N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-09-20 - 1999-11-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine

EC Number:

229-761-9

EC Name:

N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine

Cas Number:

6711-48-4

Molecular formula:

C10H25N3

IUPAC Name:

(3-{[3-(dimethylamino)propyl]amino}propyl)dimethylamine

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): JCZR50B (JEFFCAT ZR-50B)
- Substance type: Colorless liquid
- Physical state: Liquid
- Lot/batch No.: 160-0497
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan
- Age at study initiation: Males: 8 weeks, females: 10 weeks
- Weight at study initiation: 180 - 194 grams (dose range); 179 - 287 grams (assay)
- Fasting period before study: animals were fasted over the night before dose administration.
- Housing: Rats were group-housed prior to treatment initiation. During the study, animals were housed individually in stainless steel cages in compliance with USDA guidelines.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days prior to treatment initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Test article formulation:
The test article was prepared on a weight to volume basis with distilled water

Doses:

500 mg/kg, 1000 mg/kg, 1250 mg/kg, 1600 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations:
Recorded 1 and 4 hours (± 15 minutes) after dosing and once daily through Day 15. Signs of toxicity were recorded at least once daily as they were observed, including time of onset, degree and duration.
Weighing: Body weight: Recorded on day 1 (fasted) and on days 8 and 15 (at terminal sacrifice)
- Necropsy of survivors performed: yes: all rats were sacrificed on day 15 by CO2 asphyxiation and gross necropsies were performed, which included examination of the external body surfaces, all orifices and the thoracic, abdominal and pelvic cavities and their contents.

Statistics:

Evaluations were made of clinical signs and body weight data. Body weights were summarized using descriptive statistics (mean and standard deviation).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 250 - < 1 600 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at 500 and 1000 mg/kg. Three of ten and ten of ten were found dead at 1250 and 1600 mg/kg, respectively.

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

All surviving animals gained weight over the course of the study.

Gross pathology:

No visible lesions were observed at 500 and 1000 mg/kg or in the surviving animals at 1250 mg/kg. At 1250 mg/kg necropsy observations included stomach-distended and/or fluid-filled red; abdominal cavity - fluid-filled; intestines -fluid-filled (red) and distended; and liver - mottled and/or soft. At 1600 mg/kg necropsy observations included stomach - fluid-filled red; distended, red lesions; and intestines fluid-filled red.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based upon the results of this study, the estimated LD50 for the test article, was between 1250 and 1600 mg/kg.