Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to a standard even if not EU, however the substance is poorly described, no observation is done at 48 h and after 72 h. The treatment duration is 24 h instead of 4.
Qualifier:
according to
Guideline:
other: CFR Title 16, section 1500.41
Principles of method if other than guideline:
The exposure duration in this guideline is 24 h instead of 4 according to the OECD guideline.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data
Type of coverage:
occlusive
Preparation of test site:
other: both intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 inch x 1 inch (around 2.5 cm x 2.5 cm)
- % coverage: no data
- Type of wrap if used: the patch is secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material such as rubberized cloth.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h


SCORING SYSTEM: Draize score
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 24-72 h
Score:
0.9
Max. score:
3
Reversibility:
not reversible
Remarks:
over 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
1.5
Max. score:
3
Reversibility:
not reversible
Remarks:
over 72 h
Other effects:
1 animal died during the study

Animal

Effect

24 h

72 h

Left side (intact)

Right side (abraded)

Left side (intact)

Right side (abraded)

1

Erythema

1

1

1

1

Oedema

2

2

1

1

2

Erythema

0

0

0

0

Oedema

2

2

0

0

3

Erythema

0

0

1

1

Oedema

1

1

1

1

4

Erythema

1

1

2

2

Oedema

3

3

1

1

5*

Erythema

-

-

-

-

Oedema

-

-

-

-

6

Erythema

0

0

3

3

Oedema

2

2

2

2

*Animal 5 died during the study

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
After exposure for 24 h, the mean scores are below 2 but the effects are not reversible over 72h, so the substance is considered as irritating R38 according to 67/548/EEC directive, and according to CLP (cat 2).
Executive summary:

The skin irritation properties of quinoline have been assessed in a test on 6 rabbits according to a US guideline (CFR Title 16, section 1500.41). The exposure duration was 24 h. The effects were observed at 24 and 72 h only. 1 rabbit died during the test.

The mean erythema score over 24 -72 h is 0.9 on intact skin and the mean oedema score is 1.5. However, the effects are not reversible at the end of the 72 h period, so the product is considered as irritating for the skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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.
Qualifier:
according to
Guideline:
other: US CFR Title 16, Section 1500,42
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data
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
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

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

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The key studies were performed according to standard guidelines but they are too old to be compliant with GLP.

The skin irritation test was performed with a 24h-treatment on 6 rabbits. The observation period lasts only 72 h. Slight to moderate erythema and oedema were observed but the effects tend to become more severe with time (the mean erythema score over 24 -72 h is 0.9 on intact skin and the mean oedema score is 1.5).

No recovery is obtained at the end of the test. Quinoline is shown to induce irritating effects in rabbit eyes.

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.


Justification for selection of skin irritation / corrosion endpoint:
This is the only study considered as valid.

Justification for selection of eye irritation endpoint:
This is the only study considered as valid.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Skin irritation:

The effects seen in the test are overestimated due to the longer exposure period. The recovery can not be fully monitored because the observation period is only 72 h and the effects seem to strengthen with time, so as precautionary measure the current classification Xi R38 will be kept.

This corresponds to cat 2 for the CLP.

Eye irritation:

The grade of the effects would allow a classification as R36.

This corresponds to cat 2 for the CLP.