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Toxicological information

Eye irritation

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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:
2013

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

Constituent 1
Chemical structure
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

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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