Diethylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

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 1

Reference Type:

study report

Title:

Unnamed

Year:

1950

Report date:

1950

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1951

Reference 3

Reference Type:

review article or handbook

Title:

Industrial Hygiene and Toxicology

Author:

Sutton W.L.

Year:

1962

Bibliographic source:

cited in: Patty's Ind.Hyg. and Toxicol. 2, p. 2044

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize (one day cuff method)

Principles of method if other than guideline:

- Principle of test:
Penetration of rabbit skin was estimated by a technique closely to the one-day cuff method of Draize and associates, using groups of 5 male albino rabbits weighing 2 to 3 kg. The fur was removed from the entire trunk by clipping, and the dose was retained beneath an impervious plastic film. The animals are immobilized during the 24 hour contact period, after which the film was removed and the rabbits are caged for the subsequent 14 day observation period.

GLP compliance:

no

Remarks:

predating GLP

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diethylamine

EC Number:

203-716-3

EC Name:

Diethylamine

Cas Number:

109-89-7

Molecular formula:

C4H11N

IUPAC Name:

diethylamine

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 3-5 month
- Weight at study initiation: 2- 3 kg
- Diet (e.g. ad libitum): Rockland rabbit diet

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 h

Doses:

0.252, 0.5, 1.0, 2.0 mL/kg bw = 179, 355, 710 and 1420 mg/kg bw (conversion in mg/kg bw is based on the density d: 0.71 g/cm3)

No. of animals per sex per dose:

5 (males only)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 0, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

582 mg/kg bw

95% CL:

376 - 895

Remarks on result:

other: original value 0.82 mL/kg

Mortality:

1420 mg/kg bw: 5/5, days to death: 1, 1, 1, 1, 1
710 mg/kg bw: 3/5, days to death: 6, 1, 1
355 mg/kg bw: 1/5, days to death: 1
179 mg/kg bw: 0/5

Clinical signs:

other: Local effects: the substance caused hemorrhage and necrosis of the skin and underlaying muscular layers

Gross pathology:

Animals that died: pale or mottled livers, pale, mottled or roughened surfaces of the kidneys, and congested or hemorrhagic intestines. Spleens were darkened to the point of being called black, pancreas congested and testes hemorrhagic.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The mean lethal dose of the test substance after single dermal application for 24 hours was found to be 582 mg/kg bw in rabbits.

Executive summary:

Penetration of rabbit skin was estimated by a technique closely to the one-day cuff method of Draize and associates, using groups of 5 male albino rabbits weighing 2 to 3 kg. The fur was removed from the entire trunk by clipping. The different substance concentrations (0.252, 0.5, 1.0, 2.0 mL/kg bw) were retained beneath an impervious plastic film. The animals were immobilized during the 24 hour contact period, after which the film was removed and the rabbits were caged for the subsequent 14-day observation period. Based on the available mortality data a LD50 of 0.82 mg/L (equivalent to 582 mg/kg bw) was derived. The substance provoked local effects (hemorrhage and necrosis of the skin and underlaying muscular layers). Moreover, gross pathology analysis revealed effects on the liver, kidneys, intestines, spleens, pancreas and testes.