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:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EC B.14(Ames test)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538
Metabolic activation:
with
Metabolic activation system:
S9-Mix(rat liver cell fraction)
Vehicle:
Solvent: DMSO

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538
Metabolic activation:
not specified
Genotoxicity:
not specified
Cytotoxicity:
not specified
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Additional information on results:
Observations:
No genetic activity of the test material in any of the assays.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation