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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:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

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).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Methyl-2-butenal, CAS: 107-86-8
- Analytical purity: 98%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2,81- 3.41 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
7 d
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.0 x 2.0 cm
- % coverage: 100
- Type of wrap if used: plastic film


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol
- Time after start of exposure: 3 min, 1h, 4h


SCORING SYSTEM:

Erythema:
1 questionable
2 slightly
3 strong
4 severe
Oedema:
1 very slightly
2 slightly
3 strong
4 severe

S= scaling, sS= strong scaling, N=necrosis, w=weak, p=parchmenty, l=leather-like,
h=indurated slidable, t=penetrative, fn=spotted necrotic, Na=cicatris, ü= extending the site of application, id=indurated, an=anaemic

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 + 48 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 + 48 h
Score:
3.25
Max. score:
4
Reversibility:
not reversible

Any other information on results incl. tables

Readings

Animal

Exposure period: 4 h

Erythema

Edema

Additional findings

Erythema

Edema

4 h

1

2

3

ü

2

3

4

ü

24 h

1

3

3

2

3

4

ü, fl

48 h

1

3

3

ü, fl

2

3

3

ü, fl

8 d

1

4

1

Nl, ü

2

4

1

Nl, ü

Mean

24h, 48h,

1

3

3

2

3

3.5

Mean

1-2

3

3.25

Readings

Animal

Exposure period: 1 h

Erythema

Edema

Additional findings

Erythema

Edema

4 h

1

*

3

b,ü

2

4

3

Nw

24 h

1

4

4

Nw,ü

ü

2

4

4

Nw,ü

ü

48 h

1

4

4

Nw,ü

ü

2

4

4

Np,ü

ü

8 d

1

4

2

Np

2

4

2

Nl, ü

Mean

24h, 48h,

1

4

4

2

4

4

Mean

1-2

4

4

Readings

Animal

Exposure period: 3 min

Erythema

Edema

Additional findings

Erythema

Edema

4 h

1

*

0

2

*

0

24 h

1

1

0

2

1

0

48 h

1

1

0

2

1

0

8 d

1

0

0

S

2

1

0

S

Mean

24h, 48h,

1

1

0

2

1

0

Mean

1-2

1

0

Symbols:

N  - necrosis

ü   - oedema/redness extending the site of application

l    - leather-like

p   - parchmenty

fl   - blotty necrotic

w  - weak

*   - reeding not possible due to substance related dying of the skin

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Edema, erythema and necrosis of the skin were seen as early
as 1 h after treatment and persisted until the end of the
observation period on day 8.

Based on this finding no additional eye irritation test was
performed.