Amended final report on the safety assessment of ethyl methacrylate.

Ethyl Methacrylate is a methacrylate ester used as a chemical additive in artificial fingernail enhancement products. These products may be applied by trained professionals or be provided directly to consumers with instructions for use. Ethyl Methacrylate readily polymerizes and rapidly reacts with multifunction methacrylates to form a highly cross-linked polymer. The oral LD(50) of Ethyl Methacrylate for rats ranged from 12.7 to 18.14 g/kg. In acute studies with rats, hemoglobinuria and respiratory tract lesions were observed. Animal studies indicate that Ethyl Methacrylate is a skin irritant and sensitizer. In some cases the results were dependent on the vehicle. Evidence of embryotoxicity and teratogenicity were observed in rats injected intraperitoneally with 0.1223 to 0.4076 ml/kg Ethyl Methacrylate. Positive evidence of mutagenicity was observed in the L5178Y mouse lymphoma cell assay, but not in two Ames tests. Case reports cite examples of individuals suffering allergic contact dermatitis from exposure to Ethyl Methacrylate and related methacrylates, and some degree of cross-reactivity appears to exist between widely used acrylates and methacrylates. Information from several clinical registries of sensitization reactions to various agents reported that Ethyl Methacrylate is a sensitizer, but not a potent one. Because Ethyl Methacrylate monomer is short-lived in the normal course of using artificial fingernail-enhancement products, the primary hazard is expected to be inadvertant skin contact. In order to avoid sensitization, it is necessary to avoid skin contact. It is recommended that fingernail-enhancement products containing Ethyl Methacrylate include directions to avoid skin contact because of the sensitizing potential. Based on the available data on the formulation of nail products containing this ingredient, it is concluded that Ethyl Methacrylate is safe as used, when application is accompanied by directions for use as above.