Disodium 3-[[2,2'-dimethyl-4'-[[4-[[(p-tolyl)sulphonyl]oxy]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxynaphthalene-2,7-disulphonate

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

Microbial metabolic activation test was conducted to assess the potential mutagenic effect of the test item, usingSalmonella typhimuriumTA 1535, TA 1537, TA 1538, TA 100 and TA 98 strains. Dimethyl formamide was used as solvent. The substance was tested at the concentrations of 0.32, 1.6, 8, 40, 200 and 1000 µg/plate. Adequate positive controls were also assayed.

When the data from Experiment I were analysed at the 1 % level using Dunnett's test, a statistically signifrcant increase in revertant numbers was observed following TA 1538 treatments in the presence of S9. This increase showed little evidence of a dose-response and was therefore not considered to be indicative of test item mutagenic activity in this strain under the treatment condition. No statistically significant increases in revertant numbers were observed following any other treatments in this study.

Toxicity ranging from a thinning of the background bacterial lawn to a complete killing of the test bacteria was observed following the top two dose treatments of TA 1537 in the absence of S9.

No precipitation of test agent was observed following any of the dose treatments in either the presence or absence of S9.

It was concluded that test item did not induce mutation inSalmonella typhimuriumstrains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 under the conditions employed in this screening study.

Justification for classification or non-classification

GERM CELL MUTAGENICITY

This hazard class is primarily concerned with substances that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, the results from mutagenicity or genotoxicity tests in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances and mixtures within this hazard class.

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.

Categoty 2: Substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.

Classification for heritable effects in human germ cells is made on the basis of well conducted, sufficiently validated tests as In vitro mutagenicity tests such as these indicated in 3.5.2.3.8:

- in vitro mammalian chromosome aberration test;

- in vitro mammalian cell gene mutation test;

- bacterial reverse mutation tests

The substance did not create gene mutations in the strains of Salmonella typhimurium under the performed test, therefore according to the 3.5. of the CLP Regulation EC n.1272/2008, it cannot be classified as mutagenic for germ cells.