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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
substance purity not given
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

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 levelsopen allclose all
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
Sex:
male
Dose descriptor:
LD50
Effect level:
1.19 mL/kg bw
Based on:
test mat.
95% CL:
0.79 - 1.8
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.

Applicant's summary and conclusion