Bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Not Mutagenic

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In vitro Gene mutation study in bacteria  

An ames test is on going and is expercted to be negative.

 

In vitro cytogenicity study in mammalian cells – Chromosomal Aberration

[Huntsman Textile Effects GmbH; 1979] – FAT Q (Similar Substance 2)

The test item dissolved in culture medium (MEM), was assessed for its potential to induce structural chromosome aberrations in the V79 cell line of the Chinese hamster, according to the OECD Guideline 473. In the absence and the presence of S9 mix the highest possible test article concentrations were evaluated. Under the test conditions no influence of the test article on the pH value or osmolarity was observed.

Nevertheless, reduced cell numbers were observed in the absence of S9 mix after continuous treatment with 5.0 ug/ml. In the presence of S9 mix no clear toxicity was observed at the highest concentration.

Neither a significant nor a biologically relevant increase in the number of cells carrying structural chromosomal aberrations was observed after treatment with the test article.

No relevant increase in the frequencies of polyploid metaphases was found after treatment with the test article as compared to the frequencies of the control.

The substance did not induce structural chromosome aberrations as determined by the chromosome aberration test in V79 cells in vitro.

 

In vitro gene mutation study in mammalian cells - HPRT

[Huntsman Textile Effects GmbH; 1979] – FAT I (Similar Substance 2)

The substance was tested for mutagenic effects on V79 Chinese hamster cells in vitro. The experiments were performed without microsomal activation at concentrations of 0.075, 0.15, 0.30, 0.60, 1.20, 1.80, 2.40 and 3.00 µg/ml and with microsomal activation at concentrations of 0.50, 1.00, 2.00, 4.00, 8.00, 12.00, 16.00 and 20.00 µg/ml.

 

With and without microsomal activation, comparison of the numbers of mutant colonies in the controls and the cultures treated with the various concentrations revealed no significant deviations

 

The two higest concentrations tested were too toxic and the cultures could not be subjected to the mutant selection procedure

 

Tthe substance and its metabolites induced no mutagenic effects in this mutation system.

Justification for selection of genetic toxicity endpoint
The assessment of the endpoint is performed with the integrated evaluation of results for in vitro bacteria gene mutation, in vitro mammalian cell gene mutation assay and in vivo micronucleus assay.

Short description of key information:
Not Mutagenic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), for the purpose of classification for germ cell mutagenicity, substances are allocated to one of two categories:

 

CATEGORY 1

Substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans.

Substances known to induce heritable mutations in the germ cells of humans.

CATEGORY 2

Substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.

 

The classification in Category 2 is based on positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments.

 

Based on the experimental results and on the ECHA Guidance R7.a, Figure R.7.7-1, the substance is considered as not genotoxic and no classification for germ cell mutagenicity is warranted.