Registration Dossier
Registration Dossier
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EC number: 205-575-3 | CAS number: 142-96-1
Acute Toxicity: dermal
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 for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- 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:
- 1 954
- Bibliographic source:
- Arch. Ind. Hyg. Occup. Med., 10, 61-68
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- Dibutyl ether
- EC Number:
- 205-575-3
- EC Name:
- Dibutyl ether
- Cas Number:
- 142-96-1
- Molecular formula:
- C8H18O
- IUPAC Name:
- 1-butoxybutane
- Details on test material:
- dibutyl ether (purity not indicated)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system 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:
- other: 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.
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