Registration Dossier

Diss Factsheets

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
Guideline:
other: Annex V (In vivo micronucleus study)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: Mouse (CD-1)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
Arachis oil
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 7; Sacrifice time: 24 hours
Male: 0 mg/kg; No. of animals: 7; Sacrifice time: 48 hours
Male: 2000 mg/kg; No. of animals: 7; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 7; Sacrifice time: 48 hours
Male: 1000 mg/kg; No. of animals: 7; Sacrifice time: 24 hours
Male: 500 mg/kg; No. of animals: 7; Sacrifice time: 24 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: There were no deaths, and no clinical signs of toxicity were observed. No statistically significant decreases in the PCE/NCE ration were observed in the 24 and 48-hour test groups when compared to controls.
Additional information on results:
Observations:
There was no evidence of a significant increase in the
incidence of micronucleated polychromatic erythrocytes in
test group animals compared to vehicle controls. The
positive control material produced a marked increase in the
frequency of micronucleated polychromatic erythrocytes.
Negative control values were within historical ranges.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative