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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:
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

Constituent 1
Chemical structure
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
- 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 (135-51-3) 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.