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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Additional strains: S. typhimurium TA 1538 and E. coli WP2 uvrA
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
100, 316, 1000, 3160, and 5000 µg/plate
Details on test system and experimental conditions:
Positive control: Sodium azide (without metabolic activation) --> TA1535, TA100
Positive control: 2-nitrofluorene (without metabolic activation) --> TA 98, TA 1538
Positive control: 9-amino-acridine ( without metabolic activation) --> TA1537
Positive control: 9-amino-acridine ( without metabolic activation) --> TA1537
Positive control: Methyl methane sulfonate ( without metabolic activation) --> WP2 uvr A
Positive control: 2-amino-anthracene (with metabolic activation) --> TA98, TA1537, TA1538
Positive control: Cyclophosphamide ( with metabolic activation) --> TA100, TA1535, WPS uvr A
Negative control: Dimethylsulfoxide (DMSO)

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Additional information on results:
Note: TA 1538 and E. coli WP2 uvrA were also tested with and without metabolic activation; result: negative

Applicant's summary and conclusion

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

No mutagenic effect was observed for the test item in two independent experiments without and with metabolic activation.