Toluene-4-sulphonic acid

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Since the test was conducted, significant changes have been made to OECD TG guideline 471 so that additionally testing with S. typhimurium TA102 or E. coli WP2 uvrA or E. coli WP2 uvrA (pKM101) is now required.
Additionally the study lacks for the strains TA100, TA1535 and TA 1537 the metabolic activation for the positive controls.

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:

yes

Remarks:

no positive controls were used for TA100, TA1535 and TA1537 with metabolic activation. However the number of revertants is very low. Also the number of cells per culture was not specified.

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

p-toluenesulfonic acid

IUPAC Name:

p-toluenesulfonic acid

Constituent 2

Reference substance name:

Toluene-4-sulphonic acid

EC Number:

203-180-0

EC Name:

Toluene-4-sulphonic acid

Cas Number:

104-15-4

Molecular formula:

C7H8O3S

IUPAC Name:

4-methylbenzene-1-sulfonic acid

Method

Target gene:

Histidine independent mutant colonies of Salmonella typhimurium

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Additional strain / cell type characteristics:

other: histidine deficient

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 rat liver S9-mix

Test concentrations with justification for top dose:

10, 100, 500, 1000 and 5000 micrograms/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

no

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: 2-aminofluorene with S9 for TA1538 and TA98

Remarks:

no positive controls were used used for TA100, TA1535 and TA1537 with metabolic activatiion

Details on test system and experimental conditions:

The study is performed by the direct plate incorporation method with and without metabolic activation. Triplicates plates were used.

Evaluation criteria:

A mutagenic effect is significant when, at least in one strain, the number of revertants histidine+ is twice higher than that found in the control

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

not examined

Test results 3

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

not examined

Test results 4

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

not examined

Test results 5

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 6

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 7

Species / strain:

S. typhimurium TA 100

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 8

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

not examined

Additional information on results:

Precipitation concentration was > 5000 micrograms per plate

Applicant's summary and conclusion

Conclusions:

Not mutagenic in bacteria

Executive summary:

The mutagenicity potential in bacteria of Toluene 4-sulphonic acid was assessed following official guideline OECD 471, Bacterial Reverse Mutation Test. The test item does not induce reverse mutation in Salmonella typhimurium in the absence or presence of S9 metabolism, for all the tested strains (TA98, TA100, TA 1535, TA1537 and TA1538) under the reported experimental conditions.