ucb 22060

Skin sensitisation

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

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. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

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)

Results

Results 1

Parameter:

SI

Value:

0.8

Test group / Remarks:

10%

Results 2

Parameter:

SI

Value:

1.1

Test group / Remarks:

25%

Results 3

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.