Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
existing study.
Test material information:
Composition 1
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Concentration of test material and vehicle used at induction:
(i) Intradermal: 10% v/v in distilled water

(ii) Topical: Substance applied undiluted

Concentration of test material and vehicle used for each challenge:
Undiluted test substance (100%)
No. of animals per dose:
Test group: 20
Negative control group: 20
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20

Slight reactions were observed in the intradermal test and control groups and in the topical test group.

No evidence of sensitisation 

One test group animal died before challenge

Interpretation of results:
GHS criteria not met
Conclusions:
The slight effects reported were not considered to be a potential sensitising effect.
Executive summary:

The target substance is not skin sensitising, read-across from structural analogue.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
existing study.
Test material information:
Composition 1
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Concentration of test material and vehicle used at induction:
(i) Intradermal: 10% v/v in distilled water

(ii) Topical: Substance applied undiluted

Concentration of test material and vehicle used for each challenge:
Undiluted test substance (100%)
No. of animals per dose:
Test group: 20
Negative control group: 20
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20

Slight reactions were observed in the intradermal test and control groups and in the topical test group.

No evidence of sensitisation 

One test group animal died before challenge

Interpretation of results:
GHS criteria not met
Conclusions:
The slight effects reported were not considered to be a potential sensitising effect.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Reference:
Composition 0
Qualifier:
no guideline followed
Principles of method if other than guideline:
Assessment of human data. Review of patch test data of 85 000 humans following exposure ot triethanolamine
GLP compliance:
no
Type of study:
patch test
Test material information:
Composition 1
Species:
other: human
Sex:
not specified
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
2.5%
Reading:
1st reading
Group:
test group
Dose level:
2.5%
No. with + reactions:
325
Total no. in group:
85 000
Interpretation of results:
GHS criteria not met
Remarks:
expert judgment
Conclusions:
Assessment of extensive human data showed that there is no indication of sensitisation protential.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The recorded degradation products are titanium dioxide, propan-2-ol, triisopropanolamine, diethyleneglycol and ethylene glycol

These substances are not severely considered to be potential skin sensitisers.

Testing suggests no potential for sensitisation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification