Evaluation des produits chimiques

Electronic Tools for Data Submission, Evaluation and Exchange in the OECD Cooperative Chemicals Assessment Programme

 

 

The main electronic tool for data submission, evaluation and exchange used in the OECD Cooperative Chemicals Assessment Programme is the International Uniform Chemical Information Database (IUCLID). IUCLID is a software program for the administration of data on chemical substances. This database program was originally developed to fulfill requirements in the EU for the evaluation and control of the risks of existing chemical substances.

IUCLID has been designed for entering and storing in a relational database the information on the properties of substances in an agreed upon format. It can generate reports from information entered into the database in formats suitable to meet the reporting requirements of the OECD Cooperative Chemicals Assessment Programme, the USEPA HPV Chemical Challenge Program, the EU REACH, the EU Biocides Programme and the Japan HPV Challenge Program.

The properties that IUCLID is capable of compiling include among others:

  • General information (e.g. chemical name, CAS No., synonyms, impurities, additives)
  • Physical-chemical data (e.g. melting point, density)
  • Environmental fate and pathways (e.g. photodegradation, distribution, biodegradation)
  • Ecotoxicity (e.g. acute/prolonged toxicity to fish, chronic toxicity to fish)
  • Toxicity (e.g. acute toxicity to mammals, sensitisation, carcinogenicity)

The IUCLID software is the preferred tool for entering data and developing a SIDS Dossier in the OECD Cooperative Chemicals Assessment Programme.

The fifth version of IUCLID is curently available free of charge from the following web site: http://iuclid.eu

The use of the IUCLID software has several advantages which are specifically relevant in the context of an international programme for the initial assessment of chemical substances:

1) Harmonised Templates

IUCLID 5 is the first database system that has implemented the OECD Harmonised Templates.

The OECD Harmonised Templates are standard data formats for reporting results of studies with chemicals in order to determine their properties and effects on human health and the environment.

2) Data exchangeability

IUCLID allows full exchangeability of datasets between all users of the IUCLID software. As the IUCLID software is the recommended or accepted software for data submission in several chemical review programmes (OECD Cooperative Chemicals Assessment Programme, EU REACH, EU Biocides Review Programme, US HPV Challenge Program, Japan Challenge Program), data for substances covered by several programmes will only need to be gathered once.

In order to ensure that data on a substance manufactured or used by a number of companies does not have to be entered by each company individually, IUCLID makes it possible to exchange datasets between the various users. Companies in a consortium may also merge data from various sources into a single dataset. This allows for several users to work on different endpoints of the dataset for the same substance without having to worry about formatting issues. IUCLID makes it possible to group chemical substances into groups of related chemicals, called chemical categories, in order to facilitate the assessment of related chemicals together as one group.

3) Local data repository with tailored output

Each single user installation of IUCLID e.g. within a chemical company, can be used as a local data repository for all information on chemicals produced or handled by that company. IUCLID allows for tailored output which makes it possible to submit different dossiers for the same substance according to the specific requirements of different legislative systems.

4) Import into the QSAR Toolbox

Any data stored in a IUCLID installation can be imported into the OECD QSAR Toolbox and used for the formation of chemical categories and read-across.

5) Database functions

The IUCLID software sustains search facilities allowing interrogation of almost any aspect on substances within the database.

The main actors for the development, dissemination and promotion of IUCLID are the European Chemicals Agency (ECHA) and to some extent the OECD. Each have very specific roles.

1) The European Chemicals Agency (ECHA)

IUCLID is maintained under the responsibility of the European Chemicals Agency (ECHA).

The current version is IUCLID 5. It is distributed free of charge.[see http://iuclid.eu]

2) OECD

The OECD recommends the use of the IUCLID software for the elaboration of datasets for chemicals to be assessed within the OECD Cooperative Chemicals Assessment Programme. The OECD has also established, in collaboration with the ECHA, the IUCLID User Group Expert Panel, whose aim is to promote and facilitate the use of IUCLID in OECD member countries (see below).

The IUCLID User Group Expert Panel was established in 1999 to provide a catalyst for the further development of IUCLID. In 2002, the work was shifted towards user needs. Members of the Expert Panel are experts in toxicology, ecotoxicology and environmental behaviour from member countries and industry, who use IUCLID for elaborating and reviewing data sets for chemical substances within the OECD Cooperative Chemicals Assessment Programme or other chemical review programmes.

The aim of the Expert Panel is to:

1. Improve guidance documents for users for entering data into IUCLID.
2. Develop training course material for instructing new users of the IUCLID software.
3. Improve the user friendliness of the IUCLID software system.

Questions and suggestions on the above issues can be submitted to ehscont@oecd.org

IUCLID files (in export formats) for datasets elaborated under the OECD Cooperative Chemicals Assessment Programme with the IUCLID software are publicly available from the OECD Existing Chemicals Database.

The IUCLID files (in export format) for datasets which were submitted to the former European Chemicals Bureau in the context of the EU Existing Substances Regulation are available through the European Chemical Substances Information System (ESIS). These datasets are also available in PDF format through the same website.

 

 

 

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