Registration Dossier
Registration Dossier
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EC number: 930-401-4 | CAS number: 1383706-71-5
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:
- 2 015
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:
- 3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-2,3-dihydro-1H-indol-2-one
- EC Number:
- 930-401-4
- Cas Number:
- 1383706-71-5
- Molecular formula:
- C13H11FN4O3
- IUPAC Name:
- 3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-2,3-dihydro-1H-indol-2-one
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 50, 25 and 10 % (w/v)
- No. of animals per dose:
- five groups of five animals each
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index values were 0.96, 1.45 and 3.89 at concentrations of 50, 25 and 10 % (w/v), respectively.
Any other information on results incl. tables
| Test Group Name | Animal No | DPM | Stimulation Index |
| Negative control (MEK) | 1 | 70.0 | 1.00 |
| 2 | 109.0 | ||
| 3 | 207.0 | ||
| 4 | 944.0 | ||
| 5 | 70.0 | ||
| test item 50 % (w/v) in MEK | 6 | 133.0 | 0.96 |
| 7 | 264.0 | ||
| 8 | 188.0 | ||
| 9 | 541.0 | ||
| 10 | 216.0 | ||
| test item 25 % (w/v) in MEK | 11 | 696.0 | 1.45 |
| 12 | 402.0 | ||
| 13 | 260.0 | ||
| 14 | 313.0 | ||
| 15 | 359.0 | ||
| test item 10 % (w/v) in MEK | 16 | 1282.0 | 3.89 |
| 17 | 989.0 | ||
| 18 | 1093.0 | ||
| 19 | 653.0 | ||
| 20 | 1433.0 | ||
| Positive control (25 % HCA) in MEK | 21 | 4431.0 | 20.32 |
| 22 | 5596.0 | ||
| 23 | 6727.0 | ||
| 24 | 3443.0 | ||
| 25 | 8255.0 |
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 sensitization potential (sensitizer) in the Local
Lymph Node Assay.
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