Registration Dossier
Registration Dossier
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EC number: 619-484-5 | CAS number: 895525-72-1
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 to EU / OECd guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- 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:
- {[2-(trifluoromethyl)phenyl]formamido}methyl acetate
- EC Number:
- 619-484-5
- Cas Number:
- 895525-72-1
- Molecular formula:
- C11H10F3NO3
- IUPAC Name:
- {[2-(trifluoromethyl)phenyl]formamido}methyl acetate
- Test material form:
- solid: crystalline
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0.25, 0.5 and 1% in DMSO
- No. of animals per dose:
- 5 animals per group and dose
- Details on study design:
- The test substance and the vehicle were applied on external surfaces of each ear (25 μl/ear) for three consecutive days (Days 0, 1 and 2) at the appropriate concentrations. On Day 5, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated thymidine and the obtained values were used to calculate proliferation indices.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The proliferation index values of the test substance were 6.8, 13.2 and 17.8 at treatment concentrations of 0.25, 0.5 and 1%, respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: test substance concentration: 0.25 % DPM: 40907 test substance concentration: 0.5 % DPM: 79761 test substance concentration: 1 % DPM: 107501
Any other information on results incl. tables
No mortality and no clinical signs were observed during the study. No cutaneous reactions were observed in the vehicle, reference control or treated groups.
| Group Number | Test Group Name | DPM | Nodes | DPM/nodes | Stimulation Index Values |
| 1 | Vehicle control DMSO | 6030 | 10 | 603.0 | |
| 2 | Test substance at 0.25% in DMSO | 40907 | 10 | 4090.7 | 6.8 |
| 3 | Test substance at 0.5% in DMSO | 79761 | 10 | 7976.1 | 13.2 |
| 4 | Test substance at 1% in DMSO | 107501 | 10 | 10750.1 | 17.8 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was found to be a sensitizing formulation in the Local Lymph Node Assay at all concentrations tested.
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