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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
Study period:
1954
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Range-finding toxicity Data List V
Author:
Smyth HF, Carpenter CP, Weil CS & Pozzani UC
Year:
1954
Bibliographic source:
Arch. Ind. Hyg Occup. Med. 10 61–68

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
according to Draize et al. (1944)
GLP compliance:
no
Remarks:
prior to GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Morpholine

Test animals

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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
Penetration of rabbit skin was estimated by the one-day cuff method of Draize and associates. The fur was closely clipped over the entire trunk, and the close, retained beneath an impervious plastic film, contacted about 1/10 of the body surface.
Duration of exposure:
24 hours
Doses:
up to 20 mL/kg bw
No. of animals per sex per dose:
4 animals
Control animals:
not specified
Details on study design:
After 24 hours contact the film was removed. Mortality was considered complete after 14 additional days.
Statistics:
The most probable LD50 was estimated by the methods of Thompson (1947) and Weil (1952).

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 500 mg/kg bw
Remarks on result:
other: ≈ 0.5 mL/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 0.31 - <= 0.81 mL/kg bw
Remarks on result:
other: Limits of +/- 1.96 standard deviation using the method of Thompson
Mortality:
Death occurred within 14 days.
Clinical signs:
No data.
Body weight:
No data.
Gross pathology:
No data.

Applicant's summary and conclusion

Executive summary:

In an acute dermal toxicity study (Smyth et al., 1954), male rabbits were exposed to Morpholine. The test material was applied in a single dose to the clipped skin of the trunk beneath an impervious plastic film. After 24 hour exposure the film was removed, and mortality was considered complete after 14 additional days. Death occurred within the observation period. Limits of ±1.96 standard deviation using the method of Thompson were 0.31 – 0.81 mL/kg bw. The LD50 determined in this study was 0.5 mL/kg bw.

This study is classified as acceptable. It satisfies the guideline requirement for an acute dermal study according OECD 402 in principle