Workability of the guidance documents for the category or read-across approach for selected groups of chemicals
Bruikbaarheid van richtsnoeren voor categorie- of read-crossbenaderingen voor geselecteerde groepen van chemicalien
26 May 2012, PDF |
89 pages |
Rila JP, Bos PMJ, Hulzebos E, Hakkert BC
RIVM Report 601200009
The current international guidance documents for performing a group-based assessment of the possible risks caused by chemical substances with comparable structures need further elucidation if they are to be properly used. This was the result of RIVM research on the workability of guidance documents. This research was prompted by the upcoming European legislation on production, trade and use of chemical substances (REACH), which will come into force in mid-2007. This legislation stipulates that about 30,000 chemical substances are to be assessed on their possible risks. Several non-animal methods such as QSARs, in vitro methods and the category or read-across approach have been developed to assess this large number of chemicals. The physico-chemical and toxicological properties are only known for a minority of all chemical substances. These may for example include skin irritation, water solubility and degradation in the environment. The category or read-across approach uses available substance information to be able to assess chemical substances with comparable structures for which only few data are available. The current guidance document for this approach can be used as a basis, but several points still need more attention in the further development of the guidance document for REACH. One point of particular interest is establishing a clear definition of the categories for use in the read-across approach to avoid comparing unequal data. Data substantiated and clearly presented for this approach highly define the usefulness of this new system.