2-amino-5-hydroxynaphthalene-1,7-disulphonic acid

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:

Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Testing Of Some Azo Dyes and Their Reduction Products for Mutagenicity Using Salmonella typhimurium Ta 1538

Author:

R. Colin Garner and Carol A. Nutman

Year:

1977

Bibliographic source:

Mutation Research, 44 (1977) 9-19

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 2-Amino 1, 5 naphthalene disulfonic acid

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-aminonaphthalene-1,5-disulphonic acid

EC Number:

204-201-6

EC Name:

2-aminonaphthalene-1,5-disulphonic acid

Cas Number:

117-62-4

Molecular formula:

C10H9NO6S2

IUPAC Name:

2-aminonaphthalene-1,5-disulfonic acid

Details on test material:

SMILES:Nc1ccc2c(S(O)(=O)=O)cccc2c1S(O)(=O)=O

Specific details on test material used for the study:

- Name of test material: 2-Amino 1, 5naphthalene disulfonic acid
- Molecular formula: C10H9NO6S2
- Molecular weight: 303.31 g /mol
- Substance type: Organic
- Physical state: No data
- Purity: No data available
- Impurities (identity and concentrations):

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium 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:

fresh liver post-mitochondrial supernatant fraction from a male phenobarbitone pre-treated rat

Test concentrations with justification for top dose:

0, 50 or 100 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data available

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

2-acetylaminofluorene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period:
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: 2

NUMBER OF CELLS EVALUATED: No data available

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

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

OTHER: No data available

Rationale for test conditions:

No data

Evaluation criteria:

Numbers of revertants on test plates greater than 30 are classified as being significantly mutagenic

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium 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

Additional information on results:

No data

Remarks on result:

other: No mutagenic effect were observed

Any other information on results incl. tables

Table: Mutagenic activity of the test compound

Concentration	Liver enzyme	His+ revertants/plate
50	+	22
	-	25
100	+	12
	-	21

Applicant's summary and conclusion

Conclusions:

2-Amino 1, 5 naphthalene disulfonic acid (117-62-4)did not induce gene mutation in Salmonella typhimurium strain TA1538 and hence the chemical 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 2-Amino 1, 5 naphthalene disulfonic acid. The study was performed using Salmonella typhimurium strain TA1538 in th presence and absence of S9 metabolic activation system. The test chemical was dissolved in DMSO and used at dose levels of 0, 50 or 100 µg/plate. The plates were incubated for 48 hrs. Concurrent solvent and positive control chemicals were included in the study. All assays were performed in duplicate and the numbers of revertants on test plates greater than 30 was classified as being significantly mutagenic. 2-Amino 1, 5 naphthalene disulfonic acid did not induce gene mutation in Salmonella typhimurium strain TA1538 and hence the chemical is not likely to classify as a gene mutant in vitro.