Determining the Applicability of Threshold of Toxicological Concern Approaches to Substances Found in Foods

Abstract

Threshold of Toxicological Concern (TTC) decision-support methods present a pragmatic approach to using data from well-characterized chemicals and protective estimates of exposure in a stepwise fashion to inform decisions regarding low-level exposures to chemicals for which few data exist. It is based on structural and functional categorizations of chemicals derived from decades of animal testing with a wide variety of chemicals. Expertise is required to use the TTC methods, and there are situations in which its use is clearly inappropriate or not currently supported. To facilitate proper use of the TTC, this paper describes issues to be considered by risk managers when faced with the situation of an unexpected substance in food. Case studies are provided to illustrate the implementation of these considerations, demonstrating the steps taken in deciding whether it would be appropriate to apply the TTC approach in each case. By appropriately applying the methods, employing the appropriate scientific expertise, and combining use with the conservative assumptions embedded within the derivation of the thresholds, the TTC can realize its potential to protect public health and to contribute to efficient use of resources in food safety risk management.

The TTC Approach in Practice and its Impact on Risk Assessment and Risk Management in Food Safety. A Regulatory Toxicologist's Perspective

“…the potential for harm to health) is greatest. [41] It is important that the rigor, and thus the legitimacy, of the approach be maintained. In order to get transparent, non-arbitrary results, computer tools should be applied to go through the decision tree.…”

Synthesis and Characterization of Sodium Diphenylcarbamodithioate Ligand [L] and its Cobalt, Nickel, and Copper Complexes

“…The compound is a colorless solid, but commercial samples are often yellow due to oxidized impurities (Vogt and Gerulis, 2005). Diphenylamine dissolves well in many common organic solvents and is moderately soluble in water (Canady, et al, 2013). It is used mainly for its antioxidant properties.…”

Thresholds of Toxicological Concern – Setting a threshold for testing below which there is little concern

“…Several reviews of the TTC concept (Kroes and Kozianowski, 2002;Kroes et al, 2005;Barlow, 2005;Munro et al, 2008;Hennes, 2012;Canady et al, 2013 and many more cited in the following) can give broader background than is the purpose of this article. Here, especially the challenges ahead for a broader use of TTC shall be addressed.…”