Registration Dossier
Registration Dossier
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EC number: 620-313-1 | CAS number: 877179-03-8
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:
- other: GLP study according OECD/EU guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N-{3',4'-dichloro-5-fluoro-[1,1'-biphenyl]-2-yl}acetamide
- EC Number:
- 620-313-1
- Cas Number:
- 877179-03-8
- Molecular formula:
- C14H10Cl2FNO
- IUPAC Name:
- N-{3',4'-dichloro-5-fluoro-[1,1'-biphenyl]-2-yl}acetamide
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 100 , 50 , 25 %(w/v)
- No. of animals per dose:
- 5
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- A significant lymphoproliferative response (stimulation index value of 10.3) was noted for the positive control chemical and this result confirmed the validity of the assay.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Negative control
- Key result
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- 100 (w/v) %
- Key result
- Parameter:
- SI
- Value:
- 2.1
- Test group / Remarks:
- 50 (w/v) %
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 25 (w/v) %
- Parameter:
- SI
- Value:
- 10.3
- Test group / Remarks:
- Positive control
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, under the conditions of the present assay the substance was shown to have no sensitization potential (non-sensitizer) in the Local Lymph Node Assay.
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