2-Pyridinecarboxamide, 4-chloro-N-methyl-, hydrochloride (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Study period:

May to June 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2014

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 (Acute Toxicity (Oral))

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:

4-chloro-N-methylpyridine-2-carboxamide hydrochloride (1:1)

EC Number:

692-719-7

Cas Number:

882167-77-3

Molecular formula:

C7 H7 Cl N2 O . Cl H

IUPAC Name:

4-chloro-N-methylpyridine-2-carboxamide hydrochloride (1:1)

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

- Application volume: 10 mL/kg bw

- Rationale for the selection of the starting dose:
As described in the flow charts of Annex 2, OECD guideline 423, the starting dose level should be that which is most likely to produce mortality in
some of the dosed animals. Therefore, the limit dose 2000 mg/kg bw was chosen as starting dose.

Doses:

2000 mg/kg bw (1st step) and 300 mg/kg bw (2nd step)

No. of animals per sex per dose:

3 females (2000 mg/kg bw) and 6 females (300 mg/kg bw)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes

Statistics:

none

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

other: LD50 cut-off

Effect level:

500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: acc. to OECD Guideline 423

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: acc. to GHS

Mortality:

At the dose 2000 mg/kg bw all 3 females died within 4 hours after treatment. The dose 300 mg/kg bw was tolerated by all 6 females without mortalities.

Clinical signs:

other: At 2000 mg/kg bw piloerection, uncoordinated gait, accelerated breathing, aggravate breathing as well as abdominal and lateral position were observed up to 4 hours after treatment in all animals. The dose 300 mg/kg bw showed piloerection, decreased motili

Gross pathology:

No gross pathological findings were observed in animals that died during the observation period and at the end of the study.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information

Executive summary:

The acute oral toxicity of 4¿Chlorpicolinmethylamid HCl was harmful with a LD50 of 500 mg/kg bw in rats (cut-off value) according to OECD TG 423. According to EC Regulation 1272/2008 the LD50 of the test item is > 300 - 2000 mg/kg bw (Category 4 of the Globally Harmonized Classification System). At the limit-dose 2000 mg/kg bw all animals died within 4 hours after treatment. The dose 300 mg/kg bw was tolerated by all 6 females without mortalities. At 2000 mg/kg bw piloerection, uncoordinated gait, accelerated breathing, aggravate breathing as well asabdominal and lateral position were observed up to 4 hours after treatment in all animals. The dose 300 mg/kg bw showed piloerection, decreased motility and narrowed palpebral fissure in all animals up to 24 hours after administration. Neither effects on body weight gain nor gross pathological findings were observed.