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The NOED is then compared with threshold concentrations of organoleptic changes
(LC org
) and changing sanitary regimes of a water body (LC san
). The lowest of them is
taken as MCP (or ODU) with indicating the relevant hazard category (i.e. MCP tox
, MCP org
or MCP san
). If the substance appears not to be degradable, the safety factors indicated in
Table 5 are applied, i.e. the MCP for extremely stable substances is reduced by 10 and
for stable substances by 3.
Fishery water MPCs are elaborated for substances to be discharged in water or if there
is the risk that the substance reaches fishery waters. There should be a request from an
applicant in order to initiate the elaboration of the MPC for a specific substance.
There is no need to elaborate MPCs for inert and biologically inactive substances 17 like
graphite type natural minerals, glass, etc., if sufficient evidence can be provided that they
do not contain water-soluble toxic impurities. 18
3.4. Summary: test methods and data analysis
The test methods of toxicological (for hygienic assessment of water bodies) and ecotoxicological
parameters have repeatedly been stated to be similar with EU ones. Also
laboratories performing testing have to be accredited (so far according to ISO 17025,
GLP system is being still introduced in Russia). Still, the testing results might be difficult
to compare (details given in Russian methodological guidelines were not compared with
OECD testing guidelines).
If different species are used to test or data from different animals is already available, the
lowest results are selected:
1. From the chronic studies conducted on human health properties as well as aquatic
toxicity and bioaccumulation, the LC 50
and LC 0
are determined. The LC 0
value for
a specific effect is also called Lim sp.eff.
and can be compared to the NOEL used in
European chemicals assessment. The Lim value determines the concentration or
dose below which the specific effect cannot be observed.
19
2. The lowest minimal risk levels are then multiplied with specific coefficients to derive
so called „maximum permissible concentrations“ (MPCs). MPCs are derived
for fisheries waters and bathing waters, for workplace air and environmental air, for
food and for soil. (see Chapter 3.4).
17 Biologically inactive substance has LC 50
≥ 1 000 mg/l for 96 h test. If there is no literature
data, test is performed with zooplankton organisms by the laboratory elaborating the MPC.
18 Test performed by accredited laboratories
19 The Lim values for the different specific effects tested are compared and the lowest concentration
or dose is taken to derive the MPC. If an MPC for workplace air is derived, the
respective test for selecting the Lim value would have to be an inhalation study.
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