Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Directive 96/54/EEC, B.1tris
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Rat, HanBrl: WIST (SPF)

Administration / exposure

Vehicle:
other: Bidistilled water

Results and discussion

Preliminary study:
The median lethal dose of ucb 22060 after single oral administration to female rats, observed
over a period of 14 days is:
LD50 (female rat): greater than 2000 mgkg body weight
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
MORTALITY:

No deaths occured during the study.


CLINICAL SIGNS:

No clinical signs were observed during the study.


BODY WEIGHTS:

One female showed a loss of body weight (0.5%) between test
day 8 and the end of the observation period. In the other
animals the body weights were within the range commonly
recorded for this strain and age.
Gross pathology:
Effects on organs:
No treatment-related macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of ucb 22060 after single oral administration to female rats, observed
over a period of 14 days is:
LD50 (female rat): greater than 2000 mgkg body weight
Executive summary:

Two groups, each of three female HanBrl: WIST (SPF) rats were treated with ucb 22060 by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (purified water) at a concentration of 0.2 g/mL and administered at a volume dosage of 10 mUkg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined microscopically. All animals survived until the end of the study period. No clinical signs were observed during the course of the study. One female animal showed a loss of body weight (0.5 %) between test day 8 and the end of the observation period. The body weight of the other animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.