natgillin/translations-raw huggingface dataset:
Before use of the test method for regulatory testing of a mixture, it should be considered whether it will provide acceptable results for the intended regulatory purpose.
Jos halutaan tehdä yhteisvertailu yksittäisten pitoisuuksien ja kontrollien välillä, jatkuvaa vastetta varten suositellaan Jonckheere-Terpstran tai Williamsin vertailutestiä ja sellaisia dikotomisia vasteita varten Cochran-Armitagen vertailutestiä, jotka ovat yhdenmukaisia monotonisen pitoisuus-vastesuhteen kanssa eikä ole näyttöä ylihajonnasta (14).
Useful information includes the structural formula, purity of the substance, water solubility, stability in water and light, pKa, Pow and results of a test for ready biodegradability (e.g. chapters C.4 or C.29 of this Annex).
Jos ylihajonnasta on näyttöä, suositellaan käytettäväksi Cochran-Armitagen testin Rao-Scott-muunnosta (15) (16) tai Williamsin tai Dunnettin testiä (arcussinimuunnoksen jälkeen) tai Jonckheere-Terpstran testiä rinnakkaisosuuksiin.
the dissolved oxygen concentration should be > 60 % of the air saturation value throughout the test;
Jos tiedot eivät ole yhdenmukaisia monotonisen pitoisuus-vastesuhteen kanssa, Dunnettin tai Dunnin tai Mann-Whitneyn menetelmät saattavat olla hyödyllisiä jatkuvissa vasteissa ja Fisherin tarkka testi dikotomisissa vasteissa (14) (17) (18).
the water temperature should not differ by more than ± 1,5 °C between test chambers or between successive days at any time during the test, and should be within the temperature ranges specified for the test species (Appendix 2);
Kaikkien tilastomenetelmien tai -mallien käytössä on huolellisesti varmistettava, että kyseisen menetelmän tai mallin edellytykset täyttyvät (esim. astiakohtainen vaihtelu estimoidaan ja otetaan huomioon kokeen suunnittelussa ja testin tai mallin käytössä).
the analytical measure of the test concentrations is compulsory.
Tietojen normaalius on arvioitava, ja lisäyksessä 5 ilmoitetaan, mitä ANOVAn jäännöksille on tehtävä.
overall survival of fertilised eggs and post-hatch success in the controls and, where relevant, in the solvent controls should be greater than or equal to the limits defined in Appendix 2.
Lisäyksessä 6 käsitellään tarkemmin regressiomenetelmään liittyviä näkökohtia.
If a minor deviation from the validity criteria is observed, the consequences should be considered in relation to the reliability of the test data and these considerations should be included in the report.
Tilastollisen testin edellytysten täyttämiseksi on harkittava muunnoksia.
Effects on survival, hatch or growth occurring in the solvent control, when compared to the negative control, should be reported and discussed in the context of the reliability of the test data.
Regressiomallin sovittamisen edellyttämät muunnokset vaativat kuitenkin suurta huolellisuutta, sillä esimerkiksi 25 prosentin muutos muuntelemattomassa vasteessa ei vastaa 25 prosentin muutosta muunnetussa vasteessa.
Test chambers
Kaikissa analyyseissa analysoitava yksikkö ja koeyksikkö on testiastia, ei yksittäinen kala, joten sekä hypoteesitestien että regression on vastattava sitä (3) (14) (19) (20).
Any glass, stainless steel or other chemically inert vessels can be used.
kemialliset tunnistetiedot, kuten IUPAC- tai CAS nimi, CAS numero, SMILES tai InChI-koodi, rakennekaava, puhtaus, epäpuhtauksien kemialliset tunnistetiedot siltä osin, kuin se on tarpeen ja käytännössä mahdollista, jne. (tarvittaessa myös orgaanisen hiilen pitoisuus)
As silicone is known to have a strong capacity to absorb lipophilic substances, the use of silicone tubing in flow-through studies and use of silicone seals in contact with water should be minimised by the use of e.g. monoblock glass aquaria.
mahdollisimman tarkka luonnehdinta, esim. kemialliset tunnistetiedot (kuten edellä), määrällinen esiintyminen ja ainesosien fysikaalis-kemialliset ominaisuudet, jos niillä on merkitystä
The dimensions of the vessels should be large enough to allow proper growth in the control, maintenance of dissolved oxygen concentration (e.g. for small fish species, a 7 L tank volume will achieve this) and compliance with the loading rate criteria given in paragraph 19.
tieteellinen nimi, kanta, hedelmöityneiden munien toimittaja ja keräysmenetelmä sekä munien myöhempi käsittely.
It is desirable that test chambers be randomly positioned in the test area.
testauksessa käytetty menetelmä (esim. semistaattinen tai läpivirtausmenetelmä, täyttötapa)
A randomised block design with each treatment being present in each block is preferable to a completely randomised design.
valoisa aika (valoisat aikajaksot)
The test chambers should be shielded from unwanted disturbance.
testisuunnitelman kuvaus (esim. testiastioiden määrä, rinnakkaisnäytteiden määrä, mätimunien määrä rinnakkaisnäytettä kohden, testiastioiden materiaali ja koko (korkeus, leveys, tilavuus), vesimäärä testiastiaa kohden)
The test system should preferably be conditioned with concentrations of the test chemical for a sufficient duration to demonstrate stable exposure concentrations prior to the introduction of test organisms.
varastoliuosten valmistusmenetelmä ja nesteen vaihtojen väli (liuotusapuaine ja sen pitoisuus on ilmoitettava, jos sellaista käytetään)
Recommended fish species are given in Table 1.
testikemikaalin annostelumenetelmä (esim. pumput, laimennusjärjestelmät)
This does not preclude the use of other species, but the test procedure may have to be adapted to provide suitable test conditions.
menetelmän saantoteho ja nimelliset testipitoisuudet, kvantifiointiraja, mitattujen arvojen keskiarvot ja niiden keskihajonnat testiastioissa, niiden laskemiseen käytetty menetelmä sekä näyttö siitä, että mittaukset koskevat testikemikaalin pitoisuutta aidossa liuoksessa
Holding of the brood fish
laimennusveden ominaisuudet: pH, kovuus, lämpötila, liuenneen hapen pitoisuus, jäännösklooripitoisuudet (jos ne on mitattu), orgaanisiin yhdisteisiin sitoutuneen hiilen kokonaismäärä (jos se on mitattu), suspensiossa olevat kiinteät aineet (jos ne on mitattu), testiväliaineen suolapitoisuus (jos se on mitattu) ja mahdolliset muut mittaukset
Details on holding the brood stock under satisfactory conditions may be found in Appendix 3 and the references cited (3)(4)(5).
testiastioissa olevan veden laatu: pH, kovuus, lämpötila ja liuenneen hapen pitoisuus
Handling of fertilised eggs, embryos and larvae
yksityiskohtaiset tiedot ruokinnasta (esim. rehu(je)n tyyppi, alkuperä, annettu määrä ja antotaajuus)
Initially, fertilised eggs, embryos and larvae may be exposed within the main vessel in smaller glass or stainless steel vessels, fitted with mesh sides or ends to permit a flow of test solution through the vessel.
Yksittäin (tai rinnakkaisnäyteperusteella) ja tarvittaessa keskiarvoina ja variaatiokertoimina ilmoitetut seuraavia tutkittavia ominaisuuksia koskevat tulokset:
Non-turbulent flow-through in these small vessels may be induced by suspending them from an arm arranged to move the vessel up and down but always keeping the organisms submerged.
näyttö siitä, että kontrollit täyttävät yleiset testilajin elinkyvyn hyväksyttävyyttä koskevat vaatimukset (lisäys 2)
Fertilised eggs of salmonid fishes can be supported on racks or meshes with apertures sufficiently large to allow larvae to drop through after hatching.
kuolleisuustiedot kussakin vaiheessa (alkio, toukka ja juveniili) ja kertyvä kuolleisuus
Where egg containers, grids or meshes have been used to hold eggs within the main test vessel, these restraints should be removed after the larvae hatch, according to the guidance in Appendix 3, except that meshes should be retained to prevent the escape of the larvae.
päivää kuoriutumiseen, kuoriutuneiden toukkien lukumäärä kunakin päivänä ja kuoriutumisen päättyminen
If there is a need to transfer the larvae, they should not be exposed to the air and nets should not be used to release larvae from egg containers.
