Registration Dossier
Registration Dossier
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EC number: 480-320-9 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2005-07-26 to 2005-08-11
- Reliability:
- 1 (reliable without restriction)
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
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:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2004/73/EC
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Details on test material:
- Batch no: EZ06-B001;
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Age: 6-10 weeks
Body weigh at start of the experiment: 174.5 g (mean)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- NA
- Doses:
- single dose: 2000 mg/kg bw.
- No. of animals per sex per dose:
- initially 3, as no lethality occurred, 3 further animals were treated.
- Control animals:
- no
- Details on study design:
- NA
- Statistics:
- NA
Results and discussion
- Preliminary study:
- no lethality occurred.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality was observed.
- Clinical signs:
- other: after 30 to 60 min after administration of the test substance: incoordinated (ataxic) gait, drawn in flanks and hyporeactivity. No clinical signs were observed from day 3 until the end of the experiment (2 weeks after administration).
- Gross pathology:
- The animals were killed after 2 weeks and no macroscopically visible chances were observed.
- Other findings:
- None.
Any other information on results incl. tables
NA
Applicant's summary and conclusion
- Conclusions:
- Rat: LD50 > 2000 mg/kg bw.
- Executive summary:
Based on the results obtained in this study with female rats the median lethal dose value (LD50) of AVE 5530 EVA-KET is greater 2000 mg/kg bw.
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