Registration Dossier
Registration Dossier
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EC number: 671-709-6 | CAS number: 430-67-1
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-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:
- 2,2-difluoroethan-1-amine
- EC Number:
- 671-709-6
- Cas Number:
- 430-67-1
- Molecular formula:
- C2H5F2N
- IUPAC Name:
- 2,2-difluoroethan-1-amine
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- concentrations of 100 % (undiluted), 50 and 25 % (w/v) in DMF
- No. of animals per dose:
- five groups of five animals each
- Details on study design:
- the negative control group received DMF
the positive control group received 25% (w/v) α-Hexylcinnamaldehyde (HCA) in DMF - 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 (DMF) | 1 | 423.5 | 1.0 |
| 2 | 183.5 | ||
| 3 | 208.5 | ||
| 4 | 255.5 | ||
| 5 | 162.5 | ||
| 100% (undiluted) | 6 | 119.5 | 0.6 |
| 7 | 132.5 | ||
| 8 | 189.5 | ||
| 9 | 111.5 | ||
| 10 | 210.5 | ||
| 50% (w/v) in DMF | 11 | 62.5 | 0.5 |
| 12 | 53.5 | ||
| 13 | 135.5 | ||
| 14 | 294.5 | ||
|
15 |
88.5 |
|
25% (w/v) in DMF |
16 |
161.5 |
1.0 |
| 17 | 186.5 | ||
| 18 | 217.5 | ||
| 19 | 359.5 | ||
| 20 | 350.5 | ||
| Positive control (25% HCA in DMF) | 21 | 2999.5 | 11.5 |
| 22 | 3060.5 | ||
| 23 | 3006.5 | ||
| 24 | 2265.5 | ||
| 25 | 2796.5 |
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 was shown to have no sensitization potential (non-sensitizer) in the Local Lymph Node Assay.
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