SKIN IRRITATION - REFERENCE CHEMICALS DATA-BANK

A list of 176 chemicals, all of high or consistent purity and stable o n storage, has been developed using available comprehensive in vivo ra bbit skin irritation data. No new in vivo testing was conducted to qua lify a chemical for inclusion in the list. The chemicals were tested u ndiluted in in vitro studies, apart from those chemicals where high co ncentrations could be expected to cause severe effects. The in vivo da ta were generated in studies carried out since 1981 according to OECD Test Guideline 404 and following the principles of Good Laboratory Pra ctice. The data were obtained from tests normally using at least three rabbits evaluated at the same time, involving application of 0.5 g or 0.5 ml to the flank under semi-occlusive patches for 4 hr, and in whi ch observations were made at least 24, 48 and 72 hr after removal of t he patch. The chemicals represent a range of chemical classes [acids, acrylates/methacrylates, alcohols, aldehydes, alkalis, amines, bromina ted derivatives, chlorinated solvents, esters, ethers, fatty acids and mixtures, fragrance oils, halogenated aromatics, hydrocarbons (unsatu rated), inorganics, ketones, nitriles, phenolic derivatives, S-contain ing compounds, soaps/surfactants, triglycerides] and different degrees of irritancy. They are ranked for skin irritation potential on the ba sis of a 'primary irritation index'. These chemicals could be used in validation tests of promising alternatives to the in vivo rabbit skin irritation/corrosion test. This is an essential step in the progressio n to regulatory acceptance of alternative procedures.