7-anilino-4-hydroxynaphthalene-2-sulphonic acid

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity Testing of Some Drug and Cosmetic Dye Lakes with the Salmonella-Mammalian Microsome Assay

Author:

J.P. Brown, P.S. Dietrich and C.M. Bakner

Year:

1979

Bibliographic source:

Mutation Research, 66 (1979) 181-185

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Salmonella/mammalian microsome assay was performed to evaluate the mutagenic nature of the test compound C.I. Pigment Red 49.

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate

EC Number:

214-998-2

EC Name:

Sodium 2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate

Cas Number:

1248-18-6

IUPAC Name:

sodium 2-[(2-hydroxy-1-naphthyl)diazenyl]naphthalene-1-sulfonate

Constituent 2

Reference substance name:

C.I. Pigment Red 49

IUPAC Name:

C.I. Pigment Red 49

Details on test material:

- Name of test material (as cited in study report): D and C Red No. 10- Molecular formula (if other than submission substance): C20H13N2O4S.Na- Molecular weight (if other than submission substance): 400.389g/mol- Substance type: Organic- Physical state: No data available- Purity: 73 %- Impurities (identity and concentrations): No data available

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 metabolic activation system

Test concentrations with justification for top dose:

0, 50, 100, 500 or 1000 µg/plate

Vehicle / solvent:

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

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

ethylmethanesulphonate

methylmethanesulfonate

other: Anthragallol, 2-Anthramine

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)DURATION- Preincubation period: No data available - Exposure duration: 72 hrs (3 days)- Expression time (cells in growth medium): 72 hrs (3 days)- 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 availableSELECTION AGENT (mutation assays): No data availableSPINDLE INHIBITOR (cytogenetic assays): No data availableSTAIN (for cytogenetic assays): No data availableNUMBER OF REPLICATIONS: No data availableNUMBER OF CELLS EVALUATED: No data availableDETERMINATION OF CYTOTOXICITY- Method: mitotic index; cloning efficiency; relative total growth; other: No data availableOTHER EXAMINATIONS:- Determination of polyploidy: No data available- Determination of endoreplication: No data available- Other: No data availableOTHER: No data available

Evaluation criteria:

Increase in the number of His+ revertants/plate

Statistics:

No data available

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

No data available

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):negative with and withoutThe test compound D and C Red No. 10 failed to show any mutagenic activity in the Salmonella typhimurium tester strains and hence is not likely to classify as a gene mutant in vitro.

Executive summary:

Salmonella/mammalian microsome assay was performed to evaluate the mutagenic nature of the test compound D and C Red No. 10.

 

The dye was dissolved in dimethylsulfoxide and up to 0.2 ml was introduced into 2.5 ml of the tempered top agar together with 0.1 ml Salmonella typhimurium broth suspension and 0.25 ml Aroclor 1254 induced rat liver S9. The mixtures was plated on 20 ml of Vogel-Bonner E bottom agar in the usual fashion and incubated for 3 days at 35°. Each agent was tested with all 5 basic tester strains (TA1535, TA100, TA1537, TA1538, TA98) with and without microsomal activation at concentrations of 0, 50, 100, 500 or 1000 µg/plate.

 

The test compound D and C Red No. 10 failed to show any mutagenic activity in the Salmonella typhimurium tester strains with and without S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.