2-Butenoic acid, 3-amino-, 1-methylethyl ester

Endpoint summary

Description of key information

Oral (Rat-Wistar, GLP): LD50 > 2000 mg/kg
Inhalation (Rat-Wistar, GLP, OECD TG 403): LC50 > 6064 mg/m³

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Reliable study performed according to GLP and European guidelines

Qualifier:

according to guideline

Guideline:

other: Directive 84/449/EWG (Amtsblatt der Europäischen Gemeinschaften Nr. L 251 vom 19.09.1984, S. 96) and proposal of the OECD updating panels of 1986-04-11

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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 (174 g males - 175 g females)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

400

Details on oral exposure:

- Application volume: 10 mL/kg bw

Doses:

2000 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:

none

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: piloerection and increased diuresis up to 48 hours after dosing

Gross pathology:

no findings

Executive summary:

The acute oral toxicity of 3 -Aminocrotonsäurepropylester was low with an LD50 value of > 2000 mg/kg bw in rats. No mortality occurred and clinical signs became obvious in the first 2 days after treatment as piloerection and increased diuresis.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well reported GLP Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

additionally, an inhalation-risk test was performed

GLP compliance:

yes

Test type:

standard acute method

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Strain: Bor:WISW (SPF-Cpb)
- Weight at study initiation: 170 - 190 g
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: at least 5 days

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

clean air

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

nominal concentration: 50.000 µl/m³ air
analytic concentration: 6064 mg/m³

No. of animals per sex per dose:

5

Control animals:

yes

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 6 064 mg/m³ air

Exp. duration:

4 h

Mortality:

none

Clinical signs:

other: reduced respiratory frequency and unspecific symptoms

Body weight:

no changes

Gross pathology:

no findings

In the inhalation-risk test the animals were exposed in 10l restrainers to a saturated test atmosphere (35 ml test substance at 20 °C was filled in a container with 3.5 cm diameter). Aircirculation: 3.3 L air per minute. Thus, the animals (5 males, 5 females) were exposed to a nominal concentration of 657 mg/m³ air for 7 hours.

Executive summary:

The acute inhalation toxicity of 3 -Aminocrotonsäureisopropylester, tested in a GLP-compliant study according to OECD TG 403, is low with an LC50 of > 6064 mg/m³ for male and female rats. No mortalities, no changes in body weight development and no necropsy findings became obvious. At the day of exposure the animals showed reduced respiratory frequency and unspecific symptoms.

In an inhalation-risk test with exposure of rats for 7 hours the saturated atmosphere of 657 mg/m³ was tolerated well by the animals.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The acute oral toxicity of 3 -Aminocrotonsäurepropylester was low with an LD50 value of > 2000 mg/kg bw in rats. No mortality occurred and clinical signs became obvious in the first 2 days after treatment as piloerection and increased diuresis.

The acute inhalation toxicity of 3 -Aminocrotonsäureisopropylester, tested in a GLP-compliant study according to OECD TG 403, is low with an LC50 of > 6064 mg/m³ for male and female rats. No mortalities, no changes in body weight development and no necropsy findings became obvious. At the day of exposure the animals showed reduced respiratory frequency and unspecific symptoms.

In an inhalation-risk test with exposure of rats for 7 hours the saturated atmosphere of 657 mg/m³ was tolerated well by the animals.

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

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

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.