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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting 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 according to data owner, performed close to OECD TG 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report date:
1967

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other:
Deviations:
not applicable
Principles of method if other than guideline:
BASF test (single i.p. administration of test item to mice)
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
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

Test animals

Species:
mouse
Strain:
other: "Kisslegg"
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 25 - 34 g (males); 14 - 28 g (females)

ENVIRONMENTAL CONDITIONS
- no data

IN-LIFE DATES: From: 22.03.1967 To: 05.04.1967

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: aqueous traganth emulsion
Details on exposure:
VEHICLE
- Vehicle concentration: 30% (6400, 5000, 4000, 3200, 2500 mm3/kg bw) , 20% (1600 mm3/kg bw), 2% (200 mm3/kg bw)

MAXIMUM DOSE VOLUME APPLIED:
21, 3 mL / kg
Doses:
6400, 5000, 4000, 3200, 2500, 1600 or 200 mm3/kg bw, corresponds to:
7136, 5575, 4460, 3568, 2788, 1784 or 223 mg / kg bw; calculation based on density of test item
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: body weight taken at study start only for dose determination, but not reported
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs monitored but frequency unknown, gross necropsy on fatalities
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 000 mg/kg bw
Mortality:
6400 mm3 / kg bw: 9/10 (9/10 within 24 h, 1 male survived 7 days)
5000 mm3 / kg bw: 10/10 (9/10 within 24 h, 10/10 within 48 h)
4000 mm3 / kg bw: 8/10 (3/10 within 24 h, 8/10 within 48 h, 1 male / 1 female survived 7 days)
3200 mm3 / kg bw: 6/10 (0/10 within 24 h, 4/10 within 48 h - 1 male/3 females died, 6/10 within 7 days - 2 females died, 4 males survived 7 days)
2500 mm3 / kg bw: 0/10
1600 mm3 / kg bw: 0/10
1600 mm3 / kg bw: 0/10
Clinical signs:
6400 - 4000 mm3 / kg bw: saltatory convulsions immediately after injection, vocalisations indicating pain, laboured breathing, ruffled fur, licking of injection site; after 15 min at 6400 mm3 / kg bw: prone/lateral position with streched legs; animals surviving the first 24 hours were found in prone/lateral position, mild twitching, tremor, dyspnoe and clotted eyes. Within next two days: motor activity mildly decreased, then recuperating.
3200 and 2500 mm3 / kg bw: same symptoms as above, but milder
1600 and 200 mm3 / kg bw: on the day of application laboured breathing, prone position, ruffled fur, ptosis. Animals recuperated until day 2.
Body weight:
No data reported
Gross pathology:
perished animals: yellowish-pallid liver due to fatty degeneration (4x), intestinal atony (4x), blotched pallid livers, kidneys pallid, increased intraperitoneal liquids, smell of test item
Killed animals: no findings for organs, (yellowish-pallid liver, fatty degeneration questionable (2x), clottings (2x), adhesions (1x))

Applicant's summary and conclusion