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
Study period:
no data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test compliant with GLP.

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: Nucleus anomaly in somatic interphase nude; of Chinise hamster
Deviations:
not specified
GLP compliance:
yes
Type of assay:
other: Non-bacteriological test in vivo - 6th amendment data

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Chine hamster
Strain:
other: Cricetulus griseus
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
0.5 % CMC and 0.1 % Tween 80

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative