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)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test animals

Species:
other: rat, Wistar Hsd Cpb:WU

Administration / exposure

Vehicle:
other: Demineralisiertes Wasser "ENGLISH" Demineralized water

Results and discussion

Effect levels
Sex:
male/female
Mortality:
Male: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Male: 500 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 500 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 3
Clinical signs:
Signs of toxicity related to dose levels:
Bei 200 und 500 mg/kg KGW. wurden keine klinischen

Symptome beobachtet.

2000 mg/kg KGW:

Beobachtet wurden: abnehmender Bewegungsdrang, gesträubtes
Fell.

Alle drei weiblichen Tiere der 2000 mg/kg Dosisgruppe
starben im Verlauf von 7 Stunden bis 2 Tagen.

Die Körpergewichtsentwicklung der Tiere der 200 und 500
mg/kg Dosisgruppen verlief normal.

"ENGLISH"

No clinical symptoms were observed at 200 and 500 mg/kg b.w.
2000 mg/kg b.w.

The following were observed: decreasing desire for movement,
rough coat.

All three female animals from the 2000 mg/kg dose group died
in the course of 7 hours to 2 days.

The body-weight gain of the animals from the 200 and 500
mg/kg dose groups was normal.
Gross pathology:
Effects on organs:
Bei der Autopsie der während des Studienverlaufs gestorbenen
Tiere wurden die folgenden Veränderungen festgestellt:
Aufgetriebener Magen und Dünndarm, geröteter Magen und
gerötete Darmschleimhaut, Schwund von
Magenschleimhautfalten.

Bei den nach Ende der Studie getöteten Tieren wurden keine
auffälligen pathologischen Befunde beobachtet.

"ENGLISH"

The following changes were determined during the necropsy of
the animals that died during the course of the study:
Distended stomach and small intestine, reddened stomach and
reddened intestinal mucous membrane, disappearance of folds
in the mucous membrane of the stomach.

No conspicuous pathological findings were observed in the
animals killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU