FprCEN/TS 17459
(Main)Construction products: Assessment of release of dangerous substances - Determination of ecotoxicity of construction product eluates
Construction products: Assessment of release of dangerous substances - Determination of ecotoxicity of construction product eluates
(1) This document specifies a test procedure that combines horizontal leaching tests with ecotoxicity tests for the assessment of eluates of the construction products specified in this scope subjected to wet conditions in outdoor use.
(2) The method specified in this document is intended for the determination of the potential ecotoxicity of eluates extracted out of construction products containing constitutional organic components of main categories of product matrices P (plastics and rubbers), A (sealants and adhesives) or C (paints and coatings) according to CEN/TR 16045.
(3) Construction products mainly made of inorganic materials: main categories of product matrices S (silica-based and calcareous products) and M (metals) according to CEN/TR 16045 are excluded, unless
- the liquid or paste product hardens in direct contact with soil or groundwater and
- the used binder contains > 50 % organics by mass.
NOTE 1 This exception mainly refers to products used for soil injection and stabilization, e.g. grouts.
Also, the method is not intended for construction products made of treated or untreated solid wood in main category of product matrix W (wood-based products) according to CEN/TR 16045. For engineered bio-based products the test procedure can be of interest.
(4) This document is not applicable for the assessment of terrestrial ecotoxicity of construction products.
NOTE 2 Terrestrial ecotoxicity tests for construction products are described in CEN/TR 17105.
Bauprodukte: Bewertung der Freisetzung von gefährlichen Stoffen - Bestimmung der Ökotoxizität von Eluaten aus Bauprodukten
1) Dieses Dokument legt ein Prüfverfahren fest, das horizontale Auslaugprüfungen mit Ökotoxizitätsprüfungen zur Bewertung der Eluate der in diesem Anwendungsbereich definierten Bauprodukte unter nassen Nutzungsbedingungen in Außenbereichen kombiniert.
2) Das in diesem Dokument festgelegte Prüfverfahren ist für die Bestimmung der potenziellen Ökotoxizität von aus Bauprodukten, die organische Bestandteile der Hauptkategorien der Produktmatrixtabellen P (Kunststoffe und Gummi), A (Dichtstoffe und Klebstoffe) oder C (Lacke und Beschichtungen) nach CEN/TR 16045 enthalten, austretenden Eluaten vorgesehen.
3) Bauprodukte, die hauptsächlich aus anorganischen Materialien bestehen: Die Hauptkategorien der Produktmatrixtabellen S (siliziumbasierte und kalkhaltige Produkte) und M (Metalle) nach CEN/TR 16045 sind ausgeschlossen, außer wenn
- das flüssige oder pastöse Produkt in direktem Kontakt mit Erde oder Grundwasser härtet und
- das verwendete Bindemittel einen organischen Massenanteil von > 50 % enthält.
ANMERKUNG 1 Diese Ausnahme bezieht sich hauptsächlich auf für die Bodeninjektion und Stabilisierung verwendete Produkte wie etwa Mörtel.
Darüber hinaus ist das Verfahren nicht für Bauprodukte aus behandeltem oder unbehandeltem Massivholz der Hauptkategorie der Produktmatrixtabelle W (holzbasierte Produkte) nach CEN/TR 16045 vorgesehen. Für technische biobasierte Produkte kann das Prüfverfahren von Interesse sein.
4) Dieses Dokument ist nicht auf die Bewertung der terrestrischen Ökotoxizität von Bauprodukten anwendbar.
ANMERKUNG 2 Terrestrische Ökotoxizitätsprüfungen von Bauprodukten werden in CEN/TR 17105 beschrieben.
Produits de construction : évaluation de l'émission de substances dangereuses - Détermination de l'écotoxicité des éluats de produits de construction
(1) Le présent document spécifie un mode opératoire d'essai qui combine des essais de lixiviation horizontale et des essais d'écotoxicité pour l'évaluation des éluats des produits de construction spécifiés dans le présent domaine d'application, soumis à des conditions humides en utilisation extérieure.
(2) La méthode spécifiée dans le présent document est destinée à la détermination de l'écotoxicité potentielle des éluats extraits de produits de construction contenant des composants organiques constitutifs des catégories principales de matrices de produits P (plastiques et caoutchoucs), A (mastics et adhésifs) ou C (peintures et revêtements) selon le CEN/TR 16045.
(3) Produits de construction principalement constitués de matériaux inorganiques : les principales catégories de matrices de produits S (produits à base de silice et de calcaire) et M (métaux) selon le CEN/TR 16045 sont exclues, sauf si
le produit liquide ou pâteux durcit au contact direct avec le sol ou les eaux souterraines et que
le liant utilisé contient > 50 % de matières organiques en masse.
NOTE 1 Cette exception concerne principalement les produits utilisés pour l'injection et la stabilisation des sols, par exemple les injections de ciment.
De même, la méthode n'est pas destinée aux produits de construction en bois massif traité ou non traité de la catégorie principale de la matrice de produits W (produits à base de bois) selon le CEN/TR 16045. Le mode opératoire d'essai peut présenter de l'intérêt pour les produits transformés biosourcés.
(4) Le présent document n'est pas applicable à l'évaluation de l'écotoxicité terrestre des produits de construction.
NOTE 2 Les essais d'écotoxicité terrestre pour les produits de construction sont décrits dans le CEN/TR 17105.
Gradbeni proizvodi - Ocenjevanje sproščanja nevarnih snovi - Določanje ekotoksičnosti izlužkov gradbenih proizvodov
General Information
Buy Standard
Standards Content (sample)
SLOVENSKI STANDARD
kSIST-TS FprCEN/TS 17459:2022
01-september-2022
Gradbeni proizvodi - Ocenjevanje sproščanja nevarnih snovi - Določanje
ekotoksičnosti izlužkov gradbenih proizvodov
Construction products - Assessment of release of dangerous substances - Determination
of ecotoxicity of construction product eluatesBauprodukte - Bewertung der Freisetzung von gefährlichen Stoffen - Bestimmung der
Ökotoxizität von Eluaten aus BauproduktenProduits de construction : évaluation de l'émission de substances dangereuses -
Détermination de l'écotoxicité des éluats de produits de construction
Ta slovenski standard je istoveten z: FprCEN/TS 17459
ICS:
13.020.99 Drugi standardi v zvezi z Other standards related to
varstvom okolja environmental protection
91.100.01 Gradbeni materiali na Construction materials in
splošno general
kSIST-TS FprCEN/TS 17459:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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kSIST-TS FprCEN/TS 17459:2022
FINAL DRAFT
TECHNICAL SPECIFICATION
FprCEN/TS 17459
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
June 2022
ICS 13.020.99; 19.040; 91.100
English Version
Construction products: Assessment of release of
dangerous substances - Determination of ecotoxicity of
construction product eluates
Bauprodukte: Bewertung der Freisetzung von
gefährlichen Stoffen - Bestimmung der Ökotoxizität
von Eluaten aus Bauprodukten
This draft Technical Specification is submitted to CEN members for Vote. It has been drawn up by the Technical Committee
CEN/TC 351.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.Warning : This document is not a Technical Specification. It is distributed for review and comments. It is subject to change
without notice and shall not be referred to as a Technical Specification.EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TS 17459:2022 E
worldwide for CEN national Members.---------------------- Page: 3 ----------------------
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FprCEN/TS 17459:2022 (E)
Contents Page
European foreword ....................................................................................................................................................... 3
Introduction .................................................................................................................................................................... 4
1 Scope .................................................................................................................................................................... 5
2 Normative references .................................................................................................................................... 5
3 Terms and definitions ................................................................................................................................... 6
4 Abbreviations ................................................................................................................................................... 8
5 Leaching procedures for ecotoxicological testing ............................................................................... 8
5.1 Suitable leaching tests and selection of fractions from leaching tests ........................................ 8
5.1.1 General ................................................................................................................................................................ 8
5.1.2 Dynamic Surface Leaching Test (DSLT) (CEN/TS 16637-2) ............................................................. 9
5.1.3 Horizontal up-flow percolation test (CEN/TS 16637-3) ................................................................... 9
5.1.4 Alternative leaching tests.......................................................................................................................... 10
5.2 Sampling, transport and storage of eluates ........................................................................................ 10
5.3 Pre-treatment of eluates............................................................................................................................ 11
6 Aquatic ecotoxicological testing ............................................................................................................. 11
6.1 Purpose of aquatic ecotoxicity testing .................................................................................................. 11
6.2 Selection of ecotoxicity tests and minimum test battery ............................................................... 11
6.3 Testing strategy and conditions ............................................................................................................. 12
6.3.1 General ............................................................................................................................................................. 12
6.3.2 Additional blank samples.......................................................................................................................... 12
6.3.3 pH adjustment ............................................................................................................................................... 12
6.3.4 Colour and turbidity .................................................................................................................................... 13
6.3.5 Unstable eluates ........................................................................................................................................... 13
6.3.6 Expression of test concentrations and dilutions .............................................................................. 13
6.4 Limitations of aquatic ecotoxicity tests ............................................................................................... 13
7 Assessment of biodegradability .............................................................................................................. 13
8 Test report and quality assurance procedure ................................................................................... 14
Annex A (informative) Validation data.............................................................................................................. 16
Annex B (informative) Evaluation of test results .......................................................................................... 19
Bibliography ................................................................................................................................................................. 21
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European foreword
This document (FprCEN/TS 17459:2022) has been prepared by Technical Committee CEN/TC 351
“Construction products: Assessment of release of dangerous substances”, the secretariat of which is held
by NEN.This document is currently submitted to the second Vote on TS.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association.---------------------- Page: 5 ----------------------
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Introduction
The regulatory and technical background for this document is explained in CEN/TR 17105 [1]. General
information on ecotoxicity assessment is also provided there. This document describes the assessment
of ecotoxicological properties of eluates of construction products received from horizontal leaching tests
harmonized by CEN/TC 351.Aquatic ecotoxicity tests can be applied to eluates of construction products which come into contact with
soil or water in their intended use as described in CEN/TR 16098:2010, 3.2.2.2 Products relevant for soil,
surface water or groundwater [3] and in CEN/TS 16637-1. The test procedure specified in this document
covers construction products defined in the scope. Validation data are provided in Annex A.
This document is recommended to Technical Committees for construction products (product TCs), if they
have been mandated to address ecotoxicity in their product standards or if they are interested to include
ecotoxicity in a dossier prepared in the context of qualifications for a “without testing” status. This
document is also recommended to EOTA in case there is a wish to include ecotoxicity testing in European
Assessment Documents.---------------------- Page: 6 ----------------------
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1 Scope
(1) This document specifies a test procedure that combines horizontal leaching tests with ecotoxicity
tests for the assessment of eluates of the construction products specified in this scope subjected to wet
conditions in outdoor use.(2) The method specified in this document is intended for the determination of the potential ecotoxicity
of eluates extracted out of construction products containing constitutional organic components of main
categories of product matrices P (plastics and rubbers), A (sealants and adhesives) or C (paints and
coatings) according to CEN/TR 16045.(3) Construction products mainly made of inorganic materials: main categories of product matrices S
(silica-based and calcareous products) and M (metals) according to CEN/TR 16045 are excluded, unless
— the liquid or paste product hardens in direct contact with soil or groundwater and
— the used binder contains > 50 % organics by mass.NOTE 1 This exception mainly refers to products used for soil injection and stabilization, e.g. grouts.
Also, the method is not intended for construction products made of treated or untreated solid wood in
main category of product matrix W (wood-based products) according to CEN/TR 16045. For engineered
bio-based products the test procedure can be of interest.(4) This document is not applicable for the assessment of terrestrial ecotoxicity of construction products.
NOTE 2 Terrestrial ecotoxicity tests for construction products are described in CEN/TR 17105.
2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
CEN/TS 16637-1:2018, Construction products - Assessment of release of dangerous substances - Part 1:
Guidance for the determination of leaching tests and additional testing stepsCEN/TS 16637-2, Construction products - Assessment of release of dangerous substances - Part 2:
Horizontal dynamic surface leaching testCEN/TS 16637-3, Construction products - Assessment of release of dangerous substances - Part 3:
Horizontal up-flow percolation testEN 1484, Water analysis - Guidelines for the determination of total organic carbon (TOC) and dissolved
organic carbon (DOC)EN 12457-1, Characterisation of waste - Leaching - Compliance test for leaching of granular waste
materials and sludges - Part 1: One stage batch test at a liquid to solid ratio of 2 l/kg for materials with high
solid content and with particle size below 4 mm (without or with size reduction)EN ISO 5667-16, Water quality - Sampling - Part 16: Guidance on biotesting of samples (ISO 5667-16)
EN ISO 6341, Water quality - Determination of the inhibition of the mobility of Daphnia magna Straus
(Cladocera, Crustacea) - Acute toxicity test (ISO 6341)EN ISO 8692, Water quality - Fresh water algal growth inhibition test with unicellular green algae (ISO
8692)---------------------- Page: 7 ----------------------
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EN ISO 9408, Water quality - Evaluation of ultimate aerobic biodegradability of organic compounds in
aqueous medium by determination of oxygen demand in a closed respirometer (ISO 9408)
EN ISO 9439, Water quality - Evaluation of ultimate aerobic biodegradability of organic compounds in
aqueous medium - Carbon dioxide evolution test (ISO 9439)EN ISO 11348-1, Water quality - Determination of the inhibitory effect of water samples on the light
emission of Vibrio fischeri (Luminescent bacteria test) - Part 1: Method using freshly prepared bacteria (ISO
11348-1)EN ISO 15088, Water quality - Determination of the acute toxicity of waste water to zebrafish eggs (Danio
rerio) (ISO 15088)EN ISO 20079, Water quality - Determination of the toxic effect of water constituents and waste water on
duckweed (Lemna minor) - Duckweed growth inhibition test (ISO 20079)ISO 11350, Water quality — Determination of the genotoxicity of water and waste water —
Salmonella/microsome fluctuation test (Ames fluctuation test)ISO 13829, Water quality — Determination of the genotoxicity of water and waste water using the umu-
test3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp— IEC Electropedia: available at https://www.electropedia.org
3.1
biotesting
technique for evaluating the biological effect, either qualitatively or quantitatively, of various substances
in water by means of changes in a specified biological activityNote 1 to entry: Biotesting is a broader term than ecotoxicity test and covers also for instance biodegradability
tests.[SOURCE: ISO 6107:2021, 3.65]
3.2
biodegradation
mineralization of organic compounds by bacteria and fungi to carbon dioxide, water and inorganic
compounds3.3
control
mixture of control medium and organisms used in the test without test sample
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3.4
control medium
combination of dilution water and/or nutrient medium used in the test
[SOURCE: EN ISO 20079:2006, 3.6]
3.5
dilution level
reciprocal value of the volume fraction of test sample in dilution water in which the test is conducted
EXAMPLE 250 ml of test sample in a total volume of 1 000 ml (volume fraction of 25 %) represents dilution
level D = 4.[SOURCE: EN ISO 15088:2008, 3.2, modified — “waste water” replaced by “test sample”]
3.6dilution water
water added to the test sample to prepare a series of defined dilutions
Note 1 to entry: The composition of the water is specified in the specific test.
[SOURCE: EN ISO 20079:2006, 3.7]
3.7
ecotoxicity test
method for determining potential adverse effects to biological systems which a sample has an inherent
capacity to cause3.8
effective concentration
concentration of the test sample at which an effect of x % is measured, if compared to the control
[SOURCE: ISO 20227:2017, 3.1]3.9
eluate
aqueous solution recovered from a leaching test
[SOURCE: CEN/TR 16110:2010, 3.2]
3.10
leaching test
laboratory test during which a construction product is put into contact with a leachant under strictly
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3.11
lowest ineffective dilution
dilution factor
LID
lowest ineffective dilution tested, expressed as dilution level D (3.5), at which no inhibition, or only effects
not exceeding the test-specific variability, are observed[SOURCE: EN ISO 15088:2008, 3.5]
3.12
storage time
period of time between filling of the sample container and further treatment of the sample in the
laboratory, if stored under predefined conditions[SOURCE: EN ISO 5667-3:2018, 3.4]
3.13
test material
material to be tested
[SOURCE: ISO 17126:2005, 3.3]
4 Abbreviations
For the purposes of this document, the following abbreviations apply.
CEN/TC Technical Committee in CEN
CEN/TR Technical Report adopted by CEN
CEN/TS Technical Specification adopted by CEN
CI confidence interval
DOC dissolved organic carbon
DSLT dynamic surface leaching test
EC effective concentration
EOTA European Organization for Technical Assessment
LID lowest ineffective dilution
n.d. not determined
PI prediction interval
TOC total organic carbon
5 Leaching procedures for ecotoxicological testing
5.1 Suitable leaching tests and selection of fractions from leaching tests
5.1.1 General
This document is part of a modular horizontal approach and belongs to the analytical step
(CEN/TS 16637-1:2018, Figure 2, number 6). This approach was adopted in CEN/TC 351. “Horizontal”
means that the methods can be used for products with certain properties as described in
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CEN/TS 16637-1. “Modular” means that a test standard developed in this approach concerns a specific
step in assessing a property and not the whole “chain of measurement” (from sampling to analyses).
Differing from the modules for chemical analyses this document also contains limited modifications to
the leaching step (CEN/TS 16637-1:2018, Figure 2, number 5) as detailed below.A leaching method shall be selected using guidance given in CEN/TS 16637-1. Eluates from the DSLT
according to CEN/TS 16637-2 and column test according to CEN/TS 16637-3 are suitable for ecotoxicity
tests on the basis of current experience and shall be respectively chosen as the default option, where
allowed according to CEN/TS 16637-1.The selection of fractions from leaching tests for ecotoxicity tests depends on the purpose of the testing
approach. Generally, for many construction products the maximum effect is expected to occur with the
first elution steps. It is often also practicable to test the first two fractions, because organic substances
are not always stable during long immersion periods.An alternative option for the selection of fractions is to define an indicative parameter (e.g. substances of
interest) which is analysed in each eluate fraction. The two fractions with the highest amount of the
indicative parameter are combined and tested.For construction products with continuously releasing compounds, those fractions with the longest
contact time from an advanced stage of the leaching procedure can exhibit higher effects. By comparison
of effects from different fractions, the longer-term behaviour of the construction products can be
assessed. The use of this option should be justified with an indicative parameter.
NOTE For declaration purposes the default options specified in this document are considered adequate.
The results of ecotoxicity tests with the same product, but using a different leaching test are not
comparable due to the different test conditions.5.1.2 Dynamic Surface Leaching Test (DSLT) (CEN/TS 16637-2)
CEN/TS 16637-2 describes a tank test for monolithic construction products of > 40 mm edge length in all
directions and for plates or sheets with a surface area of > 100 cm exposed to the eluate. In the standard
procedure, this test is carried out for 64 days, while the eluate water is replaced at distinct time intervals
(after 6 h, 24 h, 2,25 d, 4 d, 9 d, 16 d, 36 d and 64 d).In order to generate suitable eluates for ecotoxicity testing the DSLT according to CEN/TS 16637-2 shall
be performed as follows:— only the first two elution steps after 6 h and additional 18 h are carried out and both eluates are
unified for ecotoxicity testing;2 2
(2 ml/cm ), is
— the lower limit of the liquid / surface area relation (L/A), corresponding to 20 l/m
applied in order to maximize the concentration level in the eluates (smallest liquid to surface area).
NOTE These adjustments have been applied in the European round robin tests for the ecotoxicological
characterization of construction products [9] [25].It is recommended to investigate eluates that represent other elution steps, if information on later stages
of leaching processes is desired.5.1.3 Horizontal up-flow percolation test (CEN/TS 16637-3)
The horizontal up-flow percolation test is a method to determine the leaching behaviour of non-volatile
inorganic and organic substances from granular construction products (without or with size reduction).
The construction products are subjected to percolation with water as a function of liquid to solid ratio
under specified percolation conditions. The method is a once-through column leaching test.
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Eluates from up-flow percolation tests according to CEN/TS 16637-3 shall be collected for ecotoxicity
testing until an L/S ratio of 2 l/kg is reached. Mass of test material and dimension of the applied columns
shall be adapted to obtain sufficient eluate volume for testing. Furthermore, the relationship between
maximum grain size and minimal column dimension as specified in CEN/TS 16637-3 shall be fulfilled.
It is recommended to investigate eluates that represent higher L/S ratios, if information on later stages
of leaching processes is desired.5.1.4 Alternative leaching tests
The conditions for using other leaching tests (indirect tests) are defined in CEN/TS 16637-1:2018,
Clause 7. From the alternative methods referred to in CEN/TS 16637-1 especially EN 12457-1 and
EN 16105 are known to generate suitable eluates for ecotoxicity tests on the basis of experience with
construction products.EN 12457-1 is a one stage batch test with a liquid to solid ratio of 2 l/kg for materials with high solid
content and with particle size below 4 mm (without or with size reduction). Where CEN/TS 16637-3 is
used as the reference method, EN 12457-1 shall be used for quality assurance where applicable.
Products that come into contact with water only occasionally in their intended use may not be stable in a
test set up with long time immersion in water as foreseen in the reference method CEN/TS 16637-2. For
these products a leaching test with short immersion phases according to EN 16105 is recommended
instead. In this test the construction products are exposed to cycles of wetting and drying.
5.2 Sampling, transport and storage of eluatesThe goal of sampling is to obtain a representative eluate and to supply it to the laboratory in the correct
manner. The eluates may be susceptible to changes as a result of physical, chemical or biological
reactions. The eluates should be preferably tested immediately after sampling to avoid changes in the
original composition as a result of physical and chemical reactions and/or biological processes. If this is
not possible, e.g. because several biotests are intended to be applied, samples shall be cooled down for
transport and storage in closed, dark glass bottles to temperatures between 2 °C and 8 °C and kept in the
dark or frozen down to ≤ −18 °C. The transport shall be realized in cool boxes with ice, frozen gel packs
or cooling elements. The time span between sampling and ecotoxicity tests (storage time) shall remain
within 48 h (cooled samples) or 2 months (frozen samples). For further information see EN ISO 5667-16
and related standards referred to there.Eluates are not suitable for biotesting if they have been treated to prevent biodegradation processes
during the leaching test. Preservatives such as biocides, acids or basic solutions that retard chemical and
biological activity shall not be added to the test samples. If samples are frozen, the DOC shall be
determined according to EN 1484 both before freezing and after thawing the sample.
The amount of eluates and number of replicate vessels depends on the test battery chosen and the test
design and should be decided beforehand. It is practicable to split the total volume of the eluate into
appropriate flasks. In this way, the different tests can be carried out independently from each other and
suitable test portions are available for potential repetitions. As a rough estimate about 100 ml to 200 ml
are needed for one test with one organism. For the algae test up to about 500 ml are required depending
on the size of the incubation vessels. Additional replicate samples for retesting the eluates in cases, where
the toxicity range has not been met, are required.Frozen samples shall be thawed on the day of testing before use or overnight. When thawing on the day
of testing a warm water bath at a temperature not exceeding 25 °C, together with gentle shaking, shall be
used to avoid local overheating. When thawing overnight the sample shall be kept in the dark at a
temperature between 2 °C and 8 °C. A once thawed sample shall not be frozen again for subsequent
testing, but a replicate sample shall be used. An even distribution of all soluble and particulate
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Samples thawed with a microwave treatment are not suitable for biological tests as thawing in a
microwave oven modifies the test sample in an unacceptable way and is therefore forbidden.
