3-aminopropyldiethylamine

Endpoint summary

Description of key information

In a study performed according to a protocol comparable to the OECD Guideline 401, the oral LD50 was 830 mg/kg bw in rat. In an acute dermal toxicity study performed according the OECD guideline #402, the dermal LD50 was 0.64 (0.39-1.04)ml/kg(524 mg/kg)in male New Zealand rabbit. In a inhalation risk test, no mortality was observed after a 4h-exposure to saturated vapours.

 

Oral toxicity

In a key study comparable to the OECD no. 401 Guideline (BASF AG, 1981), test groups of 5 or 10 rats were treated by single gavage application with an aqueous solution of 3-aminopropyldiethylamine. The animals were observed for mortality and for clinical symptoms of toxicity. They were weighed prior treatment and thereafter, day 3, day 7 and day 13 post-treatment. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy. The LD50 value was estimated to be ca. 830 mg/kg on the basis of the observed mortalities.

The acute oral toxicity of 3-aminopropyldiethylamine (DEAPA) was evaluated in rats according to a protocol similar to OECD no. 401 guideline (Myers and Ballantine, 1997). Groups of 5 male Wistar albino rats were given a single oral dose of DEAPA. Following treatment, rats were observed daily. Animals were weighted before treatment and 14 days after dosing, time of scheduled euthanasia. No other data is available but under these experimental conditions, the oral LD50 of DEAPA is 0.50 ml/kg (0.26-0.76 ml/kg) or 410 mg/kg (213 -623) in Wistar rats with 95% confidence interval limits.

The acute oral toxicity of 3-aminopropyldiethylamine (DEAPA) was evaluated in groups of five male Carworth-Wistar rats (Smyth et al., 1962). No precise data are available, but under these experimental conditions, the oral LD50 of DEAPA is 1410 mg/kg (1210-1650mg/kg) in male rats with 95% confidence interval limits.

 

Inhalation toxicity

Data were available from an inhalation risk test (IRT) which meets generally accepted scientific principles (BASF AG, 1961). The toxicity of an atmosphere saturated with vapours of the volatile components of 3-aminopropyldiethylamine at the temperature chosen for vapour generation (20 °C) was evaluated in 3 or 6 rats per sex exposed sequentially to the vapours, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 30 min, 2 h and 8h. The documentation of clinical signs was performed over a period of 7 days. No mortality was observed after a 30-min exposure. One female died within 24 h after a 2h-exposure and 1 male and 2 females died within 24 h after a 8h-exposure.

In 2 other IRT (Myers and Ballantyne, 1997; Smyth et al., 1962), the inhalation of a saturated vapor-air mixture for 4 or 8 hours caused no mortality.

 

Dermal toxicity

The acute dermal toxicity of 3-aminopropyldiethylamine was evaluated in five male New Zealand white rabbits (Myers and Ballantyne, 1997). The test substance was applied under an impervious plastic sheeting wrapped around the trunk and secured. The rabbit was then immobilized into a restraining apparatus for 24 hours. Animals were observed during 14 days. No other data is available. Under these experimental conditions, the dermal LD50 was 0.64 ml/kg (524 mg/kg) in male rabbits.

The acute dermal toxicity of 3-aminopropyldiethylamine (DEAPA) was evaluated in groups of four white New-Zealand rabbits (Smyth et al., 1962). No precise data are available, but under these experimental conditions, the LD50 was 0.75 ml/kg (615 mg/kg).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 May 1961 - 15 Jun 1961

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented report which meets basic scientific principles.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

other: Meyer-Arend rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 153 g (mean)

Route of administration:

oral: gavage

Vehicle:

water

Doses:

200, 400, 800, 1000, 1250 or 1600 cmm/kg bw (166, 322, 664, 830, 1037.5, 1328 mg/kg bw - conversion in mg/kg is based on density: d=0.83 g/cm3 (BASF AG MSDS)

No. of animals per sex per dose:

166, 322, 644 mg/kg: 2 males, 3 females.
830 mg/kg: 4 females, 6 males.
1037.5 mg/kg: 4 males, 6 females.
1328 mg/kg: 2 males, 3 females.

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 830 mg/kg bw

Mortality:

1328 mg/kg: all animals died within 24 h.
1037.5 mg/kg: 4 females died within 24 h and 1 male within 48 h.
830 mg/kg: 3 males and 1 female died within 24 h. 1 male died within 3 days and 1 male within 6 days.
644 mg/kg: 1 male died on day 7.

