natgillin/translations-raw huggingface dataset:
If it can be demonstrated that: i) the validity criteria in paragraph 113 are fulfilled; and ii) lack of uptake is not due to some other shortcoming of the test (e.g. uptake duration not long enough, deficiency in food spiking technique leading to poor bioavailability, lack of sensitivity of the analytical method, fish not consuming food, etc.); it may be possible to terminate the study without the need to re-run it with a longer uptake duration.
v preglednici predstavljeni podatki o teži (in dolžini) rib, povezani s posameznimi ribami za kontrolno in preskusno skupino (na primer z uporabo edinstvene identifikacijske kode za vsako ribo), in izračuni, izpeljane konstante hitrosti rasti in 95-odstotni intervali zaupanja;
If preliminary work has indicated that this may be the case, analysis of faeces, if possible, for undigested test substance may be advisable as part of a “mass balance” approach.
v preglednici predstavljeni podatki o koncentraciji preskusne snovi v ribah, povprečna izmerjena koncentracija ob koncu absorpcije (C0,m), izpeljana (skupna) konstanta hitrosti očiščenja (k2) in koncentracija v ribah ob začetku faze očiščenja (C0,d) skupaj z variancami teh vrednosti (naklon in osni odsek);
Similar to the aqueous exposure test, fish of similar weight and length should be selected, with the smallest fish being no less than two-thirds of the weight of the largest (cf. paragraphs 40-42).
v preglednici predstavljeni podatki o vsebnosti lipidov v ribah (navedeni v odvisnosti od določenih koncentracij snovi, kadar je to ustrezno), povprečne vrednosti za preskusno in kontrolno skupino ob začetku preskusa ter koncu absorpcije in očiščenja;
The total number of fish for the study should be selected based on the sampling schedule (a minimum of one sample at the end of the uptake phase and four to six samples during the depuration phase, but depending on the phases' durations), taking into account the sensitivity of the analytical technique, the concentration likely to be achieved at the end of the uptake phase (based on prior knowledge) and the depuration duration (if prior knowledge allows estimation).
krivulje (vključno z vsemi izmerjenimi podatki), ki kažejo naslednje (če je ustrezno, se lahko koncentracije izrazijo glede na celo telo živali ali določena tkiva te živali):
Five to ten fish should be sampled at each event, with growth parameters (weight and total length) being measured before chemical or lipid analysis.
rast (tj. teža (in dolžina) ribe v odvisnosti od časa) ali teža v odvisnosti od časa, pretvorjena v naravni logaritem;
Owing to the inherent variability in the size, growth rate, and physiology among fish and the likely variation in the quantity of administered diet that each fish consumes, at least five fish should be sampled at each interval from the test group and five from the control group in order to adequately establish the average concentration and its variability.
očiščenje preskusne snovi v ribi in
The variability among the fish used is likely to contribute more to the overall uncontrolled variability in the test than the variability inherent in the analytical methodologies employed, and thus justifies the use of up to ten fish per sample point in some cases.
koncentracija, pretvorjena v naravni logaritem (koncentracija ln), v odvisnosti od časa očiščenja (vključno z izpeljano konstanto hitrosti očiščenja, k2, in koncentracijo, izpeljano iz naravnega logaritma, v ribah ob začetku faze očiščenja, C0,d);
However, if background test substance concentrations in control fish are not measurable at the start of depuration, chemical analysis of two-three control fish at the final sampling interval only may be sufficient so long as the remaining control fish at all sample points are still sampled for weight and total length (so that the same number are sampled from test and control groups for growth).
izračunana konstanta hitrosti očiščenja, popravljena glede na rast, in razpolovna doba, popravljena glede na rast;
Fish should be stored, weighed individually (even if it proves necessary for the sample results to be combined subsequently) and total length measured.
izračunana učinkovitost asimilacije (α);
For a standard test with, for example, a 28-day depuration duration including five depuration samples, this means a total of 59-120 fish from test and 50-110 from control groups, assuming that the substance's analytical technique allows lipid content analysis to be carried out on the same fish.
„surovi“ prehranski BMF, kinetični BMF, popravljen glede na lipide in razredčitev zaradi rast („surovi“ in popravljen glede na lipide na podlagi mokre teže cele ribe), BMF za tkivo, če je ustrezno;
If lipid analysis cannot be conducted on the same fish as chemical analysis, and using control fish only for lipid analysis is also not feasible (cf. paragraph 56), an additional 15 fish would be required (three from the stock population at test start, three each from control and test groups at the start of depuration and three each from control and test groups at the end of the experiment).
Konstante hitrosti očiščenja snovi in biomagnifikacijski faktorji (BMFK)
An example sampling schedule with fish numbers can be found in Appendix 4.
vstavi vrednost (95-odstotni CI) [55]
Similarly high water-to-fish ratios should be used as for the aqueous exposure method (cf. paragraphs 43 and 44).
k2 (skupna konstanta hitrosti očiščenja, dan– 1):
Although fish-to-water loading rates do not have an effect on exposure concentrations in this test, a loading rate of 0,1-1,0 g of fish (wet weight) per litre of water per day is recommended to maintain adequate dissolved oxygen concentrations and minimise test organism stress.
vstavi vrednost (95-odstotni CI)
Test diet and Feeding
C0,m (izmerjena koncentracija ob času nič, koncentracija v ribah ob koncu absorpcije) (μg/g):
During the acclimatisation period, fish should be fed an appropriate diet as described above (paragraph 117).
vstavi vrednost ± SD [56]
If the test is being conducted under flow-through conditions, the flow should be suspended while the fish are fed.
C0,d (izpeljana koncentracija ob času nič v fazi očiščenja; μg/g):
During the test, the diet for the test group should adhere to that described above (paragraphs 116-121).
I (hitrost zaužitja določenega obroka hrane; g hrana/g riba/dan):
In addition to consideration of substance-specific factors, analytical sensitivity, expected concentration in the diet under environmental conditions and chronic toxicity levels/body burden, selection of the target spiking concentration should take into account palatability of the food (so that fish do not avoid eating).
Ig (dejanska stopnja hranjenja, prilagojena glede na rast; g hrana/g riba/dan) [56]:
Nominal spiking concentration of the test substance should be documented in the report.
Chrana (koncentracija kemikalije v hrani; μg/g):
Based on experience, spiking concentrations in the range of 1-1000 μg/g provide a practical working range for test substances that do not exhibit a specific toxic mechanism.
α (učinkovitost asimilacije snovi):
For substances acting via a non-specific mechanism, tissue residue levels should not exceed 5 μmol/g lipid since residues above this level are likely to pose chronic effects (19) (48) (50) [50].
BMFK (kinetični prehranski BMF):
For other substances care should be taken that no adverse effects occur from the accumulated exposure (cf. paragraph 127).
BMFKg (kinetični prehranski BMF, popravljen glede na rast):
This is especially true if more than one substance is being tested simultaneously (cf. paragraph 112).
t1/2g (razpolovna doba, popravljena glede na rast, v dnevih):
The appropriate amount of the test substance can be spiked to the fish food in one of three ways, as described in paragraph 119 and Appendix 7.
Lc (korekcijski faktor za lipide):
The methods and procedures for spiking the feed should be documented in the report.
BMFKgL (kinetični BMF, popravljen glede na rast in lipide):
Untreated food is fed to the control fish, containing an equivalent quantity of unspiked oil vehicle if this has been used in the spiked feed for the uptake phase, or having been treated with “pure” solvent if a solvent vehicle was used for test group diet preparation.
BMFSS-L (indikativen stacionarni BMF, popravljen glede na lipide) [56]:
The treated and untreated diets should be measured analytically at least in triplicate for test substance concentration before the start and at the end of the uptake phase.
Poglavje C.13 te priloge: Bioakumulacija: pretočni preskus na ribah.
After exposure to the treated feed (uptake phase), fish (both groups) are fed untreated food (depuration phase).
Poglavje A.6 te priloge: Topnost v vodi
Fish are fed at a fixed ration (dependent on species; e.g. approximately 1-2 % of wet body weight per day in the case of rainbow trout).
Poglavje A.8 te priloge: Porazdelitveni koeficient (n-oktanol/voda): metoda stresanja bučke.
The exact feeding rate set during the experiment should be recorded.
Poglavje A.24 te Priloge: Porazdelitveni koeficient (n-oktanol/voda): metoda tekočinske kromatografije visoke ločljivosti (HPLC).
Initial feeding should be based on the scheduled weight measurements of the stock population just prior to the start of the test.
Poglavje A.23 te Priloge: Porazdelitveni koeficient (1-oktanol/voda): metoda počasnega mešanja.
The amount of feed should be adjusted based on the wet weights of sampled fish at each sampling event to account for growth during the experiment.
Poglavje C.7 te priloge: Hidroliza kot funkcija pH.
Weights and lengths of fish in the test and control tanks can be estimated from the weights and total lengths of fish used at each sampling event; do not weigh or measure the fish remaining in the test and control tanks.
