1-[bis[3-(dimethylamino)propyl]amino]propan-2-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-09-06 to 1983-09-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

before 2002

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-[bis[3-(dimethylamino)propyl]amino]propan-2-ol

EC Number:

266-587-2

EC Name:

1-[bis[3-(dimethylamino)propyl]amino]propan-2-ol

Cas Number:

67151-63-7

Molecular formula:

C13H31N3O

IUPAC Name:

1-Bis(3-(dimethylamino)propylamino)-2-propanol

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 5601-23-1
- Substance type: Organic
- Physical state: Clear liquid
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration.
- Other: Specific gravity = 0.890 g/mL

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hilltop Lab Animals, Inc. Scottdale, Pennsylvania
- Weight at study initiation: 180 - 360 grams after fasting; the weight variation in animals or between groups did not exceed ± 20%
- Fasting period before study:18 hours
- Housing: Animal rooms: Separate isolation by test system; rats housed in groups, according to sex, or individually in stainless steel 1/2 wire mesh cages. Size in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 to 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:

unchanged (no vehicle)

Doses:

Dose-range finding study:
In a dose-range finding study, four fasted animals, two per sex, were administered the test article at 1000, 2000, 4000 and 8000 mg/kg, orally by gavage.
LD50 determination:
In the acute oral toxicity study, five groups of ten rats (5 males and 5 females) were administered at dose levels of 800, 1000, 1250, 1600 and 2000 mg/kg by oral gavage.

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: On days 7 and 14, body weights were recorded
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs:
The rats observed at approximately 1, 2, 4 and 24 hours after dosing and twice daily for 14 days for pharmacotoxic, CNS effects and mortality.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 344 mg/kg bw

Based on:

test mat.

95% CL:

1 153 - 1 567

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

1 332 mg/kg bw

Based on:

test mat.

95% CL:

1 066 - 1 663

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

1 357 mg/kg bw

Based on:

test mat.

95% CL:

1 173 - 1 570

Mortality:

None of the animals died at 800 mg/kg
One of ten died at 1000 mg/kg
Two of ten died at 1250 mg/kg
Nine of ten died at 1600 mg/kg
Ten of ten died at 2000 mg/kg

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

no data

Gross pathology:

Necropsy of animals dying on study revealed the stomach mucosa desquamated, dark red cecum and distended intestines. Intestines and bladders were fluid-filled and black in color. Hemorrhagic thymus, congested lungs and dark adrenals were also observed. Hemorrhagic thymus, congested lungs and dark adrenals were also observed. Terminal necropsy revealed one animal with dark foci on the kidneys. No visible lesions were observed in the remaining animals.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based upon the results of the acute oral toxicity study in rats, the calculated oral LD50 for male and female rats treated with the substance was determined to be 1344 mg/kg with 95% confidence limits of 1153 to 1567 mg/kg. Therefore, the substance is to be classified as acute oral toxicant category 4 according to the criteria laid down in the CLP Regulation.