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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
See read-across justification attached in section 13.2
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
no guideline followed
Principles of method if other than guideline:
Before OECD Guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. 50 µl of the test substance was applied to the conjunctival sac of one eye in 2 animals. The saline-treated adjacent eye served as control. The animals were observed several times on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours.
GLP compliance:
no
Remarks:
Study carried out prior to GLP principles
Test material information:
Composition 1
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 2.74 kg; female: 2.16 kg
- Diet: Ssniff ad libitum
- water: ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Amount applied 0.05 ml
- Concentration: 100%
Duration of treatment / exposure:
not specified (single application, substance was not washed out)
Observation period (in vivo):
8 days; observations at 10 min, 1 h, 3 h, 24 h, 48 h, 5 d, 7 d, 8 d
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
The original grading was converted into the numerical grading according to the OECD Draize system
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48 h
Score:
1.5
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48 h
Score:
1
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48 h
Score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48 h
Score:
0.75
Max. score:
4
Reversibility:
not fully reversible within: 5 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48 h
Score:
0.5
Reversibility:
not fully reversible within: 5 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48 h
Score:
1
Reversibility:
not fully reversible within: 5 days
Irritation parameter:
cornea opacity score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
other: observations not made at 72 h
Irritation parameter:
conjunctivae score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
other: observations not made at 72 h
Irritation parameter:
chemosis score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
other: observations not made at 72 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48 h
Remarks on result:
other: not observed
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48 h
Remarks on result:
other: not observed
Irritation parameter:
iris score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
other: observations not made at 72 h
Irritant / corrosive response data:
See table 1.
Other effects:
Residual test substance or smeary layer on the eye.
In 1 animal small retraction of the eye lid (irregular margin) was observed at the end of the observation period, which was described as Na (= Narbe/Scar) in the original German report.
This finding is not the sequel of irreversible tissue destruction as suggested by the misleading historical wording and does not impair the ocular function.
Thus, it is not relevant for evaluation.

Table1:

Scores for iris, cornea and conjunctiva:

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

1h

1

-

-

1

0

smeary charge

2

-

-

1

1

smeary charge

24 h

1

1

-

1

1

smeary charge

2

1

-

2

1

smeary charge

48 h

1

1

-

1

-

2

1

-

2

1

d 5

1

1

-

1

-

2

1

-

1

-

d 7

1

-

-

1

-

2

-

-

1

-

d 8

1

-

-

1

-

2

-

-

1

-

scars

Mean

24, 48 h

1

1

-

1

0.5

2

1

-

2

1

Mean 24, 48 h

animals

1 -2

1

-

1.5

0.75

Observations after 8 days with fluorescein: no findings

- = not observed

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
According to the study, the test item was found to be irritating to the eyes and is classified as Category 2.

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Before OECD Guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. 50 µl of the test substance was applied to the conjunctival sac of one eye in 2 animals. The saline-treated adjacent eye served as control. The animals were observed several times on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours.
GLP compliance:
no
Remarks:
Study carried out prior to GLP principles

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 2.74 kg; female: 2.16 kg
- Diet: Ssniff ad libitum
- water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Amount applied 0.05 ml
- Concentration: 100%
Duration of treatment / exposure:
not specified (single application, substance was not washed out)
Observation period (in vivo):
8 days; observations at 10 min, 1 h, 3 h, 24 h, 48 h, 5 d, 7 d, 8 d
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
The original grading was converted into the numerical grading according to the OECD Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48 h
Score:
1.5
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48 h
Score:
1
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48 h
Score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48 h
Score:
0.75
Max. score:
4
Reversibility:
not fully reversible within: 5 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48 h
Score:
0.5
Reversibility:
not fully reversible within: 5 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48 h
Score:
1
Reversibility:
not fully reversible within: 5 days
Irritation parameter:
cornea opacity score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
other: observations not made at 72 h
Irritation parameter:
conjunctivae score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
other: observations not made at 72 h
Irritation parameter:
chemosis score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
other: observations not made at 72 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48 h
Remarks on result:
other: not observed
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48 h
Remarks on result:
other: not observed
Irritation parameter:
iris score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
other: observations not made at 72 h
Irritant / corrosive response data:
See table 1.
Other effects:
Residual test substance or smeary layer on the eye.
In 1 animal small retraction of the eye lid (irregular margin) was observed at the end of the observation period, which was described as Na (= Narbe/Scar) in the original German report.
This finding is not the sequel of irreversible tissue destruction as suggested by the misleading historical wording and does not impair the ocular function.
Thus, it is not relevant for evaluation.

Any other information on results incl. tables

Table1:

Scores for iris, cornea and conjunctiva:

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

1h

1

-

-

1

0

smeary charge

2

-

-

1

1

smeary charge

24 h

1

1

-

1

1

smeary charge

2

1

-

2

1

smeary charge

48 h

1

1

-

1

-

2

1

-

2

1

d 5

1

1

-

1

-

2

1

-

1

-

d 7

1

-

-

1

-

2

-

-

1

-

d 8

1

-

-

1

-

2

-

-

1

-

scars

Mean

24, 48 h

1

1

-

1

0.5

2

1

-

2

1

Mean 24, 48 h

animals

1 -2

1

-

1.5

0.75

Observations after 8 days with fluorescein: no findings

- = not observed

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
According to the study, the test item was found to be irritating to the eyes and is classified as Category 2.