2-Butenoic acid, 3-[(1-carboxyethyl)amino]-, 1-ethyl ester, monopotassium salt, [S-(Z)]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in compliance with GLP and according to the OECD guideline 423.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

32132-92-6

EC Number:

608-707-1

Cas Number:

32132-92-6

IUPAC Name:

32132-92-6

Test animals

Species:

rat

Strain:

other: CD / Crl:CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: males approx. 6 weeks, females approx. 7 weeks
- Weight at study initiation: males 246-299 g, females 181-192 g
- Housing: 3 animals/cage
- Diet: Feeding was discontinued approx. 16 hours before administration
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.8% aqueous hydroxypropylmethylcellulose gel

Details on oral exposure:

The test substance was suspended in 0.8% aqueous hydroxypropylmethylcellulose gel to obtain a concentration of 200 mg Ala-Dane salt (W)/mL.The
administration volume was 10 ml/kg b.w. in order to obtain a dose of 2000 mg Ala-Dane salt (W)/kg b.w.

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at 5, 15, 30 and 60 minutes, 3, 6, and 24 hours after dosing and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 8 and day 15
- Necropsy of survivors performed: yes
- Other examinations performed: All gross pathological changes were recorded.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred at 2000 mg/kg bw.

Clinical signs:

other: Under the present test conditions, a single oral administration of 2000 mg Ala-Dane salt (W)/kg b.w. did not reveal any clinical signs of toxicity.

Gross pathology:

No pathological findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results of this study indicate that the LD50 of the test item is >2000 mg/kg bw.

Executive summary:

The results of this study indicate that the LD50 of the test item is >2000 mg/kg bw.