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A set ofin vitroandin vivostate of the art mutagenicity tests withHYDROXYETHYL-3,4-METHYLENE­DIOXY­ANILINE HCLof defined quality was performed which covers all scientifically relevant endpoints.HYDROXYETHYL-3,4-METHYLENE­DIOXY­ANILINE HCLdid not show any potential to cause gene mutations in bacterial or mammalian cellsin vitro, as both theand the mouse lymphoma assay were negative. Clastogenic effects were observed in a micronucleus test in human lymphocytes in the presence of S9 mix, but not in the mouse lymphoma assay. The observed increase in micronucleated lymphocytes in the micronucleus test was, however, limited to cytotoxic doses.

To clarify this finding, a micronucleus testin vivowas performed. In this study,HYDROXYETHYL-3,4-METHYLENE­DIOXY­ANILINE HCL,administered via the intraperitoneal route, did not cause clastogenic or aneugenic effects at doses up to the maximum tolerated dose of 250 mg/kg bw. For intraperitoneal administration 100% bioavailability of the test compound can be assumed.

Taken together, the available test results clearly support the absence of a genotoxic hazard underin vivoconditions. Therefore,HYDROXYETHYL-3,4-METHYLENE­DIOXY­ANILINE HCLis considered not to pose any risk to humans with regard to mutagenicity/genotoxicity.

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