Genotoxicity

Technical Summary

A comprehensive test series was conducted for all methacrylates, including both in vitro and, where necessary, in vivo genotoxicity tests in accordance with OECD guidelines. Most methacrylates yielded negative results in in vitro tests, indicating they are not mutagenic. Although some methacrylates showed positive in vitro results, these were not confirmed in in vivo follow-up studies. Therefore, methacrylates are considered to have no genotoxic potential.

More specifically, most methacrylates consistently produced negative results in bacterial reverse mutation tests (Ames test, OECD TG 471) and gene mutation tests in mammalian cells (HPRT test, OECD TG 476) — with the exception of MADAME, which tested positive in OECD TG 471.

For in vitro cytogenetic endpoints, either the chromosome aberration test (OECD TG 473) or the micronucleus test in human lymphocytes (MN; OECD TG 487) yielded negative results for most of the tested monomers. Some methacrylates were exceptions: for example, EGDMA (OECD 473), MADAME (OECD 473), and 1,4-BDDMA (OECD 473) showed positive results.

However, the available in vivo follow-up data for EGDMA, MADAME, and 1,4-BDDMA consistently show no genotoxic activity.

Overall, the results clearly demonstrate that methacrylates do not possess genotoxic potential.