The French Agency for Food, Environmental and Occupational Health and Safety (Anses) has published its proposal for a harmonised classification for titanium dioxide as a category IB carcinogen.
As of April 2016, the report says, there is one registration for titanium dioxide with 130 members, in the current REACH registration database.
France says that due to the “lack of transparent reporting” on the types and number of compositions considered to be covered, in terms of crystalline phase, morphology and surface chemistry, “the impact on the hazard profile, when the parameters vary, cannot be established from the information included in the registration dossier.”
The registration dossier “clearly states” that all possible variations are considered equivalent in terms of hazard profile, the report says. Taking these statements into account, the approach applied in the REACH dossier was used to support the scope of the proposed entry in Annex VI of CLP.
The report says that in experimental animal studies, lung tumours were reported after inhalation of titanium dioxide (fine rutile, anatase/rutile P25 nano-titanium dioxide and nano-rutile) in rats in an overload context - an impairment of normal pulmonary clearance due to high accumulation of particles.
It says the concept is “relevant for humans, and, in particular, for workers exposed to high dust concentrations”.
“Classification for titanium dioxide as category 1B carcinogen is justified, considering the increase of both malignant and benign lung tumours in one species, reported in two studies by inhalation and two studies by instillation after exposure to it.”
The report adds that since the data provided cannot distinguish if a specific characteristic is linked to such effect, this classification applies to “all existing possible crystal modifications, morphologies and surface chemistries in all possible combinations”.
Commercially, titanium dioxide particles range from non-nano (bulk) to nano sizes that can aggregate or agglomerate.
"No classification needed"
Titanium dioxide producers say it should not be classified in any of its forms for any endpoints.
In a joint statement to Chemical Watch this month, the Titanium Dioxide Manufacturers Association (TDMA) and Titanium Dioxide Industry Consortium (TDIC) said the findings of epidemiology studies of over 24,000 workers in 18 titanium dioxide manufacturing plants, over decades, "showed no adverse health effects from occupational exposure".
TDMA’s and TDIC’s initial review of the French classification proposal did not reveal any "significant, new, or substantially different scientific information" from that presented in previous hazard assessments.
The TDMA and TDIC are evaluating the proposal and preparing a response to the Echa public consultation, "which will rebut the Anses conclusions".
"Based on current and state-of-the art scientific knowledge, the TDMA and TDIC reaffirm the industry’s science-based position that classification of titanium dioxide is not supported or appropriate," the organisations said.
The public consultation will run until 15 July.