N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From December 07, 1987 to January 27, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine

EC Number:

219-145-8

EC Name:

N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine

Cas Number:

2372-82-9

Molecular formula:

C18H41N3

IUPAC Name:

bis(3-aminopropyl)(dodecyl)amine

Test material form:

liquid

Details on test material:

- Name of test material: N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
- Description: Clear, pale straw-coloured, slightly viscous liquid
- Container: Plastic screw-top bottle
- Sponsor's identification: P4150
- Batch number: 130787
- Analytical purity: 30% (concentration of the test substance in vehicle).
- Date of arrival: 17 november 1987
- Storage conditions: 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: Interfauna UK Limimted, Wyton, Huntingdon Cambridgeshire
- Age at study initiation: 5-8 weeks
- Assigned to test groups randomly: Yes
- Housing: Up to 5 per cage
- Diet : Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 40-60
- Air changes (per hr): approximately 15 times
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- Concentration in vehicle: 30%

Doses:

Dose-range finding study: 500, 1,000, 2,000, 3,000 and 5,000 mg/kg bw (as 30% aqueous solution)
Main study: 250, 500, 1,000, 2,000 mg/kg bw as 30% aqueous solution, (i.e., equivalent to 75, 150, 300, 600 mg a.i./kg bw)

No. of animals per sex per dose:

1/sex/dose in the dose-range finding study; 5/sex/dose in the main study.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 5 d in the dose-range finding study; 14 d in the main study.
- Frequency of observations and weighing: 1 and 4 h after dosing and then daily. In the dose-range finding study bodyweight was recorded on the day of dosing. In the main study individual bodyweights were recorded on the day of treatment (Day 0), Days 7 and 14 and at death.
- Necropsy of survivors performed: Yes in the main study. In the dose-range finding study no necropsies were performed.
- Other examinations performed: Clinical signs, body weight, gross pathology.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

871 mg/kg bw

Based on:

test mat.

95% CL:

704 - 1 076

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

261 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: based on 30% purity

Effect levels 3

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

933 mg/kg bw

Based on:

test mat.

95% CL:

664 - 1 310

Effect levels 4

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

280 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: based on 30% purity

Effect levels 5

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

812 mg/kg bw

Based on:

test mat.

95% CL:

616 - 1 072

Effect levels 6

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

243.6 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: based on 30% purity

Mortality:

In the dose-range finding study: Both animals survived at the 500 mg/kg bw dose level and one animal at the 1,000 mg/kg bw dose level.
In the main study: All animals dosed at 2,000 mg/kg bw died within 24 h of dosing. Three males and four females dosed at 1,000 mg/kg bw died within 24 h of dosing.

Clinical signs:

other: All treated animals showed systemic signs of toxicity, such as piloerection, hunched posture and decreased respiratory rate between 1 and 4 h of dosing. Those animals treated at 1,000 and 2,000 mg/kg bw showed additional signs of increased salivation.

Gross pathology:

Necropsy findings showed that all animals that died during the study had similar abnormalities in the lungs, liver and kidneys, gastric mucosa and intestines. Surviving animals did not show any abnormalities at necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Under the study conditions, the oral LD50 value for all animals was determined to be 261 mg a.i./kg bw (280 mg a.i./kg bw for males and 243.6 mg a.i./kg bw for females).

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 401, in compliance with GLP. Groups of 5 male and 5 female Sprague Dawley rats were administered oral gavage doses of a 30% aqueous solution of the test substance at 250, 500, 1000, 2000 mg/kg bw (equivalent to 75, 150, 300, 600 mg a.i./kg bw). Parameters evaluated included survival, clinical observations, bodyweight and necropsy findings in all animals after a 14 day observation period. The LD50 and 95% confidence intervals were calculated separately for males and females using the method of Thompson WR. All animals in the 600 mg a.i./kg bw dose group and 7 of 10 animals (3 males and 4 females) in the 300 mg a.i./kg bw dose group died within 24 h of dosing. All treated animals showed systemic signs of toxicity such as pilo-erection, hunched posture and decreased respiratory rate between 1 and 4 h after dosing. Animals treated at 300 and 600 mg a.i./kg bw showed additional signs of increased salivation. Further, reduced bodyweight gain was observed during the first week after dosing in some animals in the 75 and 150 mg a.i./kg bw dose group and all animals in the 300 mg a.i./kg bw dose group. Necropsy findings showed that all animals that died during the study had similar abnormalities in the lungs, liver and kidneys, gastric mucosa and intestines. Under the study conditions, the oral LD50 value for all animals was determined to be 261 mg a.i./kg bw (280 mg a.i./kg bw for males and 243.6 mg a.i./kg bw for females) (Jones, 1988).