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Establishing the Level of Safety Concern for Chemicals in Food without the Need for Toxicity Testing


Regulatory Toxicology and Pharmacology. 2014;68:275-296

Thousands of man-made chemicals in use today may enter the food chain. Some of these may result in human exposure, while no toxicological data may be available. The present manuscript illustrates a decision tree for risk assessors and managers to establish fast and reliable safety levels of concern associated with dietary exposures.

Thousands of man-made chemicals are in use today. Many of these compounds may enter the food chain and result in human exposure. Since toxicological information is limited or lacking for the vast majority of these chemicals, the assessment of their health significance is therefore difficult, but envisaged.

A decision tree has been developed taking into account practical application of in silico methods. Basic concepts of classical risk assessment have been integrated: 1) exposure assessment 2) hazard identification 3) hazard characterization and 4) risk characterization.

The present work indicates that if integrated according to the proposed decision tree, in silico tools can be used to establish levels of safety concern by calculating Margin of Exposure (MoE) between predicted toxicological reference points and estimated human exposure.

The data resulting from the application of the decision tree can be used to guide risk assessors and managers to take informative decisions within a very short period of time.

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The authors regret in Table 11 (page 289), the structure of lucanthone is incorrect. To download the corrigendum, please click here. The authors would like to apologise for any inconvenience caused.

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