Scientific Opinion on the safety evaluation of the substance, 1,3‐bis(isocyanatomethyl)benzene, CAS No. 3634–83‐1 for use in food contact materials

摘要

This scientific opinion of EFSA deals with the risk assessment of the monomer 1,3‐bis(isocyanatomethyl) benzene, CAS No. 3634–83‐1, FCM Substance No 988. In water and gastric fluid simulant, immediate and complete hydrolysis of the substance to 1,3‐benzenedimethanamine occurs. The toxicity of 1,3‐bis(isocyanatomethyl)benzene was tested in three in vitro genotoxicity tests, with and without metabolic activation and in an in vivo micronucleus assay in rats and was considered as non‐genotoxic in vivo. In addition, its hydrolysis product, 1,3‐benzenedimethanamine, was tested in two in vitro tests, in the presence and absence of a metabolising system, and one in vivo mouse micronucleus assay. The tests were negative. No concern for genotoxicity in vivo is raised by 1,3‐bis(isocyanatomethyl)benzene and its hydrolysis product 1,3‐benzenedimethanamine. The CEF Panel concluded that that the use of the substance 1,3‐bis(isocyanatomethyl)benzene as co‐monomer in the manufacture of a middle layer coating in a multilayer film does not raise safety concern if the migration of its hydrolysis product, 1,3‐benzenedimethanamine, does not exceed 0.05 mg/kg food.