Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation, other
Type of information:
other: expert assessment
Adequacy of study:
key study
Study period:
12 March 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was performed based on available information on the substance and experimental data on a suitable analogue.

Data source

Reference
Reference Type:
other: expert assessment
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
An assessment was performed based on available information on the substance and experimental data on a suitable analogue.
GLP compliance:
no
Type of study:
other: An assessment was performed based on available information on the substance and experimental data on a suitable analogue.

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium titanium trioxide
EC Number:
234-988-1
EC Name:
Calcium titanium trioxide
Cas Number:
12049-50-2
Molecular formula:
Ca.O3Ti
IUPAC Name:
Calcium titanium trioxide
impurity 1
Chemical structure
Reference substance name:
Titanium dioxide
EC Number:
236-675-5
EC Name:
Titanium dioxide
Cas Number:
13463-67-7
Molecular formula:
O2Ti
IUPAC Name:
dioxotitanium
impurity 2
Chemical structure
Reference substance name:
Silicon dioxide
EC Number:
231-545-4
EC Name:
Silicon dioxide
Cas Number:
7631-86-9
Molecular formula:
O2Si
IUPAC Name:
Silicon dioxide
impurity 3
Chemical structure
Reference substance name:
Aluminium oxide
EC Number:
215-691-6
EC Name:
Aluminium oxide
Cas Number:
1344-28-1
Molecular formula:
Al2O3
IUPAC Name:
oxo(oxoalumanyloxy)alumane
impurity 4
Chemical structure
Reference substance name:
Magnesium oxide
EC Number:
215-171-9
EC Name:
Magnesium oxide
Cas Number:
1309-48-4
Molecular formula:
MgO
IUPAC Name:
magnesium oxygen(-2) anion
impurity 5
Chemical structure
Reference substance name:
Diniobium pentaoxide
EC Number:
215-213-6
EC Name:
Diniobium pentaoxide
Cas Number:
1313-96-8
Molecular formula:
Nb2O5
IUPAC Name:
diniobium pentoxide
Test material form:
solid: nanoform, surface-treated

Results and discussion

In vivo (non-LLNA)

Results
Key result
Remarks on result:
other: Calcium Titanium Trioxide is not expected to induce skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Calcium Titanium Trioxide is not expected to induce skin sensitisation.
Executive summary:

An assessment was performed based on available information on the substance and experimental data on a suitable analogue. It concluded that Calcium Titanium Trioxide is not expected to induce skin sensitisation.