Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: UDS-Test in vivo/in vitro
GLP compliance:
yes
Type of assay:
other: Non-bacteriological test in vivo- 6th amendment data

Test animals

Species:
rat
Strain:
Fischer 344

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
Carboxymethylcellulose
No. of animals per sex per dose:
Male: 100 mg/kg; No. of animals: 4; Sacrifice time: hours
Male: 250 mg/kg; No. of animals: 4; Sacrifice time: hours
Male: 500 mg/kg; No. of animals: 4; Sacrificetime: hours
Male: 1000 mg/kg; No. of animals: 4; Sacrificetime: hours

Results and discussion

Additional information on results:
Observations:
Viabilities of the isolated hepatocytes were between 86.5
and 95.9 %. Isolated hepatocytes were cultivated in vitro
for4 h in the presenceand for 16 - 19 h in the absence of
3H-TdR. No increasein teh UDSeffectwas found
(autoradiography; 50 hepatocytes were analyzed from each of
3 culturesper animal).

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative