Registration Dossier
Registration Dossier
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EC number: 686-853-5 | CAS number: 46921-17-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from november 2009 to january 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- OCDE 429 Skin sensitization : Local Lymph Node Assay - 24/04/2002
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole
- EC Number:
- 686-853-5
- Cas Number:
- 46921-17-9
- Molecular formula:
- C16H31NO
- IUPAC Name:
- 4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Test material form:
- liquid
- Details on test material:
- Other name of 4,4-Dimethyl-2-undecyl-2-oxazoline : cycloceramide
Constituent 1
impurity 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- Age : 7-8 weeks at start of dosing
Lighting : 12h light / 12 h dark cycle
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10%, 25%, 50% in AOO
and undiluted - No. of animals per dose:
- 5 animals
- Details on study design:
- Treatment during 3 consecutive days by direct epicutaneous application of 25 µl of test or control
- Positive control substance(s):
- other: Isoeugenol (97-54-1)
- Statistics:
- SI values greater than 3 at 100% and 50%
SI value lower than 3 at 25% and 10%
EC-3 potency value of 7925 µg/cm²
Results and discussion
- Positive control results:
- No sign observed for AOO control and isoeugenol group
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- ca. 31.7
- Key result
- Parameter:
- SI
- Remarks:
- Cycloceramide in AOO 10%
- Value:
- ca. 0.9
- Test group / Remarks:
- 5 animals
- Key result
- Parameter:
- SI
- Remarks:
- Cycloceramide in AOO 25%
- Value:
- ca. 2.5
- Test group / Remarks:
- 5 animals
- Key result
- Parameter:
- SI
- Remarks:
- Cycloceramide in AOO 50%
- Value:
- ca. 4.8
- Test group / Remarks:
- 5 animals
- Key result
- Parameter:
- SI
- Remarks:
- Cycloceramide in AOO 100%
- Value:
- ca. 7.9
- Test group / Remarks:
- 5 animals
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- According to LLNA : weak sensitizer
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