Method for determining in-vitro dissolution rates of man-made vitreous fibres

A state-of-the-art method for determining the in-vitro dissolution rate of man-made vitreous fibres (MMVF) is described. The dissolution rate is determined using an artificial lung fluid, adjusted to pH values of 7.5 or of 4.5, reflecting that the dissolution in-vivo takes place both in the near-neutral lung fluid and in the acidic environment of the macrophages. The method is based on flow-through equipment and prescribes well-defined conditions using a ratio of the flow rate to surface area of 0.03 μm/s. The results obtained with this method correlate to results from in-vivo tests, and thus the method provides a tool for a comparative evaluation of the biodurability of different fibre types. The described method seems suitable to be established as a provisional standard test, until further investigations allow the definition of a final standard test. The empirically derived carcinogenicity index (KI) extrapolates the in-vitro results obtained for some fibre types at the neutral pH value to other very different fibre types. The proposed in-vitro method avoids these uncertain generalizations, as it is based on actually measured dissolution rates at pH values 7.5 and 4.5, respectively.