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 tes
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
other: Non-bacteriological test in vivo - 6th amendment data

Test animals

Species:
other: Mouse, Swiss CD-1

Administration / exposure

Route of administration:
oral: unspecified
No. of animals per sex per dose:
Female: 2000 mg/kg; No. of animals:; Sacrifice times: hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
(Doses producing toxicity: > 2000 mg/kg)

Any other information on results incl. tables

Observations: none

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative