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How to Calculate Predicted No-Effect Concentration (PNEC)

Little Pro on 2016-07-13 49575

Predicted No-Effect Concentration (PNEC) is the concentration of a substance in any environment below which adverse effects will
most likely not occur during long term or short term exposure. In environmental risk assessment, PNECs will be compared to actual or
predicted environmental concentration (PEC)
(http://www.chemsafetypro.com/Topics/CRA/how_to_use_EUSES_to_estimate_predicted_environmental_concentrations_PEC.html)to
determine if the risk of a substance is acceptable or not. If PEC/PNECs<1, the risk is acceptable.

Predicted No-Effect Concentration (PNEC) Example - Acetone

According to this source (http://www.reachcentrum.eu/Consortia%20Documents/P-I169/Data%20overview/P-

I169_allsubstances_data_pnec_overview.pdf), the PNEC-fresh water of acetone is 10.6mg/L. That means that if the concentration of
acetone present in fresh water (pond/lake/river) is below than 10.6mg/L, the acetone will unlikely cause adverse effects to the aquatic
environment. This value is not set randomly. There is a systematic and scientific way to derive it. Please continue reading.

How to Derive Predicted No-Effect Concentration (PNEC)?

The PNECs are usually calculated by dividing toxicological dose descriptors
(http://www.chemsafetypro.com/Topics/CRA/Toxicology_Dose_Descriptors.html) by an assessment factor. The endpoints most
frequently used for deriving PNECs are mortality (LC50), growth (ECx or NOEC) and reproduction (ECx or NOEC).

LC50 /EC50 (Median Lethal Concentration/Median Effective Concentration): They are the concentrations at which 50%
mortality or inhibition of a function (e.g. growth or growth rate) was observed. They are usually obtained from short-term eco-
toxicology studies.
NOEC (No Observed Effect Concentration): NOEC is the highest tested concentration for which there are no statistical
significant difference of effect when compared to the control group. It is usually obtained from long-term eco-toxicology studies.
In some studies, only LOEC (lowest observed effect concentration) can be obtained, in which case NOEC can be
calculated as LOEC/2.
ECx: It is the concentrations at which x % (10% for EC10) effect was observed or derived statistically when compared to the
control group. It is usually obtained from long-term eco-toxicity studies.
Typical units: mg/L or mg/kg.

The table below is an example of how to calculate Derive Predicted No-Effect Concentration (PNECs) for different environmental
compartments by dividing dose descriptors with assessment factors.

Compartment Eco-toxicology Dose Descriptors Assessment Factor PNEC value

PNEC-Fresh water 10 1mg/L

NOEC(Algae growth inhibition): 100mg/L;
NOEC(Daphnia reproduction):10mg/L;
NOEC (Fish):20mg/L.

PNEC-STP microorganism 3h-NOEC>1000mg/L (activated sludge inhibition test) 10 100mg/L

PNEC-soil LC50 (earthworm acute toxicity) >1000mg/kg 1000 1mg/kg

In above case, PNEC-water is calculated as 1mg/L. For aquatic environment, toxicological data (10mg/L) from the most sensitive
species (Daphnia) is used for PNEC-water calculation. An assessment factor of 10 is used to take into account of the differences
between laboratory conditions and natural conditions. If the actual concentration of the substance in aquatic environment is 2mg/L, the
substance will cause unacceptable risks to aquatic enviroment.

How Many Predicted No-Effect Concentrations (PNECs) You Need to Derive?

PNECs need to be derived for various environmental compartments (water, sediment, soil, air, etc.). The table below summarizes the
types of PNECs you may need to derive and how to calculate them.

Compartment PNEC How to Get

Fresh Water PNEC-fresh

The lowest value of EC50, LC50, NOEC, etc from aquatic toxicity studies (algae,
water
daphnia and fish) divided by assessment factors;
See aquatic toxicity studies
(http://www.chemsafetypro.com/Topics/CRA/ecotox_aquatic_toxicity.html).

Marine Water PNEC-marine

Derived only when exposure to marine water is possible;
water
Bigger assessment factor for marine water;
If there is not enough ecotox data on marine organisms, PNEC-marine water =
PNEC-fresh water/10.

Sediment PNEC-sediment
The lowest NOEC/EC10 value for sediment living organisms divided by assessment
factors (10~100); or
Using the equilibrium partitioning method (EPM) when only aquatic toxicity data
is available.
Larger assessment factor for marine sediment.

Soil PNEC-soil
The lowest LC50/NOEC/EC10 value for soil living organisms divided by assessment
factors (10~100); ; or
Using the equilibrium partitioning method (EPM) when only aquatic toxicity data
is available.
See terrestrial toxicity studies
(http://www.chemsafetypro.com/Topics/CRA/definition_terrestrial_toxicity_testing.html)

Sewage treatment PNEC-STP

The lowest NOEC/EC10/EC50 value from activated sludge inhibition test or
plant micro-organisms
biodegradability studies divided by assessment factors (1~100).

Air PNEC-air
No standard procedure;
Important for gases and highly volatile substances.

Predator PNEC-predator
The lowest value of LC50bird, NOECbird or NOECmammal divided by assessment
factors (30-3,000);
NOECbird/mammal=NOAELbird/mammal* conversion factors(8-40 for different
species) if only NOAEL is available;
Required when log Kow>3; or BCF >100; and there is no mitigating property such as
ready biodegradability or hydrolysis.

It is not always necessary to derive PNECs for all mentioned environmental compartments. Usually PNECs are only derived for 4
compartments: fresh water, soil, STP micro-organism and sediment.

How to Choose Appropriate Assessment Factors?

Assessment factors (AFs) are used to address the differences between laboratory data and natural conditions, taking into account
of interspecies differences and intraspecies differences. Assessment factors applied for long-term tests are smaller because the
uncertainty of the extrapolation from labs to natural environment is reduced. More data on more species in the same environmental
compartment can also reduce uncertainties, thus further decreasing assessment factors.

The picture below summarizes common assessment factors used for PNEC calculation (from ECHA guidance on chemical risk
assessment).
*Species representing 3 trophic levels : water (algae,fish and daphnia), soil (earthworm, plants, and micro-organisms).

Equilibrium Partitioning Method (EPM) for PNEC Calculation

In the absence of any ecotoxicological data for soil organisms or sediment-dwelling organisms, the PNEC-soil and PNEC-sediment
may be provisionally calculated from PNEC-water using the equilibrium partitioning method (EPM). This method might result in
overestimation or underestimation of toxicity and should only be considered as a screen for identifying substances requiring further
testing on soil organisms and sediment-dwelling organisms .

Important: EPM is usually not recommended for substances that may pose a high hazard potential to soil organisms (i.e,
logKow/Koc>5 and LC50/EC50 to <1mg/L to aquatic species).

Calculating PNEC-soil from PNEC-water using EPM

The picture below shows you how to calculate PNEC-soil from PNEC-water using equilibrium partitioning method (EPM).

If default values were used, the above equations can be simplified to:

Note 1: Organic carbon-water partition coefficient Koc is a very important parameter for predicting PNEC-soil from PNEC-water. If Koc
values are obtained from various types of soils, the mean value of Koc can be used for PNEC calculation. If you do not know what Koc
is and how to get it, please click here (http://www.chemsafetypro.com/Topics/CRA/Soil_Adsorption_Coefficient_Kd_Koc.html).
Note 2: If only one test result with soil dwelling organisms is available, PNEC-soil is calculated on the basis of this result using
assessment factors and on the basis of the equilibrium partition method (EPM). The lowest PNEC-soil value obtained will be used
for risk assessment.

Calculating PNEC-sediment from PNEC-water using EPM

The picture below shows you how to calculate PNEC-sediment from PNEC-water using equilibrium partitioning method (EPM).

If default values were used, the above equations can be simplified to:

Note: For substances with a log Kow > 5 (or for compounds with a corresponding adsorption or binding behavior, e.g. ionisable
substances, surface reactive substances), PNEC-soil and PNEC-sediment calculated need to be decreased by a factor of 10.

Quiz: Calculation of Predicted No-effect Concentration (PNEC)

You have been assigned with a task to derive PNECs for a substance (Koc=10) for 4 environmental compartments based on the
available data below.

Compartment Available data Method PNEC

PNEC-Fresh water AF=? ?

NOEC(Algae growth inhibition): 10mg/L;
NOEC(Daphnia reproduction):1mg/L;
NOEC (Fish):20mg/L.

PNEC-STP microorganism EC50(activated sludge inhibition test)=20mg/L AF=? ?

PNEC-soil LC50 (earthworm acute toxicity) =500mg/kg AF=? and EQM ?

PNEC-sediment No data EQM ?

After calculating PNECs, please answer this question: if the concentration of the substance in water is 0.05mg/L, is this risk
acceptable?

View quiz answer and explanation here. (http://www.chemsafetypro.com/Topics/Quiz/Quiz:_How_to_Calculate_Predicted_No-

effect_Concentration_(PNEC).html)

Main Reference
ECHA guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose
[concentration]-response for environment
(https://echa.europa.eu/documents/10162/13632/information_requirements_r10_en.pdf)
ECHA guidance on information requirements and chemical safety assessment Chapter R.16: Environmental Exposure
Estimation (http://echa.europa.eu/documents/10162/13632/information_requirements_r16_en.pdf)
ECETOC: Soil and Sediment Risk Assessment of Organic Chemicals (http://www.ecetoc.org/wp-
content/uploads/2014/08/ECETOC-TR-092.pdf)
Good job. You have learned what PNEC is, how many PNECs you need to derive, how to choose assessment factors and
how to derive PNECs. We will cover how to estimate predicted environmental concentrations in a separate article.
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