Registration Dossier
Registration Dossier
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EC number: 930-430-2 | CAS number: 1383692-20-3
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-guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
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:
- 1-difluoromethanesulfonyl-3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-1H-indol-2-ol
- EC Number:
- 930-430-2
- Cas Number:
- 1383692-20-3
- Molecular formula:
- C14H11F3N4O5S
- IUPAC Name:
- 1-difluoromethanesulfonyl-3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-1H-indol-2-ol
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 50, 25 and 10 % (w/v) in AOO
- No. of animals per dose:
- twenty-five female CBA/J Rj mice were allocated to five groups of five animals each
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index values were 1.87, 2.98 and 3.11 at concentrations of 50, 25 and 10 % (w/v), respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see table
Any other information on results incl. tables
| Test Group Name | Animal No | DPM | Stimulation Index |
| Negative control (AOO) | 1 | 386.5 | 1.00 |
| 2 | 276.5 | ||
| 3 | 321.5 | ||
| 4 | 529.5 | ||
| 5 | 325.5 | ||
| 50 % (w/v) in AOO | 6 | 347.5 | 1.87 |
| 7 | 950.5 | ||
| 8 | 1335.5 | ||
| 9 | 521.5 | ||
| 10 | 280.5 | ||
| 25 % (w/v) in AOO | 11 | 1626.5 | 2.98 |
| 12 | 382.5 | ||
| 13 | 1482.5 | ||
| 14 | 1292.5 | ||
| 15 | 706.5 | ||
| 10 % (w/v) in AOO | 16 | 1933.5 | 3.11 |
| 17 | 1319.5 | ||
| 18 | 1143.5 | ||
| 19 | 674.5 | ||
| 20 | 650.5 | ||
| Positive control (25 % HCA) in AOO | 21 | 1833.5 | 15.74 |
| 22 | 3812.5 | ||
| 23 | 9031.5 | ||
| 24 | 11063.5 | ||
| 25 | 3205.5 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, under the conditions of the present assay the test item was shown to have a weak sensitization potential (sensitizer) in the Local Lymph Node Assay.
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