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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969, April through June; different groups of animals were dosed between 2009-04-30 and 2009-05-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study, briefly documented; pre-GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF-Test (BASF internal method). In principle, the methods described by OECD TG 401 are used.
GLP compliance:
no
Remarks:
pre-GLP study
Test type:
standard acute method
Limit test:
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): beta-formylcrotyl-acetate (trans-3-formyl-buten-2-ol-1-acetate), synthesized by rearrangement reaction
- Physical state: liquid
- Analytical purity: 94%
- Impurities (identity and concentrations): no data
No further data

Test animals

Species:
rat
Strain:
other: Gassner
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
male and female Gassner rats
- Weight at study initiation: body weight range: 170 - 285 g (males); 160 - 200 g (females)
No further data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous Traganth
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2, 4, 8, 20 % (v/v)

MAXIMUM DOSE VOLUME APPLIED: 2500 ml/kg bw; see freetext
Doses:
ca. 212, 424, 848, 1060, 1326, 1700, 2120, 2650 mg/kg bw (200, 400, 800, 1000, 1250, 1600, 2000, 2500 ml/kg bw); see freetext
No. of animals per sex per dose:
10/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 430 mg/kg bw
Remarks on result:
other: Original value: approximate median lethal dose (ALD): ca. 1350 mm³/kg bw (ca. 1430 mg/kg bw; calculated with a density of 1.0605 g/ml).
Mortality:
At 7 days post dose, mortality was 0/20, 0/20, 0/20, 2/20, 8/20, 14/20, 20/20, and 20/20 in the groups given 200, 400, 800, 1000, 1250, 1600, 2000, and 2500 ml/kg, respectively. All deaths occurred within the first 2 days post dose. No lethality was observed within the first hour after dosing.
Clinical signs:
2500 - 1600 ml/kg:
dyspnea, intermittent respiration, serous secretion of the buccal cavity, twitching, indication of rolling fits, piloerection, high-legged gait, squatting posture, shallow respiration, apathy, adhesions at the eyes, and ruffled fur. The animals were normal from day 2 post dose onwards.

800 - 400 ml/kg:
squatting posture, intermittent respiration, piloerection. The animals were normal at the days after dosing onwards.

1250, 1000, 200 ml/kg:
no symptoms observed
Body weight:
There was no significant effect on body weight or body weight gain.
Gross pathology:
Examination of decedents:
smears at nostrils and anus, distended gastro-intestinal tract, fluid-enriched serous membranes (especially of the thorax), serous content of the stomach and putrefaction.

Examination of survivors:
adhesive-phlogistic processes in the gastric wall (possibly due to dosing by gavage).

Any other information on results incl. tables

Table: mortality data

Group

Dose level

Mortality rate after

[ml/kg bw]

[mg/kg bw]

1 h

24 h

48 h

7 d

1

2500

ca. 2650

0/20

20/20

20/20

20/20

2

2000

ca. 2120

0/20

20/20

20/20

20/20

3

1600

ca. 1700

0/20

14/20

14/20

14/20

4

1250

ca. 1326

0/20

7/20

8/20

8/20

5

1000

ca. 1060

0/20

2/20

2/20

2/20

6

800

ca. 848

0/20

0/20

0/20

0/20

7

400

ca. 424

0/20

0/20

0/20

0/20

8

200

ca. 212

0/20

0/20

0/20

0/20

 

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information: harmful if swallowed