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.  

At the present JECFA meeting, the committee considered additional toxicological studies relevant to the safety assessment of the chemical that investigated its toxicokinetics, acute toxicity, short-term toxicity, long-term toxicity and carcinogenicity, genotoxicity, and reproductive and developmental toxicity, as well as special studies addressing its short-term initiation/promotion potential for colon cancer. The experts acknowledged that a large number of toxicological studies have been conducted using test materials, including nanoparticles, having size distributions and physico-chemical properties not comparable to real-world uses of titanium dioxide as a food additive. The studies on non-representative materials were evaluated by JECFA, but the committee concluded that such studies are not relevant to the safety assessment of the additive.