natgillin/translations-raw huggingface dataset:
In the aqueous exposure test, the uptake phase is usually run for 28 days.
Ker veliko hrane temelji na ribji moki, je treba zagotoviti, da hrana ne bo vplivala na rezultate preskusa ali povzročila neželenih učinkov, npr. ker vsebuje (sledove) pesticidov, težkih kovin in/ali same preskusne snovi.
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).
Svetloba in temperatura
A prediction of the length of the uptake phase and the time to steady-state can be made from equations in Appendix 5.
Priporoča se obdobje osvetljenosti od 12 do 16 ur in temperatura (± 2 °C) mora biti ustrezna za preskusno vrsto (prim. Dodatek 3).
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.
Vrsta in lastnosti svetlobe morajo biti znane.
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.
Paziti je treba na morebitno fototransformacijo preskusne snovi pod obsevalnimi pogoji študije.
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.
Uporabiti je treba ustrezno svetlobo, da se prepreči izpostavljenost rib nenaravnim fotoproduktom.
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.
V nekaterih primerih je morda ustrezno uporabiti filter, da se zaustavi obsevanje UV pod 290 nm.
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).
Preskusne koncentracije
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).
Preskus je bil izvorno zasnovan za nepolarne organske snovi.
The BCF is based on the total concentration in the fish (i.e. per total wet weight of the fish).
Za to vrsto snovi se pričakuje, da je dovolj izpostavljenost rib eni koncentraciji, saj niso pričakovani nobeni učinki koncentracije, čeprav sta morda zahtevani dve koncentraciji zaradi ustreznega regulativnega okvira.
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.
Če se preskušajo snovi, ki ne sodijo v to področje, ali so znane druge indikacije morebitne odvisnosti od koncentracije, je treba izvesti preskus z dvema ali več koncentracijami.
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.
Če se preskuša samo ena koncentracija, je treba utemeljiti uporabo ene koncentracije (prim. odstavek 79).
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.
Preskusna koncentracija mora biti tako nizka, kot je praktično ali tehnično izvedljivo (tj. ne preblizu meje topnosti).
This is necessary to provide a basis from which results for different substances and/or test species can be compared against one another.
V nekaterih primerih se lahko predvideva, da je biokoncentracija snovi odvisna od koncentracije vode (npr. za kovine, pri katerih se lahko absorpcija v ribe vsaj delno regulira).
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).
V takem primeru je potrebno, da se preskusita vsaj dve, po možnosti pa več koncentracij (prim. odstavek 49), ki so ustrezne za okolje.
INFORMATION ON THE TEST SUBSTANCE
Tudi za snovi, pri katerih morajo biti preskušene koncentracije blizu meje topnosti zaradi praktičnih razlogov, se priporoča preskušanje vsaj dveh koncentracij, saj lahko to zagotovi razumevanje zanesljivosti koncentracij izpostavljenosti.
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)).
Izbira preskusnih koncentracij mora zajeti koncentracijo, ki je realna za okolje, in koncentracijo, ki je pomembna za namen določene ocene.
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.
Koncentracije preskusne snovi je treba izbrati tako, da so pod njeno ravnijo kroničnega učinka ali 1 % akutnega asimptotičnega LC50, v območju, ki je ustrezen za okolje, in vsaj en red velikosti nad njeno mejo določljivosti v vodi z uporabljeno analitsko metodo.
The analytical quantification limit of the test substance in both water and fish tissues should also be known.
Največja dovoljena preskusna koncentracija se lahko določi tudi z deljenjem akutnega 96-urnega LC50 z ustreznim akutnim/kroničnim razmerjem (npr. ustrezna razmerja za nekatere snovi so približno tri, nekaj pa jih je nad 100).
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.
Če se uporabi druga koncentracija, mora biti za desetkratnik drugačna od navedene.
VALIDITY OF THE TEST
Če to ni mogoče zaradi merila toksičnosti (ki omejuje zgornjo preskusno koncentracijo) in analitske meje (ki omejuje spodnjo preskusno koncentracijo), se lahko uporabi manjši faktor od deset in treba je obravnavati uporabo izotopsko označene preskusne snovi (z najvišjo čistostjo, npr. po možnosti > 98 %).
For a test to be valid the following conditions apply:
Zagotoviti je treba, da nobena uporabljena koncentracija ni nad mejo topnosti preskusne snovi v preskusnih medijih.
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;
Poleg preskusne serije je treba izvesti eno kontrolo z vodo za redčenje ali, če je ustrezno (prim. odstavka 30 in 31), eno kontrolo s topilom.
The concentration of dissolved oxygen does not fall below 60 % saturation;
Pogostost meritev kakovosti vode
The concentration of the test substance in the chambers is maintained within ± 20 % of the mean of the measured values during the uptake phase;
Med preskusom je treba meriti raztopljeni kisik, TOC, pH in temperaturo v vseh preskusnih in kontrolnih posodah.
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];
Skupna trdota in slanost (če je ustrezno) se morata meriti v kontrolah in eni posodi.
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.
Če se preskušata ena dve več koncentracij, se ti parametri merijo pri višji (ali najvišji) koncentraciji.
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.
Raztopljeni kisik in slanost (če je ustrezno) se morata meriti najmanj trikrat – na začetku, približno na sredini in na koncu faze absorpcije – in enkrat tedensko v fazi očiščenja.
REFERENCE SUBSTANCES
TOC je treba izmeriti na začetku preskusa (24 in 48 ur pred začetkom faze absorpcije v preskusu), preden se dodajo ribe, in najmanj enkrat tedensko med fazo absorpcije in očiščenja.
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).
Temperaturo je treba meriti in beležiti vsak dan, pH na začetku in koncu vsake faze, trdoto pa enkrat na preskus.
Apparatus
Temperaturo je treba po možnosti neprestano nadzirati v vsaj eni posodi.
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.
Vzorčenje ter analiza rib in vode
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.
Časovni razpored vzorčenja rib in vode
The use of soft plastic tubing should be minimised.
Vodo je treba vzorčiti iz preskusnih komor, da se določi koncentracija preskusne snovi, preden se dodajo ribe ter med fazo absorpcije in očiščenja.
Polytetrafluoroetheylene, stainless steel and/or glass tubing should be used.
Vodo je treba vzorčiti pred hranjenjem, ob istem času kot se vzorči ribe.
Experience has shown that for test substances with high adsorption coefficient, such as the synthetic pyrethroids, silanised glass may be required.
Morda je uporabno pogostejše vzorčenje, da se zagotovijo stacionarne koncentracije po dodajanju rib.
In such situations the equipment should be discarded after use.
Med fazo absorpcije je treba določiti koncentracije preskusne snovi, da se preveri skladnost z merili za veljavnost (odstavek 24).
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.
Če se z analizami vzorcev vode na začetku faze očiščenja ne zazna preskusne snovi, se to lahko uporabi kot utemeljitev, zakaj se v preostali fazi očiščenja ne bodo opravile meritve preskusne in kontrolne vode za preskusno snov.
Water
Ribe je treba za preskusno snov vzorčiti vsaj petkrat med fazo absorpcije in vsaj štirikrat med fazo očiščenja.
Natural water is generally used in the test and should be obtained from uncontaminated and uniform quality source.
Ker je v nekaterih primerih na podlagi tega števila vzorcev (zlasti če ni nakazana preprosta kinetika absorpcije in očiščenja prvega reda) težko izračunati ustrezno natančno oceno vrednosti BKF, je morda priporočljivo v obeh fazah odvzeti vzorce pogosteje (prim. Dodatek 4).
Yet, reconstituted water (i.e. demineralised water with specific nutrients added in known amounts) may be more suitable to guarantee uniform quality over time.
Vsebnost lipidov je treba določiti na istem biološkem materialu, kakršen se uporablja za določanje koncentracije preskusne snovi, vsaj na začetku in koncu faze absorpcije ter ob koncu faze očiščenja.
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.
Če to ni izvedljivo, je treba vzorčiti vsaj tri neodvisne ribe, da se določi vsebnost lipidov v vsaki od istih treh časovnih točk.
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).
Ustrezno je treba prilagoditi število rib na bazen na začetku preskusa [33].
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.
Če pa se v kontrolnih ribah (tj. ribah iz populacije staleža) ne zaznajo znatne količine preskusne snovi, se lahko analizira kontrolne ribe iz preskusa samo za vsebnost lipidov, analizo preskusne snovi v preskusnih skupinah (in z njo povezane konstanto hitrosti absorpcije, konstanto hitrosti očiščenja in vrednosti BKF) pa se lahko popravi glede na spremembe v skladu z vsebnostjo lipidov v kontrolni skupini med preskusom [34].
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.
Mrtve ali bolne ribe se ne smejo analizirati glede koncentracije preskusne snovi ali lipidov.
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.
Primer sprejemljivega časovnega razporeda vzorčenja je naveden v Dodatku 4.
In order to ensure that the dilution water will not unduly influence the test result (for example, by complexation of the test substance) or adversely affect the performance of the stock of fish, samples should be taken at intervals for analysis, at least at the beginning and end of the test.
Drugi režimi se lahko preprosto izračunajo z drugimi predvidenimi vrednostmi KOW, da se izračuna čas izpostavljenosti za 95-odstotno absorpcijo (glej Dodatek 5 za izračune).
Determination of heavy metals (e.g. Cu, Pb, Zn, Hg, Cd, and Ni), major anions and cations (e.g. Ca2+, Mg2+, Na+, K+, Cl–, and SO42–), pesticides (e.g. total organophosphorous and total organochlorine pesticides), total organic carbon and suspended solids should be conducted, for example, every three months where dilution water is known to be relatively constant in quality.
Vzorčenje je treba nadaljevati med fazo absorpcije, dokler se ne vzpostavi stacionarno stanje (za opredelitev pojmov in enote glej Dodatek 1) ali dokler se drugače ne konča faza absorpcije (po 28 ali 60 dneh, prim. odstavka 37 in 38).
If dilution water quality has been demonstrated to be constant over at least one year, determinations can be less frequent and intervals extended (e.g. every six months).
Pred začetkom faze očiščenja je treba ribe prenesti v čiste posode.
The natural particle content as well as the total organic carbon of the dilution water should be as low as possible to avoid adsorption of the test substance to organic matter, which may reduce its bioavailability and therewith result in an underestimation of the BCF.
Vzorčenje in priprava vzorcev
The maximum acceptable value is 5 mg/l for particulate matter (dry matter, not passing a 0,45 μm filter) and 2 mg/l for total organic carbon (cf. Appendix 2).
Pridobiti je treba vzorce vode za analizo, na primer tako da se voda prek inertnega cevnega materiala izčrpa iz središčne točke preskusne posode.
If necessary, the dilution water should be filtered before use.
Filtriranje in centrifugiranje ne ločita vedno biološko nedostopnega dela preskusne snovi od tega, ki je biološko dostopen.
The contribution to the organic carbon content in test water from the test fish (excreta) and from the food residues should be kept as low as possible (cf. paragraph 46).
Če se uporabi tehnika ločevanja, je treba zaradi težav z biološko dostopnostjo v poročilu o preskusu vedno zagotoviti utemeljitev ali validacijo tehnike ločevanja (25).
Test Solutions
Vzorci pa se ne smejo tako tretirati zlasti v primeru močno hidrofobnih snovi (tj. snovi, ki imajo log KOW > 5) (12), (26), pri katerih lahko pride do adsorpcije na matriko filtra ali centrifugirne posode.
Prepare a stock solution of the test substance at a suitable concentration.
Namesto tega je treba zagotoviti, da so bazeni čim bolj čisti (prim. odstavek 46), vsebnost skupnega organskega ogljika pa je treba spremljati v fazi absorpcije in očiščenja (prim. odstavek 53).
The stock solution should preferably be prepared by simply mixing or agitating the test substance in the dilution water.
Da se preprečijo morebitne težave z manjšo biološko dostopnostjo, se lahko za slabo topne in močno hidrofobne snovi uporabi vzorčenje na podlagi tehnik mikroekstrakcije na trdni fazi.
An alternative that may be appropriate in some cases is the use of a solid phase desorption dosing system.
Vzorčene ribe je treba takoj evtanazirati z najustreznejšo in najbolj humano metodo (za meritve celih rib se ne smejo opravljati nobeni nadaljnji postopki razen spiranja z vodo (prim. odstavek 28) in sušenja ribe s pivnikom).
The use of solvents and dispersants (solubilising agents) is not generally recommended (cf. (25)); however, the use of these materials may be acceptable in order to produce a suitably concentrated stock solution, but every effort should be made to minimise the use of such materials and their critical micelle concentration should not be exceeded (if relevant).
Izmeriti je treba težo in skupno dolžino [35].
Solvents which may be used are acetone, ethanol, methanol, dimethyl formamide and triethylene glycol; dispersants that have been used are Tween 80, methylcellulose 0,01 % and HCO-40.
Za vsako posamezno ribo je treba izmerjeno težo in dolžino povezati z analizirano koncentracijo snovi (in vsebnostjo lipidov, kadar je to ustrezno), na primer z uporabo edinstvene identifikacijske kode za vsako vzorčeno ribo.
The solvent concentration in the final test medium should be the same in all treatments (i.e. regardless of test substance concentration) and should not exceed the corresponding toxicity thresholds determined for the solvent under the test conditions.
Ribe in vodo je po možnosti treba analizirati takoj po vzorčenju, da se prepreči razgradnja ali druge izgube ter da se med izvajanjem preskusa izračunata približni konstanti hitrosti absorpcije in očiščenja.
The maximum level is a concentration of 100 mg/l (or 0,1 ml/l).
S takojšnjo analizo se preprečijo tudi zamude pri določanju, kdaj je bilo doseženo stacionarno stanje.
It is unlikely that a solvent concentration of 100 mg/l will significantly alter the maximum dissolved concentration of the test substance which can be achieved in the medium (25).
Če se analiza ne izvede takoj, je treba vzorce shraniti na ustrezen način.
The solvent's contribution (together with the test substance) to the overall content of organic carbon in the test water should be known.
Pred začetkom študije je treba pridobiti informacije o pravilni metodi shranjevanja za določeno preskusno snov, na primer globoka zamrznitev, shranjevanje pri 4 °C, ekstrakcija itd. Trajanje shranjevanja je treba izbrati tako, da se zagotovi, da se snov med shranjevanjem ne razgradi.
Throughout the test, the concentration of total organic carbon in the test vessels should not exceed the concentration of organic carbon originating from the test substance, and solvent or solubilising agent [32], if used, by more than 10 mg/l (± 20 %).
Kakovost analitske metode
Organic matter content can have a significant effect on the amount of freely dissolved test substance during flow-through fish tests, especially for highly lipophilic substances.
Ker so za celoten postopek pomembne predvsem točnost, natančnost in občutljivost analitske metode, uporabljene za preskusno snov, je treba preveriti s preskušanjem, da so natančnost, točnost in obnovljivost analize snovi ter izkoristek preskusne snovi iz vode in rib zadovoljivi za določeno metodo.
Solid-phase microextraction (cf. paragraph 60) can provide important information on the ratio between bound and freely dissolved compounds, of which the latter is assumed to represent the bioavailable fraction.
To mora biti del predhodnih preskusov.
The test substance concentration should be below the solubility limit of the test substance in the test media in spite of the use of a solvent or solubilising agent.
Preveriti je treba tudi, da preskusne snovi ni mogoče zaznati v vodi za redčenje.
Care should be taken when using readily biodegradable solvents as these can cause problems with bacterial growth in flow-through tests.
Vrednosti koncentracij preskusne snovi v vodi in ribah, ki so bile pridobljene s preskusi za izkoristke in vrednosti ozadja za kontrole, je treba po potrebi popraviti.
If it is not possible to prepare a stock solution without the use of a solubilising agent, consideration should be given to the appropriateness of an aqueous exposure study as opposed to a dietary exposure study.
Z vzorci rib in vode je treba ves čas ravnati tako, da se čim bolj zmanjša onesnaženost in izguba (npr. zaradi adsorpcije na napravo za vzorčenje).
For flow-through tests, a system which continuously dispenses and dilutes a stock solution of the test substance (e.g. metering pump, proportional diluter, saturator system) or a solid phase desorption dosing system is required to deliver the test concentrations to the test chambers.
Analiza vzorcev rib
Preferably allow at least five volume replacements through each test chamber per day.
Če se v preskusu uporabljajo izotopsko označeni materiali, se lahko analizira skupni izotopski označevalec (tj. matična snov in metaboliti) ali pa se vzorci očistijo, zato da se lahko matična snov analizira ločeno.
The flow-through mode is to be preferred, but where this is not possible (e.g. when the test organisms are adversely affected) a semi-static technique may be used provided that the validity criteria are satisfied (cf. paragraph 24).
Če naj bi BKF temeljil na matični snovi, je treba opredeliti glavne metabolite vsaj ob koncu faze absorpcije (prim. odstavek 6).
The flow rates of stock solutions and dilution water should be checked both 48 hours before and then at least daily during the test.
Glavni metaboliti so tisti, ki predstavljajo ≥ 10 % skupnih ostankov v ribjih tkivih, tisti, ki predstavljajo ≥ 5 % v dveh zaporednih točkah vzorčenja, tisti, ki kažejo rastoče ravni med celotno fazo absorpcije, in tisti z znanim toksikološkim učinkom.
Include in this check the determination of the flow-rate through each test chamber and ensure that it does not vary by more than 20 % either within or between chambers.
Če BKF za celo ribo v smislu skupnih izotopsko označenih ostankov znaša ≥ 500, je morda dobro, za določene kategorije snovi, kot so pesticidi, pa močno priporočljivo, identificirati in količinsko opredeliti glavne metabolite.
Important criteria in the selection of species are that they are readily available, can be obtained in convenient sizes and can be satisfactorily maintained in the laboratory.
Nekateri regulativni organi morda zahtevajo količinsko opredelitev takih metabolitov.
Other criteria for selecting fish species include recreational, commercial, ecological importance as well as comparable sensitivity, past successful use etc.
Če so identificirani in količinsko opredeljeni razkrojki, ki predstavljajo > 10 % skupnih izotopsko označenih ostankov v ribjem tkivu, je nato tudi priporočljivo, da se identificirajo in količinsko opredelijo razkrojki v preskusni vodi.
Recommended test species are given in Appendix 3.
Če to ni izvedljivo, je to treba pojasniti v poročilu.