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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl acrylate
EC Number:
202-500-6
EC Name:
Methyl acrylate
Cas Number:
96-33-3
Molecular formula:
C4H6O2
IUPAC Name:
methyl acrylate
Details on test material:
- Test substance: Methylacrylat
- Test substance No.: 82/22
- Analytical purity: ca. 99.95 %

Test animals

Species:
rabbit
Strain:
other: New Zealand, unspecified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Weight at study initiation: 2.91 kg (males); 2.98 kg (females)
- Acclimation period: 8 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): ca. 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animals
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
1 or 4 h
Observation period:
7 d
Number of animals:
6 (3 per sex)
Details on study design:
TEST SITE
- Area of exposure: 3x3cm, upper third of the flank/ back region
- Type of wrap if used: Hansamed plaster, Beiersdorf AG, D


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water 1:1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
4 h exposure
Time point:
24/48/72 h
Score:
2.17
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
mean
Remarks:
4 h exposure
Time point:
24/48/72 h
Score:
2.44
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
erythema score
Basis:
mean
Remarks:
1 h exposure
Time point:
24/48/72 h
Score:
2.44
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
mean
Remarks:
1 h exposure
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 7 d

Any other information on results incl. tables

Exposition:

4 h semi-occlusive

Animal

Reading

Erythema

Edema

Comment

1

1 h

2

3

erythema overlapping, hemorragic; edema overlapping

2

1 h

2

3

erythema and edema overlapping

3

1 h

2

3

erythema and edema overlapping

4

1 h

2

2

erythema and edema overlapping

5

1 h

2

3

erythema overlapping, hemorragic; edema overlapping

6

1 h

3

3

erythema overlapping, hemorragic; edema overlapping

1

24 h

2

2

erythema overlapping, hemorragic; edema overlapping

2

24 h

2

3

erythema and edema overlapping

3

24 h

2

3

erythema and edema overlapping

4

24 h

2

2

erythema and edema overlapping

5

24 h

2

3

erythema overlapping, hemorragic; edema overlapping

6

24 h

3

3

erythema overlapping, hemorragic; edema overlapping

1

48 h

2

2

erythema overlapping, hemorragic; edema overlapping

2

48 h

2

3

erythema and edema overlapping

3

48 h

2

3

erythema and edema overlapping

4

48 h

2

2

erythema and edema overlapping

5

48 h

2

2

erythema and edema overlapping

6

48 h

3

2

erythema overlapping

1

72 h

2

2

erythema overlapping, hemorragic; edema overlapping

2

72 h

2

3

erythema and edema overlapping

3

72 h

2

3

erythema and edema overlapping

4

72 h

2

2

erythema and edema overlapping

5

72 h

2

2

erythema and edema overlapping

6

72 h

3

2

erythema overlapping

1

7 d

2

1

scaling

2

7 d

1

0

 

3

7 d

2

1

 

4

7 d

1

0

scaling

5

7 d

1

0

erythema overlapping, scaling

6

7 d

2

1

strong scaling, edema overlapping

mean

24 - 72 h

2.17

2.44

 

Exposition:

1 h semi-occlusive

Animal

Reading

Erythema

Edema

Comment

1

1 h

2

3

erythema and edema overlapping

2

1 h

2

3

erythema and edema overlapping

3

1 h

2

3

erythema and edema overlapping

4

1 h

2

2

erythema and edema overlapping

5

1 h

2

3

erythema overlapping, hemorragic; edema overlapping

6

1 h

3

3

erythema overlapping, hemorragic; edema overlapping

1

24 h

2

3

erythema and edema overlapping

2

24 h

2

3

erythema and edema overlapping

3

24 h

2

3

erythema overlapping, hemorragic; edema overlapping

4

24 h

2

2

erythema and edema overlapping

5

24 h

1

2

erythema and edema overlapping

6

24 h

3

3

erythema and edema overlapping

1

48 h

2

2

erythema and edema overlapping

2

48 h

3

3

erythema and edema overlapping

3

48 h

3

3

erythema overlapping, hemorragic; edema overlapping

4

48 h

2

1

erythema and edema overlapping

5

48 h

4

2

necrosis, edema overlapping

6

48 h

2

3

edema overlapping

1

72 h

2

2

erythema and edema overlapping

2

72 h

3

3

erythema and edema overlapping

3

72 h

3

3

erythema overlapping, hemorragic; edema overlapping

4

72 h

2

1

 

5

72 h

4

2

necrosis, edema overlapping

6

72 h

2

1

 

1

7 d

1

0

scaling

2

7 d

1

0

 

3

7 d

2

1

scaling, erythema and edema overlapping

4

7 d

0

0

scaling

5

7 d

4

1

superficial necrosis; edema overlapping

6

7 d

1

0

scaling, erythema overlapping

mean

24 - 72 h

2.44

2.33

 

Applicant's summary and conclusion

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