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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981-02-02 to 1981-02-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well performed study under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dihydro-3-(tripropenyl)furan-2,5-dione
EC Number:
295-556-6
EC Name:
Dihydro-3-(tripropenyl)furan-2,5-dione
Cas Number:
92077-08-2
Molecular formula:
R-C4H3O3 , whereas R=C8-C10-alkyl-(branched, unsaturated)
IUPAC Name:
3-[(1E)-2-methyloct-1-en-1-yl]oxolane-2,5-dione

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9-2.5 kg
- Housing: individual cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Vehicle:
other: PEG 400
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 1%, 10% and 100%
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1, 7, 24, 48, 72 h after application
Number of animals or in vitro replicates:
2 per dose
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline solution
- Time after start of exposure: 24 h

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: fluorescein sodium of 0.01%

Results and discussion

In vivo

Results
Irritation parameter:
other: overall effect
Basis:
other: animals of 100% group
Time point:
other: no data
Reversibility:
not reversible
Remarks on result:
other: see Irritant/corrosive response data in the following
Irritant / corrosive response data:
100% group: Light corneal cloudiness was observed. The conjunctiva showed a diffuse carmine to fleshy redness and a marked swelling with partial retraction of eyelids. The treated eye had severe discharge.
10% group: Light corneal cloudiness was observed. The blood vessels of the conjunctiva were injected. Severe discharge was observed. All the effects were reversible exept for the light redness and swelling.
1% group: The treated animal showed significantly injected blood vessels and slight discharge. These findings were reversible in 48 hours.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
It is concluded that the test substance may cause serious eye damage.
Executive summary:

The eye irritation/corrosion potential of the test item was investigated using Albino Himalaya rabbits. The test item of 1, 10 and 100% was applied by instillation of 0.1 ml into the left eyes of each 2 animals. The effects were observed after 1, 7, 24, 48 and 72 hours after application. After 24 hours, the treated eyes were washed with physiological saline solution. Light to severe effects were observed in all the treated groups. In the 100% group light corneal cloudiness was observed. The conjunctiva showed a diffuse carmine to fleshy redness and a marked swelling with partial retraction of eyelids. The treated eye had severe discharge. All the effects were irreversible during the observation period. In the 10% group, light corneal cloudiness was observed. The blood vessels of the conjunctiva were injected. Severe discharge was observed. All the effects were reversible exept for the light redness and swelling. In the 1% group, the treated animal showed significantly injected blood vessels and slight discharge. These findings were reversible in 48 hours. Based on the effects observed, it is concluded that the test substance may cause serious eye damage.