Poglavje A.5 te priloge: Površinska napetost vodnih raztopin.
It is important to maintain the same set feeding rate throughout the experiment.
Poglavje A.4 te priloge: Parni tlak.
Feeding should be observed to ensure that the fish are visibly consuming all of the food presented in order to guarantee that the appropriate ingestion rates are used in the calculations.
Poglavje C.4 te priloge: Določanje „dobre“ biorazgradljivosti.
Preliminary feeding experiments or previous experience should be considered when selecting a feeding rate that will ensure that all food from once-daily feeding is consumed.
Poglavje C.29 te priloge: Dobra biorazgradljivost – CO2 v zaprtih posodah.
In the event that food is consistently being left uneaten, it may be advisable to spread the dose over an extra feeding period in each experimental day (e.g. replace once-daily feeding with feeding half the amount twice daily).
SAR QSAR Environ.
If this is necessary, the second feeding should occur at a set time and be timed so that the maximum period of time possible passes before fish sampling (e.g. time for second feeding is set within the first half of an experimental day).
Res.
Although fish generally rapidly consume the food, it is important to ensure that the substance remains adsorbed to the food.
1: 29-39.
Efforts should be made to avoid the test substance becoming dispersed in water from the food, thereby exposing the fish to aqueous concentrations of the test substance in addition to the dietary route.
Ecotoxicological environmental risk limits for total petroleum hydrocarbons on the basis of internal lipid concentrations.
This can be achieved by removing any uneaten food (and faeces) from the test and control tanks within one hour of feeding, but preferably within 30 minutes.
Poglavje C.47 te priloge: Ribe, preskus toksičnosti za zgodnje razvojne stopnje.
In addition, a system where the water is continuously cleaned over an active carbon filter to absorb any ‘dissolved’ contaminant may be used.
Poglavje C.15 te priloge: Ribe, preskus kratkotrajne toksičnosti na embriih in mladicah s hranilnim mešičkom.
Flow-through systems may help to flush away food particles and dissolved substances rapidly [51].
Poglavje C.14 te priloge: Preskus rasti ribjih mladic.
In some cases, a slightly modified spiked food preparation technique can help to alleviate this problem (see paragraph 119).
OECD (2012), OECD Environmental Health and Safety Publications Series on Testing and Assessment No.
Light and Temperature
175: Part I – Validation Report of a ring test for the OECD TG 305 dietary exposure bioaccumulation fish test.
As for the aqueous exposure method (cf. paragraph 48), a 12 to 16 hour photoperiod is recommended and temperature (± 2 °C) appropriate for the test species used (cf. Appendix 3).
OPREDELITEV POJMOV IN ENOTE
Type and characteristics of illumination should be known and documented.
Učinkovitost asimilacije (α) je merilo relativne količine snovi, absorbirane iz črevesja v organizem (α nima enote, ampak je pogosto izražena kot odstotek in ne kot delež).
One control group should be used, with fish fed the same ration as the test group but without the test substance present in the feed.
Bioakumulacija se na splošno opisuje kot postopek, pri katerem koncentracija snovi v organizmu doseže raven, ki presega to v respiratornem mediju (npr. voda za ribe ali zrak za sesalce), hrani ali obojem(1).
If an oil or solvent vehicle has been used to spike the feed in the test group, the control group food should be treated in exactly the same way but with the absence of test substance so that the diets of the test group and control group are equivalent (cf. paragraphs 121 and 139).
Biokoncentracija je povečana koncentracija preskusne snovi v ali na organizmu (ali določenih tkivih organizma), ki je odvisna od koncentracije preskusne snovi v okoliškem mediju.
The conditions described in the aqueous exposure method apply here also, except that TOC need only be measured before the test as part of the test water characterisation (cf. paragraph 53).
Biokoncentracijski faktor (BKF ali KB) je koncentracija preskusne snovi v/na ribah ali določenih ribjih tkivih kadar koli med fazo absorpcije v tem preskusu kopičenja (Cf kot mg/kg), deljena s koncentracijo snovi v okoliškem mediju (Cw kot mg/l).
Sampling and Analysis of Fish and Diet
BKF se izrazi v l kg–1.
Analysis of Diet Samples
Treba je opozoriti, da niso upoštevani popravki glede na rast in/ali standardno vsebnost lipidov.
Samples of the test and control diets should be analysed at least in triplicate for the test substance and for lipid content at least before the beginning and at the end of the uptake phase.
Biomagnifikacija je povečana koncentracija preskusne snovi v ali na organizmu (ali določenih tkivih organizma), ki je odvisna od koncentracije preskusne snovi v hrani.
