Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Read across valid as the substnace tested is also titanate complex with glycol and alkylamine, degrading in water to similar degradation products.
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Remarks:
Liquid substance used undiluted (0.5ml)
Duration of treatment / exposure:
4h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Other effects:
Slight erythema was noted in one rabbit at one hour after removal of dressing.
Interpretation of results:
GHS criteria not met
Conclusions:
Not irritating read-across from structural analogue.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Remarks:
Liquid substance used undiluted (0.5ml)
Duration of treatment / exposure:
4h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Other effects:
Slight erythema was noted in one rabbit at one hour after removal of dressing.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal irritation potential was investigated in New Zealand White rabbits.
Slight erythema was noted in one rabbit at the 1 h reading only. No oedema was noted.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Read across valid as the substnace tested is also titanate complex with glycol and alkylamine, degrading in water to similar degradation products.
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Annex V
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Vehicle:
not specified
Amount / concentration applied:
0.1 ml
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
ca. 0.5
Max. score:
0.6
Reversibility:
fully reversible within: 3d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
ca. 0.3
Max. score:
0.3
Reversibility:
fully reversible within: 3d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
Grade 1 conjunctival redness and chemosis was observed in
all three rabbits at 1 and 24 hours post-application.
Slight
discharge was also noted in all three rabbits at one hour.
Grade 1 conjunctival redness was also observed in 2 rabbits
at 48 hours. No reactions were seen at 72 hours.
Interpretation of results:
GHS criteria not met
Conclusions:
Slight effects observed, but not sufficiently severe for classification
Executive summary:

The target substance is not irritating to eyes, read-across from structural analogue.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Annex V
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Vehicle:
not specified
Amount / concentration applied:
0.1 ml
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
ca. 0.5
Max. score:
0.6
Reversibility:
fully reversible within: 3d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
ca. 0.3
Max. score:
0.3
Reversibility:
fully reversible within: 3d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
Grade 1 conjunctival redness and chemosis was observed in
all three rabbits at 1 and 24 hours post-application.
Slight
discharge was also noted in all three rabbits at one hour.
Grade 1 conjunctival redness was also observed in 2 rabbits
at 48 hours. No reactions were seen at 72 hours.
Interpretation of results:
GHS criteria not met
Conclusions:
Slight effects observed, but not sufficiently severe for classification
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

The substance is unstable in water and moist atmosphere and testing would record the results of the key degradation products.These are titanium dioxide, propan-2-ol, triisopropanolamine and ethylene glycol. These are all well evaluated low-hazard substances and further animal testing is not justified.

No studies were conducted on the traget substance. Studies read-across from structural analogue indicate no irritation to skin and eyes.