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: 2000/32/EG, B.12 (Mikrokerntest)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: rat, Wistar Hsd Cpb:WU

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Miglyolöl
No. of animals per sex per dose:
Male: 100 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 316 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 1000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 1000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: 1000 mg/kg
Additional information on results:
Observations:


Neither cytotoxic effects (PCE/NCE) nor local effects

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative