Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Metabolic activation system:
Aroclor - induced in rat liver 59
Test concentrations with justification for top dose:
Concentration range in the main test:(with metabolic activation):100...5000micro gram/plate
Concentration range in the main test:(without metabolic activation):100...5000micro gram/plate
Vehicle / solvent:
Dimethylsulphoxide
Details on test system and experimental conditions:
consentration of the test substance resulting in precipitation:500 micro gram/plate

Results and discussion

Any other information on results incl. tables

Observations:

The substance did not induce any significant, reproducible increases in the observed number of relevant colonies in any strain either in the presence or absence of metabolic activation.

Applicant's summary and conclusion

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

according to this procedure - not genetic toxic