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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
Study period:
16. March - 25. March 2010
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Species / strain:
other: S. typhimurium TA 97a
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
Plate incorporation method:
Per strain and dose, four plates with and four plates without S9 mix were used.
Concentrations tested:
5057 / 1509 / 506 / 151 / 51 µg/palte

Pre-incubation method:
Per strain and dose, four plates with and four plates without S9 mix were used.
Concentrations tested:
5015 / 2501 / 1254 / 626 / 317 µg/plate
Controlsopen allclose all
Negative controls:
yes
Solvent controls:
yes
Positive controls:
yes
Positive control substance:
other: 4-Nitro-1,2-phenylene diamine
Remarks:
Positive Controls: Without metabolic activation: 4-Nitro-1,2-penylene diamine (NPD) in DMAO, 20 µg/plate
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Positive Controls: Without metabolic activation: Sodium azide (Na-anzide) in deionised water 1 µg/plate
Positive controls:
yes
Positive control substance:
other: 2-Amino-anthracene
Remarks:
Positive Controls: With metabolic activation: 2-Amino anthracene (2-AA) in DMSO, 1 µg/plate
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
Positive Controls: With metabolic activation: Benzo-a-pyrene (BaP) in DMSO, 20 µg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: strain/cell type: TA 1535
Remarks:
Migrated from field 'Test system'.
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: strain/cell type: TA 97a
Remarks:
Migrated from field 'Test system'.
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: strain/cell type: TA 98
Remarks:
Migrated from field 'Test system'.
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: strain/cell type: TA 100
Remarks:
Migrated from field 'Test system'.
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: strain/cell type: TA 102
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative