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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Principles of method if other than guideline:
LLNA was performed instead of Maximization test. See section 4.7.00 NONS dossier
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

In vivo test system

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)

Results and discussion

Positive control results:
The test item ALPHA-HEXYLCINNAMALDEHYDE was found to be a sensitizer and an EC3
value of 7.08 YO(w/v) was derived.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
0.8
Test group / Remarks:
10%
Parameter:
SI
Value:
1.1
Test group / Remarks:
25%
Parameter:
SI
Value:
1.3
Test group / Remarks:
50%

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
at concentrations of 10 %, 25 YOand 50 % (w/v) in ethanol: water, 7:3 (v/v).
A test item is regarded as a sensitizer in the LLNA if the exposure to one or more test
concentrations resulted in 3-fold or greater increase in incorporation of 3HTdR compared
with concurrent controls, as indicated by the STIMULATION INDEX (S.1.).
The test item ucb 22060 was found to be a non-sensitizer when tested at up to the highest
achievable concentration of 50 % (w/v) in ethanol: water, 7:3 (v/v).
Executive summary:

In this study STIMULATION INDICES of 2.5, 3.7 and 9.7 were determined with the test item at concentrations of 5 Yo, 10 YOand 25 YO(w/v) in acetone: olive oil, 4:1 (v/v). A test item is regarded as a sensitizer in the LLNA if the exposure to one or more test concentrations resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the STIMULATION INDEX (S.1.). The test item ALPHA-HEXYLCINNAMALDEHYDE was found to be a sensitizer and an EC3 value of 7.08 YO(w/v) was derived.