Registration Dossier

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:
other: Well documented study report which basic scientific principles

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:
Method: BASF test following internal SOP
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isobutylacrylat
- Physical state: liquid
- Other: stabilized with 0.006% hydrochinonmonomethylether

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals 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(s) applied (volume or weight with unit): 0.2 mL/kg
- Concentration (if solution): 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
- % coverage: 100%


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:
mean
Time point:
other: 24-48-72 h
Score:
2.83
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
15 min exposure
Basis:
mean
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 24-48-72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 9 days
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 9 days

Any other information on results incl. tables

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.

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:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU