Naphthalenesulfonic acid, dinonyl-, sodium salt (1:1)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

21-01-2014 to 06-02-2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study according to the guideline under GLP. The deviation has not influenced the validity of the study ( 3 concentrations evaluated in the second experiment)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

in the second experiment only 3 concentrations were analysed. In view of the clear negative effect in the first experiment, this is considered sufficient as confirmation.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Lithium (di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate)

Molecular formula:

LiC26H39O3S to LiC30H47O3S

IUPAC Name:

Lithium (di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate)

Test material form:

other: solid

Details on test material:

Name (as cited in the report) Lithium (di C8-C10, branched, C9 rich, alkylnaphthalene sulphonic acid)
Storage Store tightly sealed original container in a cool, dry place away from any direct source of heat, light and moisture

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: LT2 TA 1535, TA 97a, TA 98, TA 100 and TA 102

Details on mammalian cell type (if applicable):

TA97a: hisD6610, uvrB, pKM 101, rfa
TA 98: hisD3052, uvrB, pKM 101, rfa
TA 100: hisG46, uvrB, pKM 101, rfa
TA102: hisG428, pKM 101, rfa
TA1535 : hisG46, uvrB, rfa.

Metabolic activation:

with and without

Metabolic activation system:

S9 produced from the livers of male Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight ip (rTinova Biochem. Gießen (Batch no. 3067)

Test concentrations with justification for top dose:

exp 1: 0.050, 0.150, 0.500, 1.500 and 5.000 mg/plate.
exp 2 (TA 100 and TA 102): 0.313, 0.625, 1.250, 2.500 and 5.000 mg/plate
exp 3 (TA97a, TA 98 and TA 1535): 0.313, 0.625, 1.250, 2.500 and 5.000 mg/plate

Vehicle / solvent:

- Vehicle used: ethanol
- Justification for choice of solvent/vehicle: the test substance was sufficiently soluble, and no effects on the viability of the bacteria or the number of spontaneous revertants are expected.

Controls

Untreated negative controls:

yes

Remarks:

DMSO (positive control solvent)

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

True negative controls:

yes

Remarks:

H2O

Positive controls:

yes

Remarks:

without metabolic activarion TA 97a, TA98 and TA102 : 4-Nitro-1,2-phenylene diamine; TA 1535 and TA 100 : Sodium azide ; with metabolic activation TA 97a, TA 100, TA 102 and TA 1535 : Aminoanthracene ; TA98: Benzo-a-pyrene

Positive control substance:

sodium azide

benzo(a)pyrene

other: 4-Nitro-1,2-phenylene diamine, aminoanthracene

Details on test system and experimental conditions:

Cell cultures: Salmonella typhimurium (all strains used) were obtained from TRINOVA BioChem

METHOD OF APPLICATION: in medium; exp 1 preincubation; exp 2 and 3 in agar (plate incorporation)

DURATION
- Preincubation period (exp 1): 20 min
- Exposure duration: 48 h at 37 °C

SELECTION AGENT (mutation assays): histidine

CELL COUNT: visually

NUMBER OF REPLICATIONS: 4 per strain and concentration

NUMBER OF CELLS: titre determined to be 1.5E09 to 3.6E09 cells/mL

Evaluation criteria:

positive when: significant, reproducible increase of revertant colonies per plate (increase factor >2) in at least one strain. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity .
biological relevance is taken into account first

Statistics:

none performed

Results and discussion

Test results

Species / strain:

S. typhimurium, other: LT2 TA 1535, TA 97a, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

exp 1: turbidity at 500, 1500 and 5000 ug/plate (no cytotoxicity): exp 2 and 3 cytotoxicity at 2500 and 5000 ug/plate (turbidity at 1250, 2500 and 5000 ug/[;ate)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

In the second and third experiment only 3 concentrations were analyzed. This has not affected the validity of the outcome of the study, as the absence of mutagenic effects in exp 1 were clearly confirmed by exp 2 and 3

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test substance did not induce mutations in 5 strains of Salmonella typhimurium both in presence and absence of metabolic activation

Executive summary:

The test substance was tested in a plate incorporation and a pre-incubation assay in Salmonella thypimurium strains TA100, TA102, TA97a, TA 98 and TA 1535 in presence and absence of metabolic activation. No mutagenic effects were seen in three experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants. Therefore the test substance is considered not mutagenic under the test conditions.