Registration Dossier
Registration Dossier
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EC number: 203-815-1 | CAS number: 110-91-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1967-02-06
- 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:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- BASF-Test, see details in the section "Any other information on materials and methods incl. tables".
- GLP compliance:
- no
- Remarks:
- study was performed 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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult (based on body weight)
- Weight at study initiation: 180 to 288 g (male), 156 - 226 g (female)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 4 and 20 % - Doses:
- 1600, 2000, 2500 and 3200 mL/kg bw = 1600, 2000, 2500 and 3200 mg/kg bw (conversion in mg/kg bw is based on the density d=1.00 g/cm³)
- No. of animals per sex per dose:
- 5 animals (at 1600, 2000 and 3200 mg/kg bw)
10 animals (at 2500 mg/kg bw) - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of application and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopical examination - Statistics:
- Not indicated.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 900 mg/kg bw
- Mortality:
- See details in the section "Any other information on results incl. tables".
- Clinical signs:
- other: At 3200 and 2500 mg/kg bw: squatting posture, ruffled fur, abdominal position, shallow and irregular respiration, closed eyes. After 24 hours the surviving animals showed red crusted eyes and noses, and trembling gait with delayed motion of the hind limbs
- Gross pathology:
- Animals that died: 4x diarrhoea, 1x haemorrhagic enteritis
Sacrificed animals: no abnormalities
Any other information on results incl. tables
Mortality:
| Dose (mg/kg bw) | Gender | 1 h | 24 h | 48 h | 7 days | 14 days |
| 3200 | male | 0/5 | 5/5 | 5/5 | 5/5 | - |
| 3200 | female | 0/5 | 5/5 | 5/5 | 5/5 | - |
| 2500 | male | 0/10 | 4/10 | 4/10 | 4/10 | 4/10 |
| 2500 | female | 0/10 | 10/10 | 10/10 | 10/10 | 10/10 |
| 2000 | male | 0/5 | 0/5 | 1/5 | 1/5 | - |
| 2000 | female | 0/5 | 5/5 | 5/5 | 5/5 | - |
| 1600 | male | 0/5 | 1/5 | 1/5 | 1/5 | - |
| 1600 | female | 0/5 | 1/5 | 1/5 | 1/5 | - |
The test substance caused dose dependent toxicity after a single ingestion and local irritations to exposed tissues.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
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