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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Genetic toxicity: in vitro

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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:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC Directive 92/69, Annex V - Method B13 and B14 and OECD No. 471.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9 mix prepared from a liver microsomal fraction (S9 fraction) of rats induced with Arochlor 1254.
Test concentrations with justification for top dose:
For all tester strains in the first experiment without S9 mix:
312.5, 625, 1250, 2500, and 5000 µg/plate for all tester strains in first experiment (except for TA 1535 and TA 100 strains) and TA 98 strain in second experiment.
625, 1250, 2500, 3750 and 5000 µg/plate for WP2 strain in second experiment
156.25, 312.5, 625, 1250 and 2500 µg/plate for TA 1535 and TA 100 strains in the first experiment
78.125, 156.25, 312.5, 625 and 1250 µg/plate for TA 1535, TA 1537, TA 100 and TA 102 strains in the second experiment

Experiments with S9 mix:
312.5, 625, 1250, 2500 and 5000 µg/plate: for all tester strains in the second experiment as well as for the TA 1537, TA 98, TA 102 and WP2 uvrA strains in the first experiment.
156.25, 312.5, 625, 1250, and 2500 µg/plate for the TA 1535 and TA 100 strains in the first experiment
Vehicle / solvent:
Solvent: Dimethylsulfoxide (DMSO).

Results and discussion

Test resultsopen allclose all
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>=1250 µg/plate)
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>= 1250 µg/plate)
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
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 activation
ambiguous without metabolic activation

Under the experimental conditions, the test substance Pseudo Kharismal Step 1 does not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli.
Executive summary:

Under the experimental conditions, the test substance Pseudo Kharismal Step 1 does not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli.