natgillin/translations-raw huggingface dataset:
Da fiskenes alder og vægt undertiden kan indvirke signifikant på BCF-værdierne (12), bør disse oplysninger noteres nøjagtigt.
The possibility of metabolism can be predicted by suitable tools (e.g. OECD QSAR toolbox (15) and proprietary QSAR programs).
Det anbefales, at man kort inden testens start danner sig et skøn over gennemsnitsvægten ved at veje en delprøve af fiskebestanden (jf. punkt 61).
The decision on whether to conduct an aqueous or dietary exposure test, and in what set-up, should be based on the factors in paragraph 3 considered together with the relevant regulatory framework.
Belastning
For example, for substances, which have a high log KOW but still show appreciable water solubility with respect to the sensitivity of available analytical techniques, an aqueous exposure test should be considered in the first instance.
Der bør være et højt fisk-til-vand-forhold, så faldet i koncentrationen af testblandingen i vand som følge af overførsel af fiskene bliver så lavt som muligt, og for at undgå fald i koncentrationen af opløst ilt.
However it is possible that information on water solubility is not definitive for these hydrophobic types of substances, so the possibility of preparing stable, measurable dissolved aqueous concentrations (stable emulsions are not allowed) applicable for an aqueous exposure study should be investigated before a decision is made on which test method to use (16).
Det er vigtigt, at belastningen afpasses efter den anvendte fiskeart.
It is not possible to give exact prescriptive guidance on the method to be used based on water solubility and octanol-water partition coefficient “cut off” criteria, as other factors (analytical techniques, degradation, adsorption, etc.) can have a marked influence on method applicability for the reasons given above.
I alle tilfælde anbefales normalt en fisk-til-vand-belastning på 0,1-1,0 g fisk (vådvægt) pr. liter vand pr. dag.
However, a log KOW above 5 and a water solubility below ~ 0,01 - 0,1 mg/l mark the range of substances where testing via aqueous exposure may become increasingly difficult.
Fisk-til-vand-belastningen kan sættes op, hvis det godtgøres, at den nødvendige koncentration af teststof kan fastholdes inden for ± 20 %, og at koncentrationen af opløst ilt ikke kommer under en mætning på 60 % (jf. punkt 24).
Other factors that may influence test choice should be considered, including the substance's potential for adsorption to test vessels and apparatus, its stability in aqueous solution versus its stability in fish food (17) (18), etc.
Der skal tages hensyn til fiskeartens normale levevilkår ved valget af belastning.
Information on such practical aspects may be available from other completed aqueous studies.
Eksempelvis kan bundfisk kræve et akvarium med større bundareal for samme vandrumfang sammenlignet med pelagiske fiskearter.
Further information on the evaluation of aspects relating to the performance of bioaccumulation studies is available in the literature (e.g. (19)).
Fodring
For substances where the solubility or the maintenance of the aqueous concentration as well as the analysis of these concentrations do not pose any constraints to the realization of an aqueous exposure method, this method is preferred to determine the bioconcentration potential of the substance.
Under akklimatiserings- og testperioder gives fiskene passende foder med kendt fedt- og proteinindhold i en sådan mængde, at de forbliver sunde og bevarer deres legemsvægt (en vis vækst er tilladt).
In any case, it should be verified that the aqueous exposure concentration(s) to be applied are within the aqueous solubility in the test media.
Fisk fodres dagligt under akklimatiserings- og testperioder i et bestemt omfang, der afhænger af den anvendte art, forsøgsbetingelserne og foderets brændværdi (f.eks. ca. 1 til 2 % af kropsvægten pr. dag for regnbueørred).
Different methods for maintaining stable concentrations of the dissolved test substance can be used, such as the use of stock solutions or passive dosing systems (e.g. column elution method), as long as it can be demonstrated that stable concentrations can be maintained and the test media are not altered from that recommended in paragraph 27.
Fodermængden bør fastsættes på en sådan måde, at hurtig vækst og stor stigning i fedtindholdet undgås.
For strongly hydrophobic substances (log KOW > 5 and a solubility below ~ 0,01-0,1 mg/l), testing via aqueous exposure may become increasingly difficult.
For at sikre samme fodring bør fodermængden omberegnes, f.eks. en gang om ugen.
Reasons for constraints may be that the aqueous concentration cannot be maintained at a level that is considered to be sufficiently constant (e.g. due to sorption to the glass of exposure containers or rapid uptake by the fish) or that the aqueous concentrations to be applied are so low that they are in the same range as or below the analytical limit of quantification [25].
Til denne beregning kan man skønne vægten af fiskene i de enkelte kamre ud fra vægten af de fisk, der senest er taget op fra det pågældende kammer.
For these highly hydrophobic substances the dietary test is recommended, provided that the test is consistent with the relevant regulatory framework and risk assessment needs.
1 time) bør overskydende foder og ekskrementer suges op fra testkamrene.
Their amphiphilic nature (i.e. they contain both a hydrophilic and a hydrophobic part) causes them to accumulate at interfaces such as the water-air interface, the water-food interface, and glass walls, which hampers the determination of their aqueous concentration.
Kamrene bør holdes så rene som muligt under testen for at sikre den lavest mulige koncentration af organisk kulstof (jf. punkt 29), eftersom tilstedeværende organisk kulstof kan nedsætte teststoffets biotilgængelighed (12).
The dietary test can circumvent some of the exposure aspects for complex mixtures with components of differing water solubility limits, in that comparable exposure to all components of the mixture is more likely than in the aqueous method (cf.
Da meget foder er fremstillet af fiskemel, bør det sikres, at foderet ikke påvirker testresultaterne eller fremkalder skadelige virkninger, f.eks. fordi det indeholder (spor af) pesticider, tungmetaller og/eller teststoffet selv.
(20)).
Lys og temperatur
It should be noted that the dietary approach yields a dietary biomagnification factor (BMF) rather than a bioconcentration factor (BCF) [26].
Det anbefales, at lysperioden er 12-16 timer, og temperaturen (± 2 °C) bør være afpasset efter testfiskenes art (jf. tillæg 3).
Approaches are available to estimate a kinetic bioconcentration factor (BCFK) from data generated in the dietary study (as discussed in Appendix 8, but these approaches should be used with caution.
Belysningens type og karakteristika bør være kendt.
In general, these approaches assume first order kinetics, and are only applicable to certain groups of compounds.
Man bør være opmærksom på en eventuel fotokemisk omdannelse af teststoffet under undersøgelsens lysforhold.
It is unlikely that such approaches can be applied for surfactants (see paragraph 12).
Der bør benyttes en passende belysning, hvor det undgås, at fisk udsættes for kunstigt fremkaldte fotokemiske omdannelsesprodukter.
A minimised aqueous exposure test set-up with fewer sampling points to reduce the number of animals and/or resources (cf. paragraph 83 onwards) should only be applied to those substances where there is reason to expect that uptake and depuration will follow approximately first order kinetics (i.e. in general non-ionized organic substances, cf. paragraph 88).
Det kan i nogle tilfælde være hensigtsmæssigt at afblænde UV-stråling under 290 nm med et filter.
C.13 - I: Aqueous Exposure Bioconcentration Fish Test
Testkoncentrationer
The test consists of two phases: the exposure (uptake) and post-exposure (depuration) phases.
Testen er oprindeligt udviklet til ikke-polære organiske stoffer.
During the uptake phase, a group of fish of one species is exposed to the test substance at one or more chosen concentrations, depending on the properties of the test substance (cf. paragraph 49).
For denne type stof forventes eksponering af fisk for en enkelt koncentration at være tilstrækkeligt, da der ikke påregnes koncentrationsvirkninger, selv om to koncentrationer kan være påkrævet i henhold til den gældende lovgivning.
They are then transferred to a medium free of the test substance for the depuration phase.
Hvis stoffer uden for dette område undersøges, eller andre tegn på mulig koncentrationafhængighed er kendt, bør testen udføres med to koncentrationer mere.
A depuration phase is always necessary unless uptake of the substance during the uptake phase has been insignificant.
Hvis kun en koncentration testes, bør dette begrundes (jf. punkt 79).
The concentration of the test substance in/on the fish (or specified tissue thereof) is followed through both phases of the test.
Den testede koncentration bør være så lav, som er praktisk eller teknisk muligt (dvs. ikke tæt på opløselighedsgrænsen).
In addition to the exposed group, a control group of fish is held under identical conditions except for the absence of the test substance, to relate possible adverse effects observed in the bioconcentration test to a matching control group and to obtain background concentrations of test substance [27].
I visse tilfælde kan det forventes, at et stofs biokoncentrering afhænger af koncentrationen i vandet (f.eks. af metaller, hvor optagelsen i fisk i det mindste delvist kan reguleres).
In the aqueous exposure test, the uptake phase is usually run for 28 days.
I sådanne tilfælde skal mindst to, men helst flere koncentrationer af miljømæssig relevans testes (jf. punkt 49).
The duration can be lengthened if necessary (cf. paragraph 18), or shortened if it is demonstrated that steady-state has been reached earlier (see Appendix 1, definitions and units).
For stoffer, hvor de testede koncentrationer af praktiske grunde skal ligge tæt på opløselighedsgrænsen, anbefales det at teste mindst to koncentrationer, da dette kan give et indblik i eksponeringskoncentrationernes pålidelighed.
A prediction of the length of the uptake phase and the time to steady-state can be made from equations in Appendix 5.
Valget af testkoncentrationer bør omfatte den miljømæssigt realistiske koncentration samt den koncentration, der er relevant for formålet med den konkrete vurdering.
The depuration period is then begun when the fish are no longer exposed to the test substance, by transferring the fish to the same medium but without the test substance in a clean vessel.
Den/de valgte koncentration/-er af teststoffet bør være under teststoffets kroniske virkning eller 1 % af dets akutte asymptotiske LC50 inden for et miljømæssigt relevant interval og mindst i en størrelsesorden over dets kvantificeringsgrænse i vand ved anvendelse af analysemetoden.
Where possible the bioconcentration factor is calculated preferably both as the ratio of concentration in the fish (Cf) and in the water (Cw) at steady-state (BCFSS; see Appendix 1, definition) and as a kinetic bioconcentration factor (BCFK; see Appendix 1, definitions and units), which is estimated as the ratio of the rate constants of uptake (k1) and depuration (k2) assuming first order kinetics [28].If a steady-state is not achieved within 28 days, either the BCF is calculated using the kinetic approach (cf. paragraph 38) or the uptake phase can be extended.
Den højest tilladte testkoncentration kan også bestemmes ved at dividere den akutte 96 h LC50 med et passende akut/kronisk forhold (f.eks. er passende forhold for nogle kemiske stoffer over 3, mens få er over 100).
Should this lead to an impractically long uptake phase to reach steady-state (cf. paragraphs 37 and 38, Appendix 5), the kinetic approach is preferred.
Hvis der anvendes en anden koncentration, bør den adskille sig fra ovenstående med en faktor på 10.
Alternatively, for highly hydrophobic substances the conduction of a dietary study should be considered [29], provided that the dietary test is consistent with the relevant regulatory framework.
Hvis dette ikke er muligt på grund af toksicitetskriteriet (som begrænser den højeste testkoncentration) og den analytiske grænse (som begrænser den laveste testkoncentration) kan en lavere faktor end 10 anvendes, og det bør overvejes at anvende radioaktivt mærket teststof (af den størst mulige renhed, f.eks. helst > 98 %).
The uptake rate constant, the depuration (loss) rate constant (or constants, where more complex models are involved), the bioconcentration factor (steady-state and/or kinetic), and where possible, the confidence limits of each of these parameters are calculated from the model that best describes the measured concentrations of test substance in fish and water (cf. Appendix 5).
Det bør sikres, at de anvendte koncentrationer ikke overstiger teststoffets opløselighedsgrænse i testmedierne.
The increase in fish mass during the test will result in a decrease of test substance concentration in growing fish (so-called growth dilution), and thus the kinetic BCF will be underestimated if not corrected for growth (cf. paragraphs 72 and 73).
Ud over testrækken bør der være en kontrol med fortyndingsvand (jf. punkt 30-31) eller, hvis det er relevant, en kontrol med et opløsningsmiddel.
The BCF is based on the total concentration in the fish (i.e. per total wet weight of the fish).
Hyppighed af målinger af vandkvaliteten
However, for special purposes, specified tissues or organs (e.g. muscle, liver), may be used if the fish are sufficiently large or the fish may be divided into edible (fillet) and non-edible (viscera) fractions.
Under testen bør opløst ilt, TOC, pH og temperatur måles i alle test- og kontrolbeholdere.
Since, for many organic substances, there is a clear relationship between the potential for bioconcentration and hydrophobicity, there is also a corresponding relationship between the lipid content of the test fish and the observed bioconcentration of such substances.
Samlet hårdhedsgrad og saltindhold (hvis relevant) bør måles i kontrollerne og i en beholder.
Thus, to reduce this source of variability in test results for those substances with high lipophilicity (i.e. with log KOW > 3), bioconcentration should be expressed as normalised to a fish with a 5 % lipid content (based on whole body wet weight) in addition to that derived directly from the study.
Hvis to eller flere koncentrationer testes, måles disse parametre ved den højeste koncentration.
This is necessary to provide a basis from which results for different substances and/or test species can be compared against one another.
Som minimum bør opløst ilt og saltholdighed (hvis det er relevant) måles tre gange — ved begyndelsen, midt i og ved afslutningen af optagelsesperioden — og en gang ugentligt i udskillelsesperioden.
The figure of 5 % lipid content has been widely used as this represents the average lipid content of fish commonly used in this test method (21).
TOC bør måles ved testens begyndelse (24 timer og 48 timer før igangsættelse af optagelsesfasen), før fiskene overføres, og mindst en gang ugentligt i både optagelses- og udskillelsesfasen.
INFORMATION ON THE TEST SUBSTANCE
Temperaturen bør måles og registreres dagligt, pH ved begyndelsen og afslutningen af hver periode, og hårdhed en gang pr. test.
In addition to the properties of the test substance given in the Introduction (paragraph 3), other information required is the toxicity to the fish species to be used in the test, preferably the asymptotic LC50 (i.e. time-independent) and/or toxicity estimated from long-term fish tests (e.g. TMs C.47 (22), C.15 (23), C.14 (24)).
Temperaturen bør helst følges kontinuerligt i mindst et af karrene.
An appropriate analytical method, of known accuracy, precision, and sensitivity, for the quantification of the substance in the test solutions and in biological material should be available, together with details of sample preparation and storage.
Prøveudtagning og analyse af fisk og vand
The analytical quantification limit of the test substance in both water and fish tissues should also be known.
Plan for udtagning af prøver af fisk og vand
When a radiolabelled test substance is used, it should be of the highest purity (e.g. preferably > 98 %) and the percentage of radioactivity associated with impurities should be known.
Der bør, inden fiskene overføres, udtages vandprøver fra testkamrene med henblik på bestemmelse af teststofkoncentrationen, både i optagelses- og i udskillelsesfasen.
VALIDITY OF THE TEST
Vandprøven bør tages før fodring, samtidig med at der udtages fiskeprøver.
For a test to be valid the following conditions apply:
Hyppigere prøveudtagning kan være nyttig for at sikre stabile koncentrationer efter overførslen af fiskene.
The water temperature variation is less than ± 2 °C, because large deviations can affect biological parameters relevant for uptake and depuration as well as cause stress to animals;
I optagelsesfasen bør teststofkoncentrationen bestemmes for at kontrollere, at validitetskriterierne er opfyldt (jf. punkt 24).
The concentration of dissolved oxygen does not fall below 60 % saturation;
Hvis analyser af vandet fra starten af udskillelsesfasen viser, at der ikke er påvist teststof, kan dette bruges som begrundelse for ikke at måle test- og kontrolvand for teststof i den resterende del af udskillelsesfasen.
The concentration of the test substance in the chambers is maintained within ± 20 % of the mean of the measured values during the uptake phase;
Der bør udtages prøver af fisk mindst fem gange i optagelsesfasen og mindst fire gange i udskillelsesfasen med henblik på analyse for teststof.
The concentration of the test substance is below its limit of solubility in water, taking into account the effect that the test water may have on effective solubility [30];
Da det i nogle tilfælde vil være vanskeligt at foretage et rimeligt præcist skøn over BCF-værdien ud fra dette prøveantal (især hvis det formodes, at udskillelsen ikke følger en simpel førsteordensoptagelse og -kinetik), kan det anbefales at øge prøveudtagningshyppigheden i begge perioder (jf. bilag 4).
The mortality or other adverse effects/disease in both control and treated fish is less than 10 % at the end of the test; where the test is extended over several weeks or months, death or other adverse effects in both sets of fish should be less than 5 % per month and not exceed 30 % in all.
Fedtindholdet bør mindst ved optagelsesfasens start og afslutning og udskillelsesfasens afslutning bestemmes på det samme biologiske materiale, som benyttes til bestemmelse af teststoffets koncentration.
Significant differences in average growth between the test and the control groups of sampled fish could be an indication of a toxic effect of the test substance.
Hvis dette ikke er muligt, bør der udtages mindst tre uafhængige fisk for at bestemme fedtindholdet på hvert af de samme tre tidspunkter.
REFERENCE SUBSTANCES
Antal fisk pr. tank ved forsøgets start bør tilpasses i overensstemmelse hermed [33].
The use of reference substances of known bioconcentration potential and low metabolism would be useful in checking the experimental procedure, when required (e.g. when a laboratory has no previous experience with the test or experimental conditions have been changed).
Hvis der alternativt ikke påvises betydelige mængder teststof i kontrolfiskene (dvs. fisk fra stampopulationen), kan det være tilstrækkeligt at analysere kontrolfiskene fra testen for fedtindhold, og analysen for teststoffet i testgruppen/-erne (og den dermed forbundne hastighedskonstant, udskillelseskonstant og BCF-værdi(er)) kan korrigeres for ændringer ifølge kontrolgruppens fedtindhold i løbet af testen [34].
Apparatus
Døde eller syge fisk bør ikke analyseres for teststof eller fedtkoncentration.
Care should be taken to avoid the use of materials — for all parts of the equipment — that can dissolve, sorb or leach and have an adverse effect on the fish.
I tillæg 4 er der vist et eksempel på en acceptabel prøveudtagningsplan.
Standard rectangular or cylindrical tanks, made of chemically inert material and of a suitable capacity in compliance with loading rate (cf. paragraph 43), can be used.
Der kan let opstilles andre planer til at beregne eksponeringstider for 95 % optagelse ud fra andre antagne KOW-værdier (der henvises til tillæg 5 for beregninger).
The use of soft plastic tubing should be minimised.
Prøveudtagningen bør fortsættes under optagelsesfasen, indtil der er opnået ligevægt (se tillæg 1, definitioner og enheder); ellers afsluttes optagelsesfasen (efter 28 eller 60 dage, jf. punkt 37 og 38).
Polytetrafluoroetheylene, stainless steel and/or glass tubing should be used.
Før udskillelsesfasen bør fiskene overføres til rene kar.
Experience has shown that for test substances with high adsorption coefficient, such as the synthetic pyrethroids, silanised glass may be required.
Udtagning og forberedelse af prøver
In such situations the equipment should be discarded after use.
Der bør udtages vandprøver til analyse, f.eks. ved opsugning gennem et rør af inert materiale fra et sted midt i testkammeret.
It is preferable to expose test systems to concentrations of the test substance to be used in the study for as long as is required to demonstrate the maintenance of stable exposure concentrations prior to the introduction of test organisms.
Hverken filtrering eller centrifugering synes altid at kunne adskille den ikke-biotilgængelige fraktion af teststoffet fra den biotilgængelige.
Water
Hvis der anvendes en separationsteknik, bør testrapporten altid indeholde en begrundelse for eller validering af denne på grund af vanskelighederne med biotilgængelighed (25).
Natural water is generally used in the test and should be obtained from uncontaminated and uniform quality source.
Især for stærkt hydrofobe stoffer (dvs. stoffer med log KOW > 5) (12) (26), hvor der kan opstå adsorption til filtermatricen eller centrifugering i beholdere, bør prøverne ikke gennemgå disse behandlinger.
Yet, reconstituted water (i.e. demineralised water with specific nutrients added in known amounts) may be more suitable to guarantee uniform quality over time.
I stedet bør tankene holdes så rene som muligt (jf. punkt 46), og det samlede indhold af organisk kulstof følges under såvel optagelses- som udskillelsesfasen (jf. punkt 53).
The dilution water, which is the water that is mixed with the test substance before entering the test vessel (cf. paragraph 30), should be of a quality that will allow the survival of the chosen fish species for the duration of the acclimation and test periods without them showing any abnormal appearance or behaviour.
For at undgå eventuelle problemer med nedsat biotilgængelighed kan der udtages prøver ved hjælp af fastfase-mikroekstraktionsteknikker, hvis stofferne er tungtopløselige og stærkt hydrofobe.
Ideally, it should be demonstrated that the test species can survive, grow and reproduce in the dilution water (e.g. in laboratory culture or a life-cycle toxicity test).
I hver enkelt fisk bør den målte vægt og længde forbindes med den analyserede stofkoncentration (og fedtindhold, hvis det er relevant), f.eks. ved hjælp af en entydig identifikatorkode for hver udtagen fisk.
The dilution water should be characterised at least by pH, hardness, total solids, total organic carbon (TOC [31]) and, preferably also ammonium, nitrite and alkalinity and, for marine species, salinity.
Fiske- og vandprøver skal helst analyseres umiddelbart efter udtagningen, så man undgår nedbrydning eller andre former for tab, og så der løbende under testen kan beregnes omtrentlige optagelses- og udskillelseshastighedskonstanter.
The parameters which are important for optimal fish well-being are not fully known, but Appendix 2 gives recommended maximum concentrations of a number of parameters for fresh and marine test waters.The dilution water should be of constant quality during the period of a test.
Ved at foretage analyserne med det samme opdager man straks, når et plateau (ligevægt) er indtrådt.
The pH value should be within the range 6,0 to 8,5 at test start, but during a given test it should be within a range of ± 0,5 pH units.