Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Single intraperitoneal injection followed by 7 day observation period.
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean 27.7 g (male), 25.4 g (female)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
VEHICLE
- Concentration: 30, 10, 6, 2%
- Amount: 0.26 - 0.58 ml/g
Doses:
200, 1600, 3200, 6400 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: day 1, 4, 7
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 400 mg/kg bw
Mortality:
no mortalities
Clinical signs:
dyspnoe, staggering, closed eyes, apathy, squatting posturenormal
Body weight:
normal increase
Gross pathology:
abdominal substance precipitation and incorporation

Applicant's summary and conclusion