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:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
The target substance is a hydrolytically unstable organotitatnate with hydrolysis half-life estimated to be less than 30 minutes, and with hydrolysis products being identified to be triethanoamine and zirconium dioxide. Because of the rapid hydrolysis, the influence of the target substance is related to the hydrolysis products.
Triethanoamine is the major hydrolysis product of the target substance. It’s toxicity property is used for read-across based on weight of evidence method.
Reason / purpose:
read-across source
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
Justification for non-LLNA method:
Existing study conducted on human and adopted by peer-revieed journal.
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.
Executive summary:

The study was conducted on triethanolamine, the strucural analogue and also the hydrolysis product of the target substance. As the target substance is hydrolytically unstable, its intrinsic property lies in the the hydrolysis products. The result is used as weight of evidence approach in hazard assessment.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key 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
Justification for type of information:
The target substance is a hydrolytically unstable organotitatnate with hydrolysis half-life estimated to be less than 30 minutes, and with hydrolysis products being identified to be triethanoamine and zirconium dioxide. Because of the rapid hydrolysis, the influence of the target substance is related to the hydrolysis products.
Triethanoamine is the major hydrolysis product of the target substance. It’s toxicity property is used for read-across based on weight of evidence method.
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
Remarks:
A review article of study conducted prior to 2008.
Type of study:
patch test
Justification for non-LLNA method:
Existing study conducted on human and adopted by peer-revieed journal.
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
Remarks on result:
no indication of skin sensitisation
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:

No studies were conducted on the target substance, Tetrakis [[2,2',2"-nitrilotris[ethanolato]](1-)-N,O]zirconium. As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance, triethanolamine (TEA).

 

There was no evidence of any skin sensitizing activity of undiluted TEA for guinea pigs.

TEA from four different suppliers was evaluated in guinea pig skin sensitization tests. The tests were conducted with 10 control and 20 treated guinea pigs. The induction patches were applied once a week for up to six hours for three weeks. Two weeks later challenge patches were applied to both control and treated guinea pigs. One test was conducted with undiluted TEA at induction and 90% TEA at challenge and all the other tests were conducted with 50% TEA at induction and 90% TEA at challenge. None of the animals showed clinical symptoms during or after the treatment period and no guinea pigs showed signs of primary irritation of the skin. Challenge reactions were measured with a reflectometer and average readings between control and experimental animals were compared. TEA was not a guinea pig skin sensitizer in these studies. (Adapted from Cosmetic Ingredient Review 1983)

 

Based on these findings, the target substance was considered not skin sensitizing.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The target substance is not classified as skin sensitizer according to CLP Regulation.