Sodium naphthalene-1-sulphonate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal.

Data source

Reference

Reference Type:

other: J-check

Title:

Gene mutationj toxicity study of the test chemical

Author:

NITE

Year:

2018

Bibliographic source:

J-check

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Guidelines for Screening Mutagenicity Testing of Chemicals(Chemical Substances Control Law of Japan) and OECD Test Guideline 471

Principles of method if other than guideline:

To evaluate the mutagenic potential of the test chemical in Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA by using preincubation method.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium toluene-4-sulphonate

EC Number:

211-522-5

EC Name:

Sodium toluene-4-sulphonate

Cas Number:

657-84-1

Molecular formula:

C7H8O3S.Na

IUPAC Name:

Sodium toluene-4-sulphonate

Details on test material:

- Name of test material (as cited in study report): sodium 4-methylbenzenesulfonate
- Molecular formula: C7H7NaO3S
- Molecular weight: 194.1853g/mol
- Substance type: Organic
- Purity : 92.7 %
- Name of test material (as cited in study report): sodium 4-methylbenzenesulfonate
- Molecular formula: C7H7NaO3S
- Molecular weight: 194.1853g/mol
- Substance type: Organic
- Purity : 92.7 %

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA.

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

not specified

Metabolic activation:

with and without

Metabolic activation system:

Rat liver, induced with phenobarbital and 5,6-benzoflavone

Test concentrations with justification for top dose:

0, 313, 625, 1250, 2500 and 5000 µg/plate(all strains) with and without metabolic activation.

Vehicle / solvent:

Distilled water.

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Distilled water

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: -S9 mix; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (TA100, TA98), Sodium azide(TA1535), 9-Aminoacridine (TA1537) and N-Ethyl-N'-nitro-N-nitrosoguanidine (WP2 uvrA) +S9 mix; 2-Aminoanthracene(all strains)

Details on test system and experimental conditions:

METHOD OF APPLICATION: Pre-incubation method

NUMBER OF REPLICATIONS: 2
Other:
Plates/test : 3

Rationale for test conditions:

Not specified

Evaluation criteria:

Not specified

Statistics:

Not specified

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

Not specified

Remarks on result:

other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:

The test chemical was observed for its mutagenic potential in Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA. The test result was considered to be negative in the presence and absence of metabolic activation.

Executive summary:

Gene toxicity in vitro study for the test chemical was assessed for its possible mutagenic effect. For this purpose AMES test was performed according to guideline 471 by the preincubation method, using test substance concentration of 0, 313, 625, 1250, 2500 and 5000 µg/plate and Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA both in the presence and absence of metabolic activation. No mutagenic effects were observed for the test substance. Therefore the test chemical was considered to be non mutagenic with and without metabolic activation. Hence the test substance cannot be classified as gene mutant in vitro.