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.
4.2.3.3 Marine biodegradation simulation tests<br />
MARINE RISK ASSESSMENT<br />
As a general rule, degradation rates or half-lives determined in tests simulating the conditions in<br />
the actual aquatic environment should be considered <strong>for</strong> use whenever available. Expert<br />
judgement of the validity <strong>and</strong> quality of the test data is necessary. The origin (e.g. relevance of<br />
sampling site) of the seawater/sediment inoculum shall always be evaluated in connection with<br />
assessment <strong>and</strong> use of simulation test results. Biotrans<strong>for</strong>mation (identification of metabolisation<br />
pathways <strong>and</strong> major metabolites) <strong>and</strong> mineralisation data may be derived from one of the<br />
st<strong>and</strong>ardised simulation tests by using samples from the particular environment as inoculum.<br />
St<strong>and</strong>ardised simulation test methods <strong>for</strong> various marine compartments are:<br />
• Aquatic (pelagic) compartment: ISO/DIS 14592-1 “Evaluation of the aerobic<br />
biodegradability of organic compounds at low concentrations – Part 1” (draft method 2001)<br />
The ISO method has been the basis <strong>for</strong> a proposal <strong>for</strong> a new OECD guideline “Simulation<br />
test - Aerobic trans<strong>for</strong>mation in surface water” (OECD, 2001d);<br />
• Turbid aquatic/sediment dispersed compartment: ISO/DIS 14592-2 “Evaluation of the<br />
aerobic biodegradability of organic compounds at low concentrations – Part 2” (draft<br />
method, 2001b) <strong>and</strong> OECD 308: “Aerobic <strong>and</strong> anaerobic trans<strong>for</strong>mation in aquatic sediment<br />
systems” (aerobic test) (draft guideline, OECD, 2000c; draft Annex V C.24);<br />
• Anaerobic sediment compartment: OECD 308 “Aerobic <strong>and</strong> anaerobic trans<strong>for</strong>mation in<br />
aquatic sediment systems” (strictly anaerobic test) (draft guideline, OECD, 2000c; draft<br />
Annex V C.24). Data from anaerobic screening tests conducted with digested sewage sludge<br />
(e.g. ISO 11734, 1994) cannot be used <strong>for</strong> predicting the degradation potential in sediments.<br />
4.2.3.4 Use of biodegradation screening test data<br />
For most chemicals, however, no test data from such simulation tests are yet available. For many<br />
chemicals only data from screening tests are available. This may be data from marine<br />
biodegradation screening tests or freshwater biodegradation screening tests. Marine screening<br />
tests may be:<br />
• the OECD 306 “Biodegradability in Seawater” test (OECD, 1992e) comprises two methods,<br />
the Shake Flask Method <strong>and</strong> the Closed Bottle Method. These tests are seawater variants of<br />
the Modified OECD Screening Test (EU Annex V C.4-B <strong>and</strong> OECD 301E, 1992f) <strong>and</strong><br />
Closed Bottle Test (EU Annex V C.4-E <strong>and</strong> OECD 301D, 1992f), respectively, the main<br />
difference being the use of a marine inoculum.<br />
• three additional screening tests were subjected <strong>for</strong> a ring test initiated by the OSPAR<br />
Commission in 1995-96. The tests are the “Marine CO2 Evolution Test”, the “Marine<br />
BODIS Test” <strong>and</strong> the “Marine CO2 Headspace Test”. The results of the ring test were<br />
reported by Elf & IARE (1996).<br />
When only results from marine or freshwater biodegradation screening tests are available, it is<br />
recommended to use the default mineralisation half-lives <strong>for</strong> the pelagic compartment as<br />
specified in Table 24.<br />
Table 24 Recommended mineralisation half-lives (days) <strong>for</strong> use in marine risk assessment when only screening test data are<br />
available<br />
Freshwater 1) Estuaries 4) Other marine<br />
environments 5)<br />
Degradable in marine screening test N.a. 15 50<br />
139