Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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:
other: OECD 423 (2000)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test animals

Species:
other: rat, Crl:Gl BrlHan:WI (SPF)

Administration / exposure

Vehicle:
other: 0.5 % aqueous hydroxyethylcellulose (Natrosol 250 HX)

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: 3; Number of deaths: 0
Female: 100 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
At 2000 mg/kg, females showed an increased respiratory rate
and slight piloerection on day 1.
Gross pathology:
Effects on organs:
At necropsy no gross macroscopical findings of toxicological
relevance were recorded either in female or male rats.

Applicant's summary and conclusion

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