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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
yes

Test animals

Species:
other: rat, Wistar Hsd Cpb:WU

Administration / exposure

Vehicle:
other: Wasser (demineralisiert) mit 2 % Cremophor EL "ENGLISH" Water (demineralized) with 2 % cremophor EL

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: 1
Clinical signs:
Signs of toxicity related to dose levels:
Bei einer Dosierung von 2000 mg/kg nahmen bei Männchen und
Weibchen Beweglichkeit und die Reaktion ab. Unkontrollierter
Gang und erschwere Atmung setzten ein. Die Augenlider waren
bei den Männchen rissig und verengt. Ein Männchen und ein
Weibchen lagen auf dem Bauch. Dieses Weibchen zeigte auch
rissige verengte Augenlider, Durchfall und Auskühlung. Das
Tier starb nach 2 Studientagen.

Die Symptome stellten sich innerhalb von 5 Minuten ein und
endeten 2 Tage nach der Dosierung.

Die Gewichtsentwicklung verlief normal.

"ENGLISH"

Mobility and reactions decreased in the males and females at
a dose of 2000 mg/kg. Uncontrolled gait and difficult
breathing started. In the males the eyelids were fissured
and narrowed. Ventricumbency in one male and one female.
This female also exhibited fissured, narrowed eyelids,
diarrhoea and loss of body heat. The animal died after 2
days of the study.

The symptoms started within 5 minutes and ended two days
after dosing.

The body-weight gain was normal.
Gross pathology:
Effects on organs:
Bei dem während der Beobachtungszeit gestorbenen Tier
zeichten sich folgende Symptome:

Harnblase: zunehmend gelbe Flüssigkeit (ca. 2.5 ml)

Leber: fleckig blasse Leber.

Speiseröhre: braun, breiige Veränderungen des Inhalts.

Bei der Autopsie wurde bei einem Weibchen eine blasse Leber
beobachtet.

"ENGLISH"

The following symptoms were revealed in the animal that died
during the observation period:

Bladder: increasingly yellow liquid (approx. 2.5 ml)

Liver: patchy, pale liver.

Oesophagus: brown, pulplike changes to the content.

During necropsy a pale liver was observed in one female.

Applicant's summary and conclusion

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