Registration Dossier

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:
other: EEC Annex V test B 12 (1984)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
mouse

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
1 % w/v methyl cellulose
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 2000 mg/kg; No. of animals: 10; Sacrifice time: 48 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 2000 mg/kg; No. of animals: 10; Sacrifice times: 48 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: The dose used (2000 mg/kg) produced signs of lethargy, prostation, unsteady gait, piloerection, tremors and eye closure. Total of 9 animals of 30 died or were killed in extremis prior to the scheduled sampling rates.
Additional information on results:
Observations:
Mice treated with test substance had PCE/NCE
(polychromatic/normochromatic) ratios similar to those
treated with vehicle only. Group mean frequencies of
micronucleated PCE were also similar to those seen in
negative control groups and were not significantly different
by X2 analysis.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative