technical guidance documents - Institute for Health and Consumer ...
technical guidance documents - Institute for Health and Consumer ...
technical guidance documents - Institute for Health and Consumer ...
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Derivation of the PNEC<br />
APPENDIX VIII<br />
PNECs can be derived through the application of assessment factors on the basis of the available<br />
data assessed according to the criteria given above. St<strong>and</strong>ard methods applied elsewhere (e.g. <strong>for</strong><br />
organic compounds) can be used <strong>for</strong> this (see Sections 3.3/3.7 of the main text). However,<br />
because of the specific mode of action that metals may have <strong>for</strong> some species, care should be<br />
taken in extrapolating short-term toxicity data to the PNEC using the st<strong>and</strong>ard assessment factors<br />
in Section 3.3. For many metals sufficient long-term toxicity data <strong>for</strong> aquatic organisms may be<br />
present to enable statistical extrapolation, results of which can support the results of PNECs<br />
calculated using assessment factors.<br />
Calculated PNECs derived <strong>for</strong> essential metals may not be lower than natural background<br />
concentrations.<br />
A prerequisite <strong>for</strong> the derivation of the PNEC is that it is done on the basis of the same level of<br />
availability as in exposure assessment:<br />
Results from aquatic toxicity tests are usually expressed as total concentrations. As a first<br />
approach total concentrations have to be recalculated to dissolved concentrations using partition<br />
coefficients. If this is not possible, the total concentration can be set equal to the dissolved<br />
concentration. Differences in test systems, e.g. (semi-)static versus continuous flow systems <strong>and</strong><br />
natural versus st<strong>and</strong>ard water, have to be considered;<br />
For the terrestrial compartment many data exist, but most are only expressed as total<br />
concentration that has been added to the test media. This added amount will be partitioned<br />
among the aqueous <strong>and</strong> the solid phase. Application of partition coefficients to calculate the<br />
available concentration in soil can be applied. Soil type correction, using reference lines should<br />
be applied to correct <strong>for</strong> differences among soil types (see also Section 3.6.2 of the main text).<br />
In future risk assessment <strong>for</strong> the terrestrial compartment one should be aware of the different<br />
routes of exposure that exist among terrestrial species: <strong>for</strong> species that are not exposed through<br />
the aqueous phase, the (physico-chemically) available fraction needs not be correlated to the<br />
bioavailability;<br />
Some of the metals are essential metals, having a function in biological processes at low<br />
concentrations. Shortage of micronutrients may cause malfunction. This implies that in setting<br />
the PNEC in<strong>for</strong>mation on deficiency levels should be taken into account. It should, however, be<br />
noted that often no in<strong>for</strong>mation on deficiency levels of various metals <strong>for</strong> various species is<br />
available.<br />
Though some exceptions exist, in general ionic metal species are considered to be the dominant<br />
metal species taken up, <strong>and</strong> are thus considered to be the metal species responsible <strong>for</strong> the toxic<br />
effect. Data on the concentration of ionic species in aquatic <strong>and</strong> terrestrial systems are not<br />
readily available, <strong>and</strong> cannot, as yet, be applied on a regular basis in risk assessment.<br />
Bioaccumulation of essential metals<br />
Metals are taken up by organisms. For essential metals, biota regulate their uptake by means of<br />
the general physiological mechanism of homeostasis. By this mechanism, organisms will keep<br />
within a certain range of varying external concentrations, their intracellular levels relatively<br />
constant, in order to satisfy their requirements <strong>for</strong> that essential element. Homeostasis implies<br />
that organisms can deliberately concentrate essential elements if concentrations in the<br />
environment are very low. This may lead to high BCF values. On the other h<strong>and</strong>, the<br />
309