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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: OECD Guideline No. 471 EC Directive 92/69/EEC Annex V Test B.13, B.14 ICH Guidelines CPMP/ICH/141/95 Step 4 EPA Pesticide Assessment Guidelines, Sub-division F, 84-2
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium Strains TA1535, TA1537,TA98, TA100. Escherichia coli Strain WP2uvrA
Metabolic activation system:
Aroclor 1254 induced S9 fraction from rat liver preparation.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 10 ... 3333.3 µg/plateConcentration range in the main test (without metabolic activation): 10 ... 3333.3 µg/plate
Vehicle / solvent:
Solvent: Dimethyl sulphoxide (DMSO)
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 1000 µg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 1667 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 1667 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 1000 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 1000 µg/plate)
Additional information on results:
Observations:Precipitation only resulted in the second mutation assay(pre-incubation method), in the presence of S9 mix.
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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