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

• Published in: Regulatory toxicology and pharmacology 2023-08, Vol.142, p.105426-105426, Article 105426
• Main Authors: Carnesecchi, Edoardo, Langezaal, Ingrid, Browne, Patience, Batista-Leite, Sofia, Campia, Ivana, Coecke, Sandra, Dagallier, Bertrand, Deceuninck, Pierre, Dorne, Jean Lou CM, Tarazona, Jose V., Le Goff, Francois, Leinala, Eeva, Morath, Siegfried, Munn, Sharon, Richardson, Jane, Paini, Alicia, Wittwehr, Clemens
• Format: Article
• Language: English
• Subjects: Adverse outcome pathway; Chemical risk assessment; Chemical strategy for sustainability; Data model; Humans; Mechanistic information; New approach methodologies; OECD Harmonised templates; OHT 201; Organisation for Economic Co-Operation and Development; Risk Assessment - methods; Skin; Structured data
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1016/j.yrtph.2023.105426

In the European Union, the Chemicals 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 a basis for chemical risk assessment is necessary. Harmonising data reporting is crucial when aiming at re-using and sharing data for chemical risk assessment across jurisdictions. The OECD has 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 (e.g., toxicokinetics, skin sensitisation, repeated dose toxicity) and the environment (e.g., toxicity to test species and wildlife, biodegradation in soil, metabolism of residues in crops). 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 on the use of OHT 201, in particular to report test results on intermediate effects and mechanistic information. •Standardisation of data reporting is crucial in chemical risk assessment and management.•OHTs ensure harmonised hazard data collection, reporting and dissemination.•OHT 201 allows structuring mechanistic information for regulatory decision making.