Registration Dossier
Registration Dossier
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EC number: 627-063-2 | CAS number: 1134960-41-0
Eye irritation
Administrative data
- Endpoint:
- eye 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:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- sodium 4-(methoxycarbonyl)-5-oxo-2,5-dihydrofuran-3-olate
- EC Number:
- 627-063-2
- Cas Number:
- 1134960-41-0
- Molecular formula:
- C6H5O5Na
- IUPAC Name:
- sodium 4-(methoxycarbonyl)-5-oxo-2,5-dihydrofuran-3-olate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 1h
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h-72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h-72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 24h-72h
- Score:
- 0.89
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h-72h
- Score:
- 0.55
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3d
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- other: 24h-72h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3d
Any other information on results incl. tables
There was no mortality observed during the study.
The body weight and body weight changes were considered to be normal with no indication of any treatment related effect.
There were no clinical signs of systemic toxicity observed that could be related to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item , applied to the rabbits’ eye mucosa, caused conjunctival irritant effects at one hour which were reduced at 24 hours after application. The effects were fully reversible within 72 hours.
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. 4) 2011: None
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