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Toxicological information

Acute Toxicity: oral

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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:
other: Meets generally accepted scientific standards, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

Principles of method if other than guideline:
Groups of 5 rats/sex were treated by gavage with 200, 400, 800, 1000, 1250, 1600 or 3200 mL/kg bw of the test material to determine the acute oral LD50
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 (as cited in study report): monoethanolamine
- no further data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 % (200 mL/kg bw), 4 % (400 and 800 mL/kg bw), 8 % (1000 and 1250 mL/kg bw) and 20 % (1600 and 3200 mL/kg bw)
Doses:
200, 400, 800, 1000, 1250, 1600, 3200 mL/kg bw (equivalent to 202, 404, 808, 1010, 1262.5, 1616 and 3232 mg/kg bw, respectively)
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 515 mg/kg bw
Remarks on result:
other: ca. 1500 mL/kg bw (calculated with a specific density of 1.01 g/mL)
Mortality:
All males and females treated with 3200 mL/kg bw died within 24 hours. Two males and four females treated with 1600 mL/kg bw died within the first 48 hours. None of the animals treated with 200, 400, 800, 1000 or 1250 mL/kg bw died.
Clinical signs:
Animals treated with 3200 or 1600 mL/kg bw exhibited calm behavior and abdominal position after application. Animals treated with 1600 mL/kg bw also exhibited calm behavior, slight staggering and piloerection in the following observation days, until day 7 (when normal behavior was noted). Squatti ng posture and calm behavior were noted up to 24 hours after treatment with 1250 and 1000 mL/kg bw. No clinical signs were noted in these groups from day 4 onward. No clinical signs were noted in animals treated with 800 or 400 mL/kg bw. Slight staggering was noted in animals treated with 200 mL/kg bw on study days 1 and 2. No clinical signs were noted later on in this group.
Body weight:
nothing abnormal reported
Gross pathology:
Animals that survived to study termination showed no internal abnormalities at necropsy.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The acute oral toxicity (LD50) of 2-aminoethanol was determined to be ca. 1515 mg/kg bw (ca. 1500 mL/kg bw; calulated with a specific density of 1.01 g/mL). The test material is therefore classified as Category 4 based on GHS criteria.
Executive summary:

The objective of this study was to determine the acute oral toxicity (LD50) of 2-aminoethanol when administered once orally to male and female rats.

Male and female Sprague-Dawley rats were used in this study. The test material was administered by oral gavage as 2% (200 mL/kg bw), 4% (400 and 800 mL/kg bw), 8% (1000 and 1250 mL/kg bw) and 20% (1600 and 3200 mL/kg bw) aqueous solutions to the animals (10 rats/dose). These doses corresponds to 200, 404, 808, 1010, 1262.5, 1616 and 3232 mg/kg bw (calculated on the basis of density of 1.01 g/ mL at 20 °C).

Post treatment, animals were examined for mortality, clinical signs and body weight changes upto day 7. After 7 days of observation, all surviving animals were euthanized, subjected to necropsy and examined for gross pathological changes. Mortalities were observed in all animals treated with 3200 mL/kg bw dose within 24 hours while two males and four females died within first 48 hours in the group treated with 1600 mL/kg bw. No mortality was observed in animals treated with 200, 400, 1000 and 1250 mL/ kg bw doses.

At 3200 and 1600 mL/kg bw doses, animals exhibited calm behaviour and abdominal position after application. Animals treated with 1600 mL/kg bw dose also exhibited slight staggering and piloerection during observation till day 7. Squatting posture and calm behaviour was observed upto 24 hours after treatment in 1250 and 1000 mL/kg bw dose groups and no clinical signs were noted in these groups after day 4. No clinical signs were observed in 800 and 400 mL/kg bw dose groups while slight staggering was noted in animals treated with 200 mL/kg bw on first two days of this study and no clinical signs were observed later on. No abnormal changes in body weight were reported. No abnormal gross pathological alterations were observed at the end of 7 days observation period in

surviving animals at necropsy.

Based on the above observation, the acute oral toxicity (LD50) of 2-aminoethanol was determined to be ca. 1515 mg/kg bw (ca. 1500 ml/kg bw; calulated with a specific density of 1.01 g/mL).

The test material is therefore classified as Category 4 based on GHS criteria.4