IMPLEMENTATION OF IN VITRO METHODS: TEAM MASTERY IS LEADER

TEAM mastery attended to the Congress of European Societies of Toxicology (EUROTOX) 2018 contributing to the discussion about the implementation of in vitro methods: we presented a poster, prepared in cooperation with the Konstanz University, CAAT-Europe and the University of Milan, Department of Pharmacological and Biomolecular Sciences.

Focal tipic is the implementation of in vitro methods in the safety evaluation of the skin sensitization potential of chemicals under REACH regulation.

Dowload the Poster.

 

Implementation of in vitro methods in the safety evaluation of the  skin sensitization potential of chemicals under REACH regulatio.

Authors: Costanza Rovida(1,2), Monica Locatelli (2) and Emanuela Corsini (3)

1 Konstanz University, CAAT-Europe, Konstanz, German; 2 TEAM Mastery srl, Como, Italy; 3 University of Milan, Department of Pharmacological and Biomolecular Sciences, Milano, Italy

 

REACH Regulation (EC 1907/2006) asks for a complete registration dossier for all substances marketed in the EU in quantity above 1 t/y. This registration dossier contains toxicological information with increasing complexity in relation to the yearly tonnage band of the registered substance. Since 2007, EU Companies have registered more than 20,000 substances to ECHA, the European Chemical Agency.

Skin sensitization endpoint is considered fundamental to guarantee safety of both workers and consumers and the assessment is mandatory for all substances, independently on the tonnage band excluding only intermediates used in low quantities and under strictly controlled conditions.

In spite of the many available guidance documents, REACH registrants have to cope with the uncertainty of using a new approach.

Through the activity of a consultancy company, there was the possibility to assess many test reports about skin sensitisation evaluation for REACH purposes and understanding the difficulties of the companies in applying in vitro methodologies.

The analysis of the final results allowed the definition of some statistics about how to use the guidance defined approach, the costs, the quality of different CROs and the examples when the in vitro strategy was not applicable.

In few cases, non standard methods were also successfully applied in a weight of evidence approach, according to the provisions of REACH Annex XI and including epidemiological data.

Acknowledgment of the hurdles in applying new approach methodologies is fundamental in improving acceptability and implementation of in vitro methods.