Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: (Micronucleous Test) Annex V, B12
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
hamster, Chinese
Strain:
other: random outbred
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
arachis oil
No. of animals per sex per dose:
Male: 5000mg/kg; No. of animals: 8; Sacrifice time: 16 hours
Male: 5000mg/kg; No. of animals: 8; Sacrifice time: 24 hours
Male: 5000mg/kg; No. of animals: 8; Sacrifice time: 48 hours

Female: 5000mg/kg; No. of animals: 8; Sacrifice time: 16 hours
Female: 5000mg/kg; No. of animals: 8; Sacrifice time: 24 hours
Female: 5000mg/kg; No. of animals: 8; Sacrifice time: 48 hours

Results and discussion

Test results
Sex:
male/female
Toxicity:
yes
Remarks:
doses producing toxicity > 5000 mg/kg

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative