Registration Dossier
Registration Dossier
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EC number: 696-543-1 | CAS number: 1369828-32-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 22 July 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-bromo-4-chloro-1-(propan-2-yl)benzene
- EC Number:
- 696-543-1
- Cas Number:
- 1369828-32-9
- Molecular formula:
- C9H10BrCl
- IUPAC Name:
- 2-bromo-4-chloro-1-(propan-2-yl)benzene
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10, 25%
- No. of animals per dose:
- 5
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- test material (5% w/v)
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- test material (10% w/v)
- Key result
- Parameter:
- SI
- Value:
- 2.5
- Test group / Remarks:
- test material (50% w/v)
- Remarks on result:
- other: significant increase compared to negative control but below SI threshold of 3
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- After two range finding tests due to signs of systemic toxicity occurring at higher doses (50 and 100% of test material), 25% was chosen as top dose for the main test. 25 µL of three different concentrations were applied to the ear of mice once daily for 3 consecutive days. On day 6 the animals were euthanised and the lymph nodes prepared for the analysis. The calculated SI values for the treated mice were below 3 (1.2, 1.1 and 2.5 at 5%, 10% and 25% of the test material, respectively), the threshold for skin sensitisation. Neither an increase in the lymph node weight nor mortality or symptoms of systemic toxicity were observed in any treatment group. No dose-related effects on body weight occured.
Therefore the test material did not reveal any skin sensitising properties in the modified local lymph node assay at any concentration tested.
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