natgillin/translations-raw huggingface dataset:
The highest permissible test concentration can also be determined by dividing the acute 96 h LC50 by an appropriate acute/ chronic ratio (e.g. appropriate ratios for some substances are about three, but a few are above 100).
metoda priprave osnovnih raztopin in pogostost obnavljanja (kadar se uporabi, je treba navesti topilo ter njegovo koncentracijo in prispevek k vsebnosti organskega ogljika v preskusni vodi) ali opis drugačnega sistema odmerjanja;
If a second concentration is used, it should differ from the one above by a factor of ten.
nominalne preskusne koncentracije, povprečja izmerjenih vrednosti in njihovih standardnih odklonov v preskusnih posodah ter metoda in pogostost, s katerima so bili izmerjeni;
If this is not possible because of the toxicity criterion (that limits the upper test concentration) and the analytical limit (that limits the lower test concentration), a lower factor than ten can be used and use of radiolabelled test substance (of the highest purity, e.g. preferably > 98 %) should be considered.
vir vode za redčenje, opis morebitne predhodne obdelave, rezultati vseh dokazovanj sposobnosti preskusnih rib, da živijo v vodi, in značilnosti vode: pH, trdota, temperatura, koncentracija raztopljenega kisika, skupni preostali klor (če je bil izmerjen), skupni organski ogljik, suspendirane trdne snovi, slanost preskusnega medija (če je ustrezno) in vse druge opravljene meritve;
Care should be taken that no concentration used is above the solubility limit of the test substance in the test media.
kakovost vode v preskusnih posodah, pH, trdota, TOC, temperatura in koncentracija raztopljenega kisika; uporabljene metode in pogostost meritev;
One dilution water control or if relevant (cf. paragraphs 30 and 31), one control containing the solvent should be run in addition to the test series.
podrobni podatki o hranjenju, na primer vrsta hrane, vir, sestava (vsaj vsebnost lipidov in proteinov, če je mogoče), izbrana stopnja hranjenja, količina dane hrane in pogostost;
Frequency of Water Quality Measurements
podatki o tretiranju ribjih in vodnih vzorcev, vključno s podrobnostmi o pripravi, shranjevanju, ekstrakciji ter analitskih postopkih (in natančnost) za preskusno snov in vsebnost lipidov;
During the test, dissolved oxygen, TOC, pH and temperature should be measured in all test and control vessels.
metode, uporabljene za naključno razporeditev tretiranja in dodelitev rib v preskusne posode;
Total hardness and salinity (if relevant) should be measured in the control(s) and one vessel.
datum dodajanja preskusnih organizmov v preskusne raztopine in trajanje preskusa;
If two or more concentrations are tested, measure these parameters at the higher (or highest) concentration.
opis preskusa in rezultatov za določanje območja, če so na voljo.
As a minimum, dissolved oxygen and salinity (if relevant) should be measured three times — at the beginning, around the middle and end of the uptake period — and once a week in the depuration period.
rezultati vseh izvedenih predhodnih študij;
TOC should be measured at the beginning of the test (24 h and 48 h prior to test initiation of uptake phase) before addition of the fish and at least once a week during both uptake and depuration phases.
smrtnost kontrolnih rib in rib v vsaki komori s preskusno snovjo ter kakršno koli ugotovljeno nenavadno vedenje;
Temperature should be measured and recorded daily, pH at the beginning and end of each period and hardness once each test.
informacije o morebitnih ugotovljenih neželenih učinkih;
Temperature should preferably be monitored continuously in at least one vessel.
popoln opis vseh uporabljenih postopkov kemijske analize, vključno z mejo zaznavnosti in določljivosti, variabilnostjo in izkoristkom;
Sampling and Analysis of Fish and Water
vsebnost lipidov v ribah, vključno z uporabljeno metodo, in, če je bil izpeljan, faktor normalizacije lipidov (Ln, faktor za izražanje rezultatov glede na 5-odstotno vsebnost lipidov ribah);
Fish and water sampling schedule
v preglednici predstavljeni podatki o teži (in dolžini) rib, povezani s koncentracijami kemikalije (in vsebnostjo lipidov, kadar je ustrezno) v posameznih ribah za kontrolno in preskusno skupino (na primer z uporabo edinstvene identifikacijske kode za vsako vzorčeno ribo), ter izračuni za izpeljane konstante hitrosti rasti;
Water should be sampled from the test chambers for the determination of test substance concentration before addition of the fish and during both uptake and depuration phases.
v preglednici predstavljeni podatki o koncentraciji preskusne snovi v ribah (Cf, povezani s posameznimi ribami) in vodi (Cw) (s povprečnimi vrednostmi za preskusno in kontrolno skupino, standardnim odklonom in območjem, kadar je ustrezno) za vsa vzorčenja (Cf, izražen v mg/kg mokre teže celega telesa ali določenih tkiv tega telesa, npr. lipidi, in Cw v mg/l).
The water should be sampled the before feeding, at the same time as the fish sampling.
Vrednosti Cw za kontrolno serijo (navesti je treba tudi ozadje);
More frequent sampling may be useful to ensure stable concentrations after introduction of the fish.
krivulje (vključno z vsemi izmerjenimi podatki), ki kažejo naslednje (če je ustrezno, se lahko koncentracije izrazijo glede na celo telo in vsebnost lipidov, normalizirano na 5 % v živali ali določenih tkivih te živali):
During the uptake phase, the concentrations of test substance should be determined in order to check compliance with the validity criteria (paragraph 24).
rast, tj. teža ribe v odvisnosti od časa ali teža v odvisnosti od časa, pretvorjena v naravni logaritem (vključno z izpeljano konstanto hitrosti rasti, kg);
If water sample analyses at the beginning of the depuration phase show that the test substance is not detected, this can be used as a justification not to measure test and control water for the test substance for the remainder of the depuration phase.
absorpcija in očiščenje preskusne snovi v ribi (na enem grafu);
Fish should be sampled on at least five occasions during the uptake phase and on at least four occasions during the depuration phase for test substance.
čas, v katerem je bilo doseženo stacionarno stanje (če je bilo doseženo);
Since on some occasions it will be difficult to calculate a reasonably precise estimate of the BCF value based on this number of samples (especially when other than simple first order uptake and depuration kinetics are indicated), it may be advisable to take samples at a higher frequency in both periods (cf. Appendix 4).
koncentracija v odvisnosti od časa absorpcije, pretvorjena v naravni logaritem (vključno z izpeljano konstanto hitrosti absorpcije, k1);
The lipid content should be determined on the same biological material as is used to determine the concentration of the test substance at least at the start and end of the uptake phase and at the end of the depuration phase.
koncentracija, pretvorjena v naravni logaritem (koncentracija ln), v odvisnosti od časa očiščenja (vključno z izpeljano konstanto hitrosti očiščenja, k2) in
Should this not be feasible, at least three independent fish should be sampled to determine lipid content at each of the same three time-points.
krivulji faz absorpcije in očiščenja, ki prikazujeta podatke in prilagojen model;
The number of fish per tank at the start of the experiment should be adjusted accordingly [33].
če vizualni pregled grafičnega prikaza pokaže očitne osamelce, se lahko uporabi statistično veljaven preskus osamelcev, da se odstranijo napačne podatkovne točke in zagotovi utemeljitev za njihovo opustitev;
Alternatively, if no significant amounts of the test substance are detected in control fish (i.e. fish from the stock population), the control fish from the test can be analysed for lipid content only and test substance analysis in the test group(s) (and the related uptake rate constant, depuration rate constant and BCF values) can be corrected for changes according to control group lipid content during the test [34].
stacionarni biokoncentracijski faktor (BKFSS), če je (skoraj) doseženo stacionarno stanje;
Dead or diseased fish should not be analysed for test substance or lipid concentration.
kinetični biokoncentracijski faktor (BKFK) ter izpeljani konstanti hitrosti absorpcije in očiščenja, k1 in k2, skupaj z variancami k2 (naklon in osni odsek), če se uporabi zaporedno prilagajanje;
An example of an acceptable sampling schedule is given in Appendix 4.
meje zaupanja, standardni odklon (kot je na voljo) in metode za izračune/analizo podatkov za vsak parameter za vsako koncentracijo uporabljene preskusne snovi;
Other schedules can readily be calculated using other assumed values of KOW to calculate the exposure time for 95 % uptake (refer to Appendix 5 for calculations).
kakršne koli informacije o metabolitih izotopsko označene preskusne snovi in njihovem kopičenju;
Sampling should be continued during the uptake phase until a steady-state has been established (see Appendix 1, definitions and units) or the uptake phase is otherwise terminated (after 28 or 60 days, cf. paragraphs 37 and 38).
konstante hitrosti rasti (vključno s 95-odstotnimi intervali zaupanja) in izračunana konstanta hitrosti očiščenja, popravljena glede na rast (k2g), ter vrednosti razpolovne dobe in BKF (BKFKg);
Before beginning the depuration phase, the fish should be transferred to clean vessels.
kar koli nenavadnega v zvezi s preskusom, kakršno koli odstopanje od teh postopkov in vsi drugi pomembni podatki;
Sampling and sample preparation
preglednica s povzetimi, ustreznimi, izmerjenimi in izračunanimi podatki, kot sledi v nadaljevanju:
Water samples should be obtained for analysis e.g. by siphoning through inert tubing from a central point in the test chamber.
Konstanti hitrosti absorpcije in očiščenja snovi ter biokoncentracijski faktorji (BKF)
Neither filtration nor centrifuging appears always to separate the non-bioavailable fraction of the test substance from that which is bioavailable.
kg (konstanta hitrosti rasti; dan– 1):
If a separation technique is applied, a justification for, or validation of, the separation technique should always be provided in the test report given the bioavailability difficulties (25).
vstavi vrednost (95-odstotni CI) [38]
Especially for highly hydrophobic substances (i.e. those substances with a log KOW > 5) (12) (26), where adsorption to the filter matrix or centrifugation containers could occur, samples should not be subjected to those treatments.
k1 (skupna konstanta hitrosti absorpcije; l kg– 1 dan- 1):
Instead, measures should be taken to keep the tanks as clean as possible (cf. paragraph 46) and the content of total organic carbon should be monitored during both the uptake and depuration phases (cf. paragraph 53).
k2 (skupna konstanta hitrosti očiščenja; dan– 1):
To avoid possible issues with reduced bioavailability, sampling by solid phase microextraction techniques may be used for poorly soluble and highly hydrophobic substances.
k2g (konstanta hitrosti očiščenja, popravljena glede na rast; dan– 1):
The sampled fish should be euthanised instantly, using the most appropriate and humane method (for whole fish measurements, no further processes than rinsing with water (cf. paragraph 28) and blot drying the fish should be done).
Cf (koncentracija kemikalije v ribi v stacionarnem stanju; mg kg– 1):
Weigh and measure total length [35].
vstavi vrednost ± SD [39]
In each individual fish, the measured weight and length should be linked to the analysed substance concentration (and lipid content, if applicable), for example using a unique identifier code for each sampled fish.
Cw (koncentracija kemikalije v vodi; mg l– 1):
It is preferable to analyse fish and water immediately after sampling in order to prevent degradation or other losses and to calculate approximate uptake and depuration rate constants as the test proceeds.
Ln (faktor normalizacije lipidov):
Immediate analysis also avoids delay in determining when a plateau (steady-state) has been reached.
vstavi vrednost (3)
Failing immediate analysis, the samples should be stored by an appropriate method.
BKFSS (stacionarni BKF; l kg– 1)
Before the beginning of the study, information should be obtained on the proper method of storage for the particular test substance — for example, deep-freezing, holding at 4 °C, extraction, etc.
BKFSSL (stacionarni BKF, normaliziran glede na lipide; l kg– 1):
The duration of storage should be selected to ensure that the substance has not degraded while in storage.
vstavi vrednost (3) ±SD [39]
Quality of analytical method
BKFK (kinetični BKF; l kg– 1)
Since the whole procedure is governed essentially by the accuracy, precision and sensitivity of the analytical method used for the test substance, check experimentally that the accuracy, precision and reproducibility of the substance analysis, as well as recovery of the test substance from both water and fish are satisfactory for the particular method.
BKFKg (kinetični BKF, popravljen glede na rast; l kg– 1)
This should be part of preliminary tests.
t1/2g (razpolovna doba, popravljena glede na rast; dan):
Also, check that the test substance is not detectable in the dilution water used.
BKFKL (kinetični BKF, normaliziran glede na vsebnost lipidov; l kg– 1):
If necessary, correct the values of test substance concentration in water and fish obtained from the test for the recoveries and background values of controls.
vstavi vrednost
The fish and water samples should be handled throughout in such a manner as to minimise contamination and loss (e.g. resulting from adsorption by the sampling device).
BKFKLG (kinetični BKF, popravljen glede na rast in normaliziran glede na vsebnost lipidov; l kg– 1):
Analysis of fish samples
Preprečiti je treba rezultate, ki so v poročilu navedeni kot „ni zaznano/količinsko opredeljeno na meji zaznavnosti/določljivosti“ pri razvoju metode in načrta preskusa pred preskusom, saj takih rezultatov ni mogoče uporabiti za izračune konstant hitrosti.
If radiolabelled materials are used in the test, it is possible to analyse for total radiolabel (i.e. parent and metabolites) or the samples may be cleaned up so that the parent substance can be analysed separately.
C.13 – II: Minimiziran preskus vodne izpostavljenosti rib
If the BCF is to be based on the parent substance, the major metabolites should be characterised, as a minimum at the end of the uptake phase (cf. paragraph 6).
Vedno več izkušenj, ki so jih laboratoriji in regulativni organi pridobili z izvedbo in razlago popolnega preskusa, kaže, da se za oceno konstant hitrosti absorpcije in očiščenja uporablja kinetika prvega reda, razen za nekatere izjeme.
Major metabolites are those representing ≥ 10 % of total residues in fish tissues, those representing ≥ 5 % at two consecutive sampling points, those showing increasing levels throughout the uptake phase, and those of known toxicological concern.
Zato se lahko konstanti hitrosti absorpcije in očiščenja ocenita s čim manjšim številom točk vzorčenja ter izpelje kinetični BKF.
If the BCF for the whole fish in terms of total radiolabelled residues is ≥ 500, it may be advisable — and for certain categories of substances such as pesticides strongly recommended — identifying and quantifying major metabolites.
Proučevanje drugačnih načrtov za študije BKF je bilo najprej namenjeno razvoju kratkega preskusa, ki bi bil uporabljen kot vmesni korak preskušanja, da se potrdi ali ovrže ocene BKF na podlagi KOW in QSAR, s tem pa odpravi potreba po popolni študiji za mnoge snovi ter zmanjša stroške in uporabo živali z zmanjšanim vzorčenjem in številom izvedenih analitskih zaporedij.
Quantification of such metabolites may be required by some regulatory authorities.
Ob upoštevanju glavnega načrta prejšnje preskusne metode, da se zagotovi združevanje rezultatov preskusa z obstoječimi podatki o BKF ter olajša izvedba preskusov in razlaga podatkov, je bil cilj zagotoviti ocene BKF z ustrezno točnostjo in natančnostjo za sprejemanje odločitev v zvezi z oceno tveganja.
If degradates representing ≥ 10 % of total radiolabelled residues in the fish tissue are identified and quantified, then it is also recommended to identify and quantify degradates in the test water.
Uporabljajo se mnoga ista načela kot pri popolnem preskusu, npr. merila za veljavnost (prim. odstavek 24) in prekinitev preskusa, če se ob koncu faze absorpcije ugotovi zanemarljiva absorpcija (prim. odstavka 16 in 38).
Should this not be feasible, this should be explained in the report.
Snovi, za katere se lahko izvede minimiziran načrt preskusa, morajo soditi v splošno območje, za katerega je bila razvita ta preskusna metoda, tj. nepolarne organske snovi (prim. odstavek 49).
The concentration of the test substance should usually be determined for each weighed individual fish.
Če kar koli kaže na to, da bi se lahko snov, ki se bo preskusila, vedla drugače (npr. očitno odstopanje od kinetike prvega reda), je treba zaradi regulativnih razlogov izvesti popoln preskus.
If this is not possible, pooling of the samples on each sampling occasion may be done but pooling does restrict the statistical procedures which can be applied to the data, so an adequate number of fish to accommodate the desired pooling, statistical procedure and power should be included in the test.
Minimiziran preskus se običajno ne izvaja v krajšem časovnem obdobju kot standardni preskus BKF, ampak zajema manj vzorčenj rib (glej Dodatek 6 za utemeljitev).
References (27) and (28) may be used as an introduction to relevant pooling procedures.
Lahko pa se skrajša faza očiščenja za snovi, ki se zelo hitro očistijo, da se prepreči padec koncentracij v ribah pod mejo zaznavnosti/določljivosti pred koncem preskusa.
BCF should be expressed as normalised to a fish with a 5 % lipid content (based on wet weight) in addition to that derived directly from the study (cf .paragraph 21), unless it can be argued that the test substance does not accumulate primarily in lipids.
Minimiziran preskus izpostavljenosti rib z eno koncentracijo se lahko uporabi za opredeljevanje potrebe po popolnem preskusu in če so rezultati preskusa, uporabljeni za izračun konstant hitrosti in BKF, zanesljivi (prim. odstavek 93), se lahko opusti izvedba popolnega preskusa, če dobljeni BKF očitno ne sodi v območje vrednosti, ki zahtevajo regulativni nadzor.
The lipid content of the fish should be determined on each sampling occasion if possible, preferably on the same extract as that produced for analysis for the test substance, since the lipids often have to be removed from the extract before it can be analysed chromatographically.
V nekaterih primerih je morda bolje izvesti minimiziran načrt preskusa z več preskusnimi koncentracijami kot predhodni preskus, da se določi, ali so ocene BKF za snov odvisne od koncentracije.
However, analysis of test substances often requires specific extraction procedures which might be in contradiction to the test methods for lipid determination.
Če ocene BKF iz minimiziranega preskusa kažejo na odvisnost od koncentracije, je treba izvesti popoln preskus.
In this case (until suitable non-destructive instrumental methods are available), it is recommended to employ a different strategy to determine the fish lipid content (cf. paragraph 56).
Če na podlagi takega minimiziranega preskusa ocene BKF niso odvisne od koncentracije, ampak se rezultati ne morejo obravnavati kot dokončni, potem se lahko kateri koli nadaljnji popolni preskus izvede z eno koncentracijo, s tem pa se zmanjša uporaba živali v primerjavi s popolnim preskusom z dvema koncentracijama (ali več).
Suitable methods should be used for determination of lipid content (20).
Snovi, za katere se lahko morebiti izvede minimiziran preskus, morajo:
The chloroform/methanol extraction technique (29) may be recommended as standard method (30), but the Smedes-method (31) is recommended as an alternative technique.
najverjetneje slediti približni kinetiki absorpcije in očiščenja prvega reda, npr. na podlagi virov o podobnih snoveh;
This latter method is characterised by a comparable efficiency of extraction, high accuracy, the use of less toxic organic solvents and ease of performance.
imeti log KOW < 6, razen če se pričakuje zelo hiter metabolizem [40];
Other methods for which accuracy compares favourably to the recommended methods could be used if properly justified.
biti dovolj topne v vodi glede na analitsko tehniko (prim. odstavek 24);
It is important to give details of the method used.
biti jasno količinsko opredeljive (tj. koncentracije morajo biti vsaj en red velikosti nad mejo določljivosti) v ribah in vodi, priporočeno je označevanje radioaktivnosti (prim. odstavek 23); in
Fish growth measurement
imeti daljšo fazo očiščenja kot je njihova predvidena razpolovna doba (prim. Dodatek 5 za izračune) ali pa je treba ustrezno prilagoditi trajanje očiščenja (prim. odstavek 91).
