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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)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed publication

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:
other:
Principles of method if other than guideline:
Gene mutation toxicity study was performed to evaluate the mutagenic response for the test chemical sodium 4-aminonaphthalene-1-sulphonate.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
CAS number: 130-13-2
Chemical Name: sodium 4-aminonaphthalene-1-sulphonate
Molecular formula: C10H9NO3S.Na
Molecular weight: 245.233 g/mol
Substance type: Organic
Smiles: c12c(c(ccc1S(=O)(=O)[O-])N)cccc2.[Na+]

Method

Target gene:
No data
Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1538
Details on mammalian cell lines (if applicable):
Not applicable
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
rat Aroclor S9 mix
Species / strain:
S. typhimurium TA 98
Details on mammalian cell lines (if applicable):
Not applicable
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
rat Aroclor S9 mix
Species / strain:
S. typhimurium TA 100
Details on mammalian cell lines (if applicable):
Not applicable
Additional strain 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
Vehicle:
No data
Controls
Negative controls:
not specified
Solvent 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 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
Evaluation criteria:
An increase in the number of revertnats was counted
Statistics:
No data

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Additional information on results:
No data

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without

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:

Gene mutation toxicity study was performed to evaluate the mutagenic response for the test chemical sodium 4-aminonaphthalene-1-sulphonate. The study was performed using Salmonella typhimurium strains TA1537, TA1538, TA98,or TA100 with and without S9 metabolic activation system at dose levels of 5, 10, 25, 50, 100, 250, 500, 1000, 2500, 5000 µg.

Maximum nontoxic dose of test substance sodium 4-aminonaphthalene-1-sulphonate was tested that was nonmutagenic TA1537, TA1538, TA98,or TA100 with and without male rat Aroclor S9 mix. Thus, the test compound is not likely to be gene mutant in vitro.