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EC number: 701-124-4
CAS number: -
The hypothesized MoA for the substances of the MDI category for mutagenicity recognizes that under physiological conditions the MDI substance readily polymerizes at the MDI/aqueous interface forming insoluble polyureas and/or reacts with extracellular biological nucleophiles to form MDI-adducts rendering the free NCO completely unavailable to react with DNA thereby negating this concern. Further, the toxicokinetic and metabolic pathways do not indicate the formation of toxicologically relevant metabolites and is described in detail below. The genotoxic potential of MDI substances has been investigated extensively in vitro and while early bacterial mutagenicity studies were positive, further experiments demonstrated that these results reflect the properties of hydrolysis products (i.e. diamine) formed under specific artificial assay conditions (aprotic solvent) and are not indicative of genotoxic potential of the parent compound under physiological conditions (Herbold et al., 1998; EC, 2005; DFG, 2008).Additional bacterial mutagenicity studies (OECD 471) will be conducted on data gaps to complete the data set. Additional in vitro micronucleus studies (OECD 487) will be conducted on ALL category substance to assess potential effects on cytogenetics. Combined with in vivo mutagenicity testing on the worst-case substance (4,4’-MDI) demonstrates the lack of mutagenic potential for the MDI Substance category.
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