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:
2 (reliable with restrictions)

Data source

Reference
Title:
No information
Author:
Benigni, R
Year:
2013
Bibliographic source:
OECD Toolbox v3.1 (CCRIS data from 2011)

Materials and methods

Test guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
Ames test
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: TA 97A/98/100/102/1537/1538
Metabolic activation:
with and without
Metabolic activation system:
S9

Results and discussion

Test results
Species / strain:
other: TA 97A/98/100/102/1537/1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative