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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 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:
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

Reference
Name:
Unnamed
Type:
Constituent
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:
S. typhimurium TA 1538
Details on mammalian cell lines (if applicable):
Not applicable
Additional strain 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:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data available
Controls
Negative controls:
not specified
Solvent controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
2-acetylaminofluorene
Details on test system and 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:
not specified
Vehicle controls valid:
yes
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: No mutagenic effect were observed
Additional information on results:
No data

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.