Technical Report

TR 066 – Skin Irritation and Corrosion: Reference Chemicals Data Bank

TR 066 : Skin Irritation and Corrosion: Reference Chemicals Data Bank | March 1995

Earlier ECETOC has published comprehensive listing of in vivo rabbit eye irritation data for 55 readily-available chemicals of high purity. The establishment of such a data bank allows investigators of in vitro or alternative methods to evaluate their own techniques without the need to carry out in vivo testing of the reference chemicals.

A companion data bank has now been developed for 176 chemicals for which comprehensive rabbit skin irritation/corrosion data are available. No new in vivotesting has been carried out to qualify a chemical for inclusion in this list. The 176 chemicals selected are readily available at high and consistent purity and are expected to be stable on storage. They have been tested undiluted in in vivostudies, excepting those chemicals where high concentrations of the substance could be expected to cause severe effects. The in vivo data have been generated since 1981 in studies carried out according to OECD Test Guideline 404 and following the principles of Good Laboratory Practice. The data presented were obtained from tests normally using at least three rabbits, involving application of 0.5ml (or 0.5g) to the flank under semi-occlusive patches and in which observations were made at least 24, 48, and 72 hours after application.

The chemicals represent a range of chemical classes (acids, acrylates/methacrylates, alcohols, aldehydes, alkalis, amides, amines, brominated derivatives, chlorinated solvents, esters, ethers, fatty acids and mixtures, fragrance oils, halogenated aromatics, hydrocarbons (unsaturated), inorganics, ketones, nitriles, phenolic derivatives, S-containing compounds, soaps/surfactants, triglycerides) and different degrees of irritancy. The chemicals are ranked for skin irritation potential on the basis of a 'primary irritation index'. They should be of use in validation tests of promising alternatives to the in vivo rabbit skin irritation/corrosion test. This is an essential step in the progression to regulatory acceptance.

Classification schemes for chemicals on the basis of their skin irritation/corrosion properties are appended to the report for the convenience of readers.