Registration Dossier
Registration Dossier
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EC number: 700-287-9 | CAS number: 877179-04-9
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:
- other: GLP study according EU/OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (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:
- 3',4'-dichloro-5-fluoro-[1,1'-biphenyl]-2-amine
- EC Number:
- 700-287-9
- Cas Number:
- 877179-04-9
- Molecular formula:
- C12H8Cl2FN
- IUPAC Name:
- 3',4'-dichloro-5-fluoro-[1,1'-biphenyl]-2-amine
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 3, 10 and 30%.
- No. of animals per dose:
- 6 mice per group
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: The NMRI mice did not show an increase in the stimulation indices for cell counts or for weights of the draining lymph nodes after application of the test substance.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
A LLNA/IMDS was carried out in female NMRI mice after epicutaneous application of a formulation containing 0%, 3%, 10% or 30% of the test substance for 3 consecutive days onto both ears of the animals.
This study does neither point to a non-specific (irritant) nor to a specific immunostimulating (sensitizing) potential of the test item.
This applies to NMRI mice, for weight and cell counts of the draining lymph nodes as well as ear swelling and ear weight indices evaluated after application of the test substance.
Taken together, no antigen specific activation of the cells of the immune system via dermal route was determined after application of up to and including 30%the test substanceby the method used. Therefore, the concentration of 30% turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.
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