Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: N-Acetylmorpholin

Test animals

Species:
mouse
Strain:
other: "Kisslegg"
Sex:
male/female
Details on test animals 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