Cobaltate(3-), bis[4-[4-[[4-[4-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium

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 GENOTOXICITY

As no data on genotoxicity of the test item was available, the following data was obtained for the Source Substance. It is expected that the Target Substance will present a similar profile. Justification for Read Across is given in Section 13 of IUCLID.

The Source Substance was evaluated for its potential to induce mutagenic effects in an in vitro bacterial inverse mutation assay, according to a method similar to the OECD 471 guideline. Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, TA 100 were used. The test material showed no toxicity to the TA-100 indicator strain during the preliminary test. Therefore, mutagenicity tests were performed at eight doses in the range of 1.0-10000.0 μg / plate with and without S9 metabolic activation.

The Source Substance showed no genetic activity in any of the tests conducted and was considered non-mutagenic in these test conditions. The high concentrations used counterbalance the shortcomings that could result from the use of a test material with a low purity used suggesting that the use of the experimental results for the evaluation of mutagenicity is acceptable.

Justification for classification or non-classification

Mutagenicity refers to the induction of permanent transmissible changes in the amount or structure of the genetic material of cells or organisms. These changes may involve a single gene or gene segment, a block of genes or chromosomes.

According to the CLP Regulation (EC) No. 1272/2008, for the purpose of the classification for germ cell mutagenicity, substances are allocated in one of two categories in consideration of the fact that they are:

-substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans or substances known to induce heritable mutations in the germ cells of humans (Category 1) or

-substances, which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans (Category 2).

Based on results of in vitro gene mutation study performed, it is concluded that the test item did not induce gene mutations in reverse mutation in Salmonella typhimurium strains tested in the absence or presence of S9 metabolism.

According to the REACH Regulation (EC) No. 1907/2006, Annex VII, Column 2, further mutagenicity studies are not necessary to be considered in case of a negative result. Therefore, it is possible to conclude that the test substance is not considered to be genotoxic.