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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:
data from handbook or collection of data
Remarks:
Acceptable publication but only limited data is given.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1954
Reference Type:
publication
Title:
The Toxicity of Allylamines
Author:
Hine C. et al.
Year:
1960
Bibliographic source:
Arch. Env. Health Vol. 1, 1960, 343-352
Reference Type:
review article or handbook
Title:
Aliphatic and Alicyclic Amines
Author:
Benya T.J. et al.
Year:
1994
Bibliographic source:
Patty's Industrial Hygiene and Toxicology, Vol. 2, Part B, Chapter 17

Materials and methods

Principles of method if other than guideline:
- Principle of the test: According to Draize, J.H. et al.: J. Pharmacol. and Exper. Therap. 82:377, 1944
- Short description of test conditions: Penetration of rabbit skin was estimated by a technique closely skin to the one-day cuff method of Draize and associates, using groups of four male. The fur was removed from the entire trunk by clipping, and the dose was 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.
GLP compliance:
no
Remarks:
predating GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylamine
EC Number:
200-834-7
EC Name:
Ethylamine
Cas Number:
75-04-7
Molecular formula:
C2H5NH2
IUPAC Name:
ethanamine
Details on test material:
- Name of test material (as cited in study report): Ethylamine
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
giant
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 to 3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Duration of exposure:
24 h
Doses:
no data
No. of animals per sex per dose:
4
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
265 mg/kg bw
95% CL:
201 - 395
Remarks on result:
other: original value LD50 = 0.39 ml/kg
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

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 265 mg/kg bw in rabbits.
Executive summary:

Penetration of rabbit skin with the test article was estimated by a technique closely skin to the one-day cuff method of Draize and associates (Draize et al. 1944), using groups of four male New Zealand giant albino rabbits. The fur was removed from the entire trunk by clipping, and the dose was 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 study results a LD50 of 265 mg/kg/bw was calculated.

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