The testing and information requirements for the registration of substances under the REACH regulation are incomplete concerning the hazards of biopersistent, respirable particles. The Federal Institute for Occupational Safety and Health (BAuA) intends to make a proposal for the revision of REACH envisaged past 2018 and plans to establish the required preparatory work for this proposal by research and development projects. The Committee on Hazardous Substances (AGS) has stipulated in Germany an occupational exposure limit of 1.25 mg/m³ (density: 2.5 g/cm³) for granular, biopersistent dusts in the Technical Rule for Hazardous Substances (TRGS 900). This OEL applies to respirable dusts that display a non-specific toxicity and biopersistence in the lung. In an ongoing project (F 2336) in-vivo (instillation) and in-vitro methods are examined concerning their applicability to detect the biopersistence and toxicity of particles. These testing methods are completed in this supplemental project by a further already established in-vivo method (inhalation). The overall objective is the development of meaningful and preferably cost-saving testing methods for nanomaterials, advanced materials and other solid materials that can release biopersistent particles.
Unit 4.3 "Toxicology"