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IUCLID – Reusable entities
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Use this section to learn how to create and manage reusable entities in IUCLID, such as legal entities, contacts, sites and reference substances.
Reusable entities allow you to enter information once and reuse it across multiple documents and datasets. Set these up early to reduce duplication and maintain consistency in your application.
What is a reusable entity in IUCLID?
Reusable entities are reference data that you can create and store in IUCLID. Once you create them, you can select and link these entities wherever they are required in your dataset.
You can create entities:
- while completing a substance dataset under Substances
- directly in the Inventory manager.
What is the Inventory manager?
The Inventory manager is where you create and manage reusable reference data (such as legal entities, sites and contacts) that your substance dataset will use.
In simple terms, it holds the ‘who, where and what’ information that substance datasets point to.
How to access the Inventory manager
Links to the Inventory manager appear under Substances on the dashboard menu from the IUCLID home page.
How to use Inventory manager to help you complete your dossier
The following examples show how the Inventory manager supports data entry in IUCLID:
Example 1 – Sites
You may have several manufacturing sites in Australia, but not all sites manufacture the substance in your application. By creating site entities in the Inventory manager, you can select only the relevant sites when completing your exposure information.
Example 2 – Literature references
Some study reports contain results for multiple endpoints. By creating a literature reference once, you can link it to multiple documents and sections within a substance dataset (for example, across different physical and chemical property endpoints).
What you manage in the Inventory manager
The Inventory manager has these entities:
Contact
Use contact entities to store details for people involved in the application, such as:
- applicants (business contacts)
- chemical data providers (application contacts)
- agents.
The IUCLID contact type list includes:
- competent person responsible for the safety data sheets (SDS)
- emergency contact
- substance manager
- toxicologist
- other.
For AICIS purposes, select Other and enter the appropriate AICIS contact role (for example, business contact, application contact, agent, chemical data provider).
You can link contact entities in Section 1.1 Identification, under Contact information.
Legal entity
Legal entities represent the businesses involved in the application.
Use to create legal entity entries under Section 1.1 Identification:
- select company if your business is the applicant
- select third party if your business is acting as an agent or chemical data provider.
You do not need to complete:
- Legal entity identifiers
- Other IT systems identifiers.
For Regulatory programme identifiers, select Other for AICIS.
Sites
- Site entities are relevant for Australian manufacturers.
- A substance can be manufactured at multiple sites.
- A site can manufacture more than one substance.
You can link sites under Section 3.3 Sites when completing Manufacture, use and exposure information.
Reference substance
Reference substance stores basic, and relatively constant information about a substance. For example, chemical name and molecular weight.
Test material
Test material stores information about variations of the substance, such as purity or concentration.
You can link each reference substance to one or more test materials for reuse across multiple substance datasets.
Literature reference
Literature references store documents and reports that support the information in your dataset.
To create a literature reference, you must:
- provide at least the document title
- complete the relevant fields.
You can upload attachments such as PDF and DOCX files to a literature reference.
How Inventory manager data is used in your application
- The entities in the Inventory manager are set up once, then reused.
- Most users will interact with it before or alongside creating documents within the substance datasets.
- Substance (chemical) datasets created under Substances will reference data held in the Inventory manager.
You do not generally submit Inventory manager data on its own. It is included automatically when you link it to a substance dataset.