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:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Animals fasted overnight were treated intraperitoneally, with a single dose. Physical condition and rate of deaths were monitored throughoutthe whole observation period.
GLP compliance:
no
Limit test:
no

Test material

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

Test animals

Species:
rat
Strain:
other: Tif: RAIf
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Basle, Switzerland
- Age at study initiation: no data
- Weight at study initiation: 186-208g
- Fasting period before study: overnight
- Housing: in groups of 5 in Macrolon cages (type 3) individually marked with picric acid (During the treatment and observation period)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10%
- Photoperiod (hrs dark / hrs light): 12 hours light per day

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: distilled water containing 0.5% carboxymethylcellulose + 0.1% polysorbate 80
Details on exposure:
Animals fasted overnight were treated intraperitoneally, with a single dose
Doses:
1000, 2000 mg/kg bw
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 and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2 000 mg/kg bw
Mortality:
none
Clinical signs:
only common effects in this type of study
Body weight:
normal body weight gain
Gross pathology:
No compound related gross organ changes were observed except for some adhesions and some pseudomembranes, which developed as a directreaction to the intraperitoneal injection.

Applicant's summary and conclusion

Conclusions:
The acute intraperitoneal LD50 of the test article in rats of both sexes observed over a period of 14 days is greater than 2000 mg/kg. The test material is therefore slightly toxic to the rat by this route of administration.