Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 96/54/EG, B.1tris
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test animals

Species:
other: rat, Sprague Dawley (SD)

Administration / exposure

Vehicle:
other: Sesamoel

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Während der gesamten Studie wurden keine Todesfälle
festgestellt. Folgende klinischen Effekte wurden beobachtet:
Hyperaktivität, unregelmässige Atmung, Hockstelluung,
unkoordiniertet, gestelzter und ataktischer Gang,
eingezogene Flanken und erweiterte Pupillen.

Zusätzlich wurde bei den männlichen Tieren Benommenheit,
zusammengekauerte Stellung, gesträubtes Fell, Keuchatmung,
negativer Stellreflex, negativer Pfotenkneifreflex und
Narkose.

Am 5. Tag p.a. waren alle Effekte reversibel.

Die Körpergewichtsentwicklung war nicht beeinflusst.

"ENGLISH"

No mortalities were determined during the entire study. The
following clinical effects were observed:

hyperactivity, irregular breathing, squatting position,
uncoordinated, high-legged and atactic gait, withdrawn
flanks and dilated pupils.

In addition, the following effects were observed in the male
animals:

numbness, crouched posture, piloerection, wheezing, negative
self-righting reflex, negative paw-pinching reflex and
narcosis.

All of the effects were reversible on the 5th day p.a.
Body-weight gain was not influenced.
Gross pathology:
Effects on organs:
Bei der Sektion der am Ende der Studie gestorbenen Tiere
wurden keine makroskopisch sichtbaren Effekte festgestellt.

"ENGLISH"

No macroscopically visible effects were determined during
the necropsy of the animals that died at the end of the
study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU

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