Reaction products of 6-amino-4-hydroxynaphthalene-2-sulphonic acid and 7-amino-4-hydroxynaphthalene-2-sulphonic acid, condensed with Formaldehyde and Sodium hydrogensulfite, coupled with diazotised Sodium 2-amino-4,6-dinitrophenoxide, metalized with Sodium Dichromate, sodium salts

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

The following data were obtained for Similar Substance 01. It is expected that Target substance will present similar mutagenicity profile. Justification for Read Across is given in Section 13 of IUCLID.

 

Two in vitro bacterial reverse mutation assays are available on the substance.

The first test was performed using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, according to the OECD Guideline 471 (1983). The assay was performed in two independent experiments, using identical procedures, both with and without liver microsomal activation. Each concentration in the range of 10 - 5000 μg/plate and the controls were tested in triplicate. Only weak toxic effects, evidenced by a reduction in the number of spontaneous revertants, occurred in the test groups with metabolic activation at the highest investigated dose in strains TA 1537 and TA 98. No significant and reproducible dose-dependent increase in revertant colony numbers was obtained in any of the strains used.

The test substance did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the substance is considered to be no-mutagenic in this Salmonella typhimurium reverse mutation assay.

Also the second test was performed according to the OECD Guideline 471 (1983). The test was performed without and with metabolic activation in the range of concentration of 100 - 5000 μg/plate, using strains of Salmonella typhimurium (TA 98, TA 100, TA 1535 and TA 1537). Each concentration and controls were tested in triplicate. The test substance did not induce a dose-related increase in the number of revertant (His+) colonies in each of the tester strains. These results were confirmed in an independently repeated experiment. Therefore, test substance can be considered as not mutagenic in this test system.

Justification for classification or non-classification

According to the CLP Regulation (EC 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 or

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

Based on the results of mutagenicity (AMES), no classification for mutagenetic toxicity is warranted under the CLP Regulation (EC 1272/2008).