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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
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: 92/69/EWG, B.12 (Mikrokerntest)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: mus, CD-1 (SPF)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Suspension der Testsubstanz in Maiskeimöl

"ENGLISH"

Suspension of the test substance in maize germ oil.
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 125 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 125 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 250 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 250 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 500 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 500 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 125 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 125 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 250 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 250 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 500 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 500 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: Bis 500 mg/kg Körpergewicht wurden keine toxischen Effekte beobachtet. "ENGLISH" No toxic effects were observed up to 500 mg/kg body weight.
Additional information on results:
Observations:
In den polychromatischen Erythrocyten des Knochenmarks der
mit BIBR 277-BIMS behandelten Tiere wurde keine Zunahme der
Häufigkeit von kleinkernigen polychromatischen Erythrocyten
beobachtet, im Gegensatz zur Positiv-Kontrollgruppe.

Die mit BIBR 277-BIMS behandelten Gruppen zeigten im
Vergleich zu den Vehikel-Kontrollgruppen keine Abnahme des
Verhältnisses von polychromatischen zu normochromatischen
Erythrocyten. Dies deutet auf das Fehlen von toxischen
Effekten dieser Verbindung gegenüber der Erythrocytenbildung
hin. Bei der Positiv-Kontrollgruppe wurde eine Abnahme im
Verhältnis der polychromatischen zu den normochromatischen
Erythrocyten beobachtet.

"ENGLISH"

In contrast to the positive control group, no increase in
the frequency of polychromatic erythrocytes with small
nuclei was observed in the polychromatic erythrocytes of the
bone marrow of the animals treated with BIBR 277-BIMS. In
comparison with the vehicle control groups, the groups
treated with BIBR 277-BIMS did not reveal any decrease in
the ratio of polychromatic to normochromatic erythrocytes.
This is an indication that the compound lacks toxic effects
on the formation of erythrocytes. In the case of the
positive control group, a decrease in the ratio of the
polychromatic to the normochromatic erythrocytes was
observed.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative