Genotoxicity

Technical Summary

Methyl methacrylate (MAA) and the alkyl methacrylate esters (MMA, EMA, nBMA, iBMA and 2-EHMA) are high production volume chemicals and have been reviewed extensively by government regulatory agencies. None of these reviews have assessed these materials as having a genotoxic potential. (See EU Risk Assessment (2002), OECD review MMA (2007). OECD review MAA (2002), OECD review esters (2009).

The materials have been subjected to screening in a variety of in vitro and in vivo assays. The results in the studies performed using accepted guidelines are summarized in tabular form below.

While not every test has been performed for every material, the unsaturated linear and branched alkyl methacrylates are rapidly metabolized to methacrylic acid and the structurally corresponding alcohol by non-specific carboxylesterases in several tissues. Since methacrylic acid, is the common metabolite of the esters, it is also assessed to be not genotoxic. Methyl methacrylate (MMA) is the largest volume methacrylate ester that has been studied extensively and provides a robust reference chemical for this category. The positive responses in the in vitro studies for clastogenicity are limited to doses associated with high cellular toxicity and the positive findings in the mouse lymphoma assay are associated with chromosomal aberrations rather than point mutations. The negative responses in the in vivo studies indicate that the doses of MMA required to elicit the same effect may not be achievable in vivo. This overall assessment for MMA is supported by the lack of carcinogenic effects in rat and mouse chronic studies and the absence of teratogenic effects in the reproduction and developmental toxicity studies. Negative results for the two butyl esters tested in vivo corresponded with the negative in vitro results. Overall the data support the assessment that these materials do not have genotoxic potential.

OECD review MAA (2001)

OECD review MMA (2007)

EU Risk Assessment (2002)

OECD review esters (2009)