Summary, Miljøstyrelsen

Report on the Advisory list for selfclassification of dangerous substances

Summary

This report features a description of the Danish Environmental Protection Agency's (EPA) Advisory list for selfclassification of dangerous substances. The substances have been identified by means of computer models, so-called QSAR models (Quantitative Structure-Activity Relationship). The list is intended as an aid to producers / importers in their selfclassification.

Part I of this report features a description of the background of the list, its contents, and its application. Part II comprises a technical description of the QSAR models used, the creation of the list, and its relationship to the criteria for classification of selected dangerous properties. The list can be found on the Danish EPA's homepage ( www.mst.dk ) under the heading "chemicals".

With the aid of QSAR models, the Danish EPA has examined approximately 47,000 chemical substances, identifying 20,624 substances which are deemed to require classification for one or more of the following dangerous properties: Acute oral toxicity, sensitization by skin contact, mutagenicity, carcinogenicity, and danger to the aquatic environment.

According to classification criteria, classification should be carried out on the basis of the knowledge available, which is most often from the results of laboratory tests on animals. However, in the experience of the Danish EPA, manufacturers / importers find it difficult to comply with their duty to assess whether a substance they wish to introduce to the market should be classified because of lack of available data. The fact is that only very little information is available on the dangerous properties of chemical substances. The Danish EPA estimates that for approximately 90 per cent of all substances, only few or no test results from animal testing etc. are available on any dangerous properties to humans or the environment.

In addition to results from animal testing, the criteria for classification also provide opportunities for using alternative methods. This could for instance be studies which do not require the use of laboratory animals, but are based on comparisons with other similar chemicals by so-called structure-activity relationships.

QSAR modelling is such an alternative method to assess the potential danger of chemical substances. For several years now, the Danish EPA has carried out work to develop and apply QSAR models in order to predict the properties of chemical substances. The models used here are now so reliable that they are able to predict whether a given substance has one or more of the properties selected with an accuracy of approximately 70-85 per cent.

In spite of the general lack of data, reliable information on the dangerous properties of substances from suitable animal testing, etc. might be available for some substances found in the Advisory list for selfclassification of dangerous substances. To the extent that this is the case, such information should be employed for selfclassification in preference to the recommendations of this list.

It should be emphasized that the list is not binding. The responsibility for carrying out correct classification still rests with the manufacturer / importer. The Danish EPA calls upon importers/manufacturers to use the Advisory list for selfclassification of dangerous substances as a tool in their assessment of the dangerous properties of chemicals in cases of insufficient or no data for the selected dangerous properties.