Cuprate(4-), [2-[[4-chloro-6-[ethyl[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-5-(hydroxy-.kappa.O)-6-[2-[2-[2-[2-(hydroxy-.kappa.O)-5-sulfophenyl]diazenyl-.kappa.N1]-4,5-dimethoxyphenyl]diazenyl-.kappa.N1]-1,7-naphthalenedisulfonato(6-)]-, sodium hydrogen (1:2:2)

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:

2012

Report date:

2012

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:

Cuprate(4-), [2-[[4-chloro-6-[ethyl[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-5-(hydroxy-kO)-6-[2-[2-[2-[2-(hydroxy-kO)-5-sulfophenyl]diazenyl-kN1]-4,5-dimethoxyphenyl]diazenyl-kN2]-1,7-naphthalenedisulfonato(6-)]-, hydrogen sodium (1:2:2)

EC Number:

700-941-3

Cas Number:

1512859-54-9

Molecular formula:

C37H28ClCuN9O19S5 . 2 Na . 2 H

IUPAC Name:

Cuprate(4-), [2-[[4-chloro-6-[ethyl[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-5-(hydroxy-kO)-6-[2-[2-[2-[2-(hydroxy-kO)-5-sulfophenyl]diazenyl-kN1]-4,5-dimethoxyphenyl]diazenyl-kN2]-1,7-naphthalenedisulfonato(6-)]-, hydrogen sodium (1:2:2)

Method

Species / strain

Species / strain / cell type:

bacteria, other: Salmonella typhimurium :TA98, TA100, TA102, TA1535 and TA1537

Metabolic activation system:

The post-mitochondrial fraction (S9) prepared from Aroclor 1254-induced Sprague-Dawley rats was purchased from MOLTOX, Molecular Toxicology Incorporated, USA (lot no. 2843, 38.9mg protein/mL and expiration date Oct. 13, 2013)

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 50, 150, 500, 1500 and 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50, 150, 500, 1500 and 5000 µg/plate

Vehicle / solvent:

Solvent: DMSO

Controls

Untreated negative controls:

yes

Remarks:

sterile deionized water

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

mitomycin C

other: Acridine mutagen ICR 191, 2-Aminofluorene, 2-Aminoanthracene

Results and discussion

Test results

Test results 1

Species / strain:

other: as specified above

Metabolic activation:

with

Genotoxicity:

not specified

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(> 5000 µg/plate)

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

other: as specified above

Metabolic activation:

without

Genotoxicity:

not specified

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(> 5000 µg/plate)

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

In the mutagenicity test, the tester cultures were exposed to Everzol SB46 at doses of 50, 150, 500, 1500 and 5000 μg/plate.
In addition, the negative control (sterile deionized water) and strain-specific positive control for each strain, either in the presence or
absence of S9 metabolic activation were included. Results including the repeated test revealed that the mean colony numbers of negative controls of
five tester strains were within an acceptable range either in the presence or absence of S9 activation. The concurrent
strain-specific positive controls for TA1535 and TA1537 induced more than a three-fold increase in the number of revertants
over the negative control values, while positive controls for the rest of the three sreains, TA98,TA100 and TA102, induced
more than a two-fold increase. In addition, at least three analyzable doses were obtained in each tester strain. Therefore,
this study met the criteria for a valid test.
No cytotoxicity was resulted from Everzol SB46 treatment at doses up to 5000 μg/plate in TA98, TA100, TA102, TA1535 and TA1537
tester strains. No precipitation was observed from Everzol SB46 treatment at doses up to 5000 μg/plate in TA98, TA100, TA102,
TA1535 and TA1537 tester strains. In the Salmonella reverse gene mutation assay, there were no increases in the revertants
numbers at doses ranging from 50 to 5000 μg/plate of Everzol SB46 in all tester strains in the presence or absence of metabolic
activation when compared with the background spontaneous revertants.

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

It was concluded that under the test conditions, Everzol SB46 did not induce reverse mutation in five tester strains of Salmonella typhimurium either in the presence or absence of metabolic activation in vitro.