Regulatory Toxicology: Here’s how Chemsafe can help you

What is regulatory toxicology

Regulatory toxicology is a particular branch of experimental toxicology, historically derived from pharmacology, for the study of the adverse effects of xenobiotics, which is based on the requirements contained in national and, now increasingly international, regulations concerning the safety of chemicals and pharmaceuticals. Regulatory toxicology, which we might call an applied science, has its beginnings in conjunction with the issuance of the first European regulations on chemical safety (Dir. ECC 67/548) and the international standards for placing pharmaceuticals on the market later harmonized by the ICH (International Conference of Harmonisation) guidelines. From regulatory toxicology that deals with hazards to human health comes eco-toxicological science that deals instead with hazards to the natural environment.


What are the purposes of the toxicological approach

The purpose of the toxicological and/or ecotoxicological assessment is to define the hazards associated with a given chemical structure (substance) or chemical mixture (product) and the subsequent assessment of the “safe dose” or “no adverse effect dose.”On the basis of this knowledge, risk assessments during the use of this substance or mixture in a given exposure scenario can then be set up and mitigation measures for the same can be planned, if necessary.The ultimate goal is to ensure that any exposure to the substance or mixture is negligible and, in any case, does not lead to adverse effects on human health or for the natural environment


What approaches are used for toxicological evaluation

Every toxicological evaluation activity begins with a careful assessment of the available data through an extensive search of specific databases accompanied by an evaluation of the reliability of the data obtained.

This is followed by the so-called “Data Gaps Analysis,” which allows the assessment of “what is missing” and which end-points are still to be evaluated.The experimental phase then starts with the conduct of ad hoc toxicological studies. Finally, an Expert Report is prepared on the toxicological profile of the substance or mixture under study. This document is signed by the evaluator and the senior toxicologist. In Chemsafe, by our two ERTs (European Registered Toxicologists).


Does toxicological testing involve the use of animals, particularly vertebrates?

It still involves the use of animals for some specific end-points, including vertebrates, although for many years under the Principle of 3Rs (Replace, Reduce, Refine) many studies have been replaced with “in vitro” and particularly “in silico” approaches.

The latter allows, through the use of structure-activity methodologies to predict the possible presence of an adverse effect based on the chemical structure of the substance. Recently, many regulations in the chemical industry, have incorporated the NAM (New Approach Methodologies) approach, which integrates the various and most modern methodologies for hazard and risk assessment of chemicals by limiting the use of animals.The replacement of the animal in testing is a process that is still ongoing and will bring us even more exciting new developments.


How to become a regulatory toxicologist

There are no specific, if not very basic, schools to become regulatory toxicologists.

You need a solid scientific foundation and then a lot of experience in the field. The process of “Learning by Doing” is essential to achieve an appropriate knowledge of the field and thus an appropriate professional capacity.

Such professionalism can be achieved by working at consulting firms, universities and/or trading companies


….in Chemsafe

Regulatory toxicology is the specialty that sets our company apart from others. It also binds like a red thread the activities carried out in our four Business Units (BU Chemical, BU Pharma, BU Medical Devices and BU Food). We consider training in this discipline an indispensable factor for our employees; training that is carried out both internally (by already experienced – senior colleagues) and externally for more specific topics (e.g. risk assessment/effect assessment, etc.). The competence in this discipline is our unique corporate asset.


If you would like to learn more, please do not hesitate to contact us at