Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: Bidistilled water

Results and discussion

Preliminary study:
The median lethal dose of ucb 22060 after single dermal administration to rats of both sexes,
observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; 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:

No changes on body weights noted.
Gross pathology:
Effects on organs:
No treatment-related macroscopic findings were observed.
Other findings:
Signs of toxicity (local):
COLORATION:

No coloration of the treated skin was noted throughout the
study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Five male and five female HanBrl: WIST (SPF) rats were treated with ucb 22060 at 2000 mg/kg by dermal application. The test item was diluted in vehicle (purified water) at a concentration of 0.5 g/mL and administered at a volume dosage of 4 mUkg. The application period was 24 hours. 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. No deaths occurred during the study. No clinical signs were observed during the course of the study. One female animal showed a loss of body weight (2.8%) during the first observation week whereas another female did not gain body weight between test day 8 and the end of the observation period. The body weight of the remaining animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.