Disodium 4-hydroxynaphthalene-2,7-disulphonate

Genetic toxicity: in vitro

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:

Datais from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity Testing of Some Commonly Used Dyes

Author:

King-Thom Chung, T George E. Fulk, And A. W. Andrews

Year:

1981

Bibliographic source:

Applied And Environmental Microbiology, Oct. 1981, P. 641-648 Vol. 42, No. 4

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Gene mutation toxicity study was performed to determine the mutagenic nature of R salt by the plate incorporation assay

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 3-hydroxynaphthalene-2,7-disulphonate

EC Number:

205-196-3

EC Name:

Disodium 3-hydroxynaphthalene-2,7-disulphonate

Cas Number:

135-51-3

Molecular formula:

C10H8O7S2.2Na

IUPAC Name:

disodium 3-hydroxynaphthalene-2,7-disulfonate

Details on test material:

- Name of test material: disodium 3-hydroxynaphthalene-2,7-disulfonate
- Molecular formula: C10H6O7S2.2Na
- Molecular weight: 348.262 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data

Specific details on test material used for the study:

- Name of test material: R salt
- IUPAC name: disodium 3-hydroxynaphthalene-2,7-disulfonate
- Molecular formula: C10H6O7S2.2Na
- Molecular weight: 348.262 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA1535, TA1537, TA1538, TA98, and TA100

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:

Liver homogenates (S9) were prepared from male Sprague-Dawley rats stimulated with Aroclor 1254

Test concentrations with justification for top dose:

Maximum nontoxic dose tested was 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The chemical was soluble in DMSO

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: No data
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):

NUMBER OF REPLICATIONS: Duplicate

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data

OTHER: No data

Rationale for test conditions:

No data

Evaluation criteria:

A compound was considered mutagenic when the number of revertants above background was at least twice the value of the historical control mean or twice the value of the current control mean, whichever was greater

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA1535, TA1537, TA1538, TA98, and TA100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated 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:

R salt did not induce gene mutation in Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98, and TA100 in the presence and absence of S9 metabolic activation system and hence it 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 R salt. The study was performed by the standard plate incorporation assay usingSalmonella typhimurium strainsTA1535, TA1537, TA1538, TA98, and TA100 with and without S9 metabolic activation system. The test chemical was dissolved in DMSO and upto a maximum nontoxic dose of 5000 µg/plate. Concurrent solvent and positive controls were also included in the study.R salt did not induce gene mutation in Salmonella typhimurium strainsTA1535, TA1537, TA1538, TA98, and TA100 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.