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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 the WP2 uvrA Strain:
Concentration range in the main test (without metabolic activation): 312.5 ... 5000 µg/plate
For the WP2 uvrA Strain and TA 98:
Concentration range in the main test (with metabolic activation): 312.5 ... 5000 µg/plate
For the remain strains:
Concentration range in the main test (with metabolic activation): 156.25 ... 2500 µg/plate
Concentration range in the main test (without metabolic activation): 156.25 ... 2500 µg/plate
Vehicle / solvent:
Solvent: Dimethylsulfoxide (DMSO).
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 5000 µg/plate

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
Remarks:
(>= 1250 µg/plate)
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)
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
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
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
without
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
negative without metabolic activation

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

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