Can we provide an acceptable daily exposure (ADE) value for any compound?

Here at Affygility Solutions we often get asked to provide an acceptable daily exposure (ADE) (a.k.a. permitted daily exposure or PDE) value for a wide variety of compounds. In order to provide a "scientifically-supported" ADE the following information must be known:

• There must be a clear dose-response relationship. This presents a problem when you have highly-sensitizing compounds where a clear dose-response relationship does not exist.
• The scientific data to support the ADE must be documented in publicly-available information.
• The scientific data to support the ADE must be longer than a single-acute dose exposure. As indicated in the EMA guidance, the use of the LD50 value as the point of departure in setting the ADE is not acceptable.