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:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Version / remarks:
Annex V (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:
intraperitoneal
Vehicle:
Corn oil
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 31.25 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 62.5 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 125 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 125 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 31.25 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 62.5 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 125 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 125 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
Observations:
There were no increases in the frequency of micronuclei and no signs of bone marrow toxicity. The negative and positive control substances gave the expected responses.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative