Registration Dossier

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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
Deionised water
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
200 mg/kg b.w.
Basis:
actual ingested
Remarks:
Doses / Concentrations:
670 mg/kg b.w.
Basis:
actual ingested
Remarks:
Doses / Concentrations:
2000 mk/kg b.w.
Basis:
actual ingested
No. of animals per sex per dose:
Male: 200 mg/kg; No. of animals: 5; Sacrifice time: 24 hours Male: 670 mg/kg; No. of animals: 5; Sacrifice time: 24 hours Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours Female: 200 mg/kg; No. of animals: 5; Sacrifice times: 24 hours Female: 670 mg/kg; No. of animals: 5; Sacrifice times: 24 hours Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Positive control(s):
cyclophosphamide

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
not specified
Toxicity:
yes
Remarks:
Doses producing toxicity: In the pretest: 2000 mg/kg
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative