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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:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
only Escherichia coli strain WP2 uvrA
Principles of method if other than guideline:
On request of the Belgian authority (Federale Overheidsdienst) the test substance was tested in an additional bacteria strain within an Ames-Test to check for oxidising mutagen properties, crosslinking actions or formation of hydrazines, which only can be detected by the strains E. coli WP2 or S. typhimurium TA102.
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
Escherichia coli strain WP2 uvrA
Species / strain
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Phenobartital/β-Naphthoflavone induced rat liver S9
Test concentrations with justification for top dose:
33; 100; 333; 1000; 2500; and 5000 µg/plate
Vehicle / solvent:
water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: w/o metabolic activation: methyl methane sulfonate
Remarks:
w metabolic activation: 2-aminoanthracene

Results and discussion

Test results
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: strain/cell type: WP2 uvrA
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Executive summary:

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations in the genome of the strain WP2 uvrA. Therefore, the test substance is considered to be non-mutagenic in this Escherichia coli reverse mutation assay.