Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Parameter:
SI
Value:
< 3
Test group / Remarks:
25%
Remarks on result:
other: see Remarks
Remarks:
Statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at the 50% and 100% test concentrations. Stimulation indexes (SIs) of less than 3.0 were observed at all test concentrations of the test substance.
Parameter:
SI
Value:
< 3
Test group / Remarks:
50%
Remarks on result:
other: see Remark
Remarks:
Statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at the 50% and 100% test concentrations. Stimulation indexes (SIs) of less than 3.0 were observed at all test concentrations of the test substance.
Parameter:
SI
Value:
< 3
Test group / Remarks:
100%
Remarks on result:
other: see Remark
Remarks:
Statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at the 50% and 100% test concentrations. Stimulation indexes (SIs) of less than 3.0 were observed at all test concentrations of the test substance.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: no data

No statistically significant differences in mean body weights and body weight gains compared to the vehicle control group were observed at any test concentration. No clinical signs of toxicity were observed in the study.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, titanium dioxide did not produce a dermal sensitization response in mice. Based on these results, it is predicted that the structural analogue Titanium oxide (Ti3O5) is also not a dermal sensitizer.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification