Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Safety data sheet of the supplier
Title:
Safety data sheet of the Ketoamide
Author:
Merck
Year:
2009
Bibliographic source:
Safety data sheet of the supplier
Report Date:
2009

Materials and methods

Principles of method if other than guideline:
Not available
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Test results
Species / strain:
not specified
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Not mutagenic in Ames test.