disodium 4-amino-6-((4-((4-(2,4-diaminophenyl)azo)phenylsulfamoyl)phenyl)azo)-5-hydroxy-3-((4-nitrophenyl)azo)naphthalene-2,7-disulfonate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test: Positive

Ames test NR: nitroreductase activity, plays a major role in the mutagenic properties of the substance

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test): negative

OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test): negative

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (positive)

Genetic toxicity in vivo

Description of key information

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test): negative

OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay), similar substance 2: testing proposal

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Two Ames tests are available on Acid Black 210; one test (Stahl, 1996) was performed on strain: TA100, TA 98, TA1535, TA 1537, WP2P and WP2PuvrA and one test (ABK210 Consortium, 2020) was performed on strain TA98, TA100, TA102, TA1535, TA1537 and the nitroreductase deficient strains, TA 98NR and TA 100 NR.

Both test were disrgegarded for the reason discussed in the expert statements.

Therefore, two expert assessments were added as Weight of evidence, in order to analyse all the results of the Ames test, considering also the structural and mechanicistic evaluations.

One In vitro mammalian cell micronucleus test following OECD 487 (Consortium, 2010) and one gene mutation in vitro, following OECD 476 (Stahl, 1996) are available and both test show negative results.

Moreover, also an in vivo test, following OECD 474 is available on Acid Black 210 (Stahl, 1996) and the results are negative.

Finally, a testing proposal for OECD 489, comet assay has been proposed on similar substance 2.
Therefore the substance is consider not mutagenic for the time being. the classification will be confirm with the results of the comet assay.

 

 

Short description of key information:

not mutagenic

 

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Classification for mutagenicity is warranted for 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, obtained from:

— somatic cell mutagenicity tests in vivo, in mammals; or

— other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.

Based on the negative results of the in vivo tests on the similar substance, OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test) no classification for mutagenicity is applied following Regulation 1272/2008.
This classification will be confirmed after the results of the OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay).