Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In the study of Herbold (1991) no increase in revertants were observed in a bacterial reverse mutation assay (Ames test).

Target compound titanium oxide sulphate hydrolyses easily in contact with wet material, particularly in the physiologically relevant pH range, producing insoluble titanium dioxide precipitate and sulphuric acid. Solid titanium dioxide is not relevant for the assessment of genotoxicity effects. Likewise the acidity of sulphuric acid is to be excluded from this assessment. Based on these grounds, the conduct of the studies on mutagenicity and cytogenicity with mammalian cell lines is proposed to get waived.


Short description of key information:
Titanium oxide sulphate does not have genotoxic properties in a bacterial reverse mutation assay. Studies on mutagenicty and cytogenicity with mammalian cell lines were being waived.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No increase in the number of revertants was observed in a bacterial reverse mutation assay (Ames test). Studies with mammalian cell lines are proposed to get waived. The classification criteria according to regulation (EC) 1272/2008, CLP, or DSD are not met, thus no classification required.