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:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
according to internal standard method
GLP compliance:
no
Limit test:
no

Test material

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

Test animals

Species:
mouse
Strain:
other: NMRI-Wiga
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males 26.0 g, females 24.0 g
- Diet (e.g. ad libitum): HERTLAN MRH Haltung, Alleinfutter für die Haltung von Mäusen, Ratten unrl Hamstern, Heinrich EGGERSMANN KG, Rinteln.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% in water
Details on exposure:
The test substance was given as a 20 or 50% suspension with a 0.5% aqueous carboxymethyl cellulose solution
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily (except on weekends)
- Frequency of weighing: before treatment and on days 2, 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical, body weight

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
None of the animals died during the exposure period.
Clinical signs:
At the first observation day a deteriorated general health. Symptoms were dyspnoea, apathy, staggering and unsteady gait
Body weight:
Initially weight loss.
Day 2, mean weight (g): males: 25.2; females 22.0
Day 7, mean weight (g): males: 30.8; females 25.7
Day 13, mean weight (g): males: 32.8; females 27.3
Gross pathology:
Intra-abdominal substance incorporation.

Applicant's summary and conclusion