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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
Study period:
18 April 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
1-cyclohexyl-1H-pyrrole-2,5-dione
EC Number:
216-630-6
EC Name:
1-cyclohexyl-1H-pyrrole-2,5-dione
Cas Number:
1631-25-0
Molecular formula:
C10H13NO2
IUPAC Name:
1-cyclohexyl-1H-pyrrole-2,5-dione
Test material form:
solid: flakes

Test animals / tissue source

Species:
rabbit
Strain:
other: house
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Medical Experimental Animals Institute
- Age at study initiation:
- Weight at study initiation: between 2.0 and 2.5 kg
- Housing: stainless steel cage
- Diet (e.g. ad libitum): Oriental RC-4 solid feed
- Water (e.g. ad libitum): yes
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 50 ± 10%.
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): artificial lighting for 8 hours a day

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
30s
Observation period (in vivo):
1, 24, 48, and 72 hours after instillation
Number of animals or in vitro replicates:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 30s

SCORING SYSTEM: draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 30 - <= 40
Max. score:
40
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 30 - <= 40
Max. score:
40
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 30 - <= 40
Max. score:
40
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
60
Max. score:
60
Reversibility:
other: Examination impossible due to severe chemosis.
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
60
Max. score:
60
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
other: Examination impossible due to severe chemosis.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
5
Max. score:
5
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
5
Max. score:
5
Reversibility:
not fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
5
Max. score:
5
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
5
Max. score:
81
Reversibility:
other: Examination impossible due to severe chemosis.
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
5
Max. score:
5
Reversibility:
fully reversible within: 7 daya
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Reversibility:
other: Examination impossible due to severe chemosis.
Remarks on result:
not determinable
Remarks:
Examination impossible due to severe chemosis.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 3 - <= 4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The results of this study indicate that the effects on the eyes are not fully reversible in 21 days therefore it has been classified a Eye irritation Cat.2.