natgillin/translations-raw huggingface dataset:
fuldstændig beskrivelse af alle kemiske analyseprocedurer, herunder detektions- og kvantificeringsgrænser samt variation og genfinding
In practice the uptake phase ends shortly before (e.g. one hour) the first feeding with unspiked test substance as the fish will continue to digest spiked food and absorb the test substance in the intervening 24 hours.
målte fedtkoncentrationer i foder (spiked foder og kontrolfoder), individuelle værdier, gennemsnitsværdier og standardafvigelser
It is important to ensure that a sufficiently high (non-toxic) body burden of the test substance is achieved with respect to the analytical method, so that at least an order of magnitude decline can be measured during the depuration phase.
i tabelform: data for den enkelte fisks vægt (og længde), både for kontrol- og eksponeringsgrupper (f.eks. ved at anvende unikke identifikatorer for hver fisk) og beregninger, afledte væksthastighedskonstant(er) og 95 %-konfidensintervaller
In special cases an extended uptake phase (up to 28 days) may be used with additional sampling to gain an insight into uptake kinetics.
i tabelform: data for teststoffets koncentration i fisk, gennemsnitlig målt koncentration ved optagelsesfasens slutning (C0,m), og afledt (samlet) udskillelseshastighedskonstant (k2) og koncentration i fisk ved udskillelsesfasens start (C0,d) sammen med varianser i disse værdier (hældning og skæringspunkt)
During uptake the concentration in the fish may not reach steady-state.
i tabelform: data for fedtindhold i fisk (sammenholdt med specifikke stofkoncentrationer, hvis disse foreligger), middelværdier for test- og kontrolgruppe ved testens start samt optagelses- og udskillelsesfasens slutning
Equations for estimating time to steady-state, as an indication of the likely duration needed to achieve appreciable fish concentrations, can be applied here as for the aqueous exposure test (cf. Appendix 5).
kurver (og alle målte data), der viser følgende (eventuelle koncentrationer kan udtrykkes både i forhold til hele dyrets krop eller specificeret væv deraf):
In some cases it may be known that uptake of substance in the fish over 7-14 days will be insufficient for the food concentration used to reach a high enough fish concentration to analyse at least an order of magnitude decline during depuration, either due to poor analytical sensitivity or to low assimilation efficiency.
vækst (dvs. fiskens vægt (og længde) i forhold til tid) eller vægt i forhold til tid transformeret ved uddragelse af den naturlige logaritme
In such cases it may be advantageous to extend the initial feeding phase to longer than 14 days, or, especially for highly metabolisable substances, a higher dietary concentration should be considered.
udskillelse af teststoffet i fiskene
However, care should be taken to keep the body burden during uptake below the (estimated) chronic no effect concentration (NOEC) in fish tissue (cf. paragraph 138).
koncentration transformeret ved uddragelse af den naturlige logaritme (ln koncentration) i forhold til udskillelsestid (herunder den afledte udskillelseshastighedskonstant k2 og koncentration transformeret ved uddragelse af den naturlige logaritme i fisk ved udskillelsesfasens start, C0,d)
Depuration typically lasts for up to 28 days, beginning once the test group fish are fed pure, untreated diet after the uptake phase.
beregnet vækstkorrigeret udskillelseskonstant og vækstkorrigeret halveringstid
Depuration begins with the first feeding of “unspiked” food rather than straight after the last “spiked” food feeding as the fish will continue to digest the food and absorb the test substance in the intervening 24 hours, as noted in paragraph 126.
stoffets assimileringseffektivitet (α)
Hence the first sample in the depuration phase is taken shortly before the second feeding with unspiked diet.
“rå” BMF for foderet, kinetisk BMF korrigeret for fedt og vækstfortynding (“rå” og lipid-korrigeret på grundlag af hele fisks vådvægt), evt. vævsspecifik BMF
This depuration period is designed to capture substances with a potential half-life of up to 14 days, which is consistent with that of bioaccumulative substances [49], so 28 days comprises two half-lives of such substances.
Udskillelseshastighedskonstanter og biomagnificeringsfaktorer (BMFK) for stof
In cases of very highly bioaccumulating substances it may be advantageous to extend the depuration phase (if indicated by preliminary testing).If a substance is depurated very slowly such that an exact half-life may not be determined in the depuration phase, the information may still be sufficient for assessment purposes to indicate a high level of bioaccumulation.
Indsæt værdi (95 % CI) [55]
Conversely, if a substance is depurated so fast that a reliable time zero concentration (concentration at the end of uptake/start of depuration, C0,d) and k2 cannot be derived, a conservative estimate of k2 can be made (cf. Appendix 7).
k2 (samlet udskillelseshastighedskonstant, dag– 1):
If analyses of fish at earlier intervals (e.g. 7 or 14 days) show that the substance has depurated below quantification levels before the full 28-day period, then subsequent sampling may be discontinued and the test terminated.
Indsæt værdi (95 % CI)
In few cases no measurable uptake of the test substance may have occurred at the end of the uptake period (or with the second depuration sample).
C0,m (målt nulstillingskoncentration, koncentrationen i fisk ved optagelsesfasens slutning) (μg/g):
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.
Indsæt værdi ± SD [56]
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.
C0,d (afledt nulstillingskoncentration efter udskillelsesfasen; μg/g):
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).
I (fastsat foderindtag; g foder/g fisk/dag):
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).
Ig (effektiv fodring, korrigeret for vækst; g foder/g fisk/dag) [56]:
Five to ten fish should be sampled at each event, with growth parameters (weight and total length) being measured before chemical or lipid analysis.
Cfood (koncentration af kemikalie i foder, μg/g).
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.
BCFKg (vækstkorrigeret kinetisk BMF i foder):
Fish should be stored, weighed individually (even if it proves necessary for the sample results to be combined subsequently) and total length measured.
T1/2G (vækstkorrigeret halveringstid i dage):
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.
Lc (korrektionsfaktor for fedtindhold):
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).
BMFKgL (fedtkorrigeret, vækstkorrigeret kinetisk BMF):
An example sampling schedule with fish numbers can be found in Appendix 4.
BMFSS-L (vejledende fedtkorrigeret BMF i ligevægt) [56]:
Similarly high water-to-fish ratios should be used as for the aqueous exposure method (cf. paragraphs 43 and 44).
Kapitel A.24 i dette bilag, Fordelingskoefficient (n-octanol/vand), HPLC-metoden.
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.
Kapitel A.23 i dette bilag, Fordelingskoefficient (1-octanol/vand): Slow-stirring-metoden
Test diet and Feeding
SAR QSAR Environ.
During the acclimatisation period, fish should be fed an appropriate diet as described above (paragraph 117).
Res.
If the test is being conducted under flow-through conditions, the flow should be suspended while the fish are fed.
1: 29-39.
During the test, the diet for the test group should adhere to that described above (paragraphs 116-121).
Ecotoxicological environmental risk limits for total petroleum hydrocarbons on the basis of internal lipid concentrations.
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).
DEFINITIONER OG ENHEDER
Nominal spiking concentration of the test substance should be documented in the report.
Assimileringseffektiviteten (α) er et mål for den relative mængde stof absorberet i organismen fra tarmen (α er ikke en enhed, men udtrykkes ofte i procent i stedet for som en fraktion).
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.
Bioakkumulering betegnes normalt som en proces, hvor stoffets koncentration i en organisme når et niveau, der overstiger niveauet i det respiratoriske medium (f.eks. vand for en fisk eller luft for et pattedyr), foderet eller begge dele(1).
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].
Ved biokoncentrering forstås en koncentrationsforøgelse af teststoffet i eller på en organisme (eller specificeret væv deraf) i forhold til koncentrationen af teststoffet i det omgivende medium.
For other substances care should be taken that no adverse effects occur from the accumulated exposure (cf. paragraph 127).
Ved biokoncentreringsfaktoren (BCF eller KB) på et givet tidspunkt under optagelsesfasen i denne akkumuleringstest forstås koncentrationen af teststoffet i/på fiskene eller specificeret væv deraf (Cf som mg/kg) divideret med koncentrationen af det kemiske stof i det omgivende medium (Cw som mg/l).
This is especially true if more than one substance is being tested simultaneously (cf. paragraph 112).
BCF udtrykkes i l·kg-1.
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.
Bemærk, at korrektioner for vækst og/eller standardfedtindhold ikke er medregnet.
The methods and procedures for spiking the feed should be documented in the report.
Ved biomagnetificering forstås en koncentrationsforøgelse af teststoffet i eller på en organisme (eller specificeret væv deraf) i forhold til koncentrationen af teststoffet i foderet.
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.
Ved biomagnificeringsfaktoren (BMF) forstås koncentrationen af et stof i et rovdyr i forhold til koncentrationen i rovdyrets bytte (eller foder) ved ligevægt.
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.
I den metode, der er beskrevet i forsøgsmetoden, undgås eksponering i vandfasen omhyggeligt, og en BMF-værdi fra denne forsøgsmetode kan derfor ikke umiddelbart sammenlignes med en BMF-værdi fra en feltundersøgelse (hvor eksponering i vand og føde kan kombineres).
After exposure to the treated feed (uptake phase), fish (both groups) are fed untreated food (depuration phase).
Fødebiomagnificeringsfaktoren (føde-BMF) anvendes i denne forsøgsmetode til at beskrive resultatet af eksponering i foder, hvor eksponering i vandfasen omhyggeligt undgås, og føde-BMF fra denne forsøgsmetode kan derfor ikke umiddelbart sammenlignes en BMF-værdi fra en feltundersøgelse (hvor eksponering i vand og føde kan kombineres).
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).
Ved udskillelsesfasen eller fasen efter eksponering forstås det tidsrum efter overførsel af forsøgsfiskene fra et medium indeholdende teststoffet til et medium uden stoffet, hvor man undersøger udskillelsen (eller nettoafgivelsen) af stoffet fra forsøgsfiskene (eller specificeret væv deraf).
The exact feeding rate set during the experiment should be recorded.
Ved hastighedskonstant for udskillelse (k2) forstås den talværdi, der angiver hastigheden for koncentrationsfaldet af teststoffet i forsøgsfiskene (eller specificeret væv deraf), efter at de er overført fra et medium indeholdende teststoffet til et medium uden dette stof (k2 udtrykkes i dag-1).
Initial feeding should be based on the scheduled weight measurements of the stock population just prior to the start of the test.
Opløst organisk kulstof (DOC) er et mål for koncentrationen af kulstof hidrørende fra opløste organiske kilder i testmediet.
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.
Ved eksponeringsfasen eller optagelsesfasen forstås det tidsrum, hvori fiskene udsættes for teststoffet.
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.
Foderindtaget (I) er den gennemsnitlige mængde foder, som hver fisk æder pr. dag, i forhold til dens anslåede gennemsnitlige hele kropsvægt (udtrykt som g foder/g fisk pr. dag).
It is important to maintain the same set feeding rate throughout the experiment.
Ved den kinetiske biokoncentreringsfaktor (BCFK) forstås forholdet mellem hastighedskonstanten for optagelse, k1, og hastighedskonstanten for udskillelse, k2 (dvs. k1/k2 — se tilsvarende definitioner i dette tillæg).
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.
I princippet skal værdien være sammenlignelig med BCFSS (se definition ovenfor), men der kan forekomme afvigelser, hvis det ikke er sikkert, at der er opnået ligevægt, eller hvis der er anvendt korrektioner for vækst på den kinetiske BCF.
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.
Den lipidnormaliserede kinetiske biokoncentreringsfaktor (BCFKL) er normaliseret til en fisk med et fedtindhold på 5 %.
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).
Den lipidnormaliserede, vækstkorrigerede kinetiske biokoncentreringsfaktor (BCFKgL) er normaliseret til en fisk med et fedtindhold på 5 % og korrigeret for vækst i forsøgsperioden som beskrevet i tillæg 5.
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).
Den lipidnormaliserede ligevægtsbiokoncentreringsfaktor (BCFSSL) er normaliseret til en fisk med et fedtindhold på 5 %.
Although fish generally rapidly consume the food, it is important to ensure that the substance remains adsorbed to the food.
Et stof bestående af flere forskellige bestanddele defineres i REACH som et stof, der har mere end en bestanddel i en koncentration på 10-80 % (vægt/vægt).
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.
Ved octanol-vand-fordelingskoefficienten (KOW) forstås forholdet mellem et stofs opløselighed i n-octanol og vand ved ligevægt (metode A.8 (2), A.24 (3) og A.23 (4)), også betegnet POW.
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.
Logaritmen til KOW benyttes som en indikation af et stofs potentiale for biokoncentrering i vandorganismer.
In addition, a system where the water is continuously cleaned over an active carbon filter to absorb any ‘dissolved’ contaminant may be used.
Organiske kulstofpartikler (POC) er et mål for koncentrationen af kulstof hidrørende fra suspenderede organiske kilder i testmediet.
Flow-through systems may help to flush away food particles and dissolved substances rapidly [51].
En fastfase-mikroekstraktion (SPME) er en analyseteknik uden opløsningsmiddel, der er udviklet med henblik på at fortynde systemer.
In some cases, a slightly modified spiked food preparation technique can help to alleviate this problem (see paragraph 119).
I denne metode eksponeres en polymerbelagt fiber for den gasfase eller flydende fase, som indeholder den relevante analyt.
Light and Temperature
Generelt kræves en minimumsanalysetid, således at der etableres ligevægtsforhold mellem faste og flydende faser, for så vidt angår de målte arter.
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).
Efterfølgende kan koncentrationen af den relevante analyt bestemmes direkte fra fiberen, eller efter at den er ekstraheret fra fiberen i et opløsningsmiddel, afhængigt af bestemmelsesteknikken.
Type and characteristics of illumination should be known and documented.
Man taler om ligevægtstilstand i plottet over testkemikaliet i fisk (Cf) mod tid, når kurven bliver parallel med tidsaksen, når tre på hinanden følgende analyser af Cf i prøver, der er udtaget med mindst to dages mellemrum, ligger inden for ± 20 % af hinanden, og når der ikke er nogen signifikant stigning i Cf i tidsrummet mellem den første og den sidste vellykkede analyse.
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.
Ved pooling af prøver til analyse kræves der mindst fire på hinanden følgende analyser.
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).
Ligevægtsbiokoncentreringsfaktoren (BCFSS) ændrer sig ikke væsentligt over et længere tidsrum, idet koncentrationen af teststoffet i det angivende medium er konstant i dette tidsrum (jf. Definition af ligevægt).
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).
Totalt indhold af organisk kulstof (TOC) er et mål for koncentrationen af kulstof hidrørende fra alle organiske kilder i testmediet, herunder partikler og opløste kilder.
Sampling and Analysis of Fish and Diet
Ved hastighedskonstant for optagelse (k1) forstås den talværdi, der angiver hastigheden for koncentrationsforøgelsen af teststoffet i eller på fiskene (eller specificeret væv deraf), når fiskene udsættes for stoffet (k1 udtrykkes i l kg-1 dag-1).
Analysis of Diet Samples
Stoffer af ukendt eller variabel sammensætning, komplekse reaktionsprodukter eller biologisk materiale betegnes UVCB
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.
Kemikalie et stof eller en blanding.
The methods of analysis and procedures for ensuring homogeneity of the diet should be included in the report.
Testkemikalie er stoffer eller blandinger, der testes med denne forsøgsmetode.
Samples should be analysed for the test substance by the established and validated method.
Kapitel A.8 i dette bilag, Fordelingskoefficient (n-octanol/vand): Rystekolbemetoden
Pre-study work should be conducted to establish the limit of quantification, percent recovery, interferences and analytical variability in the intended sample matrix.
KEMISKE EGENSKABER AF ACCEPTABELT VAND TIL FORTYNDING
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).
Komponent
Analysis of Fish
Koncentrationsgrænse
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).
Partikler
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.
Organisk kulstof i alt
Depuration begins with the first feeding of unspiked food; cf. paragraph 128).
Ikke-ioniseret ammoniak
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).
Residualt chlor
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.
Organophosphorpesticider i alt
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).
Chlorerede organiske pesticider + polychlorbiphenyler i alt
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.
Organisk chlor i alt
During the depuration phase, four to six sampling points are recommended (e.g. 1, 3, 7, 14 and 28 days).
Arsen
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.