Sub-acute Sytemic Toxicity Evaluation of Phase Pure Hydroxyapatite in Mus musculus

Abstract

To prevent a toxic or harmful effect, the biocompatibility of wear debris particles produced by implants and their coatings is particularly crucial. As a follow-up to our previously published work on pilot-scale HA synthesis, the current research looked at the toxicological features of phase pure HA in a mouse animal model. Preclinical biological effects of intraperitoneally administered particles of HA up to a concentration of 100 mg/kg in swiss albino mice were studied over a 28-day period, according to ISO 10993-part 11 and part 12 guidelines. Particle
impacts on serum biochemistry levels and full hemogram were investigated. Histopathological examinations were performed on spleen, heart, lung, kidney, and liver tissues. The current study found that all of the experimental mice, both male and female, lived well with a gradual increase in body weight and no notable changes in complete hemogram or blood biochemistry. The lack of any tissue-level toxicity signal by injected HA particles was verified by thorough histological investigation. When compared to commercial HA powders, these good results show the non-toxic nature of phase pure HA powders. This novel class of HA powders may be beneficial in terms of extended usage for joint arthroplasties, enhancing patient compliance and reducing implant failure.