Registration Dossier

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: Acceptable publication but only limited data is given. (number of animals that died not given, symptoms not described; no necropsy; purity of test substance not given).

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1969

Materials and methods

Principles of method if other than guideline:
Method: according to Smyth, Carpenter, Weil, Pozzani and Striegel: Range-Finding Toxicity Data: List VI, Amer. Ind. Hyg. Assoc. J. 23: 95 (1962), for details see any other information on materials ans methods
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Aminopropoxy-2-ethoxy ethanol

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: from own colony at testing lab
- Age at study initiation: 4 to 5 weeks
- Weight at study initiation: 90 to 120 g
- Fasting period before study: not fasted
- Diet: Rockland rat diet, complete; ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: solution as needed: in water, corn oil or suspension in semi-solid agar (not specified)
Doses:
The dosages are arranged in a logarithmic series differing by a factor of 2. Whenever possible, the chemical is administered undiluted. When a lesser concentration is necessary a suitable vehicle is used.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: no
Statistics:
Based upon mortalities during a 14 day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson (Thompson W.R.: Use of Moving Averages and Interpolation to estimate Median Effective Dose, Bacteriol. Rev. 11: 115, June 1947) using Tables of Weil (Weil C. S.: Tables for convenient calculation of Median-Effective Dose (LD50 or ED50) and Instructions in their Use, Biometrics 8: 249, Sept. 1952).

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
6 500 mg/kg bw
Based on:
test mat.
95% CL:
4 950 - 8 530
Mortality:
no details given
Clinical signs:
no details given
Body weight:
not assessed
Gross pathology:
no necropsy performed

Applicant's summary and conclusion