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 (Akute-toxische-Klassen-Methode); OECD 423
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test animals

Species:
other: rat, Wistar Hsd Cpb:WU

Administration / exposure

Vehicle:
other: Trinkwasser mit 2 % Cremophor EL "ENGLISH" Drinking water with 2 % cremophor EL

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Bei 2000 mg/KG wurden folgende klinische Symptome
beobachtet:

abnehmender Bewegungsdrang, unkoordinierte Bewegungen,
verengte Lidspalten bzw. geschlossene Augenlider, erschwerte
Atmung, gesträubtes Fell. (Zeitraum 55 Minuten bis 5
Stunden)

Die Körpergewichtsentwicklung der Tiere verlief unauffällig.

"ENGLISH"

The following clinical symptoms were observed at 2000
mg/body weight:

decreasing desire to move, uncoordinated movements, narrowed
eyelids or closed eyelids, difficult breathing,
piloerection. (Period from 55 minutes to 5 hours).

There were no anomalies with regard to the body-weight gain
of the animals.
Gross pathology:
Effects on organs:
Bei den nach Ende der Studie getöteten Tieren wurden keine
auffälligen pathologischen Befunde beobachtet.

"ENGLISH"

No conspicuous pathological findings were observed in the
animals killed 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