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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:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study not performed according to a standard even if not EU however the substance tested is poorly described, the test duration is only 7 days.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US CFR Title 16, Section 1500,42
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 110 831
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
not specified
Controls:
other: 1 eye of each animal
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize score


TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72
Score:
0.8
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: the evaluation is partly made because sometimes D is stated instead of any value
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.5
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
2.2
Max. score:
3
Reversibility:
not fully reversible within: 7 days

Any other information on results incl. tables

Animal

Effects

Day

1

2

3

7

1

Cornea

Opacity

D

0

1

2

Area

0

0

4

1

Iris

 

1

1

1

1

Conjunctiva

Redness

2

2

3

3

Chemosis

3

2

2

2

Discharge

1

2

3

2

2

Cornea

Opacity

D

1

D

0

Area

0

4

0

0

Iris

 

1

0

0

0

Conjunctiva

Redness

1

1

1

0

Chemosis

2

2

1

0

Discharge

1

2

1

0

3

Cornea

Opacity

D

D

D

1

Area

0

0

0

4

Iris

 

0

0

0

0

Conjunctiva

Redness

2

2

2

2

Chemosis

2

2

2

2

Discharge

1

2

1

2

4

Cornea

Opacity

D

1

1

1

Area

0

4

4

1

Iris

 

0

1

1

0

Conjunctiva

Redness

2

3

2

1

Chemosis

2

3

2

2

Discharge

2

3

2

2

5

Cornea

Opacity

D

D

D

0

Area

0

0

0

0

Iris

 

0

0

0

0

Conjunctiva

Redness

2

2

2

2

Chemosis

2

2

2

1

Discharge

2

2

2

1

6

Cornea

Opacity

D

1

1

1

Area

0

4

4

2

Iris

 

1

1

1

0

Conjunctiva

Redness

2

3

3

2

Chemosis

3

3

3

3

Discharge

3

3

2

2

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean scores for chemosis is > 2 , so the substance could be considered as irritating R36 according to 67/548/EEC directive, but the effects are not reversible at the end of the study (7 days), the reversibility at 21 days can not be evaluated so a classification as R41 is proposed.
The corresponding CLP classification would be cat 1.
Executive summary:

The eye irritation properties of quinoline have been assessed in a test on 6 rabbits according to a US guideline (CFR Title 16, section 1500.42). The effects were observed at 24, 48, 72 h and 7 days.

The mean chemosis score over 24 -72 h is 2.2 and the mean redness score is 2. However, the effects are not reversible at the end of the 7 days period, so the product is considered as severely irritating for the eye.