The OECD Harmonised Templates (OHTs) are standard data formats for reporting information on chemicals to determine their properties or effects on human health and the environment (e.g. toxicokinetics, skin irritation, repeated dose toxicity, biodegradation in soil, metabolism of residues in crops, etc.) and also to describe their use and related exposure to workers, consumers and the environment. They can be used as specifications for data entry screens in data management systems (e.g. IUCLID). Data elements, which could be relevant for the risk assessment of chemicals, are listed as well as the format in which the information should be entered and stored electronically, together with field-specific help texts intended to guide end users.

The OHTs constitute harmonised tools that are useful to developers and maintainers of databases on chemicals. Harmonisation in this context means that these templates can be used as models for reporting studies and other information on any type of chemicals (e.g. pesticides, biocides, industrial chemicals, food/feed additives).

In 2023, the OECD format harmonisation scope was extended to incorporate OECD Harmonised Endpoint Summaries, making them an integral part of the OHTs suite of templates. This format was originally developed in IUCLID in the context of EU REACH to offer a generic way to summarise information at endpoint level. The usage of this format was extended to other regulations and jurisdictions e.g. EU BPR, EU PPP, New Zealand HSNO and Australia AICIS legislations. To date, there are over 100 Harmonised Endpoint Summary formats.

As the templates are intended to serve as standard formats for summarising data contained in any study report or publication related to particular endpoints, including studies that were not conducted according to current guidelines, they are designed in a very flexible way. This includes:

• structured elements (i.e. fields, picklist items, freetext prompts, predefined tables and executive summaries) 
• picklists for specific test guidelines which contain the most often cited guidelines
• help texts and guidance notes which explain what kind of data entry is expected in a given field, but do not necessarily indicate whether the corresponding data are requested by any test guideline. However, most templates are nevertheless built around the OECD Test Guidelines, as these are internationally agreed standards.

The OECD Harmonised Templates allow for providing administrative data, stating the endpoint addressed by the study summary, describing the materials and methods used during the test, reporting the results and their possible discussion, delivering the applicant’s summary and conclusion. It is also possible to make overall remarks and to attach background materials that can be useful to the end users.

Not always. The degree of complexity used in these templates follows the needs of the key study / robust study summary approach. The fields provided should be considered as a maximum degree of detail. It is generally accepted that much less details are needed in case of study summaries (compared to robust study summaries).

In addition, some templates being designed to cover several test methods dealing with the same endpoint, only a part of the template might be useful for reporting summaries of studies performed according to a single method.

The endpoint-oriented templates constitute the core of the set of the available OHTs, targeted to specific hazards assessment and/or given test methods.

Beside them, other types of templates are complementary: the OHTs on physico-chemical properties are designed to characterise the chemical being studied, including nanomaterial properties where applicable.

The template No.201 on ‘Intermediate effects’, allows to report non-apical observations, i.e. intermediate effects at molecular, subcellular, cell, tissue or organ level which can be relevant when studying the hazard posed by a compound.

The series of OHTs on Use and exposure information (OHTs 301 to 306) enables to report on another range of information such as the life cycle of the substance, its uses and service life, as well as the conditions of use, releases and exposures to the substance.

Other templates are being developed to fit with new testing methods and cover emerging needs, and the series of OHTs is regularly enriched with new templates.

Yes, specific language for databases is made available. By using the OECD Harmonised Templates, governments and industry are able to electronically exchange test study summary information. In order for information technology developers to build data entry screens and/or database systems based on the OHTs, each template has to have a corresponding XML structure. An XML (Extensible Mark-up Language) schema, or export format, is a common computer language which facilitates the electronic exchange of data across different computer systems for data entry, storage and management. 

Yes, it is. IUCLID, the International Uniform ChemicaL Information Database developed by the European Chemicals Agency (ECHA), is the first system that implemented completely the OECD Harmonised Templates. Information compiled in IUCLID can be exchanged with other databases that use the same OHTs XML schemas, even if the underlying computer systems are different. By using IUCLID functionalities and reporting a large range of chemical test summaries in the system, IUCLID users are regularly identifying gaps or elements that could be improved in the OHTs.

IUCLID is a computer software that is available for free download from the ECHA website. The latest version includes the most recent templates.

For an overview of IUCLID features and how IUCLID can be configured and customised to manage chemical data in different contexts, see Customisation Opportunities of IUCLID for the Management of Chemical Data, Third edition in the OECD Series on Testing and Assessment.

The specifications of the OECD Harmonised Templates (OHTs) are made available as Word documents in order to provide the user with a readable version (the developers’ specifications being made available as XML schema definition documents). This also facilitates the review and commenting process by experts when preparing future updates of the templates.

The OHTs’ specifications are identified with a title shown at the top of each OHT Word document, providing the following information: <OHT number> - <OHT name>_<version number> -<version date>

Compared to the initial structure of the templates, the new version published in 2016 was simplified. Each OHT is now presented in six columns:

Column 1: Line no:
Each element of template definition is presented in a row. For facilitating the review of the document, each row is identified by a line number.

Column 2: Field name:
Contains the label of the field, section heading or table title, in the user interface developed by software provider.

Column 3: Field type / Display type:

• Field type: Shows the type of the element added to the user interface. Possible content can be, for example, confidentiality flag, header level, picklist with remarks, check box, text field.
• Display type: Two display levels are defined for the OHTs: ‘Basic’, and ‘Detailed’. This is used to differentiate fields that are relevant to study summaries in the first case, and to robust study summaries in the latter case.

Column 4: Picklist / Freetext template:
Contains, where relevant, the content of the agreed picklists (list of values proposed to user’s choice) and/or free text templates which are suggested for completion by the user in order to to facilitate the comprehensive description of the element considered.

Column 5: Help text:
Contains the guidance for the user to help the understanding of the purpose of the field, and give recommendations on how to fill-in relevant information.

Column 6: Remarks / Guidance / Cross-reference:
Contains different types of information, such as:

• Guidance for field condition: This proposes to software provider to implement some field conditions in order to facilitate data entry.
• Cross-reference: When a field contains a link to another piece of information (e.g. another document), the type of information is specified.
• Guidance for data migration: This proposes to software provider to implement field content migration from the previous version of the OHT.

Also contains any other remarks related to the element considered.