Registration Dossier

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:
other: 92/69/EWG, B.12 (Mikrokerntest)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: mus, Hsd Win:NMRI

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
0.5 %ige wässrige Cremophor-Emulsion
No. of animals per sex per dose:
Male: 300 mg/kg; No. of animals: 5; Sacrifice time: 16 hours
Male: 300 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 300 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 300 mg/kg; No. of animals: 5; Sacrifice times: 16 hours
Female: 300 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 300 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: 300 mg/kg
Additional information on results:
Observations:
Nach einmaliger i.p.-Verabreichung von 300 mg/kg der
Testsubstanz traten keine substanzbedingten Todesfälle auf.
Die Futteraufnahme war normal. Die behandelten Tiere zeigten
folgende substanzbedingte Symptome: Apathie, aufgerauhtes
Fell, schwankender Gang, Spasmen, Atemschwierigkeiten,
Schlitzaugen.

In den Testsubstanzgruppen war ein verändertes Verhältnis
von poly- und normochromatischen Erythrozyten festzustellen.

"ENGLISH"

No fatalities occured after single i.p.-administration of
300 mg/kg of the test substance. The food intake was The
test animals indicated the following substance-related
symptoms: apathy, roughened fur, giddy gait, spasm,
breathing difficulties, slant eyes.

A different ratio of poly- and normochromatic erythrocytes
was observed in the test group.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative