3,5-dimethylpyridine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: U.S. Department of Transportation, 49 CFR 173.132

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,5-dimethylpyridine

EC Number:

209-708-6

EC Name:

3,5-dimethylpyridine

Cas Number:

591-22-0

Molecular formula:

C7H9N

IUPAC Name:

3,5-dimethylpyridine

Test material form:

other: liquid

Details on test material:

sourced from Nepera Co.. Colorless liquid. Specific gravity: 0.95. The article was stored at room temperature and humidity.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals were quarantined for at least 1 week. The animals were born between the weeks of 8/4/98 and 8/25/98. The pretest body weight range was 237-292 g for males and 211-221 g for females. Animals were housed 5/sex/cage in suspended wire mesh cages. Bedding was placed beneath the cages and changed at least 3 times/week. Food was fresh Purina Rat Chow (diet #5012) and was available ad libitum except for 16-20 h prior to dosing. Water was available ad libitum. The animal room was temperature controlled, had a 12 h light/dark cycle and was kept clean and vermin free.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The dose was based on the sample weight as calculated from the specific gravity. All rats received the same concentration of dosing solution.

Doses:

500 mg/kg body weight.

No. of animals per sex per dose:

5/sex/dose group

Control animals:

no

Details on study design:

Animals were observed 3-4 h post dose and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects. Body weights were recorded pretest and at termination.
Animals were examined for gross pathology, post mortem. Tissues were not preserved.

Statistics:

No statistical analysis was undertaken.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

< 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 3 males and 5 females died by day 2.

Mortality:

3 Males and 5 females (of 10 animals total) died by day 2.

Clinical signs:

other: Physical signs included dyspnea, soiling of the anogenital area, flaccid muscle tone, lethargy, prostration, negative righting reflex, ataxia, diarrhea, wetness of body areas, nasal discharge and brown staining of the nose/mouth area. Physical signs amon

Gross pathology:

Necropsy results in the dead animals revealed abnormalities of the eyes, lungs, liver, kidneys, spleen and gastrointestinal tract. Necropsy results in the surviving animals were normal.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information The LD50 is less than 500 mg/kg bw. Criteria used for interpretation of results: EU

Conclusions:

The substance, when given by oral gavage to Wistar rats, displayed an LD50 of less than 500 mg/kg bw.