title: Some thoughts on a possible regulatory approach at EEC level on the classification and labeling of dangerous preparations.
abstract: At the present time no European directives on classification, packaging, and labeling exist which cover all dangerous preparations of chemicals. To develop such a directive, the Commission of the European Economic Community services, at the request of and in close collaboration with experts of the member states, has conceived a method for evaluating the toxicity of mixtures of chemicals. This method consists of (a) the characterization of each constituent by means of an index and (b) the classification of preparations for each route of administration on the basis of their toxicity. The index is a figure representing the degree of dilution needed to render the substance not dangerous in the sense of the EEC Directives on the classification of dangerous substances; the highest index among those obtained for acute and chronic toxicity is taken to characterize the substances. An indication of toxicity is obtained by applying the simple equation sigma (P X I), where P is the percentage and I is the index of each constituent. The most stringent classification among those obtained for the three routes of administration is taken for the final classification of the preparation on the basis of its acute and chronic toxicity. Other toxicological effects such as irritation, corrosion, sensitization, mutagenesis, teratogenesis, and carcinogenesis are not considered.
mesh_terms: D000818:Animals; D004304:Dosage Forms; D004348:Drug Labeling; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D007928:Lethal Dose 50; D008433:Mathematics; D014116:Toxicology
chemical_list: D004304:Dosage Forms