Nano-hydroxyapatite in oral care cosmetics: characterization and cytotoxicity assessment.
Level 5 - mechanism / opinion, no new human data
Bench research / in vitro and ex ovo laboratory study with no human clinical data
PubMed 31363145 · doi:10.1038/s41598-019-47491-z
What was done
The authors characterized a commercially available nano-hydroxyapatite formulation (morphology, phase, and chemical composition) and evaluated its safety in vitro under conditions designed to simulate tooth brushing and standard oral care product concentrations. Safety endpoints included cytocompatibility in human gingival fibroblasts and irritation potential using the in vitro HET-CAM assay.
What was found
The abstract reports no numerical values. It states that the nanoparticles exhibited a rod-like morphology, were cytocompatible without altering the normal behaviour of human gingival fibroblasts, and showed no irritation potential in the HET-CAM assay.
Why it matters
This study provides in vitro and ex ovo safety data addressing concerns raised by the European Scientific Committee on Consumer Safety regarding the cytocompatibility and irritation risk of specific rod-like nano-hydroxyapatite used in oral care cosmetics.
Limits
This is an in vitro and ex ovo bench study with no in vivo or human clinical testing. The abstract provides no quantitative metrics, exposure durations, sample sizes, or comparison to other nanoparticle morphologies, and the findings cannot be generalized beyond the single commercial product tested.
Cited by
- context European safety regulators withheld approval of nanohydroxyapatite for approximately 12 years due to concerns regarding calcification buildup in arteries.