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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2003-11-01 till 2004-03-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
technical product

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
No. of animals per sex per dose:
2x3 female rats, one dose
Control animals:
no
Statistics:
not necessary

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Clinical signs:
All animals were found normal throughout the experimental period.
Body weight:
Increase of body weight of all animals during the experimental period.
Gross pathology:
External examination of animals did not reveal any lesion of pathological significance.
No treatment related effects were observed in any animal at any steps.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 dose of the test material in Wistar rats is 2000 mg/kg bw. According to GHS (Globally Harmonized Classification System) the test item was classified into Category 5 (LD50 cut-off: unclassified).