Pilot Study of Acute and Subchronic Oral Toxicological Biosafety Evaluation of Resorcinol-Formaldehyde Aerogel Nanomaterial in Kunming Mice.

Abstract

Resorcinol-formaldehyde aerogel (RFa) is a unique nanomaterial composed of polymer nanoparticles with a three-dimensional network structure. Our previous studies have demonstrated its application in the separation and purification of alkaloids, and we are exploring its application potential as the drug delivery carrier. Therefore, it is necessary to comprehensively understand the in vivo toxicity profile of RFa and evaluate its oral biosafety. In this work, we systematically evaluated the in vivo acute toxicity and subchronic oral toxicity of RFa in both male and female Kunming mice. During the 14-day acute toxicity test, the dose administered (M = 580 mg/kg) was converted from the clinical dose of adsorbed alkaloids on RFa. The mice were gavaged only once and were observed continuously for 14 days. There were no abnormalities, and pathological changes in the major organs (heart, liver, spleen, lungs, kidneys, testes, and ovaries) were detected, followed by the 12-week subchronic toxicity test at the dose of 1/4M, 1/2M, and M. All mice were administered orally once daily and regularly observed throughout the experimental period. As a result, no abnormalities were found in body weights, food intake, and organ coefficients. Tissue section revealed no pathological changes in the major organs. In addition, there were no significant differences in hematological, blood biochemical, and coagulation parameters in both male and female mice compared to control group. These results showed that RFa was well tolerated at these dosage levels and did not cause significant toxic effects in Kunming mice. This study, as part of a broad research program on the biosafety of aerogel nanomaterials, provided the biosafety assurance for the subsequent study of RFa in biomedical applications.