Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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