Toxicology services

Toxicological Risk Assessment

The objective of a toxicological risk assessment (TRA) is to estimate or evaluate health risks posed to man and the environment by the use of chemicals. Hazard identification, exposure assessment and dose-response analysis are key characteristics to define the risk. KeyToxicology performs toxicological risk assessments to estimate the qualitative and quantitative health risks of a chemical and gives advice how to manage the risk. With respect to TRA, KeyToxicology provides the following services:

Hazard identification;
Data evaluation;
Scientific data gap analysis;
Exposure assessment;
Dose-response assessment;
Risk characterization;
Risk management.

Endocrine Disruption

An endocrine disruptor is an exogenous substance or mixture, which causes adverse health effects in an intact organism by altering function(s) of the endocrine system. Recently the European Commision have published criteria to identify endocrine disruptors in plant protection products (Regulation (EC) No. 1107/2009) and in biocidal products (Regulation (EU) No. 528/2012). Based on these EU-ED criteria the European Food Safety Authority (EFSA) and European Chemical Agency (ECHA) published a joint guidance that describes the practical implementation of these regulations. KeyToxicology has been actively involved in this debate and can provide expert support with respect to endocrine disruptors taking the stepwise approach of the EFSA/ECHA guidance into account.

Pharmacology

KeyToxicology has experience in and provides expert support for the establishment of:

PDE-values
Cross-contamination in pharmaceutical manufacturing is of high concern for the pharma industry. Cross-contamination can be the transition of an active ingredient from drug A to drug B during the manufacturing process. KeyToxicology can give support in the assessment of Permitted Daily Exposure (PDE) values, according to the European Medicines Agency guidance, which is based on the conservatibe assumption that if patients consume the drug on a daily basis for the rest of their life they should be protected from potential adverse health effects .
OELs
Working in the pharmaceutical sector implies a risk to be exposed to active ingredients of pharmaceuticals. KeyToxicology can give support in establishing Occupational Exposure Limits (OELs) that protects workers from potential adverse health effects during the manufacturing of pharmaceuticals.

Novel Foods

Under EU regulation, new food products or ingredients who have not been consumed ‘significantly’ in the EU before May 1997 are called ‘novel foods’. Authorisation of the novel food is required before entering the EU market. KeyToxicology provides expert support with the preparation of the ADME characteristics and nutritional as well as toxicological information required to apply for authorisation of your novel food, as laid down in the EFSA guidance document.