Expanding the use of a science-based tool for toxicological health risk assessment

Background

Based on the Threshold of Regulation (ToR) that was introduced by the US Food and Drug Administration, the Threshold of Toxicological Concern (TTC) concept is a science-based tool to help regulators and industry to assess potential health risk from substances when specific toxicological data are not yet available.

Objectives

The Task Force aims to strengthen the scientific fundamentals for TTC and to expand its applicability as a risk assessment tool for substances to which humans are exposed at low levels.

Impact

The Task Force organised the EUROTOX Continuing Education Course (CEC) to expand the TTC concept awareness and provide an overview of current non-animal methods to deal with data gaps in hazard and exposure assessment.
The Task Force frequently collaborates with the CEFICLong-Range Research Initiative. One of their successfully completed projects involved the creation of a carcinogen database.

Achieved Results

The ‘Alternatives to Animal Testing’, the ‘New approaches to Chemical Risk Assessment for Food and Food ingredients’ and the Threshold of Toxicological Concern Task Forces will organise a joint session at the 21st International Congress for the European Society of Toxicology In Vitro (ESTIV) in Barcelona (Spain) in 2022. The session will focus on application of non-animal methods and concepts in food risk assessment.
The Task Force, together with CEFIC-LRi, will organise a workshop on the Carcinogen Dose-Response Database for Threshold of Toxicological Concern in February 2021.
The EG on ‘Uncertainty in Hazard Assessment: A Comparison of TTC versus Chemical-Specific Approaches’ will also organise a web-seminar on its outcomes in Q1 2021.
Finally, a new activity on ‘Building cumulative assessment groups for combined exposure risk assessment based on TTC thresholds or read-across’read-across’ will start in Q1 2021.

Objectives

The task force aims to strengthen the scientific underpinnings for the TTC and expand its applicability as an important risk assessment tool for substances to which humans are exposed at low levels. We strive to develop the most scientifically robust, yet pragmatic, non-animal, safety assessment tool.

Scientific Impact

The Task Force frequently collaborates with the CEFIC-LRI and has been actively involved in the project of carcinogen database creation and producing peer-reviewed publications.

For more detailed information, please contact Angeliki Stavropoulou at AStavropoulou@ilsieurope.be  or Belinda Antonio at bantonio@ilsieurope.be

Task Force Members


* Scientific Advisor

Expert Groups

Uncertainty in Hazard Assessment: A Comparison of TTC versus Chemical-Specific Approaches

Background & Objectives
The probabilistic approach using the genotoxicity and non-cancer (Cramer class) Thresholds of Toxicological Concern (TTC) is often perceived as accepting a higher risk than traditional risk assessments. However, robust scientific activities to describe the sources of uncertainty within the TTC approach have not yet been conducted or published.

Output
The expert group examines how much uncertainty may be associated with the application of the TTC approach as compared to a substance-specific risk assessment. The group expects to produce two reviews:

  • an initial focus on qualitative description and ranking of the identified sources of uncertainty;
  • a subsequent quantitative assessment of the remaining quantifiable uncertainties.

Expert Group Members

Uncertainty in Hazard Assessment: A Comparison of TTC versus Chemical-Specific Approaches

Publications

All Publications

The Role of Hazard- and Risk-Based Approaches in Ensuring Food Safety

Trends in Food Science & Technology. 2015;46(2) Part A:176-188. Supported by the following task forces: Emerging Microbiological Issues, Food Allergy, Food Intake Methodology, Novel Foods and Nanotechnology, Process Related Compounds and Natural Toxins, Risk Analysis in Food Microbiology, and Threshold of Toxicological Concern.

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