Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate

Endpoint summary

Additional information

Both in vitro and in vivo mutagenicity tests are available for Acid Orange 7.

Both tests of Bacterial reverse mutation assay, Ames test, showed negative results both with and without metabolic activation.

The results of the in vitro mammalian cell gene mutation assay and the in vitro chromosome aberration test, made on Acid Orange 7 are both negative.

In addiction also the in vivo micronucleus (bone marrow) test, made on Acid Orange 7, showed negative results.

Based on these tests, Acid Orange 7 could be considered as not mutagenic.

Short description of key information:

Not mutagenic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

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.

For the purpose of classification for germ cell mutagenicity, substances are classified if there is at least 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.

The presented results from in vivo and the in vitro tests are negative, therefore it is concluded that Acid Orange 7 is not genotoxic with or without metabolic activation.