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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

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
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), 4 % (400 and 800 ml/kg), 8 % (1000 and 1250 ml/kg) and 20 % (1600 and 3200 ml/kg)
Doses:
200, 400, 800, 1000, 1250, 1600, 3200 ml/kg bw
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
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 died within 24 hours. Two males and 4 females treated with 1600 ml/kg died within the first 48 hours. None of the animals treated with 200, 400, 800, 1000 or 1250 ml/kg died.
Clinical signs:
Animals treated with 3200 or 1600 ml/kg exhibited calm behavior and abdominal position after application. Animals treated with 1600 ml/kg also exhibited calm behavior, slight staggering and piloerection in the following observation days, until day 7 (when normal behavior was noted). Squatting posture and calm behavior were noted up to 24 hours after treatment with 1250 ml/kg and 1000 mg/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 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