Tripropylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. They were weighed prior to treatment and thereafter, on 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.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tripropylamine

EC Number:

203-047-7

EC Name:

Tripropylamine

Cas Number:

102-69-2

Molecular formula:

C9H21N

IUPAC Name:

tripropylamine

Details on test material:

- Name of test material (as cited in study report): Tri-N-Propylamin
- Physical state: liquid
- Analytic purity: 98.7%
- Lot/batch No.: 47/89/60/88 89

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DR. K . THOMAE GMBH, Biberach, Germany
- Age at study initiation: Young adult animals
- Weight at study initiation: male: 180 g (mean), female: 183 g (mean)
- Fasting period before study: 16 h
- Housing: 5 per cage
- Diet: Kliba Labordiaet 343, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 4 and 40 %
- Justification for choice of vehicle: Test substance in insoluble in aqua dest.

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

Doses:

200 and 2000 mg/kg bw

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: at least once per day
- Frequency of weighing: days 0, 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

200 - 2 000 mg/kg bw

Mortality:

200 mg/kg bw: no mortality occurred.
2000 mg/kg bw: 4 males and 5 females died within 1 h after application. A further male died within 24h after application.

Clinical signs:

other: other: 200 mg/kg bw: no clinical signs 2000 mg/kg bw: Abdominal position, apathy, clonic convulsions, piloerection, salivation, staggering, tremor, twitching, poor general state.

Gross pathology:

Animals that died: General congestion.
Sacrificed animals: No pathologic findings noted.

Any other information on results incl. tables

Mortality:

Dose (mg/kg bw)	Gender	1 h	day 1	day 7	day 13
200	male	0/5	0/5	0/5	0/5
200	female	0/5	0/5	0/5	0/5
2000	male	4/5	5/5	5/5	5/5
2000	female	5/5	5/5	5/5	5/5

Weight (g):

Dose (mg/kg bw)	Gender	day 0	day 7	day 13
200	male	188	261	305
200	female	187	220	231
2000	male	171	-	-
2000	female	179	-	-

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information according to the criteria in CLP, Annex I Criteria used for interpretation of results: EU

Conclusions:

An oral LD50 of 200-2000 was established for tripropylamine in rats. According to Regulation (EC) No 1272/2008, tripropylamine should be classified in Cat. 3 as an acute toxic substance by the oral route (H301 Toxic if swallowed).

Executive summary:

The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401. A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. Two dose levels were used: 200 mg/kg bw and 2000 mg/kg bw. The animals were observed for mortality and for clinical symptoms of toxicity. They were weighed prior to treatment and thereafter, on 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. No mortality occurred in animals treated with 200 mg/kg bw, while 4 males and 5 females died within 1 hour after application of 2000 mg/kg bw. No clinical signs were observed in animals in the low dose group (200 mg/kg bw); the animals gained weight. In the highest dose group (2000 mg/kg bw), abdominal position, apathy, clonic convulsions, piloerection, salivation, staggering, tremor, twitching and poor general state were observed. No pathological findings were noted at necropsy in sacrificed animals. In animals that died, general congestion was noted. LD50 is in the range of 200 -2000 mg/kg bw.