Unlike the PDE (Permitted Daily Exposure), the ADI (acceptable daily intake) as well as the TDI (tolerable daily intake) consider oral intake only and represent estimates of the amount of a substance in air, food, or drinking water that can be taken daily over a lifetime without significant health risks. Therefore, these approaches might therefore be the better choice for oral-only pharmaceuticals or food related products. Additionally, the ADI / TDI approach may be applied to toxicologically qualify substances that can be present as a result of the manufacturing process or they can arise from natural or environmental sources.
The ADI concept can be understood as a measure to indicate the toxicity of long-term exposure to repeated ingestion of chemical compounds (present and/or added), as opposed to acute toxicity.
The No-Observed(-Adverse)-Effect Level, the amount of a substance that shows no toxic effects, is determined by performing studies with several doses including high doses. In several studies on different effects, the most relevant NOAEL is selected to form the basis of ADI-calculations.
Safety and Quality
The determination of an ADI is to verify the safety of an (orally administrable) compound and the provision of high quality pharmaceutical products.
Uncertainty factor provides a margin of safety for allowable human exposure, derived from measurements regarding the reaction of the most sensitive animal species in order to estimate an NOAEL or a LOAEL for humans.
Improved analysis processes allow to detect substances in low or very low concentrations. Even though it may not be possible to generate toxicological data on each substance, it is of importance to evaluate these previously non-detectable trace substances. The TTC (Threshold of Toxicological Concern) concept has now been widely accepted to qualitatively evaluate risks possibly posed by these low-concentrated substances and is part of the important scientific process prioritising from chemical substances with low exposure for which further data is necessary to substances with no significant risk to human health.
Lowest-observed-adverse-effect Level is the lowest level of a chemical stressor evaluated in a toxicity test which shows harmful effects on a plant or animal. While LOAELs and LOAECs are similar, they are not interchangeable. A LOAEL refers to a dose of a chemical that is ingested.
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