NOTE It is possible to extend the duration of storage, if it has been proved that no modification of toxicity
occurred within the storage period (e.g. through comparison with the same ecotoxicity test immediately after
sampling and at the end of storage period).5.3 Pre-treatment of eluates
In general, biotests are carried out with the original sample. In accordance with EN ISO 5667-16 any pre-
treatment of the eluates shall be limited to such cases, where suspended solids resulting from
construction products disturb the performance of the biotests.When carrying out aquatic tests in the presence of particles causing severe problems, it is recommended
that the sample be allowed to settle for 30 min to 2 h. The required quantity of supernatant can be
sampled using a pipette. Only when large amounts of particulate matter interfere with the requirements
of test organisms, this shall be removed by centrifugation or filtration. Centrifugation (e.g. 10 min at
5 000 g) in general is preferred to filtration. Alternatively, coarse particles may be separated by filtration
(>50 µm). The filter material shall be made of inert material (e.g. glass-fibre) and the filters shall be rinsed
with high-purity water prior to use to reduce the risk of contamination of the eluates. Filtration may be
carried out under pressure or with vacuum. Any method used for separation of particles shall be reported
in the test report.When phase separation is restricted, e.g. due to the specific weight of the material, it may also be
supported by sieving the eluate through a (0,5 ± 0,2) mm stainless steel sieve and subsequent
centrifugation.The eluate shall be allowed to settle for 30 min to 2 h after treatment. The required quantity of
supernatant can be sampled using a pipette.6 Aquatic ecotoxicological testing
6.1 Purpose of aquatic ecotoxicity testing
Aquatic ecotoxicity tests measure the water available fraction of the toxic components of the eluate.
When carrying out aquatic tests, attention should be focussed on possible confounding factors which
might interfere with the test results and make adaptations in the test schemes advisable. Differences in
the ionic composition might interfere with many of the test organisms; coloured or turbid samples might
interfere with algae as well as in the luminescent bacteria test and pH values might be outside the normal
range for many test organisms. In those cases tests should best be carried out twice: once according to
the standardized method to provide comparable results and once with an adaptation in the method to
provide more insight for the evaluation of results.NOTE Guidance on suitable adaptations is given in EN ISO 5667-16:2017, Clause 9 “Impairment of test
performance”.6.2 Selection of ecotoxicity tests and minimum test battery
It is generally accepted in environmental hazard assessment, that a test battery with organisms from
different trophic levels and combining different assessment end points, is required.
An appropriate test battery to be used in the aquatic ecotoxicity testing of construction product eluates
where applicable is detailed in the following tables (Table 1 and Table 2).---------------------- Page: 13 ----------------------
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Table 1 — Minimum test battery for aquatic ecotoxicity tests on construction product eluates
Mandatory Expression ofTest species Standard End point
tests results
Luminescent bacteria (Vibrio EC (30 min)
EN ISO 11348-1 Luminescence
fischeri) and LID
Algae
Pseudokirchneriella EC (72 h) and
Minim
...
SLOVENSKI STANDARD
kSIST-TS FprCEN/TS 17459:2020
01-januar-2020
Gradbeni proizvodi - Ocenjevanje sproščanja nevarnih snovi - Določevanje
ekotoksičnosti izlužkov gradbenih proizvodov
Construction products - Assessment of release of dangerous substances - Determination
of ecotoxicity of construction product eluatesBauprodukte - Bewertung der Freisetzung von gefährlichen Stoffen - Bestimmung der
Ökotoxizität von Eluaten aus BauproduktenTa slovenski standard je istoveten z: FprCEN/TS 17459
ICS:
13.020.99 Drugi standardi v zvezi z Other standards related to
varstvom okolja environmental protection
91.100.01 Gradbeni materiali na Construction materials in
splošno general
kSIST-TS FprCEN/TS 17459:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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kSIST-TS FprCEN/TS 17459:2020
FINAL DRAFT
TECHNICAL SPECIFICATION
prTS 17459
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
November 2019
ICS 91.100.01
English Version
Construction products - Assessment of release of
dangerous substances - Determination of ecotoxicity of
construction product eluates
Bauprodukte - Bewertung der Freisetzung von
gefährlichen Stoffen - Bestimmung der Ökotoxizität
von Eluaten aus Bauprodukten
This draft Technical Specification is submitted to CEN members for Vote. It has been drawn up by the Technical Committee
CEN/TC 351.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.Warning : This document is not a Technical Specification. It is distributed for review and comments. It is subject to change
without notice and shall not be referred to as a Technical Specification.EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. prTS 17459:2019 E
worldwide for CEN national Members.---------------------- Page: 3 ----------------------
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Contents Page
European foreword ....................................................................................................................................................... 3
Introduction .................................................................................................................................................................... 4
1 Scope .................................................................................................................................................................... 5
2 Normative references .................................................................................................................................... 5
3 Terms and definitions ................................................................................................................................... 6
4 Abbreviations ................................................................................................................................................... 8
5 Leaching procedures for ecotoxicological testing ............................................................................... 8
5.1 Suitable leaching tests and selection of fractions from leaching tests ........................................ 8
5.1.1 General ................................................................................................................................................................ 8
5.1.2 Dynamic Surface Leaching Test (DSLT) CEN/TS 16637-2 ................................................................ 9
5.1.3 Horizontal up-flow percolation test (CEN/TS 16637-3) ................................................................... 9
5.1.4 Alternative leaching tests............................................................................................................................. 9
5.2 Sampling, transport and storage of eluates ........................................................................................... 9
5.3 Pre-treatment of eluates............................................................................................................................ 10
6 Aquatic ecotoxicological testing ............................................................................................................. 11
6.1 Purpose of aquatic ecotoxicity testing .................................................................................................. 11
6.2 Selection of ecotoxicity tests and minimum test battery ............................................................... 11
6.3 Testing strategy and conditions ............................................................................................................. 12
6.4 Limitations of aquatic ecotoxicity tests ............................................................................................... 13
7 Assessment of biodegradability .............................................................................................................. 13
8 Test report and quality assurance procedure ................................................................................... 14
Annex A (informative) Results from a European round robin test “Ecotoxicological
characterisation of eluates from construction products” ............................................................. 15
Annex B (informative) Evaluation of test results............................................................................................. 19
Bibliography ................................................................................................................................................................. 21
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European foreword
This document (FprCEN/TS 17459:2019) has been prepared by Technical Committee CEN/TC 351
“Construction products: Assessment of release of dangerous substances”, the secretariat of which is held
by NEN.This document is currently submitted to the Vote on TS.
This document has been prepared under a standardization request given to CEN by the European
Commission and the European Free Trade Association.---------------------- Page: 5 ----------------------
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Introduction
The regulatory and technical background for this FprCEN/TS 17459 is explained in CEN/TR 17105 [1].
General information on ecotoxicity assessment is also provided there. This Technical Specification
describes the assessment of ecotoxicological properties of eluates of construction products received from
horizontal leaching tests harmonized by CEN/TC 351.Aquatic ecotoxicity tests can be applied to eluates of construction products which come into contact with
soil or water in their intended use as described in 3.2.2.2 Products relevant for soil, surface water or
groundwater of CEN/TR 16098:2010 [2] and in CEN/TS 16637-1. The test procedure specified in this
document covers construction products that fall under the scope of the leaching tests in the
CEN/TS 16637 series and have an organic content of > 50 % by mass. For the covered products adequate
validation data has been provided (see Annex A).This document is recommended to Technical Committees for construction products (product TCs), if they
have been mandated to address ecotoxicity in their product standards or if they are interested to include
ecotoxicity in a dossier prepared in the context of qualifications for a “without testing” status. This
document is also recommended to EOTA in case there is a wish to include ecotoxicity testing in European
Assessment Documents.---------------------- Page: 6 ----------------------
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1 Scope
This document specifies a test procedure that combines horizontal leaching tests with ecotoxicity tests
for the assessment of eluates of construction products.The test procedure in this document is established for construction products with an organic content
of > 50 % by mass. Mineral-based construction products are covered in the following case: 1) the liquid
or pasty product hardens in direct contact with soil or groundwater and 2) the used binder
contains > 50 % organics by mass. For the covered products adequate validation data have been provided
(see Annex A).This document is not applicable for the assessment of terrestrial ecotoxicity of construction products.
NOTE Terrestrial ecotoxicity tests for construction products are described in CEN/TR 17105.
2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 1484, Water analysis — Guidelines for the determination of total organic carbon (TOC) and dissolved
organic carbon (DOC)EN 12457-1, Characterisation of waste — Leaching — Compliance test for leaching of granular waste
materials and sludges — Part 1: One stage batch test at a liquid to solid ratio of 2 l/kg for materials with
high solid content and with particle size below 4 mm (without or with size reduction)
EN ISO 5667-16:2017, Water quality — Sampling — Part 16: Guidance on biotesting of samples (ISO 5667-
16:2017)EN ISO 6341, Water quality — Determination of the inhibition of the mobility of Daphnia magna Straus
(Cladocera, Crustacea) — Acute toxicity test (ISO 6341)EN ISO 8692, Water quality — Fresh water algal growth inhibition test with unicellular green algae
(ISO 8692)EN ISO 9408, Water quality — Evaluation of ultimate aerobic biodegradability of organic compounds in
aqueous medium by determination of oxygen demand in a closed respirometer (ISO 9408)
EN ISO 9439, Water quality — Evaluation of ultimate aerobic biodegradability of organic compounds in
aqueous medium — Carbon dioxide evolution test (ISO 9439)EN ISO 11348-1, Water quality — Determination of the inhibitory effect of water samples on the light
emission of Vibrio fischeri (Luminescent bacteria test) — Part 1: Method using freshly prepared bacteria
(ISO 11348-1:2007)EN ISO 15088:2008, Water quality — Determination of the acute toxicity of waste water to zebrafish eggs
(Danio rerio) (ISO 15088:2007)EN ISO 20079:2006, Water quality — Determination of the toxic effect of water constituents and waste
water on duckweed (Lemna minor) — Duckweed growth inhibition test (ISO 20079:2005)
ISO 11350, Water quality — Determination of the genotoxicity of water and waste water —
Salmonella/microsome fluctuation test (Ames fluctuation test)---------------------- Page: 7 ----------------------
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ISO 13829, Water quality — Determination of the genotoxicity of water and waste water using the umu-
testCEN/TS 16637-1:2018, Construction products: Assessment of release of dangerous substances — Part 1:
Guidance for the determination of leaching tests and additional testing stepsCEN/TS 16637-2, Construction products: Assessment of release of dangerous substances — Part 2:
Horizontal dynamic surface leaching testCEN/TS 16637-3, Construction products: Assessment of release of dangerous substances — Part 3:
Horizontal up-flow percolation test3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp— IEC Electropedia: available at http://www.electropedia.org/
3.1
bioassay
technique for evaluating the biological effect, either qualitatively or quantitatively, of various substances
in water by means of changes in a specified biological activityNote 1 to entry: Bioassay is a broader term than ecotoxicity test and covers also for instance biodegradability
tests.[SOURCE: ISO 6107-8:1993/Amd 1:2001 [3], no number]
3.2
biodegradation
mineralization of organic compounds by bacteria and fungi to carbon dioxide, water and inorganic
compounds3.3
control
mixture of control medium and organisms used in the test without test sample
3.4
control medium
combination of dilution water and/or nutrient medium used in the test
[SOURCE: EN ISO 20079:2005, 3.6]
3.5
dilution level
reciprocal value of the volume fraction of test sample in dilution water in which the test is conducted
EXAMPLE 250 ml of test sample in a total volume of 1 000 ml (volume fraction of 25 %) represents dilution
level D = 4.---------------------- Page: 8 ----------------------
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[SOURCE: EN ISO 15088:2008, 3.2, modified - “waste water” replaced by “test sample”]
3.6dilution water
water added to the test sample to prepare a series of defined dilutions
Note 1 to entry: The composition of the water is specified in the specific test.
[SOURCE: EN ISO 20079:2006, 3.7]
3.7
ecotoxicity test
method for determining potential adverse effects to biological systems which a sample has an inherent
capacity to cause3.8
effective concentration
concentration of the test sample at which an effect of x % is measured, if compared to the control
[SOURCE: ISO 20227:2017 [4], 3.1]3.9
eluate
aqueous solution recovered from a leaching test
[SOURCE: CEN/TR 16110:2010 [5], 3.2]
3.10
leaching test
laboratory test during which a construction product is put into contact with a leachant under strictly
defined conditions for the determination of the release of substances into water3.11
lowest ineffective dilution
dilution factor
LID
lowest ineffective dilution tested, expressed as dilution level D (3.5), at which no inhibition, or only effects
not exceeding the test-specific variability, are observed[SOURCE: EN ISO 15088:2008, 3.5]
3.12
storage time
period of time between filling of the sample container and further treatment of the sample in the
laboratory, if stored under predefined conditions[SOURCE: EN ISO 5667-3:2018 [6], 3.4]
3.13
test material
material to be tested
[SOURCE: ISO 17126:2005 [7], 3.3]
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4 Abbreviations
For the purposes of this document, the following abbreviations apply.
