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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 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:
2005
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

Constituent 1
Details on test material:
Batch no: EZ06-B001;

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:
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).
Body weight:
Development of body weight was not impaired during the whole study.
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.