Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Adequacy of study:
supporting study

Data source

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

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Duration of treatment / exposure:
24, 48 and 72 h
No. of animals per sex per dose:
5 male / 5 female

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative