natgillin/translations-raw huggingface dataset:
Firstly, it is intended to incorporate a dietary bioaccumulation [20] test suitable for determining the bioaccumulation potential of substances with very low water solubility.
Vsebnost organske snovi lahko precej vpliva na količino prosto raztopljene preskusne snovi med pretočnimi preskusi na ribah, zlasti za zelo lipofilne snovi.
Secondly, it is intended to create a test method that, when appropriate, utilises fewer fish for animal welfare reasons, and that is more cost-effective.
Mikroekstrakcija na trdni fazi (prim. odstavek 60) lahko zagotovi pomembne informacije o razmerju med vezanimi in prosto raztopljenimi spojinami, slednje pa naj bi predstavljale biološko dostopen del.
In the years since adoption of the consolidated test method C.13 (1), numerous substances have been tested, and considerable experience has been gained both by laboratories and by regulatory authorities.
Koncentracija preskusne snovi mora biti pod mejo topnosti preskusne snovi v preskusnih medijih kljub uporabi topila ali sredstva za raztapljanje.
This has led to the conviction that the complexity of the test can be reduced if specific criteria are met (cf. paragraph 88), and that a tiered approach is possible.
Ob uporabi lahko biorazgradljivih topil je treba biti previden, saj lahko povzročijo težave z rastjo bakterij v pretočnih preskusih.
Experience has also shown that biological factors such as growth and fish lipid content can have a strong impact on the results and may need to be taken into account.
Če ni mogoče pripraviti osnovne raztopine brez uporabe sredstva za raztapljanje, je treba obravnavati ustreznost študije vodne izpostavljenosti v primerjavi s študijo prehranske izpostavljenosti.
In addition, it has been recognised that testing very poorly water soluble substances may not be technically feasible.
Za pretočne preskuse je potreben sistem, ki neprestano dovaja in redči osnovno raztopino preskusne snovi (npr. metrična črpalka, proporcionalni razredčevalnik, nasičevalnik), ali sistem odmerjanja za desorpcijo iz trdne faze, da se lahko dovajajo preskusne koncentracije v preskusne komore.
In addition, for substances with very low water solubility in the aquatic environment, exposure via water may be of limited importance in comparison to the dietary route.
Po možnosti se mora v vsaki preskusni komori zamenjati vsaj pet prostornin na dan.
This has led to the development of a test method in which fish are exposed via their diet (cf. paragraph 7-14 and 97 onwards).
Priporočena je pretočna metoda, kadar pa to ni mogoče (npr. ko obstajajo neželeni učinki na preskusne organizme), se lahko uporabi polstatična tehnika, če so izpolnjena merila za veljavnost (prim. odstavek 24).
Validation (ring test) of the dietary exposure test was conducted in 2010 (51).
Hitrost pretoka osnovnih raztopin in vode za redčenje je treba preveriti 48 ur pred preskusom in nato vsak dan med preskusom.
The main changes include:
V to preverjanje je treba zajeti določanje hitrosti pretoka skozi vsako preskusno komoro in zagotoviti, da se ne spreminja za več kot 20 % v komori ali med njimi.
The testing of only one test concentration can be considered sufficient, when it is likely that the bioconcentration factor (BCF) is independent of the test concentration.
Pomembna merila za izbiro vrst so, da so lahko dostopne, da so na razpolago v primernih velikostih in da se lahko ustrezno gojijo v laboratoriju.
A minimised aqueous exposure test design in which a reduced number of sample points is possible, if specific criteria are met.
Druga merila za izbiro rib vključujejo rekreacijsko, komercialno in ekološko pomembnost ter primerljivo občutljivost, preteklo uspešno uporabo itd. Priporočene preskusne vrste so navedene v Dodatku 3.
Fish lipid content should be measured so that BCF can be expressed on a 5 % lipid content basis.
Uporabijo se lahko tudi druge vrste, vendar je morda treba prilagoditi preskusni postopek, da se zagotovijo ustrezni preskusni pogoji.
Greater emphasis on kinetic BCF estimation (when possible) next to estimating the BCF at steady state.
V tem primeru je treba utemeljiti izbiro vrste in preskusne metode.
For certain groups of substances, a dietary exposure test will be proposed, where this is considered more suitable than an aqueous exposure test.
Na splošno uporaba manjših vrst rib skrajša čas za doseganje stacionarnega stanja, ampak je verjetno potrebnih več rib (vzorcev), da se ustrezno analizira vsebnost lipidov in koncentracij preskusne snovi v ribah.
Fish weight should be measured so that BCFk can be corrected for growth dilution.
Poleg tega lahko razlike v hitrosti dihanja in metabolizmu med mladimi in starejšimi ribami ovirajo primerjave rezultatov med različnimi preskusi in preskusnimi vrstami.
Before carrying out any of the bioaccumulation tests, the following information about the test substance should be known:
Opozoriti je treba, da lahko vrste rib, preskušene med življenjskim ciklom s hitro rastjo (mlade ribe), otežijo razlago podatkov.
Sensitivity of the analytical technique for measuring tissue and aqueous or food concentrations of both the test substance and possible metabolites (cf. paragraph 65).
Vzdrževanje rib (pomembno za vodno in prehransko izpostavljenost)
Solubility in water [TM A.6; (2)]; this should be determined in accordance with a method that is appropriate for the (estimated) range of the solubility to obtain a reliable value.
Populacija staleža rib se mora vsaj dva tedna aklimatizirati v vodi (prim. odstavek 28) pri preskusni temperaturi in ves čas ji je treba zagotavljati zadostno hrano (prim. odstavek 45).
For hydrophobic substances, this will generally be the column elution method.
Voda in hrana morata biti iste vrste kot tisti, ki bosta uporabljeni med preskusom.
n-Octanol-water partition coefficient, KOW [21] [TMs A.8 (4), A.24 (5), A.23 (6)]; or other suitable information on partitioning behaviour (e.g. sorption to lipids, KOC); this should be determined in accordance with a method that is appropriate for the (estimated) range of the KOW to obtain a reliable value.
Po 48 urah prilagajanja se zabeleži smrtnost in uporabijo se naslednja merila:
For hydrophobic substances, this will generally be the slow-stirring method [TM A.23 (6)];
smrtnost, ki v sedmih dneh preseže 10 % populacije: zavrne se celotna serija;
Substance stability in water (hydrolysis [TM C.7 (7)]);
smrtnost, ki v sedmih dneh znaša od 5 do 10 % populacije: serija se mora aklimatizirati dodatnih sedem dni in če je v drugih sedmih dneh smrtnost večja od 5 %, se zavrne celotna serija;
Substance stability in food (specifically when a dietary exposure test approach is chosen);
smrtnost, ki v sedmih dneh znaša manj kot 5 % populacije: serija se sprejme.
Information on phototransformation relevant for the irradiation conditions in the test (8);
Ribe, uporabljene v preskusih, morajo biti brez vidnih bolezni in anomalij.
Surface tension (i.e. for substances where the log KOW cannot be determined) [TM A.5 (9)];
Vse bolne ribe je treba zavreči.
Vapour pressure [TM A.4 (10)];
Ribe v dveh tednih pred preskusom ali med poskusom ne smejo biti zdravljene zaradi bolezni.
Any information on biotic or abiotic degradation in water, such as (but not restricted to) ready biodegradability [TMs C.4 parts II to VII (11), C.29 (12)], where appropriate;
IZVEDBA PRESKUSA
Information on metabolites: structure, log KOW, formation and degradability, where appropriate;
Predhodni preskus
Acid dissociation constant (pKa) for substances that might ionise.
Morda je uporabno izvesti predhodni poskus, da se optimizirajo preskusni pogoji dokončnega preskusa, npr. izbira koncentracij preskusne snovi ter trajanje faze absorpcije in očiščenja, ali da se določi, ali je treba izvesti popoln preskus.
If necessary, the pH of the test water should be adjusted to ensure that the substance is in the unionised form in the test if compatible with fish species.
Načrt predhodnega preskusa mora biti tak, da se pridobijo zahtevane informacije.
Independent of the chosen exposure method or sampling scheme, this test method describes a procedure for characterising the bioaccumulation potential of substances in fish.
Obravnava se lahko, ali bo za izračun BKF morda zadoščal minimiziran preskus ali pa bo potrebna popolna študija (prim. odstavke 83–95 o minimiziranem preskusu).
Although flow-through test regimes are much to be preferred, semi-static regimes are permissible, provided that the validity criteria (cf. paragraphs 24 and 113) are satisfied.
Pogoji izpostavljenosti
In the dietary exposure route, the flow-through system is not necessary to maintain aqueous concentrations of the tested substance, but will help maintain adequate dissolved oxygen concentrations and help ensure clean water and remove influences of e.g. excretion products.
Trajanje faze absorpcije
Independent of the chosen test method, sufficient details are given in this test method for performing the test while allowing adequate freedom for adapting the experimental design to the conditions in particular laboratories and for varying characteristics of test substances.
Trajanje faze absorpcije je mogoče napovedati na podlagi praktičnih izkušenj (npr. iz pretekle študije ali študije akumulacije o strukturno sorodni snovi) ali določenih empiričnih razmerij, ki temeljijo na znanju o topnosti v vodi ali porazdelitvenem koeficientu n-oktanol/voda preskusne snovi (pod pogojem, da absorpcija sledi kinetiki prvega reda, prim. Dodatek 5).
The aqueous exposure test is most appropriately applied to stable organic substances with log KOW values between 1,5 and 6,0 (13) but may still be applied to strongly hydrophobic substances (having log KOW > 6,0), if a stable and fully dissolved concentration of the test substance in water can be demonstrated.
Fazo absorpcije je treba izvajati 28 dni, razen če se lahko dokaže, da je bilo stacionarno stanje doseženo že prej (za opredelitev pojmov in enote glej Dodatek 1).
If a stable concentration of the test substance in water cannot be demonstrated, an aqueous study would not be appropriate thus the dietary approach for testing the substance in fish would be required (although interpretation and use of the results of the dietary test may depend on the regulatory framework).
Stacionarno stanje je doseženo v grafičnem prikazu preskusne snovi v ribah (Cf) v odvisnosti od časa, ko krivulja postane vzporedna s časovno osjo in so tri zaporedne analize Cf na vzorcih, vzetih v intervalu najmanj dveh dni, v območju ± 20 % druga od druge ter ni precejšnjega povečanja Cf v času med prvo in zadnjo zaporedno analizo.
Pre-estimates of the bioconcentration factor (BCF, sometimes denoted as KB) for organic substances with log KOW values up to about 9,0 can be obtained using the equation of Bintein et al.
Pri analiziranju združenih vzorcev so potrebne najmanj štiri zaporedne analize.
The pre-estimate of the bioconcentration factor for such strongly hydrophobic substances may be higher than the steady-state bioconcentration factor (BCFSS) value expected to be obtained from laboratory experiments, especially when a simple linear model is used for the pre-estimate.
Za preskusne snovi, ki se absorbirajo počasi, so primernejši sedemdnevni intervali.
Parameters which characterise the bioaccumulation potential include the uptake rate constant (k1), loss rate constants including the depuration rate constant (k2), the steady-state bioconcentration factor (BCFSS), the kinetic bioconcentration factor (BCFK) and the dietary biomagnification factor (BMF) [22].
Če stacionarno stanje ni bilo doseženo v 28 dneh, se izračuna BKF s kinetičnim pristopom, ki ni odvisen od doseganja stacionarnega stanja, ali pa se podaljša fazo absorpcije in opravlja nadaljnje meritve, dokler ni doseženo stacionarno stanje ali 60 dni, kar koli od tega je krajše.
Radiolabelled test substances can facilitate the analysis of water, food and fish samples, and may be used to determine whether identification and quantification of metabolites will be necessary.
Koncentracija preskusne snovi v ribah ob koncu faze absorpcije mora tudi biti dovolj visoka, da se zagotovi zanesljiva ocena k2 iz faze očiščenja.
If total radioactive residues are measured alone (e.g. by combustion or tissue solubilisation), the BCF or BMF is based on the total of the parent substance, any retained metabolites and also assimilated carbon.
Če se po 28 dneh ne pokaže znatna absorpcija, se lahko preskus ustavi.
BCF or BMF values based on total radioactive residues may not, therefore, be directly comparable to a BCF or BMF derived by specific chemical analysis of the parent substance only.
Trajanje faze očiščenja
Separation procedures, such as TLC, HPLC or GC [23] may be employed before analysis in radiolabelled studies in order to determine BCF or BMF based on the parent substance.
Za snovi, ki sledijo kinetiki prvega reda, je polovica obdobja trajanja faze absorpcije običajno dovolj za ustrezno (npr. 95 %) zmanjšanje v obremenitvi telesa za snov (prim. Dodatek 5 za razlago ocene).
When separation techniques are applied, identification and quantification of parent substance and relevant metabolites should be performed [24] (cf. paragraph 65) if BCF or BMF is to be based upon the concentration of the parent substance in fish and not upon total radiolabelled residues.
Če je čas, ki je potreben, da se doseže 95 % izgube, nepraktično dolg in na primer dvakrat daljši od normalnega trajanja faze absorpcije (tj. več kot 56 dni), se lahko uporabi krajše obdobje (npr. kadar koncentracija preskusne snovi znaša manj kot 10 % koncentracije v stacionarnem stanju).
It is also possible to combine a fish metabolism or in vivo distribution study with a bioaccumulation study by analysis and identification of the residues in tissues.
Za snovi z bolj zapletenimi vzorci absorpcije in očiščenja, kot jih predstavlja enodelni model za ribe, ki zagotavlja kinetiko prvega reda, pa bodo morda potrebne daljše faze očiščenja.
The possibility of metabolism can be predicted by suitable tools (e.g. OECD QSAR toolbox (15) and proprietary QSAR programs).
Če se opazijo in/ali predvidevajo taki zapleteni vzorci, se priporoča, da se poišče nasvet biostatistika in/ali farmakokinetika, da se zagotovi ustrezen načrt preskusa.
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.
Če se čas očiščenja podaljša, je lahko na voljo manjše število rib za vzorčenje, razlike v rasti med ribami pa lahko vplivajo na rezultate.
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.
Na to obdobje lahko vpliva tudi obdobje, v katerem koncentracija preskusne snovi v ribah ostane nad analitsko mejo določljivosti.
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).
Število preskusnih rib
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.
Število rib na preskusno koncentracijo je treba izbrati tako, da so za vsako vzorčno točko na voljo najmanj štiri ribe.
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.
Ribe se lahko združi samo, če analiza posameznih rib ni izvedljiva.
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.
Če se namerava pridobiti višja natančnost pri prilagajanju krivulje (in izpeljanih parametrih) ali če so potrebne študije o metabolizmu (npr. za razlikovanje med metaboliti in matično snovjo pri uporabi izotopsko označenih preskusnih snovi), je potrebnih več rib na vzorčno točko.
Information on such practical aspects may be available from other completed aqueous studies.
Vsebnost lipidov je treba določiti na istem biološkem materialu, kot se uporablja za določanje koncentracije preskusne snovi.
Further information on the evaluation of aspects relating to the performance of bioaccumulation studies is available in the literature (e.g. (19)).
Če to ni izvedljivo, bodo mora potrebne dodatne ribe (prim. odstavka 56 in 57).
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.
Če se uporabijo odrasle (tj. spolno zrele) ribe, ne smejo biti v stanju drstenja ali nedavno po drstitvi (tj. so se že drstile) pred ali med preskusom.
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.
V poročilu je treba tudi navesti, ali so bili v preskusu uporabljeni ribji samci ali samice ali oboji.
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.
Če se uporabita oba spola, je treba pred začetkom izpostavljenosti zabeležiti, da so razlike v rasti in vsebnosti lipidov med spoloma zanemarljive, zlasti če se predvideva, da bo treba združiti ribje samce in samice, da se zagotovijo zaznavne koncentracije snovi in/ali vsebnost lipidov.
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.
Za kateri koli preskus se izberejo ribe podobne teže, tako da najmanjše niso manjše od dveh tretjin teže največjih.
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].
Vse morajo biti vzgojene v istem letu in prihajati iz istega vira.
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.
Ker lahko teža in starost ribe precej vplivata na vrednosti BKF (12), je treba te podrobnosti točno zabeležiti.
For surfactants it should be considered whether the aqueous bioconcentration test is feasible, given the substance properties, otherwise the dietary study is probably more appropriate.
Priporočeno je, da se malo pred preskusom stehta podvzorec staleža rib, da se oceni povprečna teža (prim. odstavek 61).
Surfactants are surface acting agents, which lower the interfacial tension between two liquids.
Obremenitev
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.
Uporabiti je treba visoka razmerja med vodo in ribami, da se čim bolj zmanjša upadanje koncentracije preskusne spojine v vodi zaradi dodajanja rib na začetku preskusa in da se prepreči zmanjšanje koncentracij raztopljenega kisika.
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.
Pomembno je, da stopnja obremenitve ustreza uporabljenim preskusnim vrstam.
(20)).
V vsakem primeru se običajno priporoča stopnja obremenitve med vodo in ribami, ki znaša 0,1–1,0 g rib (mokra teža) na liter vode na dan.
It should be noted that the dietary approach yields a dietary biomagnification factor (BMF) rather than a bioconcentration factor (BCF) [26].
Visoke stopnje obremenitve med vodo in ribami se lahko uporabijo, če se pokaže, da se zahtevana koncentracija preskusne snovi lahko ohranja v območju ± 20 % mejnih vrednosti, in da koncentracija raztopljenega kisika ne pade pod 60 % nasičenosti (prim.odstavek 24).
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.
Pri izbiri ustreznih režimov obremenitve je treba upoštevati naravni habitat vrste rib.
In general, these approaches assume first order kinetics, and are only applicable to certain groups of compounds.
Na primer ribe, ki živijo pri dnu, morda zahtevajo več prostora na dnu akvarija pri enaki prostornini vode v primerjavi z vrstami pelagičnih rib.
It is unlikely that such approaches can be applied for surfactants (see paragraph 12).
Hranjenje
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).
Med aklimatizacijo in preskušanjem se ribe hranijo z ustrezno hrano, ki ima znano vsebnost lipidov in skupnih proteinov, v zadostnih količinah, ki zagotavljajo zdravo stanje in ohranjanje telesne teže (nekaj rasti je dovoljene).
C.13 - I: Aqueous Exposure Bioconcentration Fish Test
Ribe se med prilagajanjem in preskušanjem hranijo vsakodnevno in z vnaprej določeno količino hrane glede na uporabljeno vrsto, preskusne pogoje in kalorično vrednost hrane (na primer za šarenko približno 1 do 2 % telesne teže na dan).
The test consists of two phases: the exposure (uptake) and post-exposure (depuration) phases.
Stopnjo hranjenja je treba izbrati tako, da se prepreči hitra rast in veliko povečanje vsebnosti lipidov.
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).
Da se ohrani enaka stopnja hranjenja, je treba količino hrane po potrebi znova ustrezno izračunati, na primer enkrat na teden.
They are then transferred to a medium free of the test substance for the depuration phase.
Za ta izračun se lahko teža rib v vsaki preskusni komori oceni glede na težo ribe, ki je bila nazadnje vzorčena v tej komori.
A depuration phase is always necessary unless uptake of the substance during the uptake phase has been insignificant.
Ribe, ki ostanejo v komori, se ne tehtajo.
The concentration of the test substance in/on the fish (or specified tissue thereof) is followed through both phases of the test.
Ostanki hrane in iztrebki se iz preskusnih komor izčrpajo vsak dan kmalu po hranjenju (v 30 minutah do ene ure).
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].
Posode morajo biti ves čas preskusa čim bolj čiste, da ostane koncentracija organskih snovi čim nižja (prim. odstavek 29), saj lahko prisotnost organskega ogljika omeji biološko dostopnost preskusne snovi (12).