Reaction mass of tetrasodium [mono(4,4'-(1Z,1'Z)-(4,4'-dioxidobiphenyl-3,3'-diyl)bis(diazene-2,1-diyl)bis(5-amino-3-oxidonaphthalene-2,7-disulfonate(3-)) cuprate (4-)] and tetraammonium [mono(4,4'-(1Z,1'Z)-(4,4'-dioxidobiphenyl-3,3'-diyl)bis(diazene-2,1-diyl)bis(5-amino-3-oxidonaphthalene-2,7-disulfonate(3-)) cuprate (4-)]

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

other: read across from analogue substance

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

B13 and B14 (Ames test, Prival modification)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Direct Blue 267

IUPAC Name:

Direct Blue 267

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation system:

S9-Mix from rat Aroclor induced

Test concentrations with justification for top dose:

Concentration range in the main test (with and without metabolic activation): 10....5000 ug/plate

Vehicle / solvent:

solvent: distilled water

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:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

5000

Test results 2

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

> 1000 ug/plate

Cytotoxicity / choice of top concentrations:

cytotoxicity

Additional information on results:

Toxic concentrations in the main testwith metabolic activation: TA89 1000-5000 ug/platewithout metabolic activatio TA 1535 at 5000 ug/plateTA 1537 1000-5000 ug/plate

Remarks on result:

other: other: preliminary test

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):negative with metabolic activationnegative without metabolic activationThe substance was tested for gene mutation following OECD 471. Under the experiemental condition no gene mutation potential was observed.

Executive summary:

The substance was tested for gene mutation following OECD 471. Strains of S. Typhimurium TA1535, TA1537, TA98; TA100 were tested at different concentrations ranging from 10 to 5000 ug/plate with and without S9 mix from rat liver. Citotoxicity was observed from 1000 ug/plate while with and without S9 mix no genotixicity was observed.