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: Annexe V , B12
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: souris

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
Huile de maïs
No. of animals per sex per dose:
Male: 1200 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 1200 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 1200 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Female: 1200 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 1200 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 1200 mg/kg; No. of animals: 5; Sacrifice times: 72 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: Mortalité à 1600 mg/kg
Additional information on results:
Observations:
Pas de symptomatologie, pas de modification NCE/PCE

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative