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EC number: 701-124-4
CAS number: -
The hypothesized MoA for the substances of the MDI category for reproductive (and other systemic toxicity endpoints) is based on the common mode of action for local and systemic toxicity and subsequent effects on fertility. Reliable evidence from an two-generation reproduction study on an analogue diisocyanate (TDI) shows no effects on any reproductive parameter and this is consistent with findings from acute and repeated exposure studies on 4,4’-MDI and pMDI that show that MDI substances will not produce toxicity in any systemic organs, including those of the reproductive system, outside the site of contact (lungs). This data will be used to support the basis of using Extended One-Generation Reproduction Studies (OECD 443) on the MDI substance boundary substances 4,4,’-MDI and 4,4,’-MDI/DPG/HMWP as the source for a category read-across to the target substance. Additional testing will be considered based on OECD 422 bridging studies on multiple other key category substances.
Since there is high confidence in the hypothesized MoA for MDI substances through the reactive NCO group and as systemic exposure is not anticipated for any substance of the MDI category to be supported by testing on the category boundary substances, then the available data is considered on a weight of evidence basis as being sufficient for risk and hazard assessment purposes.
Additional details on the hypothesized MoA are provided in the MDI Substance Category Justification Document.
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