2-Naphthalenesulfonic acid, 6-amino-5-[[4-[[4-chloro-6-[ethyl[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]azo]-4-hydroxy-, sodiumsalt

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

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Directive 2000/32/EC, B.13/14 OECD 471 (1997)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation system:

S9-mix (uninduced male Golden Syrian Hamster liver S9-mix

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 100 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 100 ... 5000 µg/plate

Vehicle / solvent:

Solvent: Dimethyl sulfoxide

Details on test system and experimental conditions:

Type of bacteria/strain: Salmonella typhimurium reverse mutation assay with four
histidine-requiring strains of Salmonella typhimurium
(TA1535, TA1537, TA100 and TA98) and in the Escherichia coli
reverse mutation assay with a tryptophan-requiring strain
of Escherichia coli WP2uvrA.

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:

not specified

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(> 5000 µg/plate)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

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

Metabolic activation:

without

Genotoxicity:

not specified

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(> 5000 µg/plate)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Observations:
The negative and strain-specific positive control values
were within our laboratory historical control data ranges
indicating that the test conditions were adequate and that
the metabolic activation system functioned properly.


In tester strain TA100, in the presence of S9-mix, the test
substance induced up to 1.9- and 2.1-fold dose-related
increases in the number of revertant colonies compared to
the solvent control in the dose range finding test and
second mutation assay, respectively. Since only in the
second experiment an increase of more than 2-fold was
observed and the highest number of revertants in both
experiments was within our historical control data range
these increases were not considered biologically relevant.
In the absence of S9-mix, TA100 did not induce a dose-
related, two-fold increase in the number of revertants.


In tester strains TA1535, TA1537, TA98 and WP2uvrA the test
substance did not induce a dose-related, two-fold increase
in the number of revertant colonies both in the absence and
presence of S9-metabolic activation. These results were
confirmed in an independently repeated experiment.

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 activation
negative without metabolic activation

The Everzol Red LF-B is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.