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:
2004

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:
CD-1
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
0.5% CMC
Duration of treatment / exposure:
Oral gavage dose
Frequency of treatment:
Twice, at 0 and 24 hours
Post exposure period:
24 hours after second dose
Doses / concentrations
Remarks:
Doses / Concentrations:
2000 mg/kg
Basis:
actual ingested
No. of animals per sex per dose:
10 males and 10 females
Control animals:
yes, concurrent vehicle
Positive control(s):
50 mg/kg Cyclophosphamide

Examinations

Tissues and cell types examined:
Bone marrow from one femur

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

No deaths or adverse reactions were observed following dosing.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
HQEE was considered to be non-mutagenic in an vivo micronucleus assay.