N,N-dimethylpyridin-4-amine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-1992

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:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethylpyridin-4-amine

EC Number:

214-353-5

EC Name:

N,N-dimethylpyridin-4-amine

Cas Number:

1122-58-3

Molecular formula:

C7H10N2

IUPAC Name:

N,N-dimethylpyridin-4-amine

Test material form:

solid: crystalline

Details on test material:

The test substance was material prepared in a company lab and recrystallized twice from benzene and three times from benzene/hexane into a fine white crystalline material. It had a constant freezing point of 11.6 degrees C, and a purity of 100% by GLC. The boiling point was 162.5 degrees C, solubility in water of 7.6 g at 25 degrees C, and a flash point of 230 degrees F. This is comparable to current commerical product.

Test animals

Species:

rat

Strain:

Sherman

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-300 grams
- Fasting period before study: 24 hours during which water was allowed
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water : ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS: No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

10%

Doses:

250, 500, 1000, 2000 and 4000 ml/kg bw of the 10% solution in water, equivalent to 25, 50, 100, 200 and 400 mg/kg bw of test material.

No. of animals per sex per dose:

Five males per group

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily for 14 days
- Necropsy of survivors performed: No
- Other examinations performed: clinical signs, body weight.

Statistics:

All animals dosed at 250 and 500 mg/kg survived the experiment, while 4 of 5 dosed at 1000 mg/kg survived. At doses over 1000 mg/kg, animals showed increased levels of nervous system depression within 2-3 hrs of dosing.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

140 mg/kg bw

Based on:

test mat.

95% CL:

> 100 - < 200

Remarks on result:

other: as 10% solution in water

Mortality:

Att 100 mg/kg 1 out of 5 animals died after 1 day. 4 animals survived the 14 day observation period.
At 200 mg/kg, 3 out of 5 animals died after 1 day and 1 animal died on day 2. 1 animal survived 14 days.
At 400 mg/kg dosing all 5 animals died at day 1.

Clinical signs:

other: From 1000 mg/kg and higher all the animals showed advancing degrees of depression with death occuring as noted above. All the surviving animals were normal at day 7 observation.

Gross pathology:

No remarkable pathology

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information LD50 is greater then 50 and less than 300 mg/kg bw. Criteria used for interpretation of results: EU

Conclusions:

4-Dimethylaminopyridine displayed a LD50 of 140 mg/kg in male albino rats in a standard acute oral toxicity assay. As the LD50 is higher than 50 mg/kg bw but less than 300 mg/kg bw, the substance is classified for acute toxicity as Category 3 according to Regulation 1272/2008.