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:
4 (not assignable)

Data source

Reference
Reference Type:
other: Body responsible of the test
Title:
Unnamed
Year:
1992

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
mouse
Strain:
CD-1

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Arachis oil BP
No. of animals per sex per dose:
Male: 50 mg/kg; No. of animals: 7; Sacrifice time: 24 hrs
Male: 100 mg/kg; No. of animals: 7; Sacrifice time: 24 hrs
Male: 200 mg/kg; No. of animals: 7; Sacrifice time: 24 hrs
Male: 50 mg/kg; No. of animals: 7; Sacrifice time: 48 hrs
Male: 100 mg/kg; No. of animals: 7; Sacrifice time: 48 hrs
Male: 200 mg/kg; No. of animals: 7; Sacrifice time: 48 hrs

Results and discussion

Any other information on results incl. tables

Doses producing toxicity: no change in P/N ratio

Other toxic signs: lethargy, hunched posture and decreased respiratory rate were noted with 200 mg/kg

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative