Registration Dossier
Registration Dossier
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EC number: 224-518-3 | CAS number: 4394-85-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
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:
- yes
- Remarks:
- only 7 days observation period
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-morpholinecarbaldehyde
- EC Number:
- 224-518-3
- EC Name:
- 4-morpholinecarbaldehyde
- Cas Number:
- 4394-85-8
- Molecular formula:
- C5H9NO2
- IUPAC Name:
- morpholine-4-carbaldehyde
- Details on test material:
- Please refer to the section "Confidential details on test material"
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: US
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: males: 172-270 g; females: 124-206 g
- no further data
ENVIRONMENTAL CONDITIONS
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- with Traganth
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 % v/v
- Amount of vehicle: 6.68, 8.33, 10.66 and 21.4 mL/kg bw of the 30 % test item solution
- Justification for choice of vehicle: The test substance was soluble in water
MAXIMUM DOSE VOLUME APPLIED:
- 6.68, 8.33, 10.66 and 21.4 mL/kg bw of the 30 % solution - Doses:
- 2285, 2875, 3657, 7314 mg/kg bw (under consideration of absolute density 1.1429 g/cm3)
- No. of animals per sex per dose:
- - 5 rats per sex and dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- no data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 7 314 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: reported as > 6.4 mL/kg bw
- Mortality:
- No deaths occured in any dose group.
- Clinical signs:
- other: Animals showed a slightly disturbed general condition and ruffled fur within the first days of observation. All clinical signs ceased from day 6.
- Gross pathology:
- No substance related abnormalities were detected after necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Based on the results observed and by applying the evaluation criteria it was concluded that N-formylmorpholine don´t need to be classified as toxic after single oral application according to Regulation 1272/2008/EC. (BASF, 1967)
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