Dinonylnaphthalenedisulphonic acid

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test substance was tested in a plate incorporation and pre-incubation assay in Salmonella typhimurium strains TA100, TA102, TA97a, TA 98 and TA 1535 in presence and absence of metabolic activation. No mutagenic effects were seen in both 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.

Link to relevant study records

Reference

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:

10-02-2014 to 20-02-2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study according to the guideline under GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

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

Target gene:

Histidine

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 (Trinova Biochem. Gießen (Batch no. 3198)

Test concentrations with justification for top dose:

exp 1: 0.050, 0.150, 0.500 and 5.000 mg/plate.
exp 2 : 0.313, 0.625, 1.250, 2.500 and 5.000 mg/plate

Vehicle / solvent:

- Vehicle used: DMSO
- Justification for choice of solvent/vehicle: the test substance was sufficiently soluble. The background lawn was visible and the number of revertant colonies was not reduced.

Untreated negative controls:

yes

Remarks:

DMSO (positive control solvent)

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

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:

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 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 1.0E09 to 5.0E09 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

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:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

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 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 both 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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Next to the Ames test with the substance, a chromosome aberration study and a mouse lymphoma assay are available with the salt of the structural analogue DNNSA. In view of the structural similarities between the substance and its analogue and the similar results in the Ames test (both negative with and without metabolic activation), it can be concluded that the substance is not expected to exhibit mutagenic or clastogenic effects.

Justification for selection of genetic toxicity endpoint
Guideline study under GLP

Justification for classification or non-classification

Based on the outcome of studies with the substance and the salt of its analogue, it is concluded that the substance is not mutagenic. No classification according to CLP (Regulation EC No 1272/2008) is considered necessary.