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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
substance purity not given
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 perinasal fur, slight red crust on periocular fur of 2 animals; slight brown stain on periurogenital fur of 1 animal at 1 day; affected survivors recovered at 2 days

0.50 mL/kg bw
one animal with slight sluggishness at 30 min, red crust at perinasal fur at 1 day; pallor, slight emaciation at 11 days; kyphosis, unkempt appearance, red crust on periocular fur at 12 days (death)

0.25 mL/kg bw
none noted

FEMALES
2.00 mL/kg bw
marked sluggishness at 15 min; piloerection, slight kyphosis, lacrimation at 3 hours; unsteady gait, marked sluggishness and lacrimation at 4 hours; death of one animal at 4 hours

1.00 mL/kg bw
sluggishness at 1 hour; piloerection, slight lacrimation at 4 hours; red crust on perinasal fur, red crust on periocular fur, slight wetness of periurogenital fur in 2 animals at 1 day; the presence of occult blood in discharge was verified by use of Hemastix Reagent Strips [Ames]; emaciation of 2 animals at 6 days, persisting through 14 days; recovery of 1 survivor at 2 days

0.50 mL/kg bw
sluggishness, slight lacrimation at 4 hours; red crust on perinasal and periocular fur at 2 days; emaciation in 1 animal at 6 days, persisting through 14 days; recovery of 4 animals at 2 days

0.25 mL/kg bw
none noted
Body weight:
No abnormalities were reported.
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