Monograph 032 – Use of Human Data in Hazard Classification for Irritation and Sensitisation


Mono 032 : Use of Human Data in Hazard Classification for Irritation and Sensitisation | July 2002

Reference to the use of human data is made throughout the European legislation relating to the classification and labelling, as well as risk assessment, of substances and preparations. In addition, relevance of animal test results to man is mentioned. However, no guidance is given on what constitutes acceptable human data. The primary purpose of this report is to provide such guidance and to propose how human data may be used in decisions on the classification of irritation and sensitisation effects and when it may be more appropriate than other data. The provisions in European law for the use of human data are reviewed in Section 2 and Appendix A. In the context of skin, eye and respiratory irritation, and skin and respiratory sensitisation, the classification of a substance or preparation based on consideration of adequate human data may be different from that based only on animal data. Specific examples are described in Section 3 and Appendix B where the classification of substances and preparations appears to be more soundly based when human data are taken into account. Indeed, human data might lead ultimately to a more accurate risk assessment. Human data fall into two main classes, observational and experimental. Section 4 lists the various types of data that may be used for classification purposes and gives guidance on factors which influence their quality. Outline protocols for experimental studies on skin irritation and skin sensitisation are presented. The criteria governing the possible use of such data in the classification process are addressed in Section 5. The Task Force proposes classification criteria based on human data for each endpoint considered (skin, eye and respiratory irritation, skin and respiratory sensitisation). In the context of this report, human clinical studies may be undertaken where there is a perceived need to develop an improved understanding of irritation and sensitisation effects. For chemicals and preparations where skin contact is unavoidable, human data has the potential to provide the most accurate information in terms of hazard and risk assessment. Classification and labelling are based currently on the inherent hazard of a chemical substance or preparation. The proposal is made that, in the future, at least labelling should be based on risk assessment and reflect risk rather than hazard. It is suggested that discussions on the global harmonisation of classification and labelling systems should provide the opportunity inter alia to incorporate quality criteria for the use of human data. The Task Force recommends that human data of good quality should always be taken into account in classification and risk assessment decisions.