Registration Dossier
Registration Dossier
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EC number: 688-269-6 | CAS number: 641571-11-1
Acute Toxicity: oral
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:
- 2 005
- 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
- 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
Constituent 1
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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