Workshop ReportClassification of Dermal Sensitizers in Pharmaceutical Manufacturing

Workers in pharmaceutical development are particularly at risk for occupational skin irritation and contact dermatitis, due to contacts with highly reactive intermediates (IM) and drug substances (DS). We examined, if alternative methods could replace presently used animal tests for hazard identification in pharmaceutical development and manufacturing, without apparent loss of worker safety and in line with regulations. The status of alternative methods for regulatory toxicology for consumer products such as cosmetics has recently been reviewed by the Organisation for Economic Co-operation and Development and the European Commission’s Joint Research Center for the European Chemicals Agency. They concluded that prediction of skin sensitization potential, extent and quality by in vitro methods, for regulatory assessments, will depend on the regulatory purpose and the level of confidence required. Some alternative methods are currently in validation. Current Globally Harmonized System regulations on classification, labelling and packaging of substances and mixtures depend on human data and animal tests, whereas alternative methods may provide supportive evidence. Since the levels of workplace skin exposure to DS and IM in pharmaceutical manufacturing and research labs are usually not known, it is not possible to conduct a quantitative risk assessments based on threshold calculations for contact sensitizers.