Genetic Toxicity
Extensive genetic toxicity testing of acrylic acid and the acrylate esters indicates a lack of potential for genetic toxicity. In vitro tests conducted include one or more of the following: the Ames test for mutagenicity both with and without metabolic activation, the mouse lymphoma assay and the chromosomal aberration tests in mammalian cell lines, the in vitro micronucleus test and the in vitro Unscheduled DNA Synthesis (UDS) test. Similarly, the in vivo tests conducted include one or more of the following: the mouse micronucleus assay, the rat unscheduled DNA synthesis assay, the rat and mouse chromosomal aberration assay and the rat dominant lethal assay.
Excerpt from ARTF Category Justification -For this endpoint, a data-gap filling is addressed by a category based read-across approach. In RAAF nomenclature, this approach is described in scenarios 4 (different compounds have qualitatively similar properties) and governed by AE 4.2 and 4.3 (common underlying mechanism, qualitative and quantitative aspects). Here, the common underlying mechanism is a direct electrophilic reaction of the intact ester. The variable part of the category approach is the length or configuration of the side chain of the parent ester and the alcohol metabolite and their impact on physico-chemical properties and consequent biological properties. Despite the variation, the available data support a weight of evidence-based conclusion that there is no genotoxicity concern for all the category members. There is a data gap for in vitro mutagenicity in mammalian cells for iBA, which is assessed by a direct read-across from a reliable mammalian cell gene mutation tests with nBA (OECD 490; 2016). nBA is considered to be a close analogue within the category without a tertiary structure. Overall, this read-across approach is applied with a high level of confidence.
For more information, see Category Justifcation Document for use under EU REACH.