Registration Dossier
Registration Dossier
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EC number: 936-882-7 | CAS number: 1352319-02-8
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 EU/OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- (2010)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1-(3-chloropyridin-2-yl)-3-{[5-(trifluoromethyl)-2H-1,2,3,4-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxylic acid
- EC Number:
- 936-882-7
- Cas Number:
- 1352319-02-8
- Molecular formula:
- C12H7ClF3N7O2
- IUPAC Name:
- 1-(3-chloropyridin-2-yl)-3-{[5-(trifluoromethyl)-2H-1,2,3,4-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxylic acid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Topical application: 10, 25 and 50% (w/v) in DMF
- No. of animals per dose:
- test group: 5 animals
control group: 5 animals
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- other: see below "Any other information on results incl. tables"
- Remarks:
- see below "Any other information on results incl. tables"
- Test group / Remarks:
- see below "Any other information on results incl. tables"
- Remarks on result:
- other: see below "Any other information on results incl. tables"
- Remarks:
- see below "Any other information on results incl. tables"
Any other information on results incl. tables
Table 1: Summary of LLNA results
Concentration (% in w/v) in DMF |
dpm/node |
Stimulation index |
Result |
Negative control |
91.2 |
1.0 |
Negative |
10 |
211.1 |
2.3** |
Negative |
25 |
139.6 |
1.5 |
Negative |
50 |
198.2 |
2.2* |
Negative |
Positive control |
1628.6 |
17.9** |
Positive |
* = Significant (p<0.05, Mann-Whitney U-test versus negative control)
** = Significant (p<0.01, Mann-Whitney U-test versus negative control)
dpm = disintegrations per minute
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No mortality or systemic toxicity was observed during the study. There were no indications of any irritancy at the site of application. The calculated stimulation index values were 2.2, 1.5 and 2.3 at concentrations of 50, 25 and 10% (w/v), respectively. The resulted stimulation index values were below the threshold limit of 3 at each examined concentrations indicating that the test material is not a skin sensitizer. A significant lymphoproliferative response (stimulation index value of 17.9) was noted for the positive control group treated with α-Hexylcinnamaldehyde.
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