2-{(E)-[6-({4-chloro-6-[(4-{[2-(sulfooxy)ethyl]sulfonyl}phenyl)amino]-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonaphthalen-2-yl]diazenyl}naphthalene-1,5-disulfonic acid

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene toxicity in-vitro:

The test result was considered to be negative in the presence and absence of metabolic activation for the test substance .Hence the substance cannot be classified as genetox in vitro

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Experimental data of structurally similar chemicals

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

WoE report is based on two in vitro gene toxicity studies
1.To evaluate the mutagenic potential of test chemical in Salmonella typhimurium TA98, TA100, TA1535, TA1537, and TA1538.
2. To evaluate the mutagenic potential of test chemical in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 by Salmonella microsome assay.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Target gene:

1.& 2. Histidine

Species / strain / cell type:

S. typhimurium, other: TA98, TA100, TA1535, TA1537, and TA1538.

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium, other: strains TA1535, TA100, TA1537, TA1538 and TA98 bacteria

Remarks:

2

Details on mammalian cell type (if applicable):

Not applicable.

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

not specified

Metabolic activation:

with and without

Metabolic activation system:

Liver S9 homogenate was prepared from male Sprague-Dawley rats and Syrian golden hamsters that had been injected with Aroclor 1254 at 500 mg/kg body weight.

Test concentrations with justification for top dose:

1.of 10-10000 µg /plate
2. 0,50,100and 500μg/plate

Vehicle / solvent:

1. - Vehicle(s)/solvent(s) used: Not specified
2. - Vehicle(s)/solvent(s) used: DMSO

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

not specified

Untreated negative controls:

yes

Remarks:

Historical value provided for comparison.

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: Ethylmethanesulfonate Methylmethanesulfonate 9-Aminoacridine Anthragallol 2-Anthramine

Remarks:

2

Details on test system and experimental conditions:

1. METHOD OF APPLICATION: Plate incorporation method
2. METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period:
- Exposure duration: 3 days

Rationale for test conditions:

Not specified.

Evaluation criteria:

1. A positive result in the Ames test, which is defined as a reproducible, dose-related, at least twofold increase in the number of revertants over background was not observed with any of the azo dyes or their metabolites either before or after incubation with S-9.
2. Number of HIS + Revertants/plate were observed for test substance and compared with positive and negative control.

Statistics:

1. Standard deviation was observed.
2.Rounded mean _+ standard deviation was observed.

Species / strain:

S. typhimurium, other: TA98, TA100, TA1535, TA1537, and TA1538.

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Species / strain:

S. typhimurium, other: strains TA1535, TA100, TA1537, TA1538 and TA98 bacteria

Remarks:

2.

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

2. COMPARISON WITH HISTORICAL CONTROL DATA: Historical Negative control values were compared with the test substance value.

Remarks on result:

other: No mutagenic effect were observed

Conclusions:

The test result was considered to be negative in the presence and absence of metabolic activation for test substance.

Executive summary:

Data available for the target chemical was reviewed to determine the mutagenic nature of the test chemical .The studies are as mentioned below:

The mutagenic potency of test chemicalwas tested by the plate incorporation method usingSalmonella typhimuriumstrainTA98, TA100, TA1535, TA1537, and TA1538. When the test bacterial strain is exposed with the test chemical for 48hrs, no mutagenic response was seen in any of the strains of Salmonella typhimurium(with and without metabolic activation system).Therefore the test substance was considered to be not classified for gene mutation.

Test chemical was assessed for its possible mutagenic potential. For this purpose bacterial reverse mutation assay was performed on Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98. The test material was exposed at the concentration of 0, 50,100and 500µg/plate in the presence and absence of S9 mix. Number of HIS + Revertants/plate was observed for test substance and compared with positive and negative control. No mutagenic effect were observed in any of the strain, both in the presence and absence of S9.Therefore, test chemical was considered to be non mutagenic in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 by bacterial reverse mutation assay. Hence the substance cannot be classified as gene mutant in vitro.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Gene toxicity in-vitro:

Gene mutation in vitro:

Data available for the target chemical was reviewed to determine the mutagenic nature of the test chemical .The studies are as mentioned below:

Ames test:

The mutagenic potency of test chemicalwas tested by the plate incorporation method usingSalmonella typhimuriumstrainTA98, TA100, TA1535, TA1537, and TA1538. When the test bacterial strain is exposed with the test chemical for 48hrs, no mutagenic response was seen in any of the strains of Salmonella typhimurium(with and without metabolic activation system).Therefore the test substance was considered to be not classified for gene mutation.

Test chemical was assessed for its possible mutagenic potential. For this purpose bacterial reverse mutation assay was performed on Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98. The test material was exposed at the concentration of 0, 50,100and 500µg/plate in the presence and absence of S9 mix. Number of HIS + Revertants/plate was observed for test substance and compared with positive and negative control. No mutagenic effect were observed in any of the strain, both in the presence and absence of S9.Therefore, test chemical was considered to be non mutagenic in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 by bacterial reverse mutation assay. Hence the substance cannot be classified as gene mutant in vitro.

Based on the data available from the test chemical does not exhibit gene toxicity in in the presence and absence of metabolic activation.. Hence the substance cannot be classified as genetox in vitro.

Justification for classification or non-classification

Based on the data available from the test chemical and CLP criteria test chemical does not exhibit gene toxicity in in the presence and absence of metabolic activation.. Hence the substance cannot be classified as genetox in vitro.