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Comprehensive Toxicological Evaluation of 3D-Printed Hydroxyapatite (3DPHA) for Bone Grafting Applications
Faungchat Thammarakcharoen1, Autcharaporn Srion1, Waraporn Suvannapruk1
1Biofunctional Materials and Devices Research Group, National Metal and Materials Technology Center (MTEC), National Science and Technology Development Agency (NSTDA), Khlong Nueng, Khlong Luang, Pathum Thani 12120, Thailand.
International Journal of Molecular Sciences
|January 28, 2026
Summary
Binder jet 3D-printed hydroxyapatite (3DPHA) scaffolds are safe for bone grafting. Rigorous testing confirmed the material is chemically pure and free from toxic effects, paving the way for clinical use.
Area of Science:
- Biomaterials Engineering
- Regenerative Medicine
- Materials Science
Background:
- Binder jet 3D printing with phase transformation offers controlled architecture for bone grafting scaffolds.
- The toxicological profile of this 3D-printed hydroxyapatite (3DPHA) material is currently unknown.
- Establishing safety is crucial for clinical translation of novel bone graft substitutes.
Purpose of the Study:
- To conduct a comprehensive compositional and toxicological assessment of 3DPHA produced via a calcium sulfate transformation route.
- To validate the chemical purity and biological safety of 3DPHA for bone grafting applications.
- To establish a regulatory foundation for the clinical translation of 3DPHA.
Main Methods:
- Fabrication of 3DPHA scaffolds using binder jet 3D printing and low-temperature phase transformation.
- Compositional analysis to determine phase purity and trace elemental impurities.
- In vitro toxicological assays including cytotoxicity, irritation, sensitization, and mutagenicity tests.
Main Results:
- The fabricated 3DPHA exhibited phase-pure hydroxyapatite with a Ca/P ratio consistent with non-stoichiometric HA.
- Low levels of trace elemental impurities were detected in the material.
- In vitro assays demonstrated no cytotoxic, irritant, sensitizing, or mutagenic effects.
Conclusions:
- 3DPHA produced via the calcium sulfate transformation route is chemically pure and biologically safe.
- The material complies with international benchmarks for safety and purity.
- This study provides a standardized validation, confirming 3DPHA's readiness for clinical translation as a bone-graft material.
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