Registration Dossier

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: Well performed study, study performance before , implementation of GLP, purity of test item not reported.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Range-finding toxicity data, List V
Author:
Smyth, H.F., Carpenter, C.P., Weil, C.S., Pozzani, U.C.
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)
Principles of method if other than guideline:
Study conducted prior to guidelines but study conduct comparable to current OECD TG 402
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
dibutyl ether (purity not indicated)

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:
other: no vehicle used
Details on dermal exposure:
The fur was closely clipped over the entire trunk, and the doses, retained beneath an impervious plastic film, the exposure area corresponded to about 1/10 of the body surface. After 24 hours of contact the film was removed.
Duration of exposure:
24 hours
Doses:
no information available
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
The acute dermal toxicity of dibutyl ether for rabbits was estimated by the technique of Draize et al. (1944), using groups of four male New Zealand giant albino rabbits weighing 2.5 to 3.5 kg. The fur was closely clipped over the entire trunk, and the doses, retained beneath an impervious plastic film, the exposed area corresponding to about 1/10 of the body surface. After 24 hours of contact the film was removed. Animals were observed for mortality fourteen days after dosing. Clinica;l signs were not reported.
Statistics:
The most probable LD50 value and its fiducial range were estimated by the method of Thompson (1947) using the tables of Weil (1952)

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
10.08 mL/kg bw
Based on:
test mat.
95% CL:
4.41 - 23.04
Sex:
male
Dose descriptor:
LD50
Effect level:
7 741 mg/kg bw
Based on:
test mat.
95% CL:
3 387 - 17 695
Mortality:
no information available
Clinical signs:
no information available
Body weight:
no information available
Gross pathology:
no information available
Other findings:
no information available

Any other information on results incl. tables

Original values given by the authors in ml/kg bw: LD50 (95 % C.I.) 10.08 (4.41 - 23.04) ml/kg bw, which is equal to 7741 (3387 - 17695) mg/kg bw (density of dibutyl ether: 0.768 g/cm³).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the LD50 of dibutyl ether was 10.8 ml/kg; which is equal to 7741 (3387 - 17695) mg/kg body weight to rabbits, therefore this substance is not classified.
Executive summary:

In this study, the acute dermal toxicity of dibutyl ether for rabbits was estimated by the technique of Draize et al. (1944), using groups of four male New Zealand giant albino rabbits weighing 2.5 to 3.5 kg. The fur was closely clipped over the entire trunk, and the doses, retained beneath an impervious plastic film, the exposed area corresponding to about 1/10 of the body surface. After 24 hours of contact the film was removed. Animals were observed for mortality for fourteen days after dosing. The most probable LD50 value and its fiducial range were estimated by the method of Thompson (1947) using the tables of Weil (1952). Clinical signs were not reported.

Under the conditions of the study, the LD50 of dibutyl ether was 10.8 ml/kg; which is equal to 7741 (3387 - 17695) mg/kg body weight to rabbits, therefore this substance is not classified.