Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting 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 402 (Acute Dermal 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:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
Male albino New Zealand strain rabbits, 3 to 5 months of age and averaging 2.5 kg in weight were utilized in the study. The rabbits were procured locally and maintained on Rockland rabbit ration.

Administration / exposure

Type of coverage:
other: "Vinylite" sheeting was used to retain the dose in contact with the clipped skin.
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The rabbits were immobilzed during the 24 hour skin contact period. Thereafter, the "vinylite" sheeting used to retain the dose in contact with the clipped skin of the trunk was removed and the animals were caged for the remainder of the 14-day observation period.
Duration of exposure:
24 hours
Doses:
Dosage (ml/kg): 0.63, 1.26, 2.52, 5.0
No. of animals per sex per dose:
Four animals per dose with the exception of the 0.63 ml/kg group which only had one animal.
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 LD50 was used. For calculation of the LD50 by Thompson's method the survival of 3 rabbits was assumed for 0.63 ml/kg.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
2.5 mL/kg bw
Based on:
test mat.
Mortality:
Three of the four animals dosed in the 2.52 and the 5.0 ml/kg dose groups died. All other animals survived.
Clinical signs:
Erythema and desquamation of the skin was caused by the application.
Body weight:
All but one animal lost weight during the course of the study. One animal in the 5.0 ml/kg dose group gained weight.
Gross pathology:
Lung damage was severe among those dying and livers were mottled.
Other findings:
This compound penetrates skin readily as may be seen by comparing these results with methyl diethanolamine which had a rat oral LD50 of 1.8 gm/kg and rabbit skin penetration LD50 of 11.9 ml/kg.

Applicant's summary and conclusion

Conclusions:
The undiluted compound had an LD50 for rabbits of 2.5 (1.3 to 4.8) ml/kg.
Executive summary:

In a skin penetration study conducted on male albino New Zealand rabbits, the undiluted test material was applied using "vinylite" sheeting to the clipped skin of the trunk of the animals for a 24 hour exposure period at either 0.63, 1.26, 2.52 or 5.0 ml/kg. Animals were weighed prior to dosing and at the end of the 14-day observation period. Thompson's method of calculating the LD50 was used. Three of the four animals dosed in the 2.52 and the 5.0 ml/kg dose groups died. All other animals survived. Erythema and desquamation of the skin was caused by the application. All but one animal lost weight during the course of the study. One animal in the 5.0 ml/kg dose group gained weight. Lung damage was severe among those dying and livers were mottled. The undiluted compound had an LD50 for rabbits of 2.5 (1.3 to 4.8) ml/kg.