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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1977-08-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment; pre-GLP study with restrictions (only one dose level tested, short observation period, limited examinations).

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: DOT guidelines
Deviations:
yes
Principles of method if other than guideline:
The test was carried out according to DOT guidelines. A definite LD50 was not calculated. No further data.
GLP compliance:
no
Remarks:
pre-GPL study
Test type:
standard acute method
Limit test:
yes

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): beta-formylcrotylacetate (2-methyl-4-acetoxy-butenal)
- Physical state: liquid
- Analytical purity: no data
No further data

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
5 male and 5 female albino rabbits
- Weight at study initiation: ca. 2 - 3 kg
- Housing: individually in stainless steel cages; size: (57 cm x 44 cm) x 35 cm
- Diet (ad libitum): pelleted standard diet for rabbits
- Acclimation period: at least 3 days
no further data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23°C
- Humidity (%): 50 - 70%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: spinal region caudal to the ribs
- % coverage: application area; 7 cm x 7 cm (ca. 50 cm²)
- Type of wrap if used: The treated skin site was covered with a vellum-paper, the vellum-paper was fixed with a cohesive tape (Gazofix (TM))
The skin of the back and flanks of each rabbit was shaved at 2 to 16 hours prior to treatment.

REMOVAL OF TEST SUBSTANCE: no data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200 µl/kg bw (ca. 212 mg/kg bw; estimated with a density of 1.605 g/ml) of the unchanged test substance
Duration of exposure:
24 hours
Doses:
ca. 212 mg/kg bw (200 µl/kg bw)
No. of animals per sex per dose:
5 males and 5 females (only one dose level tested)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 72 hours
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no

Mortality was determined at 1, 24, 48 , and 72 hour(s) after beginning of application; local signs of irritation and/or toxicity were monitored. Animals that died spontaneously were subjected to a gross post-mortem examination.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 212 mg/kg bw
Remarks on result:
other: Original value: LD50 > 200 µl/kg bw
Mortality:
No deaths occurred.
Clinical signs:
No clinical signs of toxicity were observed.

Local signs:
Slight, solid strengthening of the skin, partially cracked and fissured was seen at the application site at 5 days after beginning of the application.
Body weight:
no data
Gross pathology:
Pathological examination was not performed since no animal died.

Any other information on results incl. tables

Table: cumulative mortality
Dose
Concentration
Animals
No. of dead animals / no. of exposed animals
1 h
24 h
48 h
72 h
200 µl /kg bw
(ca. 212 mg/kg bw)
Undiluted
Males
0/5
0/5
0/5
0/5
Females
0/5
0/5
0/5
0/5
Males + Females
0/10
0/10
0/10
0/10
 

Applicant's summary and conclusion