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Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 Aug - 20 Dec 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2005

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:
2-amino-2'-chloro-5-nitrobenzophenone
EC Number:
217-929-4
EC Name:
2-amino-2'-chloro-5-nitrobenzophenone
Cas Number:
2011-66-7
Molecular formula:
C13H9ClN2O3
IUPAC Name:
(2-amino-5-nitrophenyl)(2-chlorophenyl)methanone

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 (rat)
Test concentrations with justification for top dose:
Plate incorporation method without metabolic activation [µg/plate]:
10, 50, 100, 500, 1000, 5000 S. typhimurium TA 1535 and E. coli WP2uvrA
1, 5, 10, 50, 100, 500, 1000, 5000 S. typhimurium TA 1537 and TA 100
5, 10, 50, 100, 500, 1000, 5000 S. typhimurium TA 98


Plate incorporation method with metabolic activation [µg/plate]:
5, 10, 50, 100, 500, 1000, 5000 S. typhimurium TA 1535 and TA 98
1, 5, 10, 50, 100, 500, 1000 S. typhimurium TA 100 and TA 1537
10, 50, 100, 500, 1000, 5000 E. coli WP2uvrA

Pre-incubation method without metabolic activation [µg/plate]:
1, 5, 10, 50, 100, 500, 1000 S. typhimurium TA 1535
0.5, 1, 5, 10, 50, 100 S. typhimurium TA 1537
0.5, 1, 5, 10, 50, 100, 500 S. typhimurium TA 98
0.1, 0.5, 1, 5, 10,50, 100 S. typhimurium TA 100
10, 50, 100, 500, 1000 E. coli WP2uvrA

Pre-incubation method with metabolic activation [µg/plate]:
1, 5, 10, 50, 100, 500 S. typhimurium TA 1535
0.5, 1, 5, 10, 50, 100 S. typhimurium TA 1537
0.5, 1, 5, 10, 50, 100, 500 S. typhimurium TA 98
0.1, 0.5, 1, 5, 10, 50 S. typhimurium TA 100
10, 50, 100, 500, 1000, 5000 E. coli WP2uvrA

Results and discussion

Test results
Species / strain:
other: 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
Remarks:
at higher concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results:
negative

Based on the results of the reported study it is concluded that ACN does not induce gene mutation in Salmonella typhimurium and Escherichia coli under the
experimental conditions described. Therefore, ADB is considered to be non-motagenie in the bacterial reverse mutation test.