the antenatal and postnatal periods of rat offspring development with oral administration to the mother generation during pregnancy. MATERIALS AND METHODS: Female rats were orally administered the ADF-C60 in 1-, 5-, and 50-fold therapeutic doses recommended for humans during the whole pregnancy. The general parameters of embryotoxic and teratogenic effects of the ADF-C60 before and after birth were studied. RESULTS: No evidence of embryotoxic and teratogenic effects of the ADF-C60 was found during the study of gestational parameters and general fetuses development. No adverse effects of the ADF-C60 were revealed during observation of postnatal development of offspring. CONCLUSION: ADF-C60 for the treatment of food allergy has no reproductive toxicity at doses up to 50 times higher than the therapeutic dose. After the conducted experiments it is possible to assume a significant probability of using the ADF-C60 during pregnancy, but additional preclinical and clinical studies are required to substantiate the obtained conclusion.