Registration Dossier
Registration Dossier
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EC number: 216-913-4 | CAS number: 1696-20-4
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1967-03-22 to 1967-04-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study predating guidelines and GLP, but performed close to OECD TG 403.
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 403 (Acute Inhalation Toxicity)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Based on H.F. Smyth et al.: Am. Ind. Hyg. Ass. J. 23, 95-107 (1962)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-acetylmorpholine
- EC Number:
- 216-913-4
- EC Name:
- 4-acetylmorpholine
- Cas Number:
- 1696-20-4
- Molecular formula:
- C6H11NO2
- IUPAC Name:
- 1-(morpholin-4-yl)ethan-1-one
- Details on test material:
- - Name of test material: N-Acetylmorpholin
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Two group weights at study initiation: 1280 g (28.03., 3 males / 3 females); 1325 g (29.03., 3 males / 3 females)
ENVIRONMENTAL CONDITIONS
- no data
IN-LIFE DATES: From: 1967-03-29 To: 1967-04-05
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: not specified
- Exposure chamber volume: not specified
- Method of holding animals in test chamber: not specified
- Source and rate of air: not specified
- System of generating vapour: bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 hours
- Temperature, humidity, pressure in air chamber: at 20°C, nothing else specified
TEST ATMOSPHERE
- Brief description of analytical method used: no analytical method used
- Samples taken from breathing zone: no
TEST ATMOSPHERE
- Particle size distribution: not applicable (vapour) - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 8 h
- Concentrations:
- Calculation from vapour pressure of test item:
Concentration = VP / TP * 1000000 * MW / MVo
= 0.022 / 1013 * 1000000 * 129.16 /22.414 = 125 mg/m³ or 0.125 mg/L air
Where:
- Vapour pressure (VP): 0.022 hPa
- Total pressure (TP): 1013 mm Hg
- Molecular weight (MW): 129.16
- MolVolume (MVo): 22.414
Nominal concentrations from raw data:
Group 1a.: 0.1685 g/L (269.54 g test item / 1600 L air)
Group 1b.: 0.1700 g/L (271.93 g test item / 1600 L air)
Group 2a.: 0.1374 g/L (219.87 g test item / 1600 L air)
Group 2b.: 0.1388 g/L (222.06 g test item / 1600 L air) - No. of animals per sex per dose:
- 12 males, 12 females
- Control animals:
- no
- Details on study design:
- two groups (6 males, 6 females each) exposed for 8h each
Group 1: 28. 3.1967
Group 2: 29. 3.1967
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: body weight taken at study start and end
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (groupwise) - Statistics:
- not performed
Results and discussion
- Preliminary study:
- Considering the relatively low vapour pressure of 0.022 mg Hg at 20°C, the calculated test item concentration of 170 mg/L air was implausibly high. The saturated atmospere calculated from the vapour pressure is 1.7 mg/L.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- > 0.125 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 8 h
- Remarks on result:
- other: Calculated from vapour pressure (0.027 hPa at 20°C)
- Mortality:
- No mortality occurred
- Clinical signs:
- other: None
- Body weight:
- Both groups gained body weight between day 1 and day 7:
Total group 1, day 1: 1280 g; day 7: 1415 g
Total group 2, day 1: 1325 g; day 7: 1433 g - Gross pathology:
- chronic bronchitis (1x)
- Other findings:
- None
Any other information on results incl. tables
No mortalities after 8-hour exposure to an atmosphere enriched with the substance at 20°C.
Applicant's summary and conclusion
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