Clinical signs:

other: 1328 mg/kg: staggering, beginning lameness of hind limbs, apathy, abdominal position, accelerated respiration. 1037.5 mg/kg: apathy, ruffled fur. 870 mg/kg: ruffled fur, animals were calmer as usual. 644 mg/kg: calmer as usual.

Gross pathology:

1328 mg/kg: 3x stomach filled with red-yellowish content.
1037.5 mg/kg: 1x stomach filled with red-yellowish content, congested liver.
830 mg/kg: 3x stomach filled with red-yellowish content, 2x congestion of liver, spleen and kidneys. 1x small intestine reddened, diarrhoea. 1x fundus reddened.
644 mg/kg: congestion of the lung, distinct peritonitis.

Sacrificed animals:
644 mg/kg: 1x slight paleness of kidney.

Mortality:

Dose (mg/kg bw)	conc. (%)	1 h	24 h	48 h	day 7	day 14
1328	20	0/5	5/5	5/5	5/5	5/5
1037.5	10	0/10	4/10	5/10	5/10	5/10
830	10	0/10	4/10	4/10	6/10	6/10
644	8	0/5	0/5	0/10	1/10	1/10
322	8	0/5	0/5	0/10	0/10	0/10
166	2	0/5	0/5	0/10	0/10	0/10

There is indication that the test substance causes local irritation to exposed tissues.

Interpretation of results:

Toxicity Category IV

Executive summary:

In a study comparable to the OECD Guideline 401, test groups of 5 or 10 rats were treated by single gavage application with an aqueous solution of 3 -aminopropyldiethylamine. The animals were observed for mortality and for clinical symptoms of toxicity. They were weighed prior treatment and thereafter, day 3, day 7 and day 13 post-treatment. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy. The LD50 value was estimated to be ca. 830 mg/kg on the basis of the observed mortalities.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

830 mg/kg bw

Quality of whole database:

Acceptable, well-documented report which meets basic scientific principles.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 2e

Qualifier:

no guideline followed

Principles of method if other than guideline:

Inhalation risk-test

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

no data

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
by passing 2.5L/min of dried air at room temperature through a fritted glass disc immersed to a depth of at least one inch in approximately 50 mL of the test chemical contained in a gas-washing bottle.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

4 h

Concentrations:

saturated vapor

No. of animals per sex per dose:

6

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

Sex:

male/female

Effect level:

other: atmosphere saturated with vapours

Exp. duration:

4 h

Remarks on result:

other: No mortality

Mortality:

No mortality at saturated vapor for 4 hours

Clinical signs:

other: No data

Body weight:

No data

Gross pathology:

No data

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality at saturated vapor for 4 hours.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Collection of data

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data from handbook or collection of data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: 3-5 months
- Weight at study initiation: 2-3kg
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): ad libitum commercialdiet
- Water (e.g. ad libitum): ad libitum municipal water
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Fur was carefully removed from the ventral skin, using an electric clipper. Test substance was applied and impervious plastic sheeting was wrapped around the trunk and secured.
The rabbit was immobilized into a restraining apparatus for 24 hours.

Duration of exposure:

24 hours

Doses:

No data

No. of animals per sex per dose:

5 males

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations : daily
- Weighing D1, 14
- Necropsy of survivors performed: yes

Statistics:

method of Thompson, tables of Weil

Sex:

male

Dose descriptor:

LD50

Effect level:

0.64 mL/kg bw

95% CL:

0.39 - 1.04

Sex:

male

Dose descriptor:

LD50

Effect level:

524 mg/kg bw

95% CL:

320 - 853

Remarks on result:

other: based on a density of 0.82

Mortality:

time to death=1d

Clinical signs:

other: No data

Gross pathology:

No data

Interpretation of results:

Toxicity Category III

Conclusions:

The dermal LD50 was 524 mg/kg in male rabbits.

Executive summary:

The Acute dermal toxicity of 3 -aminopropyldiethylamine was evaluated in five male New Zealand white rabbits. The test substance was applied under an impervious plastic sheeting wrapped around the trunk and secured. The rabbit was then immobilized into a restraining apparatus for 24 hours. Animals were observed during 14 days.

No other data is available. Under these experimental conditions, the dermal LD50 was 0.64 ml/kg (524 mg/kg) in male rabbits.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

524 mg/kg bw

Quality of whole database:

Data from handbook

Justification for classification or non-classification

According to the harmonised classification and labelling(CLP) approved by the European Union:

- Acute Tox. 4 * H302

- Acute Tox. 4 * H312

Self classification according to CLP criteria:

- Acute Tox. 4 H302

- Acute Tox. 3 H311