Registration Dossier
Registration Dossier
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EC number: 609-338-9 | CAS number: 371771-07-2
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:
- 2 006
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:
- N1-[4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)-2-methylphenyl]-N2-(1-methanesulfinyl-2-methylpropan-2-yl)benzene-1,2-dicarboxamide
- EC Number:
- 609-338-9
- Cas Number:
- 371771-07-2
- Molecular formula:
- C23H23F7N2O3S
- IUPAC Name:
- N1-[4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)-2-methylphenyl]-N2-(1-methanesulfinyl-2-methylpropan-2-yl)benzene-1,2-dicarboxamide
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0; 2; 10 and 50%
- 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.
Any other information on results incl. tables
The study indicate that the LLNA/MDS does neither point to a non-specific (irritating) nor to a specific immunostimulating (sensitizing) potential of the test substance.
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 epicutaneous application of the test substance onto both ears of the animals.
Taken together, no activation of the cells of the immune system via dermal route was determined after application of up to and including 50% of the test substance by the method used. Therefore, the concentration of 50% turned out to be the NOEL for the parameters investigated in this study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
The results show that the test substance has neither an irritating nor a sensitizing potential in mice after dermal application.
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