2-(2-aminoethylamino)ethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

fixed dose procedure

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

Test material form:

not specified

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: D R. K . Thomae GMBH, D-7950 Biberach, FRG
- Weight at study initiation: males: between 181 - 191 g; females: between 169-179 g
- Fasting period before study: 16 hours before adminitration, but water was available ad libitum.
- Housing: Steenless wire mesh cages Type DK-III (Becker & co. Castrop-Rauxel, FRG ) housed in fully airconditioned rooms.
- Diet: Labordiaet, fa. Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum
- Water : Tap water ad libium per day
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature : 20 -24°C
- Humidity: 30-70%
- Photoperiod: 12 Hours dark/ 12 hours light

IN-LIFE DATES: From: 22 Oct 1985 To: 26 Nov 1985

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Aqua Dest.

Details on oral exposure:

DOSAGE PREPARATION:
Administration volume: 10 mL/kg
Time of day of administration: In the morning

Doses:

1470, 2150, 3160, 5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: recording of signs and symptoms, several times on the day of administration, at least once every workday. Check for mordibund and dead animals twice each workday and once on holidays .
- Weighing of the animals: at the beginning of the test and day 3, 5, 7 and 13.
- Necropsy of survivors performed: yes, gross pathological examination performed.

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 150 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 1 470 mg/kg bw

Based on:

test mat.

Mortality:

Females: at 3160 and 5000 mg/kg bw all females died within 1 day. At 2150 mg/kg bw one female died during the first day after dosing. No mortality was observed at a concentration of 1470 mg/kg bw.
Males: At 3160 and 5000 mg/kg bw all males died within 1 day. At 2150 mg/kg bw 3 males died during the first day after exposure observation period of 14 days. No mortality was observed at a concentration of 1470 mg/kg bw.

Clinical signs:

other: For both male and female rat, several clinical signs were observed at a concentration of 2150, 3160 and 5000 mg/kg bw during the first day after administration. The severe clinical signs observed were dyspnea, apathy, stagering, piloerection and poor gen

Gross pathology:

Animals that died during the observation period: Dilated stomach with red contents. Mucosa of the small intestine deep-red, atonic with red liquid contents. At a concentration of 5000 mg/kg bw hemorrhagic gastritis was observed.
Sacrificed animals at the end of the test: No abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

In an acute oral study with rats, performed similar to OECD guideline 423 an LD50 Female > 2150 mg/kg bw and an LD50 males> 1470 mg/kg bw was determined.

Executive summary:

An acute toxicity study was performed similar to OECDguideline 423. Aminoethylethanolamin was administrated by oral gavage to five female rats and five male rats at 1470, 2150, 3160 and 5000 mg/kg body weight. At the two highest concentrations, all males and females died within 24 hours after dosing. At a concentration of 2150 mg/kg dw 3 male rats and 1 female rat died the first day after dosing. At a concentration of 1470 mg/kg bw no mortality occurred. The aminals that died during the test period showed a dilated stomach and deep red mucosa of the small intestines. At a concentation of 5000 mg/kg dw hemorrhagic gastritis was observed. No abnormalities were observed for the sacrificed animals at the end of the test. Based on these results, an LD50> 1470 mg/kg body weight was determined and Aminoethylethanolamin is classified catogory 4 for acute toxicity according to Regulation (EC) No 1272/2008.