ADE/PDE vs. OEL/OEB

Question: With so much emphasis being placed on ADEs and PDEs, do you see them replacing OELs and OEBs?

Answer: ADEs (acceptable daily exposure) and PDEs (permitted daily exposures) are exposure limits, by any route (including inhalation, ingestion, dermal, ocular, and injection), for preventing adverse health effects in the patient population due to cross-product contamination.

ADEs/PDEs must NOT be confused with OELs (occupational exposure limits) or OEBs (occupational exposure bands) that are exposure limits for preventing adverse health effects for workers.

In most cases, ADEs can be initially estimated by multiplying the OEL X 10. However; this is only an initial estimate that should be used for early-stage compounds, and should not be used once pharmacokinetic data (such as bioavailability, etc.) is available. In addition, there are often notable differences in human variability between a "healthy" worker population vs. the general population as a whole. For example, for a healthy worker population, ECHA recommends using an adjustment factor of 5, whereas for the general population covered by the ADE would use an adjustment factor of 10.