Preclinical study of reproductive toxicity of a drug based on an aqueous solution of fullerene С60 for the treatment of food allergies

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Abstract

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.

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About the authors

Elena V. Kovaleva

Research Center for Toxicology and Hygienic Regulation of Biological Products — Branch of the National Research Center — Institute of Immunology Federal Medico-Biological Agency

Author for correspondence.
Email: e-kovaleva@yandex.ru
ORCID iD: 0009-0003-8457-7391
SPIN-code: 2952-1038
Россия, Serpukhov

Yulia V. Ivanova

Research Center for Toxicology and Hygienic Regulation of Biological Products — Branch of the National Research Center — Institute of Immunology Federal Medico-Biological Agency

Email: ivanova-juliya@yandex.ru
ORCID iD: 0009-0009-1901-7244
SPIN-code: 5919-6840
Россия, Serpukhov

Nikolay M. Onatsky

Research Center for Toxicology and Hygienic Regulation of Biological Products — Branch of the National Research Center — Institute of Immunology Federal Medico-Biological Agency

Email: onatsky@toxicbio.ru
ORCID iD: 0009-0001-4826-7092
SPIN-code: 9404-4895

MD, Cand. Sci. (Biology)

Россия, Serpukhov

Vitaliia A. Shangaraeva

Research Center for Toxicology and Hygienic Regulation of Biological Products — Branch of the National Research Center — Institute of Immunology Federal Medico-Biological Agency

Email: vitaliyablik@gmail.com
ORCID iD: 0009-0005-4617-1141
SPIN-code: 7381-4940

MD, Cand. Sci. (Biology)

Россия, Serpukhov

Denis S. Gorshenin

National Research Center — Institute of Immunology Federal Medico-Biological Agency

Email: dgorhenin63@gmail.com
ORCID iD: 0000-0002-1926-6090
SPIN-code: 5426-1810
Россия, Moscow

Elena N. Baraboshkina

National Research Center — Institute of Immunology Federal Medico-Biological Agency

Email: en.baraboshkina@nrcii.ru
ORCID iD: 0009-0002-0981-5540
SPIN-code: 3080-0926

MD, Cand. Sci. (Biology)

Россия, Moscow

Anastasiia A. Galkina

National Research Center — Institute of Immunology Federal Medico-Biological Agency

Email: anastasia.a.galkina@gmail.com
ORCID iD: 0000-0003-4521-0813
SPIN-code: 7329-0197
Россия, Moscow

Darya K. Bolyakina

National Research Center — Institute of Immunology Federal Medico-Biological Agency

Email: bolyakina.dasha@gmail.com
ORCID iD: 0009-0006-2223-1514
SPIN-code: 4207-9481
Россия, Moscow

Veronika A. Parshina

National Research Center — Institute of Immunology Federal Medico-Biological Agency

Email: parshina.nicka@yandex.ru
ORCID iD: 0009-0001-7678-2489
SPIN-code: 1883-8361
Россия, Moscow

Renata A. Kurmasheva

National Research Center — Institute of Immunology Federal Medico-Biological Agency

Email: renata.adilevna@yandex.ru
ORCID iD: 0009-0003-8703-5686
SPIN-code: 2321-4718
Россия, Moscow

Nadezda N. Shershakova

National Research Center — Institute of Immunology Federal Medico-Biological Agency

Email: nn.shershakova@nrcii.ru
ORCID iD: 0000-0001-6444-6499
SPIN-code: 7555-5925

MD, Dr. Sci. (Biology)

Россия, Moscow

Larisa V. Mikhina

Research Center for Toxicology and Hygienic Regulation of Biological Products — Branch of the National Research Center — Institute of Immunology Federal Medico-Biological Agency

Email: larisa_mihina@mail.ru
ORCID iD: 0000-0003-4931-5380
SPIN-code: 4040-9486

MD, Cand. Sci. (Biology)

Россия, Serpukhov

Musa R. Khaitov

National Research Center — Institute of Immunology Federal Medico-Biological Agency; The Russian National Research Medical University named after N.I. Pirogov

Email: mr.khaitov@nrcii.ru
ORCID iD: 0000-0003-4961-9640
SPIN-code: 3199-9803

MD, Dr. Sci. (Medicine), Professor, corresponding member of Russian Academy of Sciences

Россия, Moscow; Moscow

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Supplementary files

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2. Fig. 1. Morphometric indices of fetal development in the antenatal period.

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3. Fig. 2. Time of physical parameters maturation of offspring.

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