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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:
1986-04-08 to 1986-04-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, non GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-oxoimidazolidin-1-yl)ethyl methacrylate
EC Number:
289-214-5
EC Name:
2-(2-oxoimidazolidin-1-yl)ethyl methacrylate
Cas Number:
86261-90-7
Molecular formula:
C9H14N2O3
IUPAC Name:
2-(2-oxoimidazolidin-1-yl)ethyl methacrylate
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Mean weight at study initiation: male 3.25 kg; females 3.41 kg
- Housing: single in stainless steel cages
- Diet: Kliba 341, 4mm, Fa. Klingentalmuehle AG, Kaiseraugst, CH, ca. 130 g/d
- Water: tap water, ca. 250 mL/d
- Acclimation period: at least 8 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eyes served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Application was once; the eyes were not washed out
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not rinsed

SCORING SYSTEM: OECD Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 15 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Remarks on result:
other: loss of corneal tissue, loss of hair at the margins of the eyelids, small retractions in the eyelids and suppuration observed at the final reading; see table for details
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 15 d
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 21 d
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
2
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
1.2
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 15 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 15 d

Any other information on results incl. tables

Animal  Reading  Opacity Iritis Redness Chemosis Symptoms
1 1 h 0 0 2 2  
2 1 h 0 0 2 2  
3 1 h 0 0 2 2  
1 24 h 1 0 2 2  
2 24 h 1 0 1 0 Small retractions in the eyelids
3 24 h 1 0 1 0  
1 48 h 1 1 2 2 Small retractions in the eyelids/ Suppuration 
2 48 h 1 0 0 0 Small retractions in the eyelids 
3 48 h 1 0 2 0 Loss of corneal tissue
1 72 h 1 1 2 1 Small retractions in the eyelids/ Suppuration/ Loss of corneal tissue 
2 72 h 1 0 0 0 Small retractions in the eyelids
3 72 h 1 1 1 0 Small retractions in the eyelids / Loss of corneal tissue
1 8 d 2 1 2 1 Small retractions in the eyelids/ Suppuration / Loss of corneal tissue/ pupil contracted/ Loss of hair at the margins of eyelids
2 8 d 1 0 0 0 Small retractions in the eyelids
3 8 d 2 0 0 0 Small retractions in the eyelids / Loss of corneal tissue/ Loss of hair at the margins of eyelids
1 15 d 2 0 0 0 Small retractions in the eyelids/ Suppuration/ Loss of corneal tissue/ pupil contracted/ Loss of hair at the margins of eyelids
2 15 d 0 0 0 0 Small retractions in the eyelids
3 15 d 2 0 0 0 Small retractions in the eyelids/ Loss of corneal tissue/ Loss of hair at the margins of eyelids
1 21 d 2 0 0 0 Small retractions in the eyelids/ Suppuration / Loss of corneal tissue/ Loss of hair at the margins of eyelids
2 21 d 0 0 0 0 Small retractions in the eyelids
3 21 d 2 1 0 0 Small retractions in the eyelids/ Loss of corneal tissue/ Loss of hair at the margins of eyelids
1 24 - 72 h 1.00 0.67 2.00 1.67  
2 24 - 72 h 1.00 0.00 0.33 0.00  
3 24 - 72 h 1.00 0.33 1.33 0.00  
mean  24 - 72 h 1.00 0.33 1.22 0.56  

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU

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