5-ethyl-2-methylpyridine

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))

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

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: 5-ethyl-2-methyl-pyridine

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
- 4.0 mL/kg bw

Doses:

250, 500, 640, 800, 1000, 2000, 4000 mg/kg bw.

No. of animals per sex per dose:

5 male, 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily observations
- Necropsy of survivors performed: No
- Other examinations performed: None.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD0

Effect level:

250 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD0

Effect level:

250 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

710 mg/kg bw

Based on:

test mat.

95% CL:

470 - 1 040

Effect levels 4

Sex:

female

Dose descriptor:

LD50

Effect level:

710 mg/kg bw

Based on:

test mat.

95% CL:

470 - 1 040

Effect levels 5

Sex:

male/female

Dose descriptor:

LD50

Effect level:

710 mg/kg bw

Based on:

test mat.

95% CL:

470 - 1 040

Effect levels 6

Sex:

male

Dose descriptor:

LD100

Effect level:

<= 2 000 mg/kg bw

Based on:

test mat.

Effect levels 7

Sex:

female

Dose descriptor:

LD100

Effect level:

<= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

On day one following dosing mortality was observed for all animals (5/5) of the high dose group (4000 mg/kg bw), three animals of the 2000 mg/kg bw and one animal each of the 1000, 800 and 640 mg/kg bw dose group. On day two of the observation period mortality was observed for two animals of the 2000 mg/kg bw and three animals of the 1000 mg/kg bw dose group. On day four one animal each of the 800 and 500 mg/kg bw dose groups were found dead. Following the 14 day observation period all animals (5/5) of the low dose group (250 mg/kg bw), 4/5 of the 500 and 600 mg/kg bw dose groups, 1/5 of the 800 mg/kg bw dose group and 0/5 of the 2000 and 4000 mg/kg bw dose groups survived.

Clinical signs:

other: Male animals dosed at 250 mg/kg bw and 500 mg/kg bw were languid with unkempt coats and nasal hemorrhage. Nasal hemorrhage and lethargy accompanied unkempt coats were observed in male animals at 640 mg/kg bw and 800 mg/kg bw. Male survivors appeared norma

Gross pathology:

Not determined.

Applicant's summary and conclusion

Interpretation of results:

harmful

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 250, 500, 640, 800, 1000, 2000, 4000 mg/kg bw and observed daily for 14 days. The obtained oral LD50 for males and females was 710 mg/kg bw (95% C.I. 470 – 1040 mg/kg bw). The LD0 obtained was 250 mg/kg bw and the LD100 was 2000 mg/kg bw.

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) were given a single oral dose (gavage) of 250, 500, 640, 800, 1000, 2000, 4000 mg/kg bw. The animals were observed daily for 14 days thereafter. The obtained oral LD50 for males and females was 710 mg/kg bw (95% C.I. 470 – 1040 mg/kg bw). The LD0 obtained was 250 mg/kg bw and the LD100 was 2000 mg/kg bw.