Sodium cumenesulphonate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium cumenesulphonate

EC Number:

248-983-7

EC Name:

Sodium cumenesulphonate

Cas Number:

28348-53-0

Molecular formula:

C9H12O3S.Na

IUPAC Name:

sodium cumenesulphonate

Test material form:

solid

Specific details on test material used for the study:

CAS Number: 28348-53-0
Identity: Cumene sulfonic acid, sodium salt; Na cumene sulfonate
Purity: 40% active ingredient
Remarks: Substances tested are aqueous solutions; % purity equates to chemical content

Method

Target gene:

Histidine independent mutant colonies of Salmonella typhimurium

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

- Species and cell type: Rat (Sprague Dawley strain), male, liver - Quantity: 5 % S9 mix induced with Aroclor 1254

Test concentrations with justification for top dose:

3.2, 16, 80, 400 and 2000 μg active ingredient

Vehicle / solvent:

vehicle (water), all strains.

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: Positive controls (no metabolic activation):sodium-azide for TA 1535 and TA 100. 4-nitro-o-phenylenediamine for TA 1537, TA 1538 and TA 98. Positive control (with metabolic activation): 2-aminoanthracene, all strains

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Preincubation period: no data
- Exposure duration: 2 days
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):


SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):


NUMBER OF REPLICATIONS: triplicates and entire trial repeated once


NUMBER OF CELLS EVALUATED: histidine independent colonies


DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:


OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:

Evaluation criteria:

The assay was considered valid if the number of spontaneous revertant colonies in vehicle control plates falls within the normal range and the positive control chemicals induce significant increases in the number of mutagen-induced revertant colonies compared to vehicle control. It was judged to be positive if there was a concentration-related increase over the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without the metabolic system. In addition, it was judged to have a toxic effect (antibacterial effect) when a clearing or diminution of background lawn, the appearance of micro-colonies, and/or thedecrease more than 50% in the number of colonies compared to that of vehicle control was observed.

Results and discussion

Test results

Species / strain:

other: Salmonella typihimurium TA 1535; TA 100; TA 1537; TA 1538; TA98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:

Interpretation of results :negative

In the presence and absence of metabolic system, no mutation in the Salmonella typhimurium (strains TA 98, TA 100, TA 1535 and TA 1537) occurred with sodium cumenesulphonate