An analysis of the risk of exceeding the acceptable or tolerable daily intake.

The acceptable or tolerable daily intake (ADI or TDI) for food additives and contaminants is usually derived from chronic animal toxicity studies. The basis for the ADI or TDI is the determination of the no-observed effect level (NOEL) for the most sensitive toxicological effect in the most sensitive laboratory species. This "safe intake" for animals is then divided by a safety or uncertainty factor to allow for possible differences between the test species and humans and for possible differences within the human population. Therefore, the ADI or TDI is related to a toxic effect in the test species which is considered to be of relevance to humans. Any risk to humans who exceeded the ADI or TDI can only be assessed by reference to the dose-response for the toxicity giving rise to the NOEL. The duration of a human intake in excess of the ADI should also be considered in relation to the protocol used in such animal studies.