Registration Dossier
Registration Dossier
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EC number: 676-237-4 | CAS number: 71294-03-6
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:
- 7-fluoro-2,3-dihydro-1H-indol-2-one
- EC Number:
- 676-237-4
- Cas Number:
- 71294-03-6
- Molecular formula:
- C8H6FNO
- IUPAC Name:
- 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:
- dimethyl sulphoxide
- Concentration:
- 25, 10 and 5% (w/v) in DMSO
- No. of animals per dose:
- 5
- 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: see table
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see table
Any other information on results incl. tables
| Test Group Name | Animal Number | DPM | Stimulation Index | |
| Negative control (DMSO) | 1 | 256.5 | 1.0 | |
| 2 | 151.5 | |||
| 3 | 174.5 | |||
| 4 | 82.5 | |||
| 5 | 207.5 | |||
| 25% (w/v) in DMSO | 6 | 341.5 | 2.2 | |
| 7 | 87.5 | |||
| 8 | 854.5 | |||
| 9 | 518.5 | |||
| 10 | 78.5 | |||
| 10% (w/v) in DMSO | 11 | 186.5 | 1.5 | |
| 12 | 303.5 | |||
| 13 | 279.5 | |||
| 14 | 259.5 | |||
| 15 | 280.5 | |||
| 5% (w/v) in DMSO | 16 | 568.5 | 1.2 | |
| 17 | 130.5 | |||
| 18 | 184.5 | |||
| 19 | 76.5 | |||
| 20 | 130.5 | |||
| Positive control (25% HCA in DMSO) | 21 | 3024.5 | 14.8 | |
| 22 | 2279.5 | |||
| 23 | 2542.5 | |||
| 24 | 2427.5 | |||
| 25 | 2663.5 | |||
Applicant's summary and conclusion
- Interpretation of results:
- not 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 no sensitization potential (non-sensitizer) in the Local
Lymph Node Assay.
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