2-Butenoic acid, 3-amino-, 2-methylpropyl ester

Endpoint summary

Description of key information

Oral (Rat-Wistar): LD50 1400 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliable study performed according to scientific standards

Qualifier:

according to guideline

Guideline:

other: Directive 84/449/EWG (Amtsblatt der Europäischen Gemeinschaften Nr. L 251 vom 19.09.1984, S. 96)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Strain: Bor:WISW (SPF Cpb)
- Age at study initiation: adult mean (173 g males - 175 g females)
- Diet: ad libitum
- Water: ad libitum

Route of administration:

oral: gavage

Vehicle:

other: Lutrol (PEG 400)

Details on oral exposure:

- Application volume: 20 mL/kg bw

Doses:

1000, 1300, 1600, 2000, and 2500 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes

Statistics:

Rosiello et al, J. Tox and Environ. Health 3, 797-809, 1977

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 400 mg/kg bw

Based on:

test mat.

Mortality:

1000 mg/kg bw: 0/5 males, 0/5 females
1300 mg/kg bw: 3/5 males, 2/5 females
1600 mg/kg bw: 4/5 males, 2/5 females
2000 mg/kg bw: 4/5 males, 4/5 females
2500 mg/kg bw: 5/5 males, 5/5 females

Clinical signs:

other: doses of 1300 mg/kg and above: poor general condition, dazed condition, abdominal or lateral position, piloerection; on day 4 signs had disappeared

Gross pathology:

At necropsy dead animals showed loss of gastric mucosal relief, the stomach fundus and the intestines were reddened; final necropsy at day 14 revealed no abnormalities.

Interpretation of results:

harmful

Remarks:

Migrated information

Executive summary:

The acute oral toxicity of 3 -Aminocrotonsäurebutylester was determined with an LD50 value of 1400 mg/kg bw in rats. Doses of 1000 up to 2500 mg/kg bw were tested in groups of 5 male and 5 female rats. Mortality occurred at doses of 1300 mg/kg bw and above. All animals in the 2500 mg/kg bw group died. Thus, the test item should be considered as harmful after oral uptake.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Additional information

The acute oral toxicity of 3 -Aminocrotonsäurebutylester was determined with an LD50 value of 1400 mg/kg bw in rats. Doses of 1000 up to 2500 mg/kg bw were tested in groups of 5 male and 5 female rats. Mortality occurred at doses of 1300 mg/kg bw and above. All animals in the 2500 mg/kg bw group died. Thus, the test item should be considered as harmful after oral uptake.

Justification for selection of acute toxicity – oral endpoint
only one study available

Justification for classification or non-classification

Based on the study results (oral LD50: 1400 mg/kg bw) a classification with R22 (harmful if swallowed) according to Directive 67/548/EEC or with Acute Toxicity Cat. 4 (H302:harmful if swallowed) according to Regulation (EC) No. 1272/2008 (CLP) is required.