3-aminopropyldimethylamine

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-aminopropyldimethylamine

EC Number:

203-680-9

EC Name:

3-aminopropyldimethylamine

Cas Number:

109-55-7

Molecular formula:

C5H14N2

IUPAC Name:

N,N-dimethylpropane-1,3-diamine

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River laboratories, Inc., Wilmington Massachusetts
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 180-334 g
- Fasting period before study: yes
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): no data
- Acclimation period: min 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h light, 12h dark


IN-LIFE DATES: From: july 14, 1992 To: july 17, 1992 (dose-finding study);
IN-LIFE DATES: From: sept 10, 1992 To: sept 24, 1992 (difinitive LD50 study)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

no vehicle

Doses:

dose range finding study: 500, 2500, 5000 mg/kg
definitive LD50 study: 320, 630, 1000 mg/kg

No. of animals per sex per dose:

5 rats per sex per dose

Control animals:

other: not required according to OECD guideline 401

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1h, 4h and 24h after dosing + daily until day 14
- Necropsy of survivors performed: yes
- Other examinations performed: incidence of clinical signs, toxic signs, mortality; body weight, gross necropsy findings

Statistics:

using the method of Litchfield and Wilcoxon via the Innovative Programming Associates, LABCAT Module Version 4.24

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

377.1 mg/kg bw

95% CL:

203.3 - 699.3

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

442.7 mg/kg bw

95% CL:

322.8 - 607.1

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

410 mg/kg bw

95% CL:

288.1 - 584

Mortality:

320 mg/kg: male 1/5 dead (day6); female 2/5 dead (day1 and day3)
630 mg/kg: male 4/5 dead (2x day1, day3; day6); female 4/5 dead (2x 3h after dosing, 2x day6)
1000 mg/kg: male 5/5 dead (3x 3h after dosing, 2x on day 1); female 5/5 dead (3 x 3h, 2x day 1)
5/5 died between 6h and 24h after exposure (dosage: 2.5 ml/kg)
1/5 died between 6h and 24h after exposure (dosage: 1.25 ml/kg)
2/5 died on the 4th day after exposure (dosage: 1.25 ml/kg)

Clinical signs:

other: following clinical signs are observed: decreased activity, abnormal gait, abnormal stance, dyspnea, chromodacryorrhea, diarrhea, decreased body tone, piloerection, prostration, tremors, flaccid body tone, salivation, discolored urine, body drop and poor

Gross pathology:

Necropsy of the animals dying on study revealed fluid-filled, discolored and/or distended intestines, spleen, bladder and stomach. No visible lesions
were observed in any animal at terminal necropsy.