Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

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.

Data source

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

Materials and methods

Test guideline
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

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

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.