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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Annex V
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: Mouse (Crl NMRI BR)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
dimethylsulfoxide
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: 1000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 1500 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2000 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: 1000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 1500 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Additional information on results:
Doses producing toxicity:
P/N ratio: significant decrease in male dosed with 2000
mg/kg and sacrificed after 48h

In all test substance treated animals sedation and decreased
motor activites were noted some minutes after
administration.

Yellow-stained bedding may indicate that the substance or
its metabolites were excreted.

Observations:
Negative control values were within the historical control
ranges.

An increased incidence of micronuclei was observed in the
positive control group treated with cyclophosphamide.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative