ClassificationandLabellingofSurfactants.docVIP

Classification and Labelling of Surfactants for human health hazards according to the Dangerous Substances Directive CESIO recommendations for Anionic and Non-ionic surfactants (including 1990 recommendations on Quaternary Ammonium Compounds and Fatty Amines and Derivatives) January 2000Introduction On two separate occasions during the 1980’s, CESIO reviewed company reports of toxicology studies on marketed surfactants to provide guidance for classification and labelling in line with the requirements of Annex VI of the Dangerous Substances Directive [DSD] (1). By reviewing all available experimental results, CESIO believed that “weight of evidence” enabled them to provide the most accurate guidance. The first of these reviews was reported in 1984 (2). At this time many of the studies had not been conducted strictly according to developing OECD/EC guidelines (3, 4-Annex V) and for that reason, a second review was undertaken several years later. This was completed in 1990 (5). For both reviews, surfactants were grouped into 4 categories (anionics [for convenience this group also contained 3 amphoteric categories], non-ionics, quaternary ammonium compounds and fatty amines and their derivatives) and several sub-categories on the basis of their chemical and physical properties. Acute oral toxicity, skin and eye irritation and skin sensitisation studies were reviewed by an expert task force (TF) and recommendations for classification and labelling were made. In 1993, the European Union revised their criteria for classification and labelling of substances and preparations based on their potential to cause ocular lesions (6). Two of these new criteria are very specific for the use of risk phrase R41 (Risk of serious damage to eyes). Additionally, in 1995 new experimental data on the irritation potential of several surfactant raw materials became available, which were considered to be of value for a further refinement of the classification and labelling recommendations