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EC number: 701-124-4
CAS number: -
The principle route of exposure for human concern is via inhalation. This is supported by the toxicokinetic profile of exposure and indicates oral exposure cannot be extrapolated for the hazard or risk assessment of inhaled aerosols. Accordingly, inhalation toxicity data on developmental toxicity is the most relevant as the source read-across for the MDI substance category evaluation.
The available reliable study data for the developmental toxicity endpoint are consistent with the hypothesized MoA and based on the high reactivity of the NCO group (Gamer et al., 1994 and Buschmann et al., 1996). The hypothesized MoA predicts local effects in the lungs and no significant systemic exposure to unreacted NCO since it reacts with biological nucleophiles before being absorbed as GHS/protein adducts. Minor fetal effects related to growth were considered secondary to the maternal irritation and toxicity. No direct toxicity was noted in the developmental toxicity study which is consistent with the observed lack of systemic toxicity in combined chronic toxicity and carcinogenicity studies on 4,4’-MDI and pMDI as well as the proposed mechanism for MDI absorption toxicokinetics. Accordingly, the target substance like the rest of the MDI substance category is not classified as a developmental toxicant by EU GHS 1272/2008 CLP.
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