EFSA’s scientific advice will be used by risk managers (the European Commission, Member States) to inform any decisions they take on possible regulatory actions.
In an early study Jani et al. administred rutile TiO2 (500 nm) as a 0.1 ml of 2.5 % w/v suspension (12.5 mg/kg BW) to female Sprague Dawley rats, by oral gavage daily for 10 days and detected presence of particles in all the major gut associated lymphoid tissue as well as in distant organs such as the liver, spleen, lung and peritoneal tissue, but not in heart and kidney. The distribution and toxicity of nano- (25 nm, 80 nm) and submicron-sized (155 nm) TiO2 particles were evaluated in mice administered a large, single, oral dosing (5 g/kg BW) by gavage. In the animals that were sacrificed two weeks later, ICP-MS analysis showed that the particles were retained mainly in liver, spleen, kidney, and lung tissues, indicating that they can be transported to other tissues and organs after uptake by the gastrointestinal tract. Interestingly, although an extremely high dose was administrated, no acute toxicity was observed. In groups exposed to 80 nm and 155 nm particles, histopathological changes were observed in the liver, kidney and in the brain. The biochemical serum parameters also indicated liver, kidney and cardiovascular damage and were higher in mice treated with nano-sized (25 or 80 nm) TiO2 compared to submicron-sized (155 nm) TiO2. However, the main weaknesses of this study are the use of extremely high single dose and insufficient characterisation of the particles.
The report also provides detailed information related to the lithopone manufacturing process flow and various unit operations involved in a manufacturing plant. Furthermore, information related to mass balance and raw material requirements has also been provided in the report with a list of necessary quality assurance criteria and technical tests.
Durabo White, 24.5 per cent zinc sulphide, 51 per cent barium sulphate, 18 per cent white clay, 5.5 per cent infusorial earth.