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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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.