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:
comparable to guideline study with acceptable restrictions

Data source

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

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:
1,4-butanediyl diacrylate
EC Number:
213-979-6
EC Name:
1,4-butanediyl diacrylate
Cas Number:
1070-70-8
Molecular formula:
C10H14O4
IUPAC Name:
1,4-butanediyl diacrylate
Details on test material:
- Name of test material (as cited in study report): Butandioldiacrylat
- Analytical purity: > 90 %

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: M. Gaukler, Offenbach
- Weight at study initiation: about 3 kg
- Diet: ad libitum (Ssniff K; supplying company: Intermast GmbH, Soest)
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
Duration of treatment / exposure:
1 hour (2 animals, one male and one female) and 4 hours (2 animals both male)
Observation period:
8 days; reading:
(4 hours exposure): 4 hours, 1 day, 4 days and 8 days after the end of the exposure
(1 hour exposure): 1 hour, 1 day, 2 days, 8 days after the end of the exposure
Number of animals:
2 animals exposed for 1 hour, 2 other animals for 4 hours
Details on study design:
TEST SITE
- Area of exposure: trunk
- coverage: 2 x 2 cm

REMOVAL OF TEST SUBSTANCE
- Washing with lutrol or a water/lutrol mixture (1+1)
- Time after start of exposure: 1 and 4 hours after application

SCORING SYSTEM:
similar to the one described in 404 OECD guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 48 hours
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 48 hours
Score:
3.25
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 hour exposure
Other effects:
4h: Necrosis detected in both animals, though in one animal reduced to scaling at the end of the observation period.
1h: Scaling at the end of the obervation period. No necrosis occured.

Any other information on results incl. tables

Draize scores of individual animals:

1 hour exposure

time

animal 1

animal 2

erythema

1 h

2

2

24 h

2

2

48 h

3

3

8 d

2

2

edema

1 h

2

2

24 h

2

4

48 h

3

4

8 d

2

2

4 hours exposure

time

animal 1

animal 2

 

erythema

4 h

3

3

 

24 h

3

3

 

4 d

4

3

 #1: necrosis

8 d

4

4

 #1: scaling, #2: necrosis

edema

1 h

4

3

 

24 h

4

4

 

4 d

2

3

 

8 d

2

3

 

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria