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ILSI

Structure-Based Thresholds of Toxicological Concern (TTC): Guidance for Application to Substances present at Low Levels in the Diet.

2004

B. Kroes et al.

Published in Food and Chemical Toxicology 2004; 42:65-83

The Thresholds of Toxicological Concern (TTC) is a pragmatic risk assessment tool that is based on the principle of establishing a human exposure threshold value for all chemicals, below which there is a very low probability of an appreciable risk to human health. The concept that there are levels of exposure that do not cause adverse effects is inherent in setting acceptable daily intakes (ADIs) for chemicals with known toxicological profiles. The TTC principle extends this concept by proposing that a de minimis value can be identified for many chemicals, in the absence of a full toxicity database, based on their chemical structures and the known toxicity of chemicals which share similar structural characteristics. The establishment and application of widely accepted TTC values would benefit consumers, industry and regulators.

An Expert Group of the ILSI Europe Threshold of Toxicological Concern Task Force has examined the TTC principle for its wider applicability in food safety evaluation, and concluded that the TTC principle could be applied for low concentrations in food of chemicals that lack toxicity data. The use of a decision tree to apply the TTC principle was proposed, and this paper describes the step-wise process in detail.

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