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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1962
Report date:
1962

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Before OECD Guideline 404 was established in 1982, skin irritation was tested using an internal method (BASF test). White Vienna rabbits were used. 2 animals were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. In addition, skin tissue from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal / lateral flank of the back. After the application time, the skin was washed with water which contained a mild detergent. The animals were observed 7 to 8 days and skin changes were recorded on working days. The report usually describes findings after 24 hours and at the end of the observation period. Thus, for final evaluation, the findings after 48 and 72 hours from the raw data have to be taken into account.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyl acrylate
EC Number:
203-417-8
EC Name:
Isobutyl acrylate
Cas Number:
106-63-8
Molecular formula:
C7H12O2
IUPAC Name:
isobutyl acrylate
Specific details on test material used for the study:
- Name of test material: Isobutylacrylat
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.68, 2.62, 2.66, 2.39 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.2 mL/kg
- Concentration: undiluted


Duration of treatment / exposure:
1, 5, 15 min, and 20 hours
Observation period:
8 days
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol concentrated and Lutrol (50%)
- Time after start of exposure: 1 min, 5 min, 15 min respectively

SCORING SYSTEM:
Erythema formation:
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet-redness) to slight, eschar formation (injuries in depth)

Edema formation:
0: No edema
1: Very slight edema (barely perceptible)
2: Slight edema (edges of area well defined by definite rising)
3: Moderate edema (raised approx. 1 mm)
4: Severe edema (raised more than 1 mm and extending beyond the area of exposure)

The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
15 min exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
15 min
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritant / corrosive response data:
Well defined erythema (Draize grade 2) and edema (grade 2) as well as skin petechiae were seen at 24 hours after exposure periods of 5 and 15 minutes, and 20 hours. Slight erythema (grade 1) and edema (grade 1) were seen at 24 hours after an exposure period of 1 minute. 8 days after exposure slight erythema (grade 1) and scaling was noted in animals of all exposure groups.

The test substance led to clearly visible skin irritation in both animals when treated for 1, 5, 15 min and 20 hours. To evaluate the skin irritation potential of the test substance, the scores of the 20 hour incubation have been used, but the scores for the 1 -15 min incubation have been also taken into account.

Any other information on results incl. tables

Readings

Animal

Exposure period: 1 min

Erythema

Edema

Additional findings

1 h

1

3

2

2

2

0

spotted appearance

24 h

1

2

2

spotted bleedings

2

2

0

spotted appearance

48 h

1

3

2

bleedings

2

2

0

72 h

1

2

0

2

0

0

7 d

1

1

0

desquamation

2

0

0

desquamation

Mean 24, 48, 72 h

1

2.66

1.33

2

2

0

Mean 24, 48, 72 h

1-2

2.33

0.665

Readings

Animal

Exposure period: 5 min

Erythema

Edema

Additional findings

1 h

1

3

2

2

2

0

24 h

1

3

3

spotted bleedings

2

3

0

48 h

1

3

2

bleedings

2

3

2

72 h

1

1

0

2

2

0

7 d

1

1

0

desquamation

2

0

0

desquamation

Mean 24, 48, 72 h

1

2.66

1.33

2

2

0

Mean 24, 48, 72 h

1-2

2.33

0.665

Readings

Animal

Exposure period: 15 min

Erythema

Edema

Additional findings

1 h

1

3

2

2

3

2

24 h

1

3

3

spotted bleedings

2

3

2

exceeding beyond area of exposure

48 h

1

3

2

bleedings

2

3

2

72 h

1

2

0

brown-red colouring

2

3

0

7 d

1

2

0

desquamation

2

0

0

desquamation

Mean 24, 48, 72 h

1

2.66

1.66

2

3

1.33

Mean 24, 48, 72 h

1-2

2.83

1.0

Readings

Animal

Exposure period: 20 hours

Erythema

Edema

Additional findings

24 h

1

3

3

2

3

0

spotted appearance

48 h

1

3

2

2

3

2

72 h

1

2

2*

2

2

2*

9 d

1

2

0

desquamation

2

0

0

desquamation

Mean 24, 48, 72 h

1

2.66

2.33

2

2.66

1.66

Mean 24, 48, 72 h

1-2

2.66

2.0

* The value was not given in the raw data, but at the 48-hours reading an edema was scored with 2 and at the 96-hour reading the same animal was also scored with an edema of 2, therefore it seems likely that the experimenters forgot to note the edema scoring at the 72-hours reading.  

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria