Potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

end on 8 July 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: screening test, sufficiently described

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

yes screening test (few dose levels and animals used)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate

EC Number:

213-510-5

EC Name:

Potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate

Cas Number:

961-69-3

Molecular formula:

C14H17NO4.K

IUPAC Name:

potassium [(3-ethoxy-1-methyl-3-oxoprop-1-en-1-yl)amino](phenyl)acetate

Details on test material:

- Name of test material (as cited in study report): FG-KZE
- Substance type: monoconstituent substance
- Physical state: data not available
- Analytical purity: data not available
- Impurities (identity and concentrations): data not available
- Purity test date: data not available
- Lot/batch No.: 989 A
- Expiration date of the lot/batch: data not available
- Stability under test conditions: data not available
- Storage condition of test material: data not available

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source, Age at study initiation, Weight at study initiation, Fasting period before study, Housing, Diet, Water, Acclimation period: data not available

ENVIRONMENTAL CONDITIONS
- Temperature, Humidity, Air changes, Photoperiod: data not available

IN-LIFE DATES: data not available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE: corn oil

MAXIMUM DOSE VOLUME APPLIED: dose volume of 10 ml/kg body weight

Doses:

2000, 1000 and 200 mg/kg bw

No. of animals per sex per dose:

1 male and 1 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> clinical signs and mortality: at 0.05h, 2.10h and 3.55h after exposure and therafter each day for 15 days
> individual body weight: on days 1, 8 and 15
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality observed

Mortality:

no mortality was observed

Clinical signs:

other: Piloerection was observed on days 2 and 3 at 200 mg/kg bw and on days 9 and 10 at 1000 mg/kg bw. No other effect was observed

Gross pathology:

No effect was observed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

oral LD50 (male, female) > 2000 mg/kg bw

Executive summary:

In an acute oral toxicity study (screening test), groups of Wistar rats (1/sex) were given a single oral dose of PG (D-(-)-α-phenylglycine) in distilled water at doses of 200, 1000 and 2000 mg/kg bw and observed for 14 days.

Oral LD50 (male/female) > 2000 mg/kg (no mortality observed)

Piloerection was observed on days 2 and 3 at 200 mg/kg bw and on days 9 and 10 at 1000 mg/kg bw. No other clinical sign was observed. No abnormalities were observed on body weight or at necropsy.

PG-ds (potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate) is of low toxicity based on the LD50 in males and females. It is not classified as dangerous according to EU criteria.