Octasodium 2,2'-[(2,2'-disulphonato[1,1'-biphenyl]-4,4'-diyl)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino(1-hydroxy-3-sulphonatonaphthalene-6,2-diyl)azo]]bisnaphthalene-1,5-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:

Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Ames Testing of Direct Black 38 Parallels Carcinogenicity Testing

Author:

Arthur R. Gregory, John Elliott and Paul Kluge

Year:

1981

Bibliographic source:

Journal of Applied Toxicology, Vol. 1, No. 6, 1981, 308-313

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Ames assay was performed for Acid red 97 to evaluate its mutagenic nature

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4,4'-bis(2-hydroxynaphthalen-1-ylazo)biphenyl-2,6'-disulphonate

Cas Number:

10169-02-5

Molecular formula:

C32H20N4O8S2.2Na

IUPAC Name:

Disodium 4,4'-bis(2-hydroxynaphthalen-1-ylazo)biphenyl-2,6'-disulphonate

Details on test material:

- Name of test material: Acid red 97
- IUPAC name: Disodium 4,4'-bis(2-hydroxynaphthalen-1-ylazo)biphenyl-2,6'-disulphonate
- Molecular formula: C32H20N4O8S2.2Na
- Molecular weight: 698.642 g/mol
- Substance type: Organic

Specific details on test material used for the study:

- Name of test material: Acid red 97
- IUPAC name: Disodium 4,4'-bis(2-hydroxynaphthalen-1-ylazo)biphenyl-2,6'-disulphonate
- Molecular formula: C32H20N4O8S2.2Na
- Molecular weight: 698.642 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: TA98 and TA100

Details on mammalian cell type (if applicable):

Not appliicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

S-9 fractions from Arochlor 1254-induced rats were prepared

Test concentrations with justification for top dose:

No data

Vehicle / solvent:

No data

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Positive control substance:

not specified

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: No data
- Exposure duration: 72 hrs
- Expression time (cells in growth medium): 72 hrs
- 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): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

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 response was considered positive if the reversion rate was twice (or more) the reversion rate in simultaneously run controls.

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98 and TA100

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 potential

Applicant's summary and conclusion

Conclusions:

Acid red 97 did not induce gene mutation in the Salmonella typhimurium strain TA100 and TA98 both in the presence and absence of S9 metabolic activation system and hence the chemical is not likely to classify as a gene mutant in vitro.

Executive summary:

Gene mutation toxicity study was performed for Acid red 97 to evaluate its mutagenic nature. The study was performed as per the standard plate incorporation protocol using Salmonella typhimurium strain TA100 and TA98 both in the presence and absence of S9 metabolic activation system. The plates were incubated for 72 hrs before the evaluation of the revertant colonies could be made. Acid red 97 did notinduce gene mutation in the Salmonella typhimurium strain TA100 and TA98 both in the presence and absence of S9 metabolic activation system and hence the chemical is not likely to classify as a gene mutant in vitro.