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Toxicological information

Skin irritation / corrosion

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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:
1964
Report Date:
1964

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid test substance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
tert. Butylacrylate, stabilized with 0.02 % hydroquinone

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 2.04 - 2.97 kg


ENVIRONMENTAL CONDITIONS
not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
ca. 1 mL
Duration of treatment / exposure:
20 h and 1, 5, 15 min
Observation period:
7/8 days
Number of animals:
4 (in two trials)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: The skin area exposed for 20 h was not washed, while the shorter treated areas were washed twice, with Lutrol and Lutrol : water 1:1 solution

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
animal #1
Time point:
24/48 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Remarks on result:
other: animal died before 48h reading
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
animal: animal #3, #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 or 8 days (animal #4 or #3, respectively)
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
animal #1
Time point:
24/48 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Remarks on result:
other: animal died before 48h reading
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
animal: #3, #4
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
animal #1
Time point:
24/48 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Remarks on result:
other: animal died before 48h reading
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
15 min exposure
Basis:
animal #1
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
15 min exposure
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: animal died before 48h reading
Irritation parameter:
edema score
Remarks:
15 min exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
15 min exposure
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
See comments in table below.
Other effects:
Reversible clinical signs (apathy and abdominal position with stretched extremities) were seen directly after the 20 h exposure.

Any other information on results incl. tables

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h and the 15 min exposition will serve as approximation.

Exposure:

20 h

Animal

Reading

Erythema

Edema

Comment

1

24 h

2

2

largely extending beyond the area of exposure; reversible apathy

2

24 h

2

2

largely extending beyond the area of exposure; apathy, followed by abdominal position and convulsions of the extremities before exitus

3

24 h

2

2

abdominal position with stretched extremities for one hour after exposure was finished

4

24 h

2

2

abdominal position with stretched extremities for one hour after exposure was finished

1

48 h

3

2

largely extending beyond the area of exposure

2

48 h

       animal died

3

48 h

3

2

 

4

48 h

3

2

 

3

72 h

1

0

fine scaling

4

72 h

1

0

fine scaling

3

4 d

1

0

fine scaling

4

4 d

1

0

 

1

5 d

1

0

largely extending beyond the area of exposure

2

5 d

       animal died

1

7 d

0

0

scaling

2

7 d

       animal died

3

7 d

1

0

fine scaling

4

7 d

0

0

fine scaling

1

8 d

0

0

scaling

2

8 d

       animal died

3

8 d

0

0

fine scaling

4

8 d

0

0

fine scaling

mean

24 - 48 h

2.11

1.56

 

Exposure:

15 min

Animal

Reading

Erythema

Edema

Comment

1

24 h

2

0

largely extending beyond the area of exposure

2

24 h

2

0

largely extending beyond the area of exposure

3

24 h

2

0

 

4

24 h

2

2

 

1

48 h

3

2

largely extending beyond the area of exposure

2

48 h

       animal died

3

48 h

2

0

 

4

48 h

2

0

 

3

72 h

1

0

 

4

72 h

0

0

 

3

4 d

0

0

 

4

4 d

0

0

 

1

5 d

2

2

parchment-like

2

5 d

       animal died

1

7 d

1

0

rough scaling

2

7 d

       animal died

3

7 d

0

0

 

4

7 d

0

0

fine scaling

1

8 d

0

0

scaling

2

8 d

       animal died

mean

24 - 48 h

1.78

0.44

 

Applicant's summary and conclusion

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