(2-hydroxyethyl)ammonium nitrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

substance purity not given

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

no

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

IUPAC Name:

2-aminoethanol

Details on test material:

- Name of test material: Monoethanolamine (2-Aminoethanol)
- Analytical purity: no data

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: 200-300 g
- Fasting period before study: overnight

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 bw dosing groups)
2 males (4.0 mL/kg bw 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 days 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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 089 mg/kg bw

Based on:

test mat.

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

Based on:

test mat.

95% CL:

0.79 - 1.8

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

1.07 mL/kg bw

Based on:

test mat.

95% CL:

0.72 - 1.59

Mortality:

The numbers of deaths at each dose were as follows:

0.25 mL/kg bw: 0 male, 0 female (N/A)
0.50 mL/kg bw: 1 male, 0 female (at 12 days)
1.00 mL/kg bw: 1 male, 2 females (at 1 or 2 days)
2.00 mL/kg bw: 5 males, 5 females (at 4 hours to 1 day)
4.00 mL/kg bw: 2 males (at 3 hours)

All deaths occurred relatively rapidly after dosing (within 2 days), except for one male rat that died after 12 days following a dose of 0.50 mL/kg bw. Both of the male rats receiving the test item at the maximum peroral dosage of 4.00 mL/kg bw died after 3 hours. One female in the 2.00 mL/kg bw group died after 4 hours.

Clinical signs:

other: MALES 4.00 mL/kg bw sluggishness at 15 min; slight piloerection at 1 hour, death at 3 hours 2.00 mL/kg bw sluggishness at 1.5 hours; slight piloerection at 2 hours 1.00 mL/kg bw slight red crust on per

Gross pathology:

MALES
4.00 mL/kg bw
lungs pale red; stomachs, intestines dark red

2.00 mL/kg bw
lungs of 1 animal mottled light and dark red; stomachs, intestines distended, filled with dark red liquid

1.00 mL/kg bw
in deceased, stomach, intestines red; stomach filled with clear red liquid; in survivors, kidneys mottled dark red

0.50 mL/kg bw
in deceased, stomach severely distended, filled with brown liquid; emaciation; in survivors, nothing remarkable

0.25 mL/kg bw
nothing remarkable

FEMALES
2.00 mL/kg bw
lungs mottled or bright red; stomachs, intestines dark red, filled with red liquid

1.00 mL/kg bw
in deceased, glandular portion of stomachs dark red; in survivors, livers of 2 animals adhered to glandular portion of stomachs, stomachs distended with gas; kidneys dark red

0.50 mL/kg bw
liver of 1 animal adhered to glandular portion of stomach; stomach of 1 animal distended with gas, kidneys of 1 animal dark red

0.25 mL/kg bw
nothing remarkable

Any other information on results incl. tables

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