Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
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
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
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 for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Annex V
Deviations:
no
GLP compliance:
yes
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Annex V
Deviations:
no
GLP compliance:
yes
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.