Registration Dossier
Registration Dossier
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EC number: 203-815-1 | CAS number: 110-91-8
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Range-finding toxicity Data List V
- Author:
- Smyth HF, Carpenter CP, Weil CS & Pozzani UC
- 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)
- 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 substance name:
- Morpholine
- EC Number:
- 203-815-1
- EC Name:
- Morpholine
- Cas Number:
- 110-91-8
- Molecular formula:
- C4H9NO
- IUPAC Name:
- morpholine
- Test material form:
- liquid
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:
- 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
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 500 mg/kg bw
- Remarks on result:
- other: ≈ 0.5 mL/kg bw
- Key result
- 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:
- other: No data.
- Gross pathology:
- No data.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
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