2-(2-aminoethylamino)ethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to GLP guideline study with acceptable restrictions. Low purity of test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-aminoethylamino)ethanol

EC Number:

203-867-5

EC Name:

2-(2-aminoethylamino)ethanol

Cas Number:

111-41-1

Molecular formula:

C4H12N2O

IUPAC Name:

2-[(2-aminoethyl)amino]ethan-1-ol

Details on test material:

AEEA (2-(2-aminoethylamino)ethanol; substance 85/404),
technical, degree of purity 70-85%. Typical impurities
included: diethylenetriamine 2-4%, aminoethylpiperazine
8-12%, hydroxyethylpiperazine 2-5%, diethylenetriamine
(residue) 3-6%.

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, D-7950 BIBERACH . FRG
- Age at study initiation: young adult
- Weight at study initiation: male: 181-191 g , female 169-179 g
- Fasting period before study: 16 h
- Housing: stainless steel wire mesh cages type DK-III (Becker & Co. Castrop-Rauxel. FRG)
- Diet: KLIBA-Labordiet FA. Klingentalmühle AG CH-4303 Kaiseraugst, Switzerland, 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 h / 12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 , 31.6 , 21.5 , 14.7 w/v

DOSE VOLUME APPLIED:
- 10 mL / kg (for all dose levels)

Doses:

1470; 2150; 3160; 5000 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 and weighing: clinical signs were assessed at least once each work day and body weights were recorded on days 3, 5, 7 and 13
- other: check for moribund and dead animals was performed twice on workdays and once on holidays
- Necropsy of survivors performed: yes

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 150 mg/kg bw

Remarks on result:

other: calculated combined for males and females

Mortality:

please refer to "Remarks on results tables and figures"

Clinical signs:

other: Animals of both sexes receiving 3160 or 5000 mg/kg bw showed symptoms from 30 min until 4 hrs. after dosing. The symptoms included dyspnoea,apathy, staggering, and poor general state. Animals at 2150 mg/kg bw showed the same symptoms, but the onset (after

Gross pathology:

Necropsy revealed no abnormalities in animals that survived. In animals that died a general congestive hyperemia was noted. Stomach was found dilated with red liquid contents, hemorrhagic gastritis in animals at 5000 mg/kg bw. The intestines also contained red liquids, the mucosa of the
small intestine was often found deep-red. This is probably due to the caustic nature of AEEA.

Any other information on results incl. tables

Mortality was noted as follows:

Sex	Dose Group [mg/kg bw]
	1470	2150	3160	5000
Males	0/5	3/5	5/5	5/5
Females	0/5	1/5	5/5	5/5

Applicant's summary and conclusion

Executive summary:

In this acute oral toxicity study (BASF AG, Department of Toxicology, 1986), groups of fasted, young adult wistar rats (5/sex) were given a single oral dose of AEEA (70 -85 % a.i.) in destilled water at doses of  1470, 2150, 3160 or  5000  mg/kg bw and observed for 14 days.

 

Oral LD₅₀

Males =  2150 mg/kg bw

Females = 2380 mg/kg bw

Combined =  2150 mg/kg bw