Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.14 (Ames-Test)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Method

Species / strain
Species / strain / cell type:
bacteria, other: sat TA 98, 100, 102, 1535, 1537
Metabolic activation system:
Mit Aroclor 1254 induzierter Rattenleber S9-Mix. "ENGLISH" Rat-liver S9 mix induced with Aroclor 1254.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 16 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 16 ... 5000 µg/plate
Vehicle / solvent:
Solvent: DMSO

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 500 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 500 µg/plate)
Additional information on results:
Observations:
Der Stamm TA 1537 zeigte einen biologisch relevanten

Anstieg im Vergleich zur negativ-Kontrolle.

Der Anstieg wurde nur mit S9-Mix beobachtet.

"ENGLISH"

The species TA 1537 exhibited a biologically relevant
increase in comparison with the negative control.

The increase was only observed with the S9 mix.
Remarks on result:
other: other: main test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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