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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8 Feb - 4 Mar 2005
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

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

Test material

Constituent 1
Reference substance name:
641571-1 1-1
IUPAC Name:
641571-1 1-1
Details on test material:
- Name of test material (as cited in study report):AMN 107 B6
- - Physical state:solid
- Analytical purity:100.3 %
-- Lot/batch No.:CHAD0409
- Expiration date of the lot/batch:30 June 2005
- - Stability under test conditions:Stable
- Storage condition of test material:At room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Doses:
2000 mglkg
300 mglkg
50 mglkg
No. of animals per sex per dose:
3
Control animals:
yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
50 - 300 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50value of AMN107 B6 in Wistar rats was established 50-300 mglkg body weight.
Executive summary:

The body weight gain shown by the surviving animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50value of AMN107 B6 in Wistar rats was established 50-300 mglkg body weight. According to the OECD 423 test guideline the LD50 cut-off value was considered to be 200 mglkg body weight.

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