Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
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
GLP compliance:
no
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1-48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: all tested substances
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1-48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: all tested substances
Irritant / corrosive response data:
No dermal irritation in any of the rabbits during the study. Test sites treated with test items 1, 2 and 3 were stained by the test substance.
Other effects:
No clinical signs, no body weight loss.
Interpretation of results:
GHS criteria not met
Conclusions:
According to the criteria specified by Directive 67/548/EC and subsequent regulations titanium dioxide is not a skin irritant and therefore no classification is required. Based on these results, it is predicted that the structural analogue Titanium oxide (Ti3O5) is also not a skin irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
in vivo
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
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
The test substance produced conjunctival redness (score of 1 or 2) in the treated eye of all three rabbits. Fluorescein stain examinations were negative for corneal injury. The treated eyes of the rabbits were normal by 24 or 48 hours after instillation of the test substance.
Other effects:
No clinical signs were observed, and no body weight loss occurred.
Interpretation of results:
GHS criteria not met
Conclusions:
Titanium dioxide produced conjunctival redness (score of 1 or 2) in the treated eye of all three rabbits. Fluorescein stain examinations were negative for corneal injury. The treated eyes of the rabbits were normal by 24 or 48 hours after instillation of the test substance. Based on these results, it is predicted that the structural analogue Titanium oxide (Ti3O5) is also not irritating to the eye.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification