Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-03-23 (day of application)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.

Data source

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

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
(E)-3-formylbut-2-enyl acetate
EC Number:
247-825-4
EC Name:
(E)-3-formylbut-2-enyl acetate
Cas Number:
26586-02-7
Molecular formula:
C7H10O3
IUPAC Name:
(2E)-3-methyl-4-oxobut-2-en-1-yl acetate
Details on test material:
- Name of test material (as cited in study report): C5-Acetat
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
2 male and 1 female Vienna White rabbits
- Source: Gaukler, 6050 Offenbach, Germany
- Age at study initiation: no data
- Weight at study initiation: 3.82 (animal no. 1; male); 2.70 kg (animal no. 2; male); 2.92 kg (animal no. 2; female)
- Housing: individually in stainless steel cages, area 40 cm x 51 cm
- Diet: ca. 130 g/day; Ovator Solikanin 4 mm; Muskator, Düsseldorf, Germany
- Water: ca. 250 ml/day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the test animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 ml of the unchanged test substance
Duration of treatment / exposure:
1 hour
Observation period:
8 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: upper third of the back or flanks; a test patch (ca. 2.5 cm x 2.5 cm) was soaked with 0.5 ml of the liquid test substance

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 1 h

SCORING SYSTEM: Draize / OECD
The skin of each animal was read at 30-60 minutes after removal of the application patches as well as at 24 hours, 48 hours, 72 hours, and 8 days after beginning of application.

After sacrifice, the animals were subjected to gross pathology.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of n=3
Time point:
other: 24 - 72 h
Score:
1.56
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
of n=3
Time point:
other: 24 - 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible

Any other information on results incl. tables

Table: Individual scores and findings

Reading
Animal no.
Erythema
Edema
Symptoms
24 h
1
2
0
R:U
 
2
2
0
R:U
 
3
2
1
R:U/OE:U
48 h
1
1
0
R:U
 
2
1
0
R:U
 
3
2
1
R:U/OE:U
72 h
1
1
0
R:U
 
2
1
0
R:U
 
3
2
1
 
8 d
1
1
0
 
 
2
1
0
R:U
 
3
1
0
S
 
Abbreviations:
OE:U = edema exceeds the application area
R:U = erythema exceeds the application area
S= desquamation

Applicant's summary and conclusion

Conclusions:
Irritating after 1-hour exposure.