A simplified index to quantify the irritation/corrosion potential of chemicals - Part I: Skin.

Abstract

Skin irritation is a key human health endpoint assessed by in vitro and in vivo methods. The OECD TG 404 guideline (in vivo) is based on erythema and oedema translated semi-quantitatively into Draize scores, providing hazard statements for substance classification following EUCLP/UNGHS criteria. Draize scores require quantitation from subjective in vivo observations, to obtain a scoring index, the Primary Irritation Index (PII). However, it is not recognised under REACH due to translating difficulties, notably the cut-off limit for classification and non-inclusion of corrosive effects. The aim of this study was to determine if classification can be driven by just one of the observed effects, erythema only, to create a Simplified Irritation Index (SIISKIN). This simplifies the scoring calculation and reduces subjectivity. A quantitative approach with cut-off limits is thus proposed for classification. Substances can be classified as non-irritant, potentially irritant, irritant, or corrosive. The Simplifed Irritation Index (SIISKIN) is based on validated studies, representing multiple chemical groups. A significant correlation between SIISKIN and the harmonised classification was observed, and a proportionate relationship between the SIISKIN and the corresponding PII. The index proved to be useful in the development of an in silico model.