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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test performed under GLP but no access to full documentation.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

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

Test animals

Species:
other: Chinese Hamster (random outbred strain)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
0.5% aqueous sodium carboxymethyl cellulose
No. of animals per sex per dose:
Male: 5000 mg/kg; No. of animals: 8; Sacrifice time: hours
Female: 5000 mg/kg; No. of animals: 8; Sacrifice times: hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: P/N ratio. There was a small decrease at 48 hours only No other signs of toxicity

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative