Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.3; OECD 402 (1987)
GLP compliance:
yes
Limit test:
yes

Test animals

Species:
other: rat, Wistar Hsd Cpb:WU

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: none
Duration of exposure:
24 h

Results and discussion

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:
other: Signs of toxicity related to dose levels: There were no systemic intolerance reactions. In the males the body weight gain was unaffected. In one female a decrease in body weight gain was observed in the first week.
Gross pathology:
Effects on organs:
A dose of 2000 mg/kg body weight was tolerated by male and
female rats without mortalities and gross pathological
findings.
Other findings:
Signs of toxicity (local):
In two females partial reddening of the treatment area was
observed until 2 days after treatment.

Applicant's summary and conclusion

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

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