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.tris (Akute-toxische-Klassen-Methode); OECD 423
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test animals

Species:
other: rat, Sprague-Dawley

Administration / exposure

Vehicle:
other: Gereinigtes Wasser "ENGLISH" Purified water

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
< 2 000 mg/kg bw
Mortality:
Male: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 3
Female: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
2000 mg/kg (3 männliche Tiere):

Alle drei Tiere sind in den vier Behandlungsstunden
gestorben.

Linderung, seitliche Ausdehnung, Dyspnea, Piloerektion und
Koma wurden vor dem Tod beobachtet.

200 mg/kg (3 männliche und 3 weiblichen Tiere):

Keine klinischen Effekte und keine Todesfälle beobachtet.
Die Behandlung zeigte keinen Einfluss auf das Körpergewicht
der Tiere.

Körpergewicht von den Tieren hat sich bei der Behandlung
nicht verändert.

"ENGLISH"

2000 mg/kg (3 male animals):

All three animals died in the four hours of treatment.
Relief, lateral extension, dyspnoea, piloerection and coma
were observed prior to death.

200 mg/kg (3 male and 3 female animals):

No clinical effects and no mortalities were observed.

The treatment did not show any influence on the body weight
of the animals.

The body weight of the animals did change during treatment.
Gross pathology:
Effects on organs:
Bei Nekropsie, keine sichtbaren Unregelmäßigkeiten in

Tieren beobachtet.

"ENGLISH"

During necropsy, no visible anomalies in the animals were
observed.

Applicant's summary and conclusion

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

Categories Display