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Toxicological information

Genetic toxicity: in vitro

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
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 resultsopen allclose all
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
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
Remarks:
Migrated from field 'Test system'.

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:
Interpretation of results (migrated information):
negative

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.