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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:
04.-12. August 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD testing guideline compliant study with well-characterized test material.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
A mixture of: tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium ((1-(4(or 5)-nitro-2-oxidophenylazo)-2-naphtholato)(1-(3-nitro-2-oxido-5-pentylphenylazo)-2-naphtholato))chromate(1-)
EC Number:
403-720-7
EC Name:
A mixture of: tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium ((1-(4(or 5)-nitro-2-oxidophenylazo)-2-naphtholato)(1-(3-nitro-2-oxido-5-pentylphenylazo)-2-naphtholato))chromate(1-)
Cas Number:
117527-94-3
Molecular formula:
C21H21N304.C16H11N304.Cr unspecified.C12-C14 chain unspec.
IUPAC Name:
hexachromium(3+) hexakis(2-methyltridecan-2-aminium) tetrakis(1-[(1E)-2-(4-nitro-2-oxidophenyl)diazen-1-yl]naphthalen-2-olate) tetrakis(1-[(1E)-2-(5-nitro-2-oxidophenyl)diazen-1-yl]naphthalen-2-olate) tetrakis(1-[(1E)-2-[5-(2-methylbutan-2-yl)-3-nitro-2-oxidophenyl]diazen-1-yl]naphthalen-2-olate)
Details on test material:
- Lot/batch No.: 217342.89

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix from rat liver prepared five days after i.p. treatment with 500 mg Aroclor (20% solution in corn oil; w/v).
Test concentrations with justification for top dose:
Doses:
Preliminary toxicity test in TA100 strain: 0, 1, 3.3, 10, 33.3, 100, 333, 1000, 3330, 5000 µg/plate tested. Solvent was 0.1 ml DMSO. 2 plates per dose and control.
Main test (1st and 2nd experiment):
standard plate test 0, 100, 333, 1000, 3330, 5000 µg/plate tested with all tester strains. Solvent was 0.1 ml DMSO
3 plates per dose and control.
Vehicle / solvent:
0.1 ml DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Without S9-mix: Sodium azide; 9-aminoacridine; daunomycine; methylmethanesulfonate. With S9-mix: 2-aminoanthracene
Evaluation criteria:
Reaction to a substance is regarded as positive if all of the following criteria are met
- doubling of spontaneous control mutation rate
- dose-response relationship
- reproducibility of results
Statistics:
Mean and standard deviation from 3 plates/concentration were calculated

Results and discussion

Test resultsopen allclose all
Species / strain:
bacteria, other: S. typhimurium TA 1535, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
Precipitation occured at dose levels of 1000; 3330 and 5000 µg/plate in all tester strains.
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):
positive