Data gathering, literature searches and evaluation
- In the registration dossier, all relevant and reliable data on a specific substance shall be considered. This includes, e.g.
- Physico-chemical data and analytical methods
- Ecotoxicity, environmental fate data
- Toxicity data obtained from animal testing
- Human clinical and epidemiological data
- Exposure data, such as workplace air monitoring and emissions to ambient air or water
- Therefore, initially the proprietary data held by the client (e.g. in-house study reports) is collected and archived. In addition, publicly and commercially available sources are searched for physico-chemical, toxicological and ecotoxicological properties. These sources include bibliographic databases and factual handbooks, as well as data published by national and international authorities and chemical review programmes, such as OECD, WHO, ATSDR, IARC, etc.
- Based on these sources, all relevant data are identified and then subjected to a quality and reliability assessment, in accordance with REACH guidance documents.
Full copies, for example of scientific publications, are obtained and archived.