Registration Dossier
Registration Dossier
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EC number: 930-401-4 | CAS number: 1383706-71-5
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 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 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- 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: 24h - 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h - 72h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The treated skin surface was examined at 1, 24, 48 and 72 hours after patch removal. At observation one, 24, 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals.
As no clinical signs and no skin irritation effects were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation. No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to the skin according to the Draize classification system.
The study result triggers the following classification/labelling:
- EU Directive 1999/45/EC (as amended): none
- Regulation (EC) No 1272/2008 (CLP): none
- GHS (rev. 5) 2013: none
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