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Toxicological information

Genetic toxicity: in vivo

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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:
other: Body responsible for the test
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Mouse
Strain:
CD-1
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
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: 1250 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 1250 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: 1250 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 1250 mg/kg; No. of animals: 5; Sacrifice times: 49 hours

Results and discussion

Additional information on results:
Doses producing toxicity:
No deaths were observed in this study. Adverse reactions in test substance treated animals included subdued nature,
hunched posture, piloerection, splayed gait, downward curvature of the spine and eyes half shut. No clinical signs were observed in any other group.

Observations:
A significant decrease in mean percentage of polychromatic

erythrocytes was only observed at 48 hours in test

substance-treated male mice. No statistically significant

increase in the frequency of micronuclei was observed in the

test substance-treated groups compared with controls.

Negative control values were within the range of historical

controls and a significant increase in the incidence of

micronuclei was observed with the positive control,

cyclophosphamide.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative