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Toxicological information

Acute Toxicity: dermal

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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:
other: Acceptable, well documented report which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1951
Reference Type:
study report
Title:
Unnamed
Year:
1950
Report Date:
1950
Reference Type:
secondary source
Title:
Industrial Hygiene and Toxicology
Author:
Sutton W.L.
Year:
1962
Bibliographic source:
cited in: Patty's Ind.Hyg. and Toxicol. 2, 2044

Materials and methods

Principles of method if other than guideline:
Penetration of rabbit skin is estimated by a technique closely to the one-day cuff method of Draize and associates, using groups of 5 male albino rabbits weighing 2.5 to 3.5 kg. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. The animals are immobilized during the 24 hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period.
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): diethylamine

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 month
- Weight at study initiation: 2.5 - 3.5 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

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
582 mg/kg bw
95% CL:
376 - 895
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:
Local effects: the substance caused hemorrhage and necrosis of the skin and underlaying muscular layers.
Body weight:
The survivors of the 355 and 710 mg/kg bw dose group lost weight.
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