2-[bis(2-ethylhexyl)amino]ethanol

Acute Toxicity: dermal

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

Test material information

Constituent 1

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:

other: Erythema and desquamation of the skin was caused by the application.

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.