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 Overall, the genotoxicity of 2-methoxy-methyl-p-phenylenediamine is sufficiently investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene utations, chromosome aberrations and aneuploidy.

2-Methoxy-methyl-p-phenylenediamine was mutagenic in all in vitro tests performed. It did induce gene mutations both in a gene mutation test in bacteria as well as in a mouse

lymphoma assay in mammalian cells and chromosome aberrations in an in vitro micronucleus test although these positive findings were considered of questionable biological importance. The finding in the mouse lymphoma assay that both the number of large and small colonies increased and the ratio large/small colonies decreased indicated to a clastogenic effect of 2-methoxy-methyl-p-phenylenediamine next to a mutagenic one.

The positive findings from the in vitro tests could not be confirmed in in vivo tests. In an UDS test exposure to 2-methoxy-methyl-p-phenylenediamine did not result in unscheduled DNA synthesis in liver of rats. In an in vivo micronucleus test, an increase in bone marrow cells with micronuclei was not seen indicating that 2-methoxy-methyl-p- phenylenediamine is not clastogenic nor aneugenic in this test. The results of a comet assay, an indicator test covering gene mutations and chromosome aberrations, confirmed that 2-methoxy-methylp-phenylenediamine is not genotoxic (mutagenic and clastogenic) in stomach cells and bladder epithelial cells of rats.

Although the results obtained in the comet assay for liver cells were equivocal, the negative UDS test covers for DNA damage in these cells.

Consequently, based on these tests, 2-methoxy-methyl-p-phenylenediamine can be considered to have no genotoxic potential and additional tests are unnecessary.


Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In in vitro studies some mutagenic effects were reported, but this was not confirmed in in vivo studies therefore, the substance was not considered as genotoxic.

 

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