Registration Dossier
Registration Dossier
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EC number: 606-793-5 | CAS number: 21535-43-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-09-26 to 2012-09-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- issued 2010
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N-(2-benzylphenyl)-2-chloroacetamide
- EC Number:
- 606-793-5
- Cas Number:
- 21535-43-3
- Molecular formula:
- C15 H14 Cl N O
- IUPAC Name:
- N-(2-benzylphenyl)-2-chloroacetamide
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- at 10%,25, 50 % w/v (main test) in DMF
- No. of animals per dose:
- 2/ 5 (pretest / test, positive control, vehicle)
- Details on study design:
- PRE-SCREEN TESTS:
RANGE FINDING TESTS: 2 animals treated with test item at 25% and 50% w/v.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The SI for the positive control substance was 12.1 which demonstrates the validity of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 12.1
- Test group / Remarks:
- HCA
- Parameter:
- SI
- Value:
- 7.2
- Test group / Remarks:
- 10% w/v
- Parameter:
- SI
- Value:
- 8.8
- Test group / Remarks:
- 25% w/v
- Parameter:
- SI
- Value:
- 2.3
- Test group / Remarks:
- 50%
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test item is regarded as potential skin sensitizer , at least one concentration of the chemical has a SI of three or more.
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