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: 92/69/EWG, B.1; OECD 401
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test animals

Species:
other: rat, Wistar, HOE WISKf (SPF71)

Administration / exposure

Vehicle:
other: Sesamöl (Ph. Eur. III) "ENGLISH" Sesame oil (Ph. Eur. III)

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: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Während der Studie traten keine Todesfälle auf. Die
folgenden Symptome wurden beobachtet:

Hochbeiniger, unkoordinierter ataxischer Gang, reduzierte
Spontanaktivität, eingezogene Flanken und Bauchlage.

Nach 2 Tagen waren die Symptome reversibel. Die
Körpergewichtsentwicklung war nicht beeinträchtigt.

"ENGLISH"

No mortalities occurred during the study. The following
symptoms were observed:

High-legged gait, uncoordinated, ataxic gait, reduced
spontaneous activity, drawn-in flanks and ventricumbency.
The symptoms were reversible after 2 days. The body-weight
gain was not impaired.
Gross pathology:
Effects on organs:
Die am Ende der Studie getöteten Tiere zeigten keine
makroskopisch sichtbaren Veränderungen.

"ENGLISH"

The animals killed at the end of the study did not exhibit
any macroscopically visible changes.

Applicant's summary and conclusion

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