sodium 5-(4-amino-6-(4-((E)-4-(4-(bis(2-hydroxyethyl)amino)-6-(8-hydroxy-7-((E)-phenyldiazenyl)-3,6-disulfonatonaphthalen-1-ylamino)-1,3,5-triazin-2-ylamino)-2-sulfonatostyryl)-3-sulfonatophenylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-3-((E)-phenyldiazenyl)naphthalene-2,7-disulfonate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1994-01-06 and 1994-04-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1983

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Version / remarks:

1992

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Direct Red 227:1 – Similar Substance 01

IUPAC Name:

Direct Red 227:1 – Similar Substance 01

Test material form:

not specified

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

post mitochondrial supernatant (S9 fraction) induced by Aroclor 1254

Test concentrations with justification for top dose:

61.73, 185.19, 555.56, 1666.67, 5000.00 µg/plate

Vehicle / solvent:

distilled water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO and bidistilled water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: with S9: 2-aminoanthracene (TA 100, TA 102, TA 98, TA 1537), cyclophosphamide (TA 1535); without S9: sodium azide (TA 100, TA 1535), mitomycin-C (TA 102), 2-nitrofluorene ( TA 98), 9-aminoacridine (TA 1537)

Remarks:

with metabolic activation:

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 hours

DETERMINATION OF CYTOTOXICITY
- Method: counting the colonies
The test was run 2 times to confirm the results.

Evaluation criteria:

At least a reproducible meaningful increase of the mean number of revertants per plate above that of the negative control at any concentration for one or more of the strains tested. A concentration-related effect should be demonstrable.

Statistics:

not required

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES: strain TA 100 (six concentrations ranging from 20.6 to 5000.0 µg/plate), with and without metabolic activation, normal background growth was observed, the numbers of revertant colonies were reduced at the upper concentrations

COMPARISON WITH HISTORICAL CONTROL DATA: yes

ADDITIONAL INFORMATION ON CYTOTOXICITY: The numbers of revertant colonies were reduced at the upper concentrations. The test substance thus exerted a slight inhibitory effect on the growth of the bacteria.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Not mutagenic

Executive summary:

The substances has been tested for its mutagenic effects according to the procedure described in the OECD guideline 471.

Under test condition the substance didn't show mutagenic effects.