OECD harmonised template 201: Structuring and reporting mechanistic information to foster the integration of new approach methodologies for hazard and risk assessment of chemicals

In the EU, the Chemical Strategy for Sustainability (CSS) highlights the need to enhance the identification and assessment of substances of concern while reducing animal testing, thus fostering the development and use of New Approach Methodologies (NAMs) such as in silico, in vitro and in chemico. In the United States the Tox21 strategy aims at shifting toxicological assessments away from traditional animal studies towards target-specific, mechanism-based and biological observations mainly obtained by using NAMs. Many other jurisdictions around the world are also increasing the use of NAMs. Hence, the provision of dedicated non-animal toxicological data and reporting formats as basis for the (regulatory) risk assessment of chemicals is necessary, and also foreseen. The OECD has therefore developed a series of OECD Harmonised Templates (OHT), which are standard data formats designed for reporting information used for the risk assessment of chemicals relevant to their intrinsic properties, including effects on human health and the environment. The objective of this paper is to demonstrate the applicability of the OHT standard format for reporting information under various chemical risk assessment regimes, and to provide users with practical guidance, especially for using OHT 201, the template specifically designed to report test results on intermediate effects and mechanistic information.

CARNESECCHI Edoardo;  LANGEZAAL Ingrid;  BROWNE Patience;  BATISTA LEITE Sofia;  CAMPIA Ivana;  COECKE Sandra;  DAGALLIER Bertrand;  DECEUNINCK Pierre;  DORNE Jean-Lou;  TARAZONA Jose;  LE GOFF François;  LEINALA Eeva;  MORATH Siegfried;  MUNN Sharon;  RICHARDSON Jane;  PAINI Alicia;  WITTWEHR Clemens; 

2023-06-21

ACADEMIC PRESS INC ELSEVIER SCIENCE

JRC131552

0273-2300 (online),   

https://www.sciencedirect.com/science/article/pii/S0273230023000946,    https://publications.jrc.ec.europa.eu/repository/handle/JRC131552,   

10.1016/j.yrtph.2023.105426 (online),