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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from publication.

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:
other: as below
Principles of method if other than guideline:
To evaluate the genetic toxicity of the given test chemical 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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
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

Target gene:
Histidine
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
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
S9 liver homogenate metabolic activation
Test concentrations with justification for top dose:
0, 50, 150, 500, 1500, and 5000 μg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: A vehicle control was used.
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 for TA1538
Details on test system and experimental conditions:
NUMBER OF REPLICATIONS:
- Number of cultures per concentration - triplicate
Rationale for test conditions:
No data
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

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
True negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
No data
Remarks on result:
other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:
The given test chemical did not induce mutation in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
Executive summary:

Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical by Ames assay in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538. Five dose levels (50, 150, 500, 1500, and 5000 μg/plate) were studied, in triplicate, with and without addition of S9 liver homogenate metabolic activation. Positive controls included N-ethyl-N-nitro-Nnitroguanidine for TA100 and TA1535; 9-aminoacridine for TA1537; 4-nitro-o-phenylenediamine for TA1538, and 4-nitroquinoline-1-oxide for TA98. A vehicle control was used, as well as a positive control with 2-aminoanthracene, which is mutagenic only with metabolic activation. The increase in the mutation frequency in any of the strains tested at any of the concentrations tested considered for the mutagenic potential of the test chemical. Test chemical was not toxic to any of the strains tested at any of the concentrations tested. It 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.

Therefore, the given test chemical did not induce mutation in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.