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Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Adequacy of study:
other information

Data source

Reference Type:
other: Body responsible for the test

Materials and methods

Test guideline
according to guideline
other: 96/54/EG, B.1tris (Akute-toxische-Klassen-Methode)
GLP compliance:
Test type:
standard acute method
Limit test:

Test animals

other: rat, Wistar Hsd Cpb:WU (SPF)

Administration / exposure

other: Polyethylenglykol 400 "ENGLISH" Polyethylene glycol 400

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 200 mg/kg bw
Male: 2000 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: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 2
Clinical signs:
Signs of toxicity related to dose levels:
Bei einer Dosierung von 2000 mg/kg KGW an weiblichen Tieren
wurde beobachtet:

Auszehrung (vom 7. bis zum 9. Tag); schlechter
Allgemeinzustand (7.Tag); verminderte Beweglichkeit (7.

Bei einer Dosierung von 2000 mg/kg KGW an männlichen Tieren
und 200 mg/kg KGW an weiblichen Tieren wurden keine
Toxizitätssymptome beobachtet.


The following symptoms were observed in the female animals
after administration of 2000 mg/kg body weight:

Emaciation (from the 7th to the 9th day)

Poor general state of health (7th day)

Reduced mobility (7th day)

No signs of toxicity were observed in the male animals which
were treated with 2000 mg/kg body weight and in the female
animals which were treated with 200 mg/kg body weight.
Gross pathology:
Effects on organs:
Ein weibliches Tier, das während der Studie starb, hatte
eine dunkel verfärbte Leber und Niere, einen schwarz
verfärbten Darm, eine leicht rosa verfärbte Lunge und war

Das andere weibliche, während der Studie verstorbene Tier,
konnte wegen Kannibalismus nicht untersucht werden.

Der pathologische Befund an den nach Studienende getöteten
Tieren war nicht auffällig.


A female animal which died during the study had a dark
discolored liver and kidney, a dark discolored intestine, a
slightly pink discolored lung and was emaciated.

The other animal that died during the study could not be
examined due to cannibalism.

The pathological findings relating to the animals killed at
the end of the study did not reveal any anomalies.

Applicant's summary and conclusion

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