Methods for the determination of the hazardous properties - TSAR

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- 12 - This document was prepared from the draft paper sent for publication and is provided as informative material only. Possibility of errors cannot be excluded although care has been taken to avoid them. In case of doubt, please refer to the published paper (report EUR 18748 (1999))or contact the editors.
ECB/TM/26 rev.7 B.XX. Biopersistence of Fibres. Short Term Exposure by Inhalation 1. METHOD 1.1 INTRODUCTION See General Introduction Part B(in Annex V to Dir 67/548/EC). 1.2 DEFINITIONS 1. See General Introduction Part B in addition to the following. 2. Biopersistence: The ability of a material (fibre) to persist in the lung in spite of the lung’s physiological clearance mechanisms and environmental conditions. 3. Fibre (also referred to as fibrous particles): An object with a length to width ratio (aspect ratio) of at least 3:1. 4. WHO fibre: A fibre with a length greater than 5 µm and a diameter less than 3 µm (reference (1)). 5. Particle (also referred to as non-fibrous particles): An object with a length to width ratio of less than 3:1. 1.3 PRINCIPLE OF THE TEST METHOD The objective of this method is to assess the in-vivo pulmonary biopersistence of inhaled fibrous and nonfibrous particles in the rat following repeated exposure for 5 days. This method is designed for the evaluation of synthetic mineral fibres, however, it can be applied with appropriate modification to organic and natural fibres. This testing protocol is intended to be used as part of a tiered approach to the evaluation of fibres. This protocol evaluates the pulmonary biopersistence of fibres as a function of fibre length, however, it does not evaluate the effect of fibre diameter on human pulmonary deposition. The specific use of the clearance of fibres longer than 20 µm in length in this protocol is designed to reflect the removal of fibres by dissolution and disintegration and is considered to be analogous in both humans and rats. 1.4 DESCRIPTION OF THE TEST METHOD Laboratory rats are exposed by inhalation for 6 hours/day for 5 consecutive days to well characterised fibre test atmospheres which have been optimised to be largely rat respirable. Following the end of the exposure period, subgroups of animals are sacrificed at pre-determined intervals and the lung burden determined by suitably validated extraction and measurement methods. - 13 -
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ECB/TM/21(97) Annex 1 ECB/TM/21(97)
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Annex 2 LIST OF MEETINGS 1996 - Jul
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