The Lautenberg Chemical Safety Act joins an array of newer, national or supranational regulatory schemes including REACh in the European Union and similar regulations elsewhere that require substantial data on chemical health hazard prior to chemical registration and sale.  There are consumer product manufacturers, however, for whom evaluation of product and associated chemical safety fall outside the scope of these large chemical registration programs, but who are interested in specific health endpoints related to use of their products or proposed products.  In response, we developed and validated a read-across framework aimed specifically at filling dermal sensitization and irritation data gaps.  This read-across methodology quantifies structural similarity between proposed surrogates and target chemicals, shows an expected common mode of action via structural alerts and relevant chemical properties, and it has resulted in formation of chemical categories from which we can infer toxicological information.  This endpoint-specific read-across framework may be less detailed than what may be required for a full chemical registration, but is fit-for-purpose for product development and stewardship needs.  We used several case studies to validate this tailored read-across framework and the tools used therein.  These case studies indicate that the accuracy of our tailored framework in identifying a sensitizing target chemical may approach 100% when physicochemical properties and structural alerts related to skin sensitization are considered in tandem.  Our experience with read-across within and separate from large chemical registration schemes indicates that robust chemical read-across is not necessarily one-size-fits-all.  Rather, read-across approaches can be tailored to specific criteria and needs, which should be considered by agencies developing read-across guidance.

Does one size fit all? Tailoring read-across methodology based on endpoint-specific criteria

255th National Meeting (2018)

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