Biosecurity Test of Conjugated Nanoparticles of Chitosan-Protoporphyrin IX-Vitamin B9 for Their Use in Photodynamic Therapy.

Nanotechnology proposes new applications for the development of nanotransporters and active targeting molecules with the use of biodegradable polymeric nanoparticles to improve the specificity towards target cells. However, these products must comply with safety tests to be endorsed as therapeutic alternatives by regulatory organizations. The goal of this work was to evaluate the biosafety (cytotoxicity and genotoxicity) of chitosan polymeric nanoparticles conjugate with protoporphyrin IX and vitamin B9 (CNPs-PpIX-B9) that were previously optimized from the established protocol by our laboratory and tested in CHO-K1 cells by bioassay following the recommendations of the chromosomal aberrations test by OECD 473 (2016) guideline. The conjugate did not show evidence of genotoxicity (clastogenicity). Surprisingly, the significant differences between the treatments performed and the negative control do not represent increases in chromosomal aberrations, whereby the safe concentrations to use the conjugate without inducing cytotoxic or genotoxic effects are less than 0.25 mg/mL. Since it induced a significant decrease of structural chromosomal aberrations, generating a positive effect on the genomic stability of CHO-K1 cells cultured in this test system.