2-methoxyethyl cyanoacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1976

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

gas under pressure: refrigerated liquefied gas

Details on test material:

- Name of test material: 2-methoxyethyl cyanoacetate

Test animals

Species:

rat

Strain:

other: Albino rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young
- Weight at study initiation: 200 -300 g
- Fasting period before study: 24 h
- Housing: Common cage
- Diet: Ad libitum
- Water: Ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000, 4000, 5000, 6300, 8000, 16000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: No
- Other examinations performed: Clinical signs, body weight, organ weights, histopathology, other: None

Statistics:

No data.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

4 700 mg/kg bw

Based on:

test mat.

95% CL:

4 100 - 5 500

Effect levels 3

Sex:

male

Dose descriptor:

LD100

Effect level:

6 300 mg/kg bw

Based on:

test mat.

Effect levels 4

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 5

Sex:

female

Dose descriptor:

LD50

Effect level:

4 300 mg/kg bw

Based on:

test mat.

95% CL:

3 900 - 4 700

Effect levels 6

Sex:

female

Dose descriptor:

LD100

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

See table 1 and 2 below for details.

Clinical signs:

other: Male and female animals dosed at 2000 mg/kg bw and 4000 mg/kg bw were languid with unkempt coats. At the 5000 mg/kg bw dosage level, the animals were sluggish with ruffled unkempt coats after dosing. Commencing on the second day unsteady and staggering ga

Gross pathology:

No data.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study groups of fasted young albino rats (5 male/5 female per dose group) were given a single oral dose (gavage) of 2000, 4000, 5000, 6300, 8000, 16000 mg/kg bw and observed daily for 14 days. The obtained oral LD50 for males was 4700 mg/kg bw (95% C.I. 4100 – 550 mg/kg bw) and females was 4300 mg/kg bw (95% C.I. 3900 – 4700 mg/kg bw). The LD0 obtained for males and females was 2000 mg/kg bw. The LD100 for males was 6300 mg/kg bw and for females 5000 mg/kg bw. The test item was considered practically non-toxic.

Executive summary:

A study similar or equivalent to EU Method B.1 and OECD Guideline 401 (Acute toxicity oral) was carried out. Groups of fasted young albino rats (5 male/5 female per dose group) were given a single oral dose (gavage) of 2000, 4000, 5000, 6300, 8000, 16000 mg/kg bw and observed daily for 14 days. The obtained oral LD50 for males was 4700 mg/kg bw (95% C.I. 4100 – 550 mg/kg bw) and females was 4300 mg/kg bw (95% C.I. 3900 – 4700 mg/kg bw). The LD0 obtained for males and females was 2000 mg/kg bw. The LD100 for males was 6300 mg/kg bw and for females 5000 mg/kg bw. The test item was considered practically non-toxic.