Registration Dossier
Registration Dossier
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EC number: 936-882-7 | CAS number: 1352319-02-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- GLP compliance:
- yes (incl. QA statement)
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. Neither erythema nor edema formation was observed during the study period. The body weights of all rabbits were considered to be within the normal range of variability. The test material is considered to be a non-irritant to the skin according to the Draize classification system.
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