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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)
Rationale for reliability incl. deficiencies:
other: GLP study according EU/OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1-diphenylethylene
EC Number:
208-482-6
EC Name:
1,1-diphenylethylene
Cas Number:
530-48-3
Molecular formula:
C14H12
IUPAC Name:
1,1'-ethene-1,1-diyldibenzene

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
first experiment:
a: without metabolic activation: 4, 20, 100, 500, 2500, 5000 ug/plate
b: with metabolic activation: 4, 20, 100, 500, 2500, 5000 ug/plate

second experiment:
a: without metabolic activation: 0.032, 0.16, 0.8, 4, 20, 100, 500 ug/plate
b: with metabolic activation: 0.16, 0.8, 4, 20, 100, 500, 2500 ug/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: a: without metabolic activation: sodium-azide (TA 100, TA 1535), 9-aminoacridine (TA 1537), 2-nitrofluorene (TA 98), MNNG (WP2uvrA), b: with metabolic activation: 2-aminoanthracene (all strains)

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative Genotoxicity negativ

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