Registration Dossier
Registration Dossier
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EC number: 446-640-8 | CAS number: -
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 form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
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.
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