Registration Dossier
Registration Dossier
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EC number: 676-237-4 | CAS number: 71294-03-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex 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 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
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
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 30 mg
- Duration of treatment / exposure:
- 10s
- Observation period (in vivo):
- The control eyes and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse.
Minor variations within approximately ±5 minutes were considered acceptable. - Number of animals or in vitro replicates:
- in vitro
Results and discussion
In vivo
Results
- Remarks on result:
- other: Based on this in vitro eye irritation in the isolated chicken eyes test, the test item is classified as non-irritating. UN GHS Classification: Not classified.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on this in vitro eye irritation in the isolated chicken eyes test, the test item is classified as non-irritating. UN GHS Classification: Not classified.
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