CEN/TC Technical Committee in CEN
CEN/TR Technical Report adopted by CEN
CEN/TS Technical Specification adopted by CEN
DOC dissolved organic carbon
DSLT dynamic surface leaching test
EC effective concentration
EOTA European Organization for Technical Assessment
LID lowest ineffective dilution
TOC total organic carbon
5 Leaching procedures for ecotoxicological testing
5.1 Suitable leaching tests and selection of fractions from leaching tests
5.1.1 General
This Technical Specification is part of a modular horizontal approach and belongs to the analytical step
(CEN/TS 16637-1:2018, Figure 2, number 6). This approach was adopted in CEN/TC 351. “Horizontal”
means that the methods can be used for products with certain properties as described in
CEN/TS 16637-1. “Modular” means that a test standard developed in this approach concerns a specific
step in assessing a property and not the whole “chain of measurement” (from sampling to analyses).
Differing from the modules for chemical analyses this Technical Specification also contains limited
modifications to the leaching step (CEN/TS 16637-1:2018, Figure 2, number 5) as detailed below.
A leaching method shall be selected using guidance given in CEN/TS 16637-1. Eluates from the DSLT
according to CEN/TS 16637-2 and column test according to CEN/TS 16637-3 are suitable for ecotoxicity
tests on the basis of current experience.The selection of fractions from leaching tests for ecotoxicity tests depends on the purpose of the testing
approach. Generally, for many construction products the maximum effect is expected to occur with the
first elution steps. It is often also practicable to test the first two fractions, because organic substances
are not always stable during long immersion periods.An alternative option for the selection of fractions is to define an indicative parameter (e.g. TOC or
substances of interest) which is analysed in each eluate fraction. The two fractions with the highest
amount of the indicative parameter are combined and tested.For construction products with continuously releasing compounds, those fractions with the longest
contact time from an advanced stage of the leaching procedure can exhibit higher effects. By comparison
of effects from different fractions, the longer term behaviour of the construction products can be
assessed. The use of this option should be justified with an indicative parameter.
The results of ecotoxicity tests with the same product, but using a different leaching test are not
comparable due to the different test conditions.---------------------- Page: 10 ----------------------
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5.1.2 Dynamic Surface Leaching Test (DSLT) CEN/TS 16637-2
CEN/TS 16637-2 describes a tank test for monolithic construction products of > 40 mm edge length in all
directions and for plates or sheets with a surface area of > 100 cm exposed to the eluate. In the standard
procedure, this test is carried out for 64 days, while the eluate water is replaced at distinct time intervals
(after 6 h, 24 h, 2,25 d, 4 d, 9 d, 16 d, 36 d and 64 d).In order to generate suitable eluates for ecotoxicity testing the DSLT shall be performed as follows:
— only the first two elution steps after 6 h and additional 18 h are carried out and both eluates are
unified for ecotoxicity testing;2 2
— the lower limit of the liquid / surface area relation (L/A), corresponding to 20 l/m (2 ml/cm ), is
applied in order to maximize the concentration level in the eluates (smallest liquid to surface area).
NOTE These adjustments have been applied in the European round robin test for the ecotoxicological
characterization of construction products [8].It is recommended to investigate eluates that represent other elution steps, if information on later stages
of leaching processes is desired.5.1.3 Horizontal up-flow percolation test (CEN/TS 16637-3)
The horizontal up-flow percolation test is a method to determine the leaching behaviour of non-volatile
inorganic and organic substances from granular construction products (without or with size reduction).
The construction products are subjected to percolation with water as a function of liquid to solid ratio
under specified percolation conditions. The method is a once-through column leaching test.
Eluates from up-flow percolation tests according to CEN/TS 16637-3 shall be collected for ecotoxicity
testing until an L/S ratio of 2 l/kg is reached. Mass of test material and dimension of the applied columns
have to be adapted to obtain sufficient eluate volume for testing. Furthermore the relationship between
maximum grain size and minimal column dimension as specified in CEN/TS 16637-3 has to be fulfilled.
It is recommended to investigate eluates that represent higher L/S ratios, if information on later stages
of leaching processes is desired.5.1.4 Alternative leaching tests
The conditions for using other leaching tests (indirect tests) are defined in CEN/TS 16637-1:2018,
Clause 7. From the alternative methods referred to in CEN/TS 16637-1 especially EN 12457-1 and
EN 16105 are known to generate suitable eluates for ecotoxicity tests on the basis of experience with
construction products.EN 12457-1 is a one stage batch test with a liquid to solid ratio of 2 l/kg for materials with high solid
content and with particle size below 4 mm (without or with size reduction). Where CEN/TS 16637-3 is
used as the reference method, EN 12457-1 shall be used for quality assurance where applicable.
Products that come into contact with water only occasionally in their intended use may not be stable in a
test set up with long time immersion in water like foreseen in the reference method CEN/TS 16637-2.
For these products a leaching test with short immersion phases according to EN 16105 is recommended
instead. In this test the construction products are exposed to cycles of wetting and drying.
5.2 Sampling, transport and storage of eluatesThe goal of sampling is to obtain a representative eluate and to supply it to the laboratory in the correct
manner. The eluates may be susceptible to changes as a result of physical, chemical or biological
reactions. The eluates should be preferably tested immediately after sampling to avoid changes in the
original composition as a result of physical and chemical reactions and/or biological processes. If this is
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not possible, e.g. because several bioassays are intended to be applied, samples shall be cooled down for
transport and storage in closed, dark glass bottles to temperatures between 2 °C and 8 °C and kept in the
dark or frozen down to ≤ −18 °C. The transport shall be realized in cool boxes with ice, frozen gel packs
or cooling elements. The time span between sampling and ecotoxicity tests (storage time) shall remain
within 48 h (cooled samples) or 2 months (frozen samples). For further information see EN ISO 5667-16
and related standards referred to there.Eluates are not suitable for bioassays, if they have been treated to prevent biodegradation processes
during the leaching test. Preservatives such as biocides, acids or basic solutions that retard chemical and
biological activity shall not be added to the test samples. If samples are frozen, the DOC shall be
determined according to EN 1484 both before freezing and after thawing the sample.
The amount of eluates and number of replicate vessels depends on the test battery chosen and the test
design and should be decided beforehand. It is practicable to split the total volume of the eluate into
appropriate flasks. In this way, the different tests can be carried out independently from each other and
suitable test portions are available for potential repetitions. As a rough estimate about 100 ml to 200 ml
are needed for one test with one organism. For the algae test up to about 500 ml are required depending
on the size of the incubation vessels. Additional replicate samples for retesting the eluates in cases, where
the toxicity range has not been met, are required.Frozen samples shall be thawed on the day of testing before use or overnight. When thawing on the day
of testing a warm water bath at a temperature not exceeding 25 °C, together with gentle shaking, shall be
used to avoid local overheating. When thawing overnight the sample shall be kept in the dark at a
temperature between 2 °C and 8 °C. A once thawed sample shall not be frozen again for subsequent
testing, but a replicate sample shall be used. An even distribution of all soluble and particulate
components shall be ensured (e.g. by gentle agitation or vigorous shaking).Samples thawed with a microwave treatment are not suitable for biological tests as thawing in a
microwave oven modifies the test sample in an unacceptable way and is therefore forbidden.
NOTE It is possible to extend the duration of storage, if it has been proved that no modification of toxicity
occurred within the storage period (e.g. through comparison with the same ecotoxicity test immediately after
sampling and at the end of storage period).5.3 Pre-treatment of eluates
In general, bioassays are carried out with the original sample. In accordance with EN ISO 5667-16 any
pre-treatment of the eluates shall be limited to such cases, where suspended solids resulting from
construction products disturb the performance of the bioassays.When carrying out aquatic tests in the presence of particles causing severe problems, it is recommended
that the sample be allowed to settle for 30 min to 2 h. The required quantity of supernatant can be
sampled using a pipette. Only when large amounts of particulate matter interfere with the requirements
of test organisms, this shall be removed by centrifugation or filtration. Centrifugation (e.g. 10 min at
5 000 g) in general is preferred to filtration. Alternatively coarse particles may be separated by filtration
(>50 µm). The filter material shall be made of inert material (e.g. glass-fibre) and the filters shall be rinsed
with high-purity water prior to use to reduce the risk of contamination of the eluates. Filtration may be
carried out under pressure or with vacuum. Any method used for separation of particles shall be reported
in the test report.When phase separation is restricted, e.g. due to the specific weight of the material, it may also be
supported by sieving the eluate through a (0,5 ± 0,2) mm stainless steel sieve and subsequent
centrifugation.The eluate shall be allowed to settle for 30 min to 2 h after treatment. The required quantity of
supernatant can be sampled using a pipette.---------------------- Page: 12 ----------------------
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6 Aquatic ecotoxicological testing
6.1 Purpose of aquatic ecotoxicity testing
Aquatic ecotoxicity tests measure the water available fraction of the toxic components of the eluate.
When carrying out aquatic tests, attention should be focussed on possible confounding factors which
might interfere with the test results and make adaptations in the test schemes advisable. Differences in
the ionic composition might interfere with many of the test organisms; coloured or turbid samples might
interfere with algae as well as in the luminescent bacteria test and pH values might be outside the normal
range for many test organisms. In those cases tests should best be carried out twice: once according to
the standardized method to provide comparable results and once with an adaptation in the method to
provide more insight for the evaluation of results.NOTE Guidance on suitable adaptations is given in EN ISO 5667-16:2017, Clause 9 “Impairment of test
performance”.6.2 Selection of ecotoxicity tests and minimum test battery
It is generally accepted in environmental hazard assessment, that a test battery with organisms from
different trophic levels and combining different assessment end points, is required.
An appropriate test battery to be used in the aquatic ecotoxicity testing of construction product eluates
where applicable is detailed in the following tables (Table 1 and Table 2).Table 1 — Minimum test battery for aquatic ecotoxicity tests on construction product eluates
Mandatory Expression ofTest species Standard End point
tests results
EC (30 min),
Luminescent bacteria (Vibrio
EN ISO 11348-1 Luminescence
fischeri)
LID
Algae
Minimum Pseudokirchneriella
EC (72 h), LID
EN ISO 8692 Growth
battery subcapitata or
Desmodesmus subspicatus
Crustacea
EC (48 h), LID
EN ISO 6341 Mobility
Daphnia magna
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Table 2 — Extended test battery in addition to the minimum test battery for aquatic ecotoxicity
tests on construction product eluatesOptional Expression of
Test species Standard End point
tests results
EC (48 h),
Danio rerio (zebrafish eggs) EN ISO 15088 Mortality
LID
umu-assay with Salmonella
typhimurium TA
Induction ratio
Extended
ISO 13829 Gene induction
1535/pSK1002
(24 h)
test battery
or,
Increase in the
increase of
Ames fluctuation test ISO 11350 number of
revertant wells
mutant colonies
6.3 Testing strategy and conditions
6.3.1 General
As a general guidance for testing strategy and conditions the guidance given in EN ISO 5667-16 should
be followed.6.3.2 Additional blank samples
Additional blank vessels and eluates, which include all experimental steps (from dilution water over the
leaching vessels to the sampling vessels) shall be prepared in parallel and examined in the ecotoxicity
tests, in order to detect possible influence from the testing device such as the quality of theleachant,
contamination of the leaching vessels or the surrounding environment, the storage conditions etc.
Normally no ecotoxicity should be detectable in these additional blanks at a dilution level of 2 (50 % by
volume of the blank eluate and 50 % dilution water).6.3.3 pH adjustment
pH of test mixtures (i.e. test sample diluted with control/dilution medium) may significantly differ from
pH of test sample according to the selected dilution range and according to buffer capacity of
control/dilution medium or test sample. A pH adjustment shall be performed according to the following
rules given in EN ISO 5667-16:— samples with extreme pH values exceedi
...
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