TY - CONF A1 - Schwirn, K. A1 - Völker, D. A1 - Ahtiainen, J. A1 - Schmidt, Alexandra A1 - Bresch, Harald A1 - Kämpf, K. A1 - Bachmann, V. A1 - Kuhlbusch, T. T1 - OECD Test Guidelines development for chemicals safety assessment of nanomaterials N2 - The OECD test guidelines (TGs) for testing chemicals have been widely used for regulatory purposes all over the world since the establishment of the Mutual Acceptance of Data (MAD) principle in 1984. This MAD principle ensures that, if a chemical is tested under the Good Laboratory Practice (GLP) conditions accordingly to an OECD TG, the data should be accepted in all OECD countries. The TGs have been developed, harmonized, internationally validated (round robin tests) and adopted by OECD countries to be used for the physical-chemical characterisation, fate estimation, and hazard identification for risk assessment of various chemicals. In addition to the TGs, OECD Guidance Documents (GDs) usually provide guidance on how to use TGs and how to interpret the results. These GDs do not have to be fully experimentally validated, and hence they are not under MAD, but they are based on relevant published scientific research. But are the existing TGs and the related GDs applicable and adequate for the regulatory testing of nanomaterials? In general, it is accepted that most of the "endpoints" or more precisely measurement variables are applicable also for nanomaterials. However, for some endpoints new or amended TGs are needed. In addition, several GDs are needed to give more precise advice on the test performance in order to gain regulatory relevant data on nanomaterials. The poster will present the status quo on recent TGs and GDs development for nanomaterials at OECD level with relevance for physical-chemical characterisation. Emphasis will be given to the proposed OECD TG on particle size and size distribution for manufactured nanomaterials. The development of such a TG is of special importance as particle size and size distribution is considered as major information for nanomaterial identification and characterization. A reliable and reproducible characterisation of particle size and size distribution is also needed for chemicals risk assessment of nanomaterials, for instance to interpret and compare test results and - in future – to forecast interaction and effects of nanomaterials. The presented poster will illustrate the way from the idea for a new TG and new GD to an accepted OECD TG/GD. T2 - BAM-PTB Workshop 2018 CY - Berlin, Germany DA - 14.05.2018 KW - Nano KW - OECD KW - Nanomaterials KW - Test Guideline KW - Prüfrichtlinie PY - 2018 AN - OPUS4-45108 LA - eng AD - Bundesanstalt fuer Materialforschung und -pruefung (BAM), Berlin, Germany ER - TY - CONF A1 - Kämpf, K. A1 - Schmidt, Alexandra A1 - Bresch, Harald A1 - Bachmann, V. A1 - Kuhlbusch, T. A1 - Schwirn, K. A1 - Völker, D. T1 - Test Guideline on Particle Size and Size Distribution of Manufactured Nanomaterials N2 - The particle size distribution is considered the most relevant information for nanoscale property identification and material characterization. The current OECD test guideline on particle size and size distribution (TG 110) is not applicable to ‘nano-sized’ objects. In this project we thus develop a new OECD test guideline for the measurement of the size and size distribution of particles and fibers with at least one dimension in the nanoscale. A fiber is defined as an object having an aspect ratio of length/diameter l/d >3. The width and length of each fiber should be measured concurrently. In order to measure the particle size distributions, many techniques are available. 9 methods for particles and 2 methods for fibres have been tested in a prevalidation study and appropriate methods will be compared in an interlaboratory round robin test starting in February 2019. T2 - Workshop zur gemeinsamen Forschungsstrategie der Bundesoberbehörden „Nanomaterialien und andere innovative Werkstoffe: anwendungssicher und umweltverträglich“ CY - Berlin, Germany DA - 02.09.2019 KW - OECD KW - Nano KW - Guideline KW - Particle size distributuion KW - Prüfrichtlinie PY - 2019 AN - OPUS4-49507 LA - eng AD - Bundesanstalt fuer Materialforschung und -pruefung (BAM), Berlin, Germany ER -