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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
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: according to an acceptable internal BASF method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Internal method (BASF test): Two animals were treated for 5 and 15 min, 2 and 20 hours using occlusive conditions. An application site of 2.5 x 2.5 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. The animals were observed 8 days and the skin changes were recorded on working days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyric anhydride
EC Number:
202-603-6
EC Name:
Isobutyric anhydride
Cas Number:
97-72-3
Molecular formula:
C8H14O3
IUPAC Name:
isobutyric anhydride
Details on test material:
- Physical state: liquid
no further information provided

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean: 2.82 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
5 and 15, 2 and 20 hours
Observation period:
24 and 48 hours and 8 days
Number of animals:
2 male rabbits
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm of the back per treating time point

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 5 and 15 min, 2 and 20 hours, respectively

SCORING SYSTEM: Draize (data were re-evaluated according to the scoring system of Draize, as recommended by the actual guideline requirements)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 48 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: after 2 hours of treatment
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 48 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: after 2 hours of treatment

Any other information on results incl. tables

 

 

Exposure period: 5 min

Exposure period: 15 min

Exposure period: 2 h

Exposure period: 20 h

Readings

Animal

Erythema

Edema

Additional findings

Erythema

Edema

Additional findings

Erythema

Edema

Additional findings

Erythema

Edema

Additional findings

24 h

1

2

0

c

2

2

c

3

3

c

3

3

 

2

2

0

c

2

2

c

3

3

c

3

3

 

48 h

1

1

0

 

1

0

 

3

3

c

3

3

c

2

2

1

c

2

1

c

3

3

c

3

3

 

8 d

1

0

0

d

0

0

d

2

1

d

4

2

Np

2

0

0

d

0

0

d

2

2

d

4

2

Np

Mean 24 - 48 h

1

1.5

0.0

 

1.5

1.0

 

3.0

3.0

 

3.0

3.0

 

2

2.0

0.5

 

2.0

1.5

 

3.0

3.0

 

3.0

3.0

 

Mean

1.8

0.3

 

1.8

1.3

 

3.0

3.0

 

3.0

3.0

 

c: comprehensive; d: desquamation; N: necrosis; p: parchmenty

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information