Registration Dossier

Toxicological information

Skin sensitisation

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Administrative data

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.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
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.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
other: human
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
2.5%

Results and discussion

In vivo (non-LLNA)

Results
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

Applicant's summary and conclusion

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.