Cuprate(3-), [3-[2-[5-(hydroxy-.kappa.O)-4-[2-[1-(hydroxy-.kappa.O)-6-(phenylamino)-3-sulfo-2-naphthalenyl]diazenyl-.kappa.N1]-2-methylphenyl]diazenyl]-1,5-naphthalenedisulfonato(5-)]-, sodium (1:3)

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:

key study

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Analogue substance tested.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Analogue substance (refer to IUCLID chapter 13)

IUPAC Name:

Analogue substance (refer to IUCLID chapter 13)

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Test concentrations with justification for top dose:

1.58, 5, 15.8, 50, 158, 500, 1580, 5000 micrograms per plate (mcg/pl.)

Vehicle / solvent:

Bidistilled water

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

bidistilled water

Controls 2

Positive controls:

yes

Remarks:

not requiring microsomal drug-metabolizing enzyme

Positive control substance:

methylmethanesulfonate

Remarks:

500 mcg/pl. for TA 100

Controls 3

Positive controls:

yes

Remarks:

not requiring microsomal drug-metabolizing enzyme

Positive control substance:

9-aminoacridine

Remarks:

40 mcg/pl. for TA 1537

Controls 4

Positive controls:

yes

Remarks:

not requiring microsomal drug-metabolizing enzyme

Positive control substance:

2-nitrofluorene

Remarks:

5 mcg/pl. for TA 98, TA 100, TA 1537, TA 1538

Controls 5

Positive controls:

yes

Remarks:

not requiring microsomal drug-metabolizing enzyme

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

10 mcg/pl. for TA 98, TA 100, TA 1535

Controls 6

Positive controls:

yes

Remarks:

requiring microsomal drug-metabolizing enzyme

Positive control substance:

other: 2-aminoanthracene

Remarks:

0.5 mcg/pl. for TA 98, TA 100, TA 1538; 1 mcg/pl. for TA 1535; 10 mcg/pl. for TA 1537

Controls 7

Positive controls:

yes

Remarks:

requiring microsomal drug-metabolizing enzyme

Positive control substance:

benzo(a)pyrene

Remarks:

5 mcg/pl. for TA 98, TA 100, TA 1537, TA 1538

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 3

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 4

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

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 metabolic activation
negative without metabolic activation

The test was performed with the analogue substance. In conclusion, it can be stated that the analogue substance induced no point mutations by base-pair changes or frameshifts in the genome of the strains used. Therefore the analogue substance is not considered to be mutagenic in this Salmonella typhimurium reverse mutation assay. Due to the structural similarity of the analogue substance and the substance subject of registration, the substance subject of registration is expected to show a comparable behaviour.