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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:
2012
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-amino-4,5-dichlorobenzene-1-sulfonic acid
EC Number:
700-413-2
Cas Number:
6331-96-0
Molecular formula:
C6 H5 Cl2 N O3 S
IUPAC Name:
2-amino-4,5-dichlorobenzene-1-sulfonic acid
Test material form:
other: solid
Details on test material:
approximately 99 % (as indicated by the sponsor)

Method

Target gene:
Histidine-deficient mutants of Salmonella typhimurium LT2
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9 mix from the livers of Aroclor 1254-induced male Sprague Dawley rats
Test concentrations with justification for top dose:

µg per plate
Negative control 0
Test item 50
Test item 160
Test item 500
Test item 1600
Test item 5000
Positive control, NaN3 5 (only TA 100, TA 1535)
Positive control, 2NF 10 (only TA 98)
Positive control, 4NPDA 10 (only TA 1537)
Positive control, MMC 0.2 (only TA 102)
Positive control, Cum 50 (only TA 102 )
Positive control, 2AA 3 all strains

Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
sodium azide
monomeric acrylamide
cumene hydroperoxide
mitomycin C

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
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'.

Any other information on results incl. tables

None of the five strains concerned showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls. This applied both to the tests with and without S9 mix

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative
Executive summary:

None of the five strains concerned showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls. This applied both to the tests with and without S9 mix