Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: tap water with the aid of 2% Cremophor EL
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
3 per dose
2 replicates each
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
A dose of 300 and 2000 mg/kg bw. was tolerated by female rats without mortalities.
Clinical signs:
A dose of 300 and 2000 mg/kg bw. was tolerated by female rats without clinical signs.
Body weight:
A dose of 300 and 2000 mg/kg bw. was tolerated by female rats without effects on weight gain.
Gross pathology:
A dose of 300 and 2000 mg/kg bw. was tolerated by female rats without gross pathological findings.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category V
Remarks:
Migrated information Criteria used for interpretation of results: EU