Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine

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

Study period:

24 June 1992 - 27 July 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed according to older guidelines (No strain susceptible to cross-linking mutagens included (e.g. TA 102))

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Version / remarks:

Test actually performed according to method B.14 (84/449/EEC) applicable at that time

Deviations:

no

Remarks:

; no deviation from the 1984 guideline

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine

EC Number:

939-464-2

Cas Number:

121617-08-1

Molecular formula:

C6 H15 N O3 . C6 H6 O3 S

IUPAC Name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Marlopon AT 50
- Substance type: technical product
- Physical state: yellow-brown liquid
- Composition of test material, percentage of components: 51.7% linear alkenylbenzene sulfonate triethanolamine, 3.1% triethanolamine sulfate, 43.8% water
- Lot/batch No.: 621
- CAS no.: 68411-31-4

Method

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:

S9 mix as produced by Aroclor rats

Test concentrations with justification for top dose:

Direct plate incorporation:
8.4, 43, 217, 1090, and 5430 µg Benzenesulfonic acid, C10-13-alkyl derivs., compds. with triethanolamine (CAS no. 68411-31-4)/plate (concentrations of test material Marlopon AT50: 15, 77, 387, 1934, and 9670 µg/plate)

Preincubation method:
68, 136, 272, 543, and 1090 µg Benzenesulfonic acid, C10-13-alkyl derivs., compds. with triethanolamine (CAS no. 68411-31-4)/plate (concentrations of test material Marlopon AT50: 121, 242, 484, 967 and 1934 µg/plate)

The active substance concentrations reported in this summary differ slightly from those in the study report. In the study report the AS was defined as one specific component of Benzenesulfonic acid, C10-13-alkyl derivs., compds. with triethanolamine (CAS no. 68411-31-4). In this summary the test concentrations were recalculated to include all substance components (which is MARLOPON AT 50 without the water fraction).

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Remarks:

Since water was used as vehicle the solvent control is in fact a true negative control

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: 2-aminoanthracene

Remarks:

2-aminoanthracene is used to test the metabolic system in TA 100 only

Details on test system and experimental conditions:

METHOD OF APPLICATION: direct plate incorporation and preincubation

DURATION
- Preincubation period: 30 minutes at 30 ± 1°C
- Exposure duration:96 hours (at 37°C)

SELECTION AGENT (mutation assays): histidine

NUMBER OF REPLICATIONS: 3

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

Evaluation criteria:

A test substance is considered positive (mutagenic) in the test if it induces a number of revertant colonies, dose related, greater than two-times the number of revertants induced by the solvent control in any of the tester strains, either with or without metabolic activation.

Statistics:

Mean values with standard deviations.

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

At 217 µg a.s. (CAS no. 68411-31-4)/plate and higher

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

At 217µg a.s. (CAS no. 68411-31-4)/plate and higher

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation at the tested concentrations

Remarks on result:

other: all strains/cell types tested

Any other information on results incl. tables

For detailed results see the attached background material:

Tables 1 -5 show the results for the main test using plate incorporation method for each test strain.

Tables 6 -10 show the results for the test using the preincubation method for each test strain.

The active substance concentrations reported in the Tables differ slightly from those reported in this summary. In the study report the AS was defined as one specific component of Benzenesulfonic acid, C10-13-alkyl derivs., compds. with triethanolamine (CAS no. 68411-31-4). In this summary the test concentrations were recalculated to include all substance components (which is MARLOPON AT 50 without the water fraction).

Applicant's summary and conclusion

Conclusions:

Benzenesulfonic acid, C10-13-alkyl derivs., compds. with triethanolamine (CAS no. 68411-31-4) is not mutagenic under the conditions tested.

Executive summary:

In a reverse gene mutation assay in bacteria, strains TA98, TA100, TA1535, TA1537 and TA1538 of S. typhimurium were exposed to Benzenesulfonic acid, C10-13-alkyl derivs., compds. with triethanolamine (CAS no. 68411-31-4) at concentrations of 0, 8.4, 43, 217, 1090, and 5430 µg/plate in the presence and absence of mammalian metabolic activation according to the direct plate incorporation method and 0, 68, 136, 272, 543, and 1090 µg/plate in the presence and absence of mammalian metabolic activation according to the preincubation method.

The test substance was tested up to cytotoxic concentrations. The positive control induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background. 2- Benzenesulfonic acid, C10-13-alkyl derivs., compds. with triethanolamine (CAS no. 68411-31-4) was judged to have no reverse mutagenic potential under the conditions tested.