natgillin/translations-raw huggingface dataset:
Chrom
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).
Kobolt
Individual fish that are sampled should be weighed (and their total length measured) to allow growth rate constants to be determined.
Kobber
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.
Jern
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).
Bly
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).
Nikkel
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.
Zink
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.
Kviksølv
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.
Sølv
(cf. paragraphs 56 and 67).
FISKEARTER ANBEFALET TIL TEST
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.
Anbefalet art
This is preferred on the grounds of minimising fish numbers.
Anbefalet testtemperaturinterval (°C)
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).
Anbefalet længde af testfisk (cm) [2]
The method used to quantify the lipid content should be documented in the report.
(Hamilton-Buchanan) Zebrafisk
Quality of the analytical method
(Rafinesque) Tykhovedet elritse
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.
(Linnaeus) Skælkarpe
At the start of the test a sample of fish from the stock population need to be weighed (and their total length measured).
(Temminck and Schlegel) Japansk risfisk
These fish should be sampled shortly before the first spiked feeding (e.g. one hour), and assigned to experimental day 0.
(Rafinesque)
The number of fish for this sample should be at least the same as that for the samples during the test.
(Walbaum) Regnbueørred
Some of these can be the same fish used for lipid analysis before the start of the uptake phase (cf. paragraph 153).
(Linnaeus) Trepigget hundestejle
At each sampling interval fish are first weighed and their length measured.
18-20
In each individual fish the measured weight (and length) should be linked to the analysed chemical concentration (and lipid content, if applicable), for example using a unique identifier code for each sampled fish.
En række brakvands- og saltvandsarter er blevet anvendt i mindre omfang, f.eks.
The measurements of these sampled fish can be used to estimate the weight (and length) of fish remaining in the test and control tanks.
Trommefisk
Experimental Evaluation
Fårehovedelritse
Observations of mortality should be performed and recorded daily.
Stribefisk
Additional observations for adverse effects should be performed, for example for abnormal behaviour or pigmentation, and recorded.
Brændingsaborre
Fish are considered dead if there is no respiratory movement and no reaction to a slight mechanical stimulus can be detected.
»English sole«
Any dead or clearly moribund fish should be removed.
»Staghorn sculpin«
Test results are used to derive the depuration rate constant (k2) as a function of the total wet weight of the fish.
Trepigget hundestejle
Growth rate constant, kg, based on mean increase in fish weight is calculated and used to produce the growth-corrected depuration rate constant, k2g, if appropriate.
Havaborre
In addition, the assimilation efficiency (a; absorption from the gut), the kinetic biomagnification factor (BMFK) (if necessary growth corrected, BMFKg), its lipid-corrected value (BMFKL or BMFKgL, if corrected for growth dilution) and feeding rate should be reported.
Løje
Also, if an estimate of the time to steady-state in the uptake phase can be made (e.g. 95 % of steady-state or t95 = 3,0/k2), an estimate of the steady-state BMF (BMFSS) can be included (cf. paragraphs 105 and 106, and Appendix 5) if the t95 value indicates that steady-state conditions may have been reached.
De i ovenstående tabel opregnede ferskvandsfisk er lette at opdrætte og/eller fremskaffe hele året, mens saltvands- og brakvandsarterne til dels kun findes i bestemte lande.
The same lipid correction should be applied to this BMFSS as to the kinetically-derived BMF (BMFK) to give a lipid-corrected value, BMFSSL (note that no agreed procedure is available to correct a steady-state BMF for growth dilution).
De kan opdrættes enten i fiskedamme eller i laboratoriet under kontrollerede forhold med hensyn til sygdomme og parasitter, så testdyrene er sunde og af kendt afstamning.
Formulae and example calculations are presented in Appendix 7.
Disse fisk kan fås over det meste af verden.
Approaches are available that make it feasible to estimate a kinetic bioconcentration factor (BCFK) from data generated in the dietary study.
Det skal bemærkes, at i testen er vægt den foretrukne målestok for afvigelser, for så vidt angår størrelse og væksthastighedskonstant.
This is discussed in Appendix 8.
Det erkendes dog, at længde er en mere praktisk målestok, hvis fiskene skal vælges ud fra udseende ved et forsøgs start (dvs. fra stampopulationen).
Individual fish wet weights and lengths for all time periods are tabulated separately for test and control groups for all sampling days during the uptake phase (stock population for start of uptake; control group and test group for end of uptake and, if conducted, the early phase (e.g. day 1-3 of uptake) and depuration phase (e.g. days 1, 2, 4, 7, 14, 28, for control and test group).
Dette længdeinterval er beskrevet i forsøgsmetoder for nye kemiske stoffer osv., baseret på Japans lov om kontrol med kemiske stoffer (CSCL).
Weight is the preferred measure of growth for growth dilution correction purposes.
Teoretisk eksempel på en prøveudtagningsplan for komplet biokoncentreringstest med eksponering for et stof med log KOW = 4.
See below (paragraphs 162 and 163) and Appendix 5 for the method(s) used to correct data for growth dilution.
Antal vandprøver [1]
Test substance concentration in fish data
I ALT
Individual fish test substance residue measurements (or pooled fish samples if individual fish measurements are not possible), expressed in terms of wet weight concentration (w/w), are tabulated for test and control fish for individual sample times.
Teoretisk eksempel på prøveudtagningsplan for bioakkumuleringstest af stof i foder efter 10 dages optagelsesfase og 42 dages udskillelsesfase.
If lipid analysis has been conducted on each sampled fish then individual lipid-corrected concentrations, in terms of lipid concentration (w/w lipid), can be derived and tabulated.
Prøveudtagning
Test substance residue measurements in individual fish (or pooled fish samples if individual fish measurements are not possible, cf. paragraph 66) for the depuration period are converted to their natural logarithms and plotted versus time (day).
Tidspunkt for prøveudtagningen
If a visual inspection of the plot shows obvious outliers, a statistically valid outlier test may be applied to remove spurious data points as well as documented justification for their omission.
Antal foderprøver
A linear least squares correlation is calculated for the ln(concentration) vs. depuration (day) data.
Antal fisk pr. prøve
The slope and intercept of the line are reported as the overall depuration rate constant (k2) and natural logarithm of the derived time zero concentration (C0,d) (cf. Appendix 5 and Appendix 7 for further details).
Dag i fase
Should this not be possible because concentrations fall below the limit of quantification for the second depuration sample, a conservative estimate of k2 can be made (cf. Appendix 7).
Prøver af flere fisk?
The variances in the slope and intercept of the line are calculated using standard statistical procedures and the 90 % (or 95 %) confidence intervals around these results evaluated and presented.
Testgruppe
The mean measured fish concentration for the final day of uptake (measured time zero concentration, C0,m) is also calculated and compared with the derived value C0,d.
3 — kontrolgruppe [7]
To calculate the biomagnification factor from the data, first the assimilation efficiency (absorption of test substance across the gut, α) should be obtained.
Ja [10]
To do this, equation A7.1 in Appendix 7 should be used, requiring the derived concentration in fish at time zero of the depuration phase (C0,d), (overall) depuration rate constant (k2), concentration in the food (Cfood), food ingestion rate constant (I) and duration of the uptake period (t) to be known.
Optagelsesfasen slutter kort før den første fodring med ikke-spiked foder, hvor udskillelsesfasen begynder (fiskene i testgruppen fordøjer sandsynligvis stadig det spikede foder i de mellemliggende 24 timer efter den sidste fodring med spiked foder).
Once the assimilation efficiency (α) is obtained, the biomagnification factor can be calculated by multiplying α by the ingestion rate constant (I) and dividing by the (overall) depuration rate constant (k2).
Det betyder, at der bør udtages en prøve ved optagelsesfasens slutning, kort tid før den første fodring med ikke-spiked foder, og den første prøve i udskillelsesfasen bør udtages ca. 23 timer efter den første fodring med ikke-spiked foder.
The growth-corrected biomagnification factor is calculated in the same way but using the growth-corrected depuration rate constant (k2g; cf. paragraphs 162 and 163.
Tallene i parentes angiver, hvor mange prøver (vand, fisk) der skal udtages, hvis der foretages supplerende prøveudtagning.
An alternative estimate of the assimilation efficiency can be derived if tissue analysis was performed on fish sampled in the early, linear phase of the uptake phase; cf. paragraph 151 and Appendix 7.
Disse fisk udtages fra stampopulationen.
Lipid contents of test fish (which are strongly associated with the bioaccumulation of hydrophobic substances) and lipid contents of food can vary enough in practice such that their correction is necessary to present biomagnification factors in a meaningful way.
Hvis der er behov for større præcision eller undersøgelser af metabolisme, der kræver flere fisk, bør disse navnlig udtages ved slutningen af optagelses- og udskillelsesfasen (jf. punkt 40).
The biomagnification factor should be corrected for growth dilution (as is the kinetic BCF in the aqueous exposure method) and corrected for the lipid content of the food relative to that of the fish (the lipid-correction factor).
Der kan være behov for yderligere tre fisk til analyse af fedtindhold, hvis det ikke er muligt at bruge samme fisk som dem, der blev udtaget til måling af stofkoncentrationer ved testens start, optagelsesfasens slutning og udskillelsesfasens afslutning.
Equations and examples for these calculations can be found in Appendix 5 and Appendix 7, respectively.
Det skal bemærkes, at det i mange tilfælde burde være muligt kun at bruge tre kontrolfisk (jf. punkt 56).
To correct for growth dilution, the growth-corrected depuration rate constant (k2g) should be calculated (see Appendix 5 for equations).
Tre foderprøver fra både kontrol- og testgruppe analyseret for teststofkoncentrationer og fedtindhold.
This growth-corrected depuration rate constant (k2g) is then used to calculate the growth-corrected biomagnification factor, as in paragraph 73.
Fisk udtages fra stampopulationen så tæt ved undersøgelsens start som muligt.
In some cases this approach is not possible.
Mindst tre fisk fra stampopulationen bør udtages til analyse af fedtindhold ved teststart.
This can be easily achieved as tests according to this method should link recorded tissue concentrations to individual fish weights.
(Ikke-obligatorisk) prøveudtagning tidligt i optagelsesfasen giver data til beregning af teststoffets assimilering i foder, som kan sammenholdes med den assimileringseffektivitet, der beregnes ud fra data fra udskillelsesfasen.
Note that k2 should still be estimated and reported even if this alternative approach is used.
Der kan udtages fem ekstra fisk til vævsspecifik analyse.
To correct for the lipid content of the food and fish when lipid analysis has not be conducted on all sampled fish, the mean lipid fractions (w/w) in the fish and in the food are derived [52].
Det skal bemærkes, at det i mange tilfælde burde være muligt kun at bruge tre kontrolfisk (jf. punkt 56 og 153).
The lipid correction factor ( Lc) is then calculated by dividing the fish mean lipid fraction by the mean food lipid fraction.
ALMINDELIGE BEREGNINGER
The biomagnification factor, growth corrected or not as applicable, is divided by the lipid correction factor to calculate the lipid-corrected biomagnification factor.
Indledning
If chemical and lipid analyses were conducted on the same fish at each sampling point, then the lipid-corrected tissue data for individual fish may be used to calculate a lipid-corrected BMF directly (cf. (37)).
Forudsigelse af optagelsesfasens længde
The plot of lipid-corrected concentration data gives C0,d on a lipid basis and k2.
Forudsigelse af udskillelsesfasens længde
Mathematical analysis can then proceed using the same equations in Appendix 7, but assimilation efficiency (a) is calculated using the lipid-normalised food ingestion rate constant (Ilipid) and the dietary concentration on a lipid basis (Cfood-lipid).
Sekventiel metode: bestemmelse af udskillelseshastighedskonstanten k2
Lipid corrected parameters are similarly then used to calculate BMF (note that growth rate constant correction should also be applied to the lipid fraction rather than the fish wet weight to calculated the lipid-corrected, growth corrected BMFKgL).
Sekventiel metode: bestemmelse af optagelseshastighedskonstanten k1 (kun metoden med eksponering i vand)
The growth rate constants or the growth curves of the two groups should be compared by an appropriate procedure [53]).Test report
Samtidig metode til beregning af hastighedskonstanterne for optagelse og udskillelse (tab) (kun metoden med eksponering i vand)
After termination of the study, a final report is prepared containing the information on Test Substance, Test Species and Test Conditions as listed in paragraph 81 (as for the aqueous exposure method).
Korrigering for vækstfortynding for kinetisk BCF og BMF
In addition, the following information is required:
Lipidnormalisering til 5 % fedtindhold (kun for metoden med eksponering i vand)
Test Substance:
Den almindelige model for fisk med bioakkumulering i vand kan beskrives i optagelses- og tabsprocesser, idet der ses bort fra optagelse fra foder.
Any information on stability of the test substance in prepared food;
Den differentialligning (dCf/dt), der beskriver ændringer i koncentrationen i fisk (mg·kg– 1·dag– 1) fås ved (1):
Substance nominal concentration in food, spiking technique, amount of (lipid) vehicle used in food spiking process (if used), test substance concentration measurements in spiked diet for each analysis (at least in triplicate before study start and at end of uptake) and mean values;
[Ligning A5.1]
If used, type and quality of carrier oil or solvent (grade, supplier, etc.) used for food spiking;
hvor
Food type employed (proximate analysis [54], grade or quality, supplier, etc.), feeding rate during uptake phase, amount of food administered and frequency (including any adjustments based on sampled fish weight);
Konstant af første orden for optagelse i fisk (l·kg– 1·dag– 1).
Time at which fish were collected and euthanised for chemical analysis for each sample point (e.g. one hour before the following day's feeding);
Konstant af første orden for udskillelse fra fisk (dag– 1).
Results from any preliminary study work;
Konstant af første orden for fisks vækst (»vækstfortynding«) (dag– 1)
Information on any adverse effects observed;
Konstant af første orden for metabolisk transformation (dag– 1).
Complete description of all chemical analysis procedures employed including limits of detection and quantification, variability and recovery;
Konstant af første orden for fækal egestion (dag– 1).
Measured lipid concentrations in food (spiked and control diet), individual, mean values and standard deviations;
Koncentration i vand ((mg·l-1).
Tabulated fish weight (and length) data linked to individual fish, both for control and exposure groups (for example using unique identifiers for each fish) and calculations, derived growth rate constant(s) and 95 % confidence interval(s);
Koncentration i fisk (mg·kg– 1 vådvægt).
Tabulated test substance concentration data in fish, mean measured concentration at end of uptake (C0,m), and derived (overall) depuration rate constant (k2) and concentration in fish at start of depuration phase (C0,d) together with the variances in these values (slope and intercept);
For bioakkumulerende stoffer kan det forventes, at et tidsvægtet gennemsnit (TWA) er den mest relevante eksponeringskoncentration i vand (CW) inden for det tilladte udsving (jf. punkt 24).
Tabulated fish lipid contents data (listed against specific substance concentrations if applicable), mean values for test group and control at test start, end of uptake and end of depuration;
Det anbefales at beregne et TWA for koncentration i vand ved hjælp af proceduren i tillæg 6 til TM C.20 (2).
Curves (including all measured data), showing the following (if applicable, concentrations may be expressed in relation to the whole body of the animal or specified tissues thereof):
Det skal bemærkes, at ln-transformationen af vandkoncentrationen er velegnet, når der forventes et eksponentielt henfald mellem fornyelsesperioder, f.eks. i et semistatisk testdesign.
growth (i.e. fish weight (and length) vs. time) or natural logarithm transformed weight vs. time;
I et gennemstrømningssystem er der ikke nødvendigvis behov for ln-transformation af eksponeringskoncentrationer.
the depuration of the test substance in the fish; and
Hvis der udledes TWA-vandkoncentrationer, bør disse rapporteres og anvendes i efterfølgende beregninger.
natural logarithm transformed concentration (ln concentration) vs. depuration time (including the derived depuration rate constant k2, and natural logarithm derived concentration in fish at start of depuration phase, C0,d).
I en standardtest for BCF i fisk kan optagelse og udskillelse beskrives som to kinetiske processer af første orden.
Calculated growth-corrected depuration rate constant and growth-corrected half-life.
Optagelseshastighed = k1 × Cw
Calculated assimilation efficiency (α).
[Ligning A5.2]
“Raw” dietary BMF, lipid and growth-dilution corrected kinetic BMF (“raw” and lipid-corrected based on whole fish wet weight), tissue-specific BMF if applicable.
Generel tabshastighed = (k2 + kg + km + ke) × Cf
Substance Depuration Rate constants and Biomagnification Factors (BMFK)
[Ligning A5.3]
Insert Value (95 % CI) [55]
Ved ligevægt, og hvor det antages, at vækst og metabolisme er ubetydelig (dvs. værdierne for kg og km ikke kan skelnes fra nul), svarer optagelseshastigheden til udskillelseshastigheden, og ved at kombinere ligning A5.2 og ligning A5.3 fås derfor følgende forhold:
k2 (overall depuration rate constant, day– 1):
[Ligning A5.4]
Insert Value (95 % CI)
koncentration i vand ved ligevægt (mg l– 1).
Insert Value ± SD [56]
Men da k1 og k2 er konstanter, er ligevægt ikke et krav for at udlede en BCFK.
I (set feed ingestion rate; g food/g fish/day):
Den sekventielle metode til at bestemme k2 (afsnit 4) er vigtig for metoden med eksponering i foder, da den er nødvendig for at kunne beregne både assimileringseffektivitet og BMF.
Cfood (chemical concentration in the food; μg/g):
FORUDSIGELSE AF OPTAGELSESFASENS LÆNGDE
BMFK (kinetic dietary BMF):
Det skal dog bemærkes, at ligningerne i dette afsnit kun gælder, når optagelse og udskillelse følger førsteordenskinetik.
t1/2g (growth-corrected half-life in days):
Hvis dette tydeligvis ikke er tilfældet, anbefales det at søge råd hos en biostatistiker og/eller en farmakokinetiker, hvis det er ønskeligt at forudsige optagelsesfasen.
Lc (lipid correction factor):
(r2=0,95) [(3), ligning A5.5]
Chapter C.13 of this Annex, Bioconcentration: Flow-through Fish Test.
[Ligning A5.6]
Chapter A.6 of this Annex, Water Solubility
hvor k1 = 520 × W– 0,32 ((for stoffer med en log KOW > 3)
Chapter A.8 of this Annex, Partition Coefficient (n-octanol/water): Shake Flask Method.
(r2= 0,85)[(4), Ligning A5.7]
Chapter A.24 of this Annex, Partition Coefficient (n-octanol/water), HPLC Method.
OgBCF
Chapter A.23 of this Annex, Partition Coefficient (1-Octanol/Water): Slow-Stirring Method.
(r2= 0,90)[(5), ligning A5.8]
Chapter C.7 of this Annex, Hydrolysis as a Function of pH.
W = gennemsnitlig fiskevægt (gram vådvægt) ved slutningen af optagelsesfasen/starten på udskillelsesfasen [2]
Chapter A.5 of this Annex, Surface Tension of Aqueous Solutions.
Der henvises til (6) for andre dermed relaterede forbindelser.
Chapter A.4 of this Annex, Vapour Pressure.
Tilstedeværelsen af nitrogrupper kan f.eks. være tegn på hurtig metabolisme, men dette er ikke altid tilfældet.
SAR QSAR Environ.
Derfor bør brugeren afveje resultaterne af den prognostiske metode mod kemisk struktur og eventuelle andre relevante oplysninger (f.eks. forundersøgelser) i planlægningen af en undersøgelse.
Res. 1: 29-39.
I så fald er det bedre at bruge den vækstkorrigerede k2g som beskrevet senere (se afsnit 7 i dette tillæg):
Ecotoxicological environmental risk limits for total petroleum hydrocarbons on the basis of internal lipid concentrations.
[Ligning A5.9]
Chapter C.47 of this Annex, Fish, Early-Life Stage Toxicity Test.
eller, hvis Cw er konstant:
Chapter C.15 of this Annex, Fish, Short-term Toxicity Test on Embryo and Sac-Fry Stages
[Ligning A5.10]
Chapter C.14 of this Annex, Fish, Juvenile Growth Test.
Når der er næsten ligevægt (t → ∞), kan ligning A5.10 reduceres (jf. (9)(10)) til:
OECD (2012), OECD Environmental Health and Safety Publications Series on Testing and Assessment No. 175: Part I — Validation Report of a ring test for the OECD TG 305 dietary exposure bioaccumulation fish test.
[Ligning A5.11]
DEFINITIONS AND UNITS:
[Ligning A5.12]
The assimilation efficiency (α) is a measure of the relative amount of substance absorbed from the gut into the organism (α is unitless, but it is often expressed as a percentage rather than a fraction).
Derefter er BCF × Cw en tilnærmelse til koncentrationen i fiskene ved ligevægt (Cf-SS).
Bioaccumulation is generally referred to as a process in which the substance concentration in an organism achieves a level that exceeds that in the respiratory medium (e.g. water for a fish or air for a mammal), the diet, or both (1).
I dette tilfælde erstattes BCF med BMF og Cw med Cfood, koncentration i foderet, i ovenstående ligninger]
The bioconcentration factor (BCF or KB) at any time during the uptake phase of this accumulation test is the concentration of test substance in/on the fish or specified tissues thereof (Cf as mg/kg) divided by the concentration of the substance in the surrounding medium (Cw as mg/l).