Sodium naphthalene-2-sulphonate

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)

Data source

Reference

Reference Type:

publication

Title:

Final Report on the Amended Safety Assessment of Sodium Polynaphthalene sulfonate and Sodium Naphthalenesulfonate

Author:

Cosmetic Ingredient Review Expert Panel

Year:

2003

Bibliographic source:

International Journal of Toxicology, 22(Suppl. 2):37–44, 2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

To evaluate the genetic toxicity of Sodium 2-naphthalenesulfonate in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 by Ames assay.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium naphthalene-2-sulphonate

EC Number:

208-523-8

EC Name:

Sodium naphthalene-2-sulphonate

Cas Number:

532-02-5

Molecular formula:

C10H8O3S.Na

IUPAC Name:

sodium naphthalene-2-sulphonate

Constituent 2

Reference substance name:

Sodium 2-naphthalenesulfonate

IUPAC Name:

Sodium 2-naphthalenesulfonate

Details on test material:

- Name of test material (as cited in study report): sodium 2-naphthalenesulfonate
- Molecular formula (if other than submission substance): C10H8O3S.Na
- Molecular weight (if other than submission substance): 230.23 g/mol
- Substance type: Organic
- Physical state: No data available.
Purity
- Impurities (identity and concentrations): Not more than 0.5% sulfate (as sodium sulfate); not more than 20 mg/kg of heavy metals; and not more than 2 mg/kg arsenic.

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, and TA 1538

Details on mammalian cell type (if applicable):

Not applicable.

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 liver homogenate metabolic activation

Test concentrations with justification for top dose:

50, 150, 500, 1500, and 5000 μg/plate

Vehicle / solvent:

No data available

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

other: 4-nitro-o-phenylenediamine

Remarks:

N-ethyl-N-nitro-Nnitroguanidine - TA100 and TA1535; 9-aminoacridine TA1537; 4-nitro-o-phenylenediamine for TA1538, 4- nitroquinoline-1-oxide for TA98.

Details on test system and experimental conditions:

No data available

Evaluation criteria:

If there were increase in the mutation frequency in any of the strains tested at any of the concentrations tested.

Statistics:

No data available

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, and TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

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

In a gene toxicity test , Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 were exposed to Sodium 2-naphthalenesulfonate by Ames assay. The result was found to be negative with without addition of S9 liver homogenate metabolic activation

Executive summary:

Gene toxicity test was observed for Sodium 2-naphthalenesulfonate in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 at concentration 50, 150, 500, 1500, and 5000 μg/plate by Ames assay. SNS was not toxic to any of the strains tested at any of the concentrations tested. Sodium 2-naphthalenesulfonate produced no significant increase in the mutation frequency in any of the strains tested at any of the concentrations tested. All of the positive controls produced marked increases in the mutation frequency, and the S9 liver homogenate metabolic activation was confirmed active with the additional positive control. The authors concluded that Sodium 2-naphthalenesulfonate is not mutagenic under the conditions of the test.