5-ethyl-2-methylpyridine

Endpoint summary

Description of key information

Several acute toxicity studies were carried out, with key studies available for all relevant routes. In addition, two supporting studies assessed acute oral toxicity. In a study similar or equivalent to EU Method B.1 and OECD Guideline 401 (Acute toxicity oral) the LD50 oral was determined to be 710 mg/kg bw. In a study similar or equivalent to EU Method B.2 and OECD Guideline 403 (Acute Inhalation Toxicity) the LC50 inhalation was determined 2.67 mg/L. In a study similar or equivalent to EU Method B.3 and OECD Guideline 402 (Acute Dermal Toxicity) the LD50 dermal was determined 1000 mL/kg bw. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

not specified

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

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

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.

Sex:

male

Dose descriptor:

LD0

Effect level:

250 mg/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

LD0

Effect level:

250 mg/kg bw

Based on:

test mat.

Sex:

male

Dose descriptor:

LD50

Effect level:

710 mg/kg bw

Based on:

test mat.

95% CL:

470 - 1 040

Sex:

female

Dose descriptor:

LD50

Effect level:

710 mg/kg bw

Based on:

test mat.

95% CL:

470 - 1 040

Sex:

male/female

Dose descriptor:

LD50

Effect level:

710 mg/kg bw

Based on:

test mat.

95% CL:

470 - 1 040

Sex:

male

Dose descriptor:

LD100

Effect level:

<= 2 000 mg/kg bw

Based on:

test mat.

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

710 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

not specified

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

female

Route of administration:

inhalation

Type of inhalation exposure:

not specified

Vehicle:

not specified

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Control animals:

not specified

Sex:

female

Dose descriptor:

LC50

Effect level:

2.67 mg/L air

Exp. duration:

4 h

Interpretation of results:

toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute inhalation toxicity study with rats a 4 h LC50 of 2.67 mg/L was determined.

Executive summary:

A study similar or equivalent to EU Method B.2 and OECD Guideline 403 (Acute Inhalation Toxicity) was carried out. Rats were dosed for 4 hours. An LC50 of 2.67 mg/L was revealed.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

2.67 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

not specified

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

not specified

Sex:

not specified

Type of coverage:

not specified

Vehicle:

not specified

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

1 000 mg/kg bw

Based on:

not specified

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal toxicity study with rabbits a LD50 of 1000 mg/kg bw was determined.

Executive summary:

A study similar or equivalent to EU Method B.3 and OECD Guideline 402 (Acute Dermal Toxicity) was carried out. Rabbits were administered a single dermal dose. An LD50 of 1000 mg/kg bw was revealed.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 000 mg/kg bw

Additional information

Acute oral toxicity

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 at 2000 mg/kg bw.

Support - Acute oral toxicity

A study similar or equivalent to EU Method B.1 and OECD Guideline 401 (Acute toxicity oral) was carried out. Groups of fasted Sprague Dawley-derived rats of the Crl :CD(WI)BR strain (5 male/5 female per dose group) were given a single oral dose (gavage) of 730, 1020, 1430, 1620, 1810, 2000 mg/kg bw and observed daily for 14 days. The obtained oral LD50 for all animals was 1737 mg/kg bw (95 % CL 1640-1839), for males only 1697 mg/kg bw (95 % CL 1484-1914) and females only 1797 mg/kg bw (95% fiducial limits could not be calculated). The LD0 obtained for males was 1020 mg/kg bw and 1620 mg/kg bw for females. The LD100 obtained for males and females was < 2000 mg/kg bw.

Support - Acute oral toxicity

A study similar or equivalent to EU Method B.1 and OECD Guideline 401 (Acute toxicity oral) was carried out. Groups of fasted Tylers Original Mice (5 male/5 female per dose group) were given a single oral dose (gavage) of 200, 400, 600, 800, and 1000 mg/kg bw and observed daily for 14 days. The obtained oral LD50 was620mg/kg bw (95 % CL 516-744).

Key - Acute inhalation toxicity

A study similar or equivalent to EU Method B.2 and OECD Guideline 403 (Acute Inhalation Toxicity) was carried out. Rats were dosed for 4 hours. An LC50 of 2.67 mg/L was revealed.

Key- Acute dermal toxicity

A study similar or equivalent to EU Method B.3 and OECD Guideline 402 (Acute Dermal Toxicity) was carried out. Rabbits were administered a single dermal dose. An LD50 of 1000 mL/kg bw was determined.

Justification for classification or non-classification

Based on the data available the substance is classified and labeled according to Regulation 1272/2008/EEC (CLP) as Acute toxicity category 4, Oral H302 Harmful if swallowed, acute toxicity category 3, Dermal H311 Toxic in contact with skin, acute toxicity category 3, Inhalation H331 Toxic if inhaled and Xn harmful, R20/21/22 Harmful by inhalation, in contact with skin and if swallowed according to Directive 67/548/EEC (DSD).