The methods of analysis and procedures for ensuring homogeneity of the diet should be included in the report.
Biomagnifikacijski faktor (BMF) je koncentracija snovi v plenilcu, ki je odvisna od koncentracije v plenilčevem plenu (ali hrani) v stacionarnem stanju.
Samples should be analysed for the test substance by the established and validated method.
V metodi, opisani v tej preskusni metodi, je izpostavljenost prek vodne faze previdno izpuščena, zato vrednosti BMF iz te preskusne metode ni mogoče neposredno primerjati z vrednostjo BMF iz terenske študije (v kateri sta morda združeni vodna in prehranska izpostavljenost).
Pre-study work should be conducted to establish the limit of quantification, percent recovery, interferences and analytical variability in the intended sample matrix.
Prehranski biomagnifikacijski faktor (prehranski BMF) je pojem, ki se v tej preskusni metodi uporablja za opis rezultata preskusa prehranske izpostavljenosti, v katerem je izpostavljenost prek vodne faze previdno izpuščena, zato vrednosti prehranskega BMF iz te preskusne metode ni mogoče neposredno primerjati z vrednostjo BMF iz terenske študije (v kateri sta morda združeni vodna in prehranska izpostavljenost).
At each fish sampling event, 5-10 individuals will be sampled from exposure and control treatments (in some instances numbers of control fish can be reduced; cf. paragraph 134).
Raztopljeni organski ogljik (DOC, dissolved organic carbon) je merilo koncentracije ogljika, ki izvira iz raztopljenih organskih virov v preskusnih medijih.
Sampling events should occur at the same time on each experimental day (relative to feeding time), and should be timed so that the likelihood of food remaining in the gut during the uptake phase and the early part of the depuration phase is minimised to prevent spurious contributions to total test substance concentrations (i.e. sampled fish should be removed at the end of an experimental day, keeping in mind that an experimental day starts at the time of feeding and ends at the time of the next feeding, approximately 24 hours later.
Faza izpostavljenosti ali absorpcije je obdobje, v katerem so ribe izpostavljene preskusni snovi.
Depuration begins with the first feeding of unspiked food; cf. paragraph 128).
Stopnja zaužitja hrane (I) je povprečna količina hrane, ki jo vsak dan pojedo ribe in je odvisna od ocene povprečne celotne telesne teže ribe (izražena v g hrana/g riba/dan).
The first depuration phase sample (taken shortly before the second feeding with unspiked food) is important as extrapolation back one day from this measurement is used to estimate the time zero concentration (C0,d, the concentration in the fish at the end of uptake/start of depuration).
Kinetični biokoncentracijski faktor (BKFK) je razmerje med konstanto hitrosti absorpcije, k1, in konstanto hitrosti očiščenja, k2 (tj. k1/k2 – glej ustrezne opredelitve v tem Dodatku).
Optionally, the gastrointestinal tract of the fish can be removed and analysed separately at the end of uptake and at days 1 and 3 of depuration.
Načeloma bi ta vrednost morala biti primerljiva z BKFSS (glej že navedeno opredelitev), vendar lahko pride do odstopanj, če stacionarno stanje ni bilo zagotovo doseženo ali če je bil kinetični BKF popravljen glede na rast.
At each sampling event fish should be removed from both test vessels and treated in the same way as described in the aqueous method (cf. paragraphs 61-63).
Kinetični biokoncentracijski faktor, normaliziran glede na lipide (BKFKL), je normaliziran na ribo s 5-odstotno vsebnostjo lipidov.
Concentrations of test substance in whole fish (wet weight) are measured at least at the end of the uptake phase and during the depuration phase in both control and test groups.
Kinetični biokoncentracijski faktor, normaliziran glede na lipide in popravljen glede na rast (BKFKgL), je normaliziran na ribo s 5-odstotno vsebnostjo lipidov in popravljen glede na rast med obdobjem študije, kot je opisano v Dodatku 5.
During the depuration phase, four to six sampling points are recommended (e.g. 1, 3, 7, 14 and 28 days).
Stacionarni biokoncentracijski faktor, normaliziran glede na lipide (BKFSSL), je normaliziran na ribo s 5-odstotno vsebnostjo lipidov.
Optionally, an additional sampling point may be included after 1-3 days' uptake to estimate assimilation efficiency from the linear phase of uptake for the fish while still near the beginning of the exposure period.
Snov z več sestavinami je za namene registracije, evalvacije, avtorizacije in omejevanja kemikalij (REACH) opredeljena kot snov, ki ima več kot eno glavno sestavino s koncentracijo, ki znaša od 10 % do 80 % (masni delež).
Two main deviations from the schedule exist: i) if an extended uptake phase is employed for the purposes of investigating uptake kinetics, there will be additional sampling points during the uptake phase and so additional fish will need to be included (cf. paragraph 126); ii) if the study has been terminated at the end of the uptake phase owning to no measurable uptake (cf. paragraph 131).
Porazdelitveni koeficient n-oktanol/voda (KOW) je razmerje med topnostjo snovi v n-oktanolu in vodi v stacionarnem stanju (metode A.8 (2), A.24 (3), A.23 (4)); izrazi se tudi kot POW.
Individual fish that are sampled should be weighed (and their total length measured) to allow growth rate constants to be determined.
Logaritem KOW se uporablja kot pokazatelj potenciala snovi za biokoncentracijo v vodnih organizmih.
Concentrations of the substance in specific fish tissue (edible and non-edible portions) can also be measured at the end of uptake and selected depuration times.
Delci organskega ogljika (POC, particulate organic carbon) so merilo koncentracije ogljika, ki izvira iz suspendiranih organskih virov v preskusnih medijih.
If a radiolabelled material is being tested, similar considerations as those for the aqueous exposure method should be considered with feed analysis replacing water analysis (cf. paragraph 65).
Mikroekstrakcija na trdni fazi (SPME) je analitska tehnika, pri kateri se ne uporablja topilo in ki je bila razvita za sisteme redčenja.
For the periodic use of a reference substance (cf. paragraph 25), it is preferable that concentrations are measured in the test group at the end of uptake and at all depuration times specified for the test substance (whole fish); concentrations need only be analysed in the control group at end of uptake (whole fish).
Pri tej metodi se vlakno, prevlečeno s polimerom, izpostavi plinski ali tekoči fazi, ki vsebuje preiskovani analit.
In certain circumstances (for example if analysis techniques for test substance and reference substance are incompatible, such that additional fish would be needed to follow the sampling schedule) another approach may be used as follows to minimise the number of additional fish required.
Načeloma se uporabi čim krajši čas analize, da se vzpostavijo pogoji stacionarnega stanja med trdno in tekočo fazo glede na izmerjeno vrsto.
Concentrations of the reference substance are measured during depuration only on days 1, 3 and two further sampling points, selected such that reliable estimations of time zero concentration (C0,d) and k2 can be made for the reference substance.
Nato se lahko koncentracija preiskovanega analita določi neposredno iz vlakna ali po njegovi ekstrakciji iz vlakna v topilo glede na tehniko določanja.
If possible the lipid content of the individual fish should be determined on each sampling occasion, or at least at the start and end of the uptake phase and at the end of the depuration phase.
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.
(cf. paragraphs 56 and 67).
Pri analiziranju združenih vzorcev so potrebne najmanj štiri zaporedne analize.
Depending on the analytical method (refer to paragraph 67 and to Appendix 4), it may be possible to use the same fish for both lipid content and test substance concentration determination.
Stacionarni biokoncentracijski faktor (BKFSS) se v daljšem časovnem obdobju znatno ne spreminja, pri čemer je koncentracija preskusne snovi v okoliškem mediju v tem obdobju konstantna (prim. opredelitev stacionarnega stanja).
This is preferred on the grounds of minimising fish numbers.
Skupni organski ogljik (TOC, total organic carbon) je merilo koncentracije ogljika, ki izvira iz vseh organskih virov v preskusnih medijih, vključno z viri v obliki delcev in raztopljenimi viri.
However, should this not be possible, the same approach as described in the aqueous exposure method can be used (see paragraph 56 for these alternative lipid measurement options).
Konstanta hitrosti absorpcije (k1) je številčna vrednost, ki določa hitrost povečanja koncentracije preskusne snovi v/na preskusni ribi (ali določenem ribjem tkivu), ko so ribe izpostavljene navedeni snovi (k1 se izrazi v l kg–1 dan–1).
The method used to quantify the lipid content should be documented in the report.
Snovi z neznano ali spremenljivo sestavo, kompleksni reakcijski produkti ali biološki materiali so znani kot UVCB.
Quality of the analytical method
Kemikalija je snov ali zmes.
Experimental checks should be conducted to ensure the specificity, accuracy, precision and reproducibility of the substance-specific analytical technique, as well as recoveries of the test substance from both food and fish.
Preskusna kemikalija je vsaka snov ali zmes, preskušena s to preskusno metodo.