CSPI says it might reconsider its rating if specifications for food-grade titanium dioxide in the U.S. are updated to ensure nanoparticles are minimized, and new studies are conducted to assess its capacity to cause cancer or other health problems. 

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The biological activity, biocompatibility, and corrosion resistance of implants depend primarily on titanium dioxide (TiO₂) film on biomedical titanium alloy (Ti6Al4V). This research is aimed at getting an ideal temperature range for forming a dense titanium dioxide (TiO₂) film during titanium alloy cutting. This article is based on Gibbs free energy, entropy changes, and oxygen partial pressure equations to perform thermodynamic calculations on the oxidation reaction of titanium alloys, studies the oxidation reaction history of titanium alloys, and analyzes the formation conditions of titanium dioxide. The heat oxidation experiment was carried out. The chemical composition was analyzed with an energy dispersive spectrometer (EDS). The results revealed that titanium dioxide (TiO₂) is the main reaction product on the surface below 900°C. Excellent porous oxidation films can be obtained between 670°C and 750°C, which is helpful to improve the bioactivity and osseointegration of implants.

Additionally, the committee noted that the available data did not provide convincing evidence of genotoxicity for titanium dioxide as a food additive, but recognized the limitations in current methodologies with respect to the testing of poorly soluble particulate materials. Although there were uncertainties in the genotoxicity data, the experts took into account the fact that the additive was not carcinogenic in adequately conducted two-year studies in mice and rats at doses of up to 7,500 mg/kg BW per day for mice, and 2,500 mg/kg BW per day for rats, the highest doses tested. There was also no evidence of reproductive or developmental toxicity in studies in rats at doses up to 1,000 mg/kg BW per day, the highest doses tested.  

In a 2016 study published in Scientifica (Cairo), Egyptian researchers examined the effects of titanium dioxide nanoparticles on the organs of mice by orally administering the food additive daily, for five days. The results showed that the exposure produced “mild to moderate changes in the cytoarchitecture of brain tissue in a time dependent manner.” Furthermore, “Comet assay revealed the apoptotic DNA fragmentation, while PCR-SSCP pattern and direct sequencing showed point mutation of Presenilin 1 gene at exon 5, gene linked to inherited forms of Alzheimer’s disease.” The researchers wrote: “From these findings, “the present study concluded that TiO2NPs is genotoxic and mutagenic to brain tissue which in turn might lead to Alzheimer’s disease incidence.”