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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
DATA QUALITY: Study meets minimum scientific standards for an eye irritation study and provides sufficient information regarding the irritation potential of the test substance. However, there was a limited description of the substance (i.e. purity, CAS#, etc.) Thus, the results are regarded as reliable with restriction.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Hazardous Substances Labelling Act Regulations, Section 191.12, Federal Register: 29, 13009 (1964)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Ethyl methacrylate, purity not specified but typicallly > 99 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
72 hour(s)
Number of animals or in vitro replicates:
6
Details on study design:
Six female NZ White rabbits, weighing 2-2.5 kg,  were administered 0.1 ml  (vol) of test compound into the everted lower lid of one eye of each  rabbit; eyelids were closed and held shut for 1 second. Prior to  administration the eyes of each rabbit were examined.  Eyes remained  unwashed. Eyes scored at 24, 48 and 72 hrs after administration with the  aid of an ophthalmoscope and Fluorescein sodium. The eyes were unwashed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: scores are showing tendency in reversibility
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #1, #3
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: scores are showing tendency in reversibility
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.66
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: scores are showing tendency in reversibility
Irritation parameter:
chemosis score
Basis:
animal: #4, 5, 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: scores are showing tendency in reversibility
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: scores are showing tendency in reversibility
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: scores are showing tendency in reversibility
Irritant / corrosive response data:
Conjunctival irritation, redness (max. grade 3 in 3/6 rabbits) and  chemosis (max. grade 3 in 2/6 rabbits) at 24 hr. Irritation (redness and  chemosis), grade 3, was still present at 48 hr in 3/6 rabbits. At 72 hrs  the irritation (redness) was grade 2 in 1/6,  grade 1 in 3/6; chemosis  was grade 2 in 1/6, grade 1 in 1/6 and 0 in 4/6 rabbits. Slight  irritation of the cornea was observed after 24 h in 2/6 animals which was  reversible after 48 h. There was no involvement of the iris.

Any other information on results incl. tables

Animal No.

Corneal opacity/Hornhauttrübung[Scores]

 

Mean Draize score

after 24 h

after 48 h

after 72 h

 

1)

0

0

0

0,0

2)

1

0

0

0,33

3)

1

0

0

0,33

4)

0

0

0

0,0

5)

0

0

0

0,0

6)

0

0

0

0,0

 

0,33

0,0

0,0

0,11

 

 

 

 

 

Animal No.

Iritis/Regenbogenhautentzündung[Scores]

 

Mean Draize score

after 24 h

after 48 h

after 72 h

 

1)

0

0

0

0

2)

0

0

0

0,0

3)

0

0

0

0,0

4)

0

0

0

0,0

5)

0

0

0

0,0

6)

0

0

0

0,0

 

0,0

0,0

0,0

0,0

 

 

 

 

 

Animal No.

Conjunctiva redness (erythem) /Bindehautrötung[Scores]

 

Mean Draize score

after 24 h

after 48 h

after 72 h

 

1)

3

3

1

2,33

2)

3

3

2

2,67

3)

3

3

1

2,33

4)

2

1

1

1,33

5)

1

0

0

0,33

6)

2

1

0

1

 

2,33

1,83

0,83

1,67

Animal No.

Conjunctiva chemosis /Bindehautödem[Scores]

 

Mean Draize score

after 24 h

after 48 h

after 72 h

 

1)

3

2

1

2

2)

3

2

2

2,33

3)

2

2

0

1,33

4)

0

0

0

0,0

5)

0

0

0

0,0

6)

1

0

0

0,33

 

1,5

1

0,5

1

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Conclusions:
Classification: not irritating
Executive summary:

In an occular irritation test acc. the federal Hazardous Substances and Labelling Act Regulations, Section 191.12 published in the Federal Register - 29 F.R. 13009, 1964. Ethyl methacrylate (0.1 ml) was placed in the conjunctival sac of the right eye of six New Zealand White rabbits. The lids were then gently held together for one second.   The test eyes were not washed out following the instillation.   The left eye remained untreated for control.  The eyes were examined at 1, 24, 48 and 72 hours. Eye irritation was scored for signs of corneal damage (density, area), iris reaction and lesions of the conjunctivae (erythema, chemosis). Additionally, the cornea was examined with the aid of fluorescein after recording the observations at 24 hours. No observation after 72 hrs. Scores were reevaluated acc. CLP criteria. Highest mean cornea score (24+48+72 h) was 0.33 in 2/6 animals, no animal showed iritis, 3/6 animals showed conjunctival erythema > 2 and 2/6 animals cunjunctival chemosis > 2. Scores showed clear tendency in rapid reversibility but during the short observation time (72 h) full reversibility could not be observed in all animals (scores in 2/6 animals were fully reversible).