At the start of the test, five to ten fish from the stock population need to be weighed individually and their total length measured.
Izjema k temu pravilu je dovoljena, če se pričakuje zelo hiter metabolizem snovi.
These can be the same fish used for lipid analysis (cf. paragraph 56).
ČASOVNI RAZPORED VZORČENJA ZA ŠTUDIJE, KI SLEDIJO MINIMIZIRANEMU NAČRTU
The weight and length of fish used for each sampling event from both test and control groups should be measured before chemical or lipid analysis is conducted.
Vzorčenje rib
The measurements of these sampled fish can be used to estimate the weight and length of fish remaining in the test and control tanks (cf. paragraph 45).
Vzorčenje rib je zmanjšano na štiri točke vzorčenja:
Treatment of results
na sredini in ob koncu faze absorpcije (slednja je hkrati začetek očiščenja), npr. po 14 in 28 dneh (33);
The uptake curve of the test substance should be obtained by plotting its concentration in/on fish (or specified tissues) in the uptake phase against time on arithmetic scales.
na sredini faze očiščenja in ob koncu študije (ko je koncentracija snovi < 10 % največje koncentracije ali vsaj očitno po eni razpolovni dobi snovi), npr. po 7 in 14 dneh očiščenja (33).
If the curve has reached a plateau, that is, become approximately asymptotic to the time axis, the steady-state BCF (BCFSS) should be calculated from:
Če se pričakuje ali ugotovi zelo hitro očiščenje, je morda treba skrajšati fazo očiščenja, da se prepreči padec koncentracij v ribah pod mejo določljivosti;
at steady-statemean
merjenje lipidov kot v popolni študiji;
The development of Cf may be influenced by fish growth (cf. paragraphs 72 and 73).
popravljanje zaradi rasti kot v popolni študiji;
The mean exposure concentration (Cw) is influenced by variation over time.
BKF se izračuna kot kinetični BKF.
It can be expected that a time-weighted average concentration is more relevant and precise for bioaccumulation studies, even if variation is within the appropriate validity range (cf. paragraph 24).
Vzorčenje vode
A time weighted average (TWA) water concentration can be calculated according to Appendix 5, section 1.
Pri minimiziranem načrtu se voda vzorči kot v popolni študiji (prim. odstavek 54) ali vsaj petkrat, ta vzorčenja pa so enakomerno porazdeljena v fazi absorpcije, in enkrat tedensko v fazi očiščenja.
The kinetic bioconcentration factor (BCFK) should be determined as the ratio k1/k2, the two first order kinetic rate constants.
Spremembe načrta
Rate constants k1 and k2 and BCFK can be derived by simultaneously fitting both the uptake and the depuration phase.
Ob upoštevanju lastnosti preskusne snovi, veljavnih napovedi QSAR in določenega namena študije se lahko obravnavajo nekatere spremembe načrta študije:
Alternatively, k1 and k2 can be determined sequentially (see Appendix 5 for a description and comparison of these methods).
če je potrebna večja natančnost, se lahko za vzorec ob koncu faze absorpcije uporabi več rib (6 ali 8 namesto 4);
The depuration rate constant (k2) may need correction for growth dilution (cf. paragraphs 72 and 73).
Če očiščenje v 14 dneh (ali ob predvidenem koncu faze očiščenja) ni bilo dovolj za ustrezno očiščenje (tj. > 50 %), se lahko uporabi „dodatna“ skupina rib.