potassium {[(2Z)-4-ethoxy-4-oxobut-2-en-2-yl]amino}acetate

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 has been 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:

32085-79-3

EC Number:

608-700-3

Cas Number:

32085-79-3

IUPAC Name:

32085-79-3

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 210-242 g, females 200-203 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

Details on oral exposure:

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

Doses:

2000 mg Gly-Dane salt (W)/kg b.w.

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Observations were performed before and immediately, at 5, 15, 30 and 60 min, as weil as at 3, 6 and 24 hours after administration. All surviving
animals were observed for a period of 14 days.
During the follow-up period (2 weeks), changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and
central nervous system, somatomotor activity as weil as behaviour pattern were observed at least once a day until all symptoms subsided,
thereafter each working day. Attention was also paid to possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on mortality were made at least once daily to minimize loss of animals during the study. The time of death was recorded as precisely aspossible. Individual body weights were recorded before administration of the substance and thereafter in weekly intervals up to the end of the
study, and at death. Changes in weight were calculated and recorded.
At the end of the experiments, all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were
recorded. No histopathology was carried out as no macroscopical findings were noted at autopsy. Autopsy and macroscopic inspection of animals which died prematurely were carried out as soon as possible after exitus.

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

Clinical signs:

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

Body weight:

The animals gained the expected weight throughout the whole study period.

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.