technical guidance documents - Institute for Health and Consumer ...
technical guidance documents - Institute for Health and Consumer ...
technical guidance documents - Institute for Health and Consumer ...
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ENVIRONMENTAL EXPOSURE ASSESSMENT<br />
2.3.6 Abiotic <strong>and</strong> biotic degradation rates<br />
In this section, the following processes are described:<br />
• hydrolysis in surface water;<br />
• photolysis in surface water <strong>and</strong> in the atmosphere;<br />
• biodegradation in the sewage treatment plant;<br />
• biodegradation in the environmental compartments (surface water, soil, sediment).<br />
Transport <strong>and</strong> trans<strong>for</strong>mation (“fate”) describe the distribution of a substance in the environment,<br />
or in organisms, <strong>and</strong> its changes with time (in concentration, chemical <strong>for</strong>m, etc.), thus including<br />
both biotic <strong>and</strong> abiotic trans<strong>for</strong>mation processes. In general, the assessment of degradation<br />
processes should be based on data, which reflect the environmental conditions as realistically as<br />
possible. Data from studies where degradation rates are measured under conditions that simulate<br />
the conditions in various environmental compartments are preferred. The applicability of such<br />
data should, however, be judged in the light of any other degradation data including results from<br />
screening tests. Most emphasis is put on the simulation test results but in the absence of simulation<br />
test data, degradation rates <strong>and</strong> half-lives have to be estimated from screening test data.<br />
For substances where a range of degradation data is available, a “weight of evidence” approach<br />
should be employed. When more than one simulation test result is available, a suitable half-life<br />
in the higher end of the observed range should be selected taking into account the realism,<br />
relevance, quality <strong>and</strong> documentation of the studies in relation to environmental conditions.<br />
When more than one screening test result is available, positive test results should be considered<br />
valid, irrespective of negative results, when the scientific quality is good <strong>and</strong> the test conditions<br />
are well documented, i.e. guideline criteria are fulfilled, including the use of non-adapted<br />
inoculum (cf. OECD, 2001c). The results of screening tests may be negative due to toxic effects<br />
of the test substance, whereas simulation tests employing a low concentration of the test<br />
substance may give a more realistic estimate of the degradation in the environment. By using all<br />
available degradability test data in this way, it is possible to establish a comprehensive<br />
evaluation of the degradability of the substance.<br />
In this section, methods <strong>for</strong> derivation of degradation rate constants are described <strong>for</strong> abiotic<br />
degradation (hydrolysis <strong>and</strong> photolysis) <strong>and</strong> biotic degradation (in soil, sediment, water, <strong>and</strong><br />
sewage treatment). For hydrolysis <strong>and</strong> photolysis, only primary degradation is measured. In<br />
general, risk assessment focuses on the parent compound. Nevertheless, if stable degradation<br />
products are <strong>for</strong>med, the risk assessment should include these. It is possible that the rate of<br />
reaction is such that only the products need to be considered, or in intermediate cases both the<br />
substance <strong>and</strong> the degradation products will require consideration. It is important to have<br />
in<strong>for</strong>mation about which chemical species were responsible <strong>for</strong> any effects that were observed in<br />
the aquatic toxicity studies.<br />
Where substances degrade by complex interaction mechanisms, <strong>for</strong> example abiotic degradation<br />
followed by biodegradation, <strong>and</strong> where there are no internationally recognised protocols <strong>for</strong><br />
simulation tests, the use of relevant field data could be considered provided that the kinetics of<br />
full mineralisation or <strong>for</strong>mation of possible metabolites have been determined.<br />
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