Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1953
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1953
Report date:
1953

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[bis(2-ethylhexyl)amino]ethanol
EC Number:
202-912-6
EC Name:
2-[bis(2-ethylhexyl)amino]ethanol
Cas Number:
101-07-5
Molecular formula:
C18H39NO
IUPAC Name:
2-[bis(2-ethylhexyl)amino]ethan-1-ol
Specific details on test material used for the study:
A sample of di (2-ethylhexyl) ethanolamine (S-5223) was received from S. Charleston on 11-12-52 for toxicological assay.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
Carworth-Wistar, non-fasted rats, 5 to 6 weeks of age and 90-120 grams in weight were dosed at levels differing by a factor of 2.0 in a geometric series. The rats were reared in our own colony and maintained from time of weaning on Rockland rat diet (complete).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Single doses of test material were given by stomach tube to non-fasted male albino rats by mouth as a dilution in corn oil, 1 ml = .010 gm.
Doses:
Dosage (gm/kg): 2.00, 3.98 and 7.95
No. of animals per sex per dose:
5 males/dose group
Control animals:
no
Details on study design:
Animals were weighed prior to dosing and at the end of the 14-day observation period.
Statistics:
Thompson's method of calculating the median-effective dose (LD50) was applied to the 14-day mortality data. For calculation of the LD50 by the method of moving averages the death of 5 of 5 rats was assumed at 15.8 gm/kg.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
4 900 mg/kg bw
Based on:
test mat.
Remarks:
10% dilution in corn oil.
Mortality:
The rats that were dosed at 7.95 gm/kg died within 1 to 5 days; 1 rat from the 3.98 gm/kg group died on day 3. All other rats survived.
Clinical signs:
The rats that survived 3.98 gm/kg lost their hair in patches over their bodies.
Body weight:
All animals surviving the 14-day observation period gained weight with the exception of one animal in the 3.98 gm/kg dose group. This animal lost 13 g by the end of the observation period.
Gross pathology:
Autopsy findings on those that died included congested lungs, mottled livers, pale spleens and kidneys, and irritation of the intestines.
Other findings:
Butyl ethanolamine, for comparison, had an LD50 of 1.2 gm/kg, Phenyl 2.2, isopropanolamines (mixed) 4.5 and dihydroxyethyl ethylene diamine 10.0 gm/kg.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 for Wistar rats, given a 10% dilution in corn oil of the test material Di(2 -Ethylhexyl) ethanolamine by stomach tube, was 4.9 (3.8 to 6.5) gm/kg.
Executive summary:

Single doses of test material were given by stomach tube to non-fasted male albino rats by mouth as a dilution in corn oil, 1 ml = .010 gm. Five males/dose group were given 2.00, 3.98 or 7.95 gm/kg. Animals were weighed prior to dosing and at the end of the 14-day observation period. Thompson's method of calculating the median-effective dose (LD50) was applied to the 14-day mortality data. The rats that were dosed at 7.95 gm/kg died within 1 to 5 days; 1 rat from the 3.98 gm/kg group died on day 3. All other rats survived. The rats that survived 3.98 gm/kg lost their hair in patches over their bodies. All animals surviving the 14-day observation period gained weight with the exception of one animal in the 3.98 gm/kg dose group. This animal lost 13 g by the end of the observation period. Autopsy findings on those that died included congested lungs, mottled livers, pale spleens and kidneys, and irritation of the intestines. Butyl ethanolamine, for comparison, had an LD50 of 1.2 gm/kg, Phenyl 2.2, isopropanolamines (mixed) 4.5 and dihydroxyethyl ethylene diamine 10.0 gm/kg.

The LD50 for Wistar rats, given a 10% dilution in corn oil of the test material Di(2 -Ethylhexyl) ethanolamine by stomach tube, was 4.9 (3.8 to 6.5) gm/kg.