Registration Dossier
Registration Dossier
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EC number: 202-051-6 | CAS number: 91-22-5
Eye irritation
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:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US CFR Title 16, Section 1500,42
- GLP compliance:
- no
Test material
- Reference substance name:
- Quinoline
- EC Number:
- 202-051-6
- EC Name:
- Quinoline
- Cas Number:
- 91-22-5
- Molecular formula:
- C9H7N
- IUPAC Name:
- quinoline
- 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
Constituent 1
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.
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