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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3.7 EFFECTS ASSESSMENT FOR THE AIR COMPARTMENT<br />
For the risk assessment of the air compartment biotic <strong>and</strong> abiotic effects are considered.<br />
3.7.1 Biotic effects<br />
EFFECTS ASSESSMENT<br />
The methodology used <strong>for</strong> effects assessment (<strong>and</strong> there<strong>for</strong>e the risk characterisation) of<br />
chemicals in water <strong>and</strong> soil cannot be applied yet in the same manner to the atmosphere.<br />
Methods <strong>for</strong> the determination of effects of chemicals on species arising from atmospheric<br />
contamination have not yet been fully developed, except <strong>for</strong> inhalation studies with mammals.<br />
It is evident that the quantitative characterisation of risk by comparison of the PECair to PNECair<br />
is not possible at the moment: only a qualitative assessment <strong>for</strong> air is feasible.<br />
For the air compartment toxicological data on animal species other than mammals are usually<br />
not or only scarcely available. For volatile compounds acute or short-term inhalation tests may<br />
be present. On the basis of these data there may be indications of adverse effects. Short-term<br />
LC50 data can be used <strong>for</strong> a coarse estimation of the risk a chemical poses <strong>for</strong> animals.<br />
However, in most cases, it is unlikely that the atmospheric concentration of a chemical will be<br />
high enough to cause short-term toxic effects in the environment, so data on long-term or chronic<br />
toxicity should be considered. For example, a chemical may be dangerous <strong>for</strong> the atmospheric<br />
environment at a low concentration, if it is classified as R 48 (“Danger of serious damage to<br />
health by prolonged exposure”). Also mutagenic effects <strong>and</strong> toxic effects on reproduction by a<br />
chemical indicate a toxic potential <strong>for</strong> terrestrial vertebrates.<br />
Fumigation tests on invertebrates are usually not available. For some existing substances <strong>and</strong><br />
biocides investigations on the toxicity to honey bees (Apis mellifera), which are conducted<br />
according to guidelines <strong>for</strong> the testing of plant protection agents, may be available. In these tests,<br />
it is sometimes difficult to determine the effective concentration <strong>and</strong> there<strong>for</strong>e a PNECair cannot<br />
be derived.<br />
Concerning the toxicity <strong>for</strong> plants, data from tests where a chemical is applied directly via air<br />
(gaseous or deposited) are normally scarce. When toxicity data are available or in<strong>for</strong>mation is<br />
available that plants might be affected this in<strong>for</strong>mation must be carefully screened <strong>and</strong> if<br />
necessary further plant toxicity testing can be requested. When no specific in<strong>for</strong>mation on<br />
toxicity to plants is available <strong>for</strong> the substance <strong>and</strong> considerable air emissions <strong>and</strong> exposure are<br />
expected the in<strong>for</strong>mation on related compounds (e.g. toxicity, phys.chem. properties) should be<br />
screened <strong>and</strong> a decision should be made whether there is reason <strong>for</strong> concern <strong>and</strong> whether actual<br />
plant testing should be considered.<br />
Some experience has been obtained over the last years on existing substances <strong>for</strong> which actual<br />
plant testing has been requested <strong>and</strong> per<strong>for</strong>med (e.g. Risk assessment reports on<br />
tetrachloroethylene <strong>and</strong> dibutylphthalate, ECB, 2001). The test protocols have been developed<br />
on a case-by-case basis <strong>and</strong> varied from relatively simple laboratory test designs that can be<br />
considered as screening tests, to very extensive long-term open-top chambers with a large<br />
variety of species. Further discussion is needed be<strong>for</strong>e these test designs can be st<strong>and</strong>ardised <strong>and</strong><br />
inserted in a more rigid testing strategy <strong>for</strong> plants.<br />
How the results of the available toxicity test should be used in the actual setting of a PNEC <strong>for</strong><br />
plants has yet to be decided on a case-by-case basis. Like with the effects assessments <strong>for</strong> the<br />
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