Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28.11.1965-04.01.1966
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, 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:
The acute oral toxicitiy of the test substance was assessed in rats.
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): Triethanolamine

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 ccm/kg) and 20 % (all other dose levels) (v/v)
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: test substance is readily soluble in water
Doses:
200, 1600, 3200, 4000, 5000, 6400 mg/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
- Frequency of observations and weighing: daily on working 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:
6 400 mg/kg bw
Mortality:
6400 mg/kg bw dosing group: 5/10 animals (2 males, 3 females) within 24 hours
no further deaths recorded
Clinical signs:
200 mg/kg bw dosing group: slight agitation up to 4 hours following treatment
other dosing groups: unsteady, elevated respiration; anancasm to chew; apathy lasting for 1 or 2 days; reduced grooming;
All animals were without findings two days after dosing.
Gross pathology:
Organs without findings

Applicant's summary and conclusion