2-aminoethanol

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:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-aminoethanol

EC Number:

205-483-3

EC Name:

2-aminoethanol

Cas Number:

141-43-5

Molecular formula:

C2H7NO

IUPAC Name:

2-aminoethanol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-300g
- Fasting period before study: over night

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

0.25, 0.50, 1.0, 2.0, 4.0 mL/kg bw (based on a density of 1.018 g/mL: 254, 509, 1018, 2036, 4072 mg/kg bw)

No. of animals per sex per dose:

5 males and 5 females (0.25-2.0 mL/kg dosing groups)
2 males (4.0 mL/kg dosing group)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights

Statistics:

LD50 values and the estimated LD50 slopes were calculated by the moving average method (Thompson 1947; Weil 1983).

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 089 mg/kg bw

Remarks on result:

other: based on a density of 1.018 g/mL

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

1.19 mL/kg bw

95% CL:

> 0.79 - < 1.8

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

1.07 mL/kg bw

95% CL:

> 0.72 - < 1.59

Mortality:

Dose (mL/kg) Numbers of Animals Dead Time of Death
(M,F)
0.25 0,0 N/A
0.50 1,0 12 days
1.0 1,2 1 or 2 days
2.0 5,5 4 hrs to 1 day
4.0 2 (M) 3 hrs

All deaths occurred relatively rapidly after dosing (within 2 days), except for one male rat that died after 12 days after a dose of 0.5 mlLkg. Both of the male rats receiving monoethanolamine at the maximum peroral dosage of 4.0 mL/kg died after 3 hours. One female in the 2.00 mL/kg group died after 4 hours.

Clinical signs:

other: MALES Dosage (mL/kg) Signs of Toxicity - 4.00 sluggishness at 15 min; slight piloerection at 1 hr. death at 3 hr. - 2.00 sluggishness at 1.5 hr; slight piloerection at 2 hr. - 1.00 slight red crust on perinasal fur, slight red crust on periocula

Gross pathology:

MALES
Dosage (mL/kg) Gross Pathology
- 4.00 lungs pale red; stomachs, intestines dark red.
- 2.00 lungs of 1 mottled light and dark red; stomachs, intestines distended, filled with dark red liquid.
- 1.00 in deceased, stomach, intestines red; stomach filled with clear red liquid; in survivors, kidneys mottled dark red.
- 0.50 in deceased, stomach severely distended, filled with brown liquid; emaciation; in survivors, nothing remarkable.
- 0.25 nothing remarkable

FEMALES
Dosage (mL/kg) Gross Pathology
- 2.00 lungs mottled or bright red; stomachs, intestines dark red, filled with red liquid.
- 1.00 in deceased, glandular portion of stomachs dark red; in survivors, livers of 2 adhered to glandular portion of stomachs; stomachs distended with gas; kidneys dark red.
- 0.50 liver of 1 adhered to glandular portion of stomach; stomach of 1 distended with gas; kidneys of 1 dark red.
- 0.25 nothing remarkable

Any other information on results incl. tables

The LD50 values (with confidence limits if calculated) in males and females were 1.19 (0.79 - 1.80) mL/kg and 1.07 (0.72 - 1.59) mL/kg, respectively. The slopes of the curves were 3.84 and 4.96 for males and females, respectively.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria