Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study report meets generally acceptable scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Principles of method if other than guideline:
Study to determine the acute i.p. toxicity ot the test substance in mice
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Morpholin-Rueckstand (morpholin remainder)
- Substance type: remainder mixture
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
2%-20%
Doses:
200-1600 µL/kg (=ca. 212-1700 mg/kg; calculated with a density of 1.06 g/mL)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 742 mg/kg bw
Remarks on result:
other: original data: ca. 0.7 mL/kg bw
Mortality:
no mortality up to 400 µL/kg bw
500 µL/kg bw: 2/20
640 µL/kg bw: 3/20
800 and 1600 µL/kg bw: 20/20
Clinical signs:
800 and 1600 µL/kg bw: directly after injection tremor, convulsion, stretching, crying, sunken flanks, high stepping and slightly staggering gait, avoidance of abdominal position, agitation, closed eye lids; intense stretching convulsions in agony
<= 640 µL/kg bw: symptoms as decribed for higher doses but in weaker extension; reversible within at least 6 days
Body weight:
not measured at study termination
Gross pathology:
Animals that died: Intestines filled with bloody liquids, lobular pataatern visible;4* intraabdominal adhesions
Sacrificed animals: in most of the animals intrabdominal adhesions, 12* truncated liver edges

Applicant's summary and conclusion