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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:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity testing of some commonly used dyes.
Author:
K T Chung, G E Fulk and A W Andrews
Year:
1981
Bibliographic source:
APPLIED AND ENVIRONMENTAL MICROBIOLOGY, Oct. 1981, p. 641-648

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Data is from J. of APPLIED AND ENVIRONMENTAL MICROBIOLOGY
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 4-aminonaphthalene-1-sulphonate
EC Number:
204-975-5
EC Name:
Sodium 4-aminonaphthalene-1-sulphonate
Cas Number:
130-13-2
Molecular formula:
C10H9NO3S.Na
IUPAC Name:
sodium 4-aminonaphthalene-1-sulfonate
Details on test material:
CAS number: 130-13-2
Chemical Name: sodium 4-aminonaphthalene-1-sulphonate
Molecular formula: C10H9NO3S.Na

Method

Target gene:
Fusobacterium sp. 2 (6) was inoculated into 500 ml of brain heart infusion broth in a 1-liter round-bottom flask and incubated statically at 37°C for 17 to 19 h.The culture was then centrifuged at 20,000 x g for 20 min and washed once with 0.4 M potassium phosphate buffer solution (pH 7.4). Four milliliters of this suspension was added to 4 ml of the phosphate buffer and 2 ml of the dye (2 to 5 pmol/ml). The mixture was incubated anaerobically in a 37°C water bath with slow shaking for 1 h. This suspension was then centrifuged at 7,000 x g for 20 min. To further purify the supematant, it was drawn through an ultrafine fritted
glass disk filter. The filtrate was screened for mutagenicity in the Ames assay.
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
rat Aroclor S9 mix
Test concentrations with justification for top dose:
5,10,25,50,100,250,500,1000,2500,5000 µg
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
2-nitrofluorene
sodium azide
other: Dimethyl sulfoxide,2-Aminoanthracene
Details on test system and experimental conditions:
The Salmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98,and TA100 were grown in nutrient broth shaken for 14 h at 370C. The plate incorporation assays were performed as described by Ames with the modifications of Andrews. The liquid preincubation assays (1, 21) were timed for 30 min at 37°C in a Dri-block. The revertant colonies were counted by using a hand-held tally. Dimethyl sulfoxide was the solvent, except sterile distilled water was the solvent when sulfanilic acid was used. Liver homogenates (S9) were prepared from male Sprague-Dawley rats stimulated with Aroclor 1254 (500 mg/kg intraperitoneally 5 days before sacrifice). The S9 mix, added in samples of 0.5 ml per plate, contained 3 mg of protein, determined by the method of Lowry et al. (16). The positive control chemicals sodium azide, 9-aminoacridine, 2-nitrofluorene, and 2-aminoanthracene were used with the tester strains. The dose-response curves for the mutagenic compounds used the tester strain which showed maximum mutagenicity and covered a range of 1 to 1,000 or 5 to 5,000 tig. Mutagenic compounds were assayed by using duplicate plates in at least two independent dose-response curves; the mean values of representative curves are used in the table. A compound was considered mutagenic when the number of revertants above background was at least twice the value of the historical control mean or twice the value of the current control mean, whichever was greater,and a dose-response curve could be demonstrated

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
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

Maximum nontoxic dose of test substance sodium 4-aminonaphthalene-1-sulphonate was tested that was nonmutagenic in TA1535, TA1537, TA1538, TA98,or TA100 with and without male rat Aroclor S9 mix.
Executive summary:

Maximum nontoxic dose of test substance sodium 4-aminonaphthalene-1-sulphonate was tested that was nonmutagenic in TA1535, TA1537, TA1538, TA98,or TA100 with and without male rat Aroclor S9 mix.

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