terveiden kalojen lukumäärä testin lopussa
The timing of this transfer varies with the species and should be documented in the report.
eloonjääneiden eläinten pituus (on ilmoitettava, onko kyseessä vakio- vai kokonaispituus) ja paino
However, a transfer may not always be necessary.
mahdollisten epämuodostumien ilmaantuvuus, kuvaus ja lukumäärä
Any water in which the test species shows suitable long-term survival and growth may be used as test water (see Appendix 4).
mahdollisten käyttäytymismuutosten ilmaantuvuus, kuvaus ja lukumäärä
It should be of constant quality during the period of the test.
tilastollinen analyysimenetelmä (regressio- tai varianssianalyysi) ja tietojenkäsittelymenetelmä (käytetty tilastollinen testi tai malli)
In order to ensure that the dilution water will not unduly influence the test result (for example by complexation of test chemical), or adversely affect the performance of the brood stock, samples should be taken at intervals for analysis.
pitoisuus, josta ei aiheudu vaikutuksia kullekin arvioidulle vasteelle (NOEC)
Measurements of heavy metals (e.g. Cu, Pb, Zn, Hg, Cd, Ni), major anions and cations (e.g. Ca2+, Mg2+, Na+, K+, Cl–, SO42–), ammonia, total residual chlorine pesticides, total organic carbon and suspended solids should be made, for example, on a bi-annual basis where a dilution water is known to be relatively constant in quality.
pienin havaittavan vaikutuksen aiheuttava pitoisuus (p = 0,05) kullekin arvioidulle vasteelle (LOEC)
If the water is known to be of variable quality the measurements have to be conducted more often; the frequency is dependent of how variable the quality is.
tarvittaessa ECx kullekin arvioidulle vasteelle ja luottamusvälit (esim. 90 tai 95 prosenttia) sekä kaavio sen laskentaan käytetystä sovitetusta mallista, pitoisuus-vastekäyrän kaltevuus, regressiomallin kaava, estimoidut mallimuuttujat ja niiden vakiovirheet.
Some chemical characteristics of an acceptable dilution water are listed in Appendix 4.
Kaikki poikkeamat testimenetelmästä
For flow-through tests, a system which continually dispenses and dilutes a stock solution of the test chemical (e.g. metering pump, proportional diluter, saturator system) is required to deliver a series of concentrations to the test chambers.
Tulosten pohdinta, mukaan luettuna mahdolliset vaikutukset, joita testimenetelmästä poikkeamisella on ollut testin tuloksiin
The flow rates of stock solutions and dilution water should be checked at intervals during the test and should not vary by more than 10 % throughout the test.
Kalalajit, joita suositellaan käytettäväksi testissä
A flow rate equivalent to at least five test chamber volumes per 24 hours has been found suitable (3).
MAKEAN VEDEN KALAT
However, if the loading rate specified in paragraph 19 is respected, a lower flow rate of e.g. 2-3 test chamber volumes is possible to prevent quick removal of food.
SUISTO- JA MERIKALAT
Test solutions of the chosen concentrations are prepared by dilution of a stock solution.
Kirjolohi
The stock solution should preferably be prepared by simply mixing or agitating the test chemical in dilution water by using mechanical means (e.g. stirring and/or ultrasonication).
Rasvapäämutu
Saturation columns (solubility columns) or passive dosing methods (6) can be used for achieving a suitable concentrated stock solution.
Seeprakala
The use of a solvent carrier is not recommended.
Medaka
However, in case a solvent is necessary, a solvent control should be run in parallel, at the same solvent concentration as the chemical treatments; i.e. the solvent level should preferably be equal across all concentrations as well as the solvent control.
OECD (2000), Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, Environmental Health and Safety Publications, Series on Testing and Assessment.
For some diluter systems this might be technically difficult; here the solvent concentration in the solvent control should be equal to the highest solvent concentration in the treatment group.
No.
For difficult to test substances, the OECD Guidance Document No. 23 on aquatic toxicity testing of difficult substances and mixtures should be consulted (2).
23, OECD, Pariisi.
If a solvent is used, the choice of solvent will be determined by the chemical properties of the substance.
ECx (Effect concentration for x % effect): Pitoisuus, joka aiheuttaa x prosentin suuruisen vaikutuksen testiorganismeihin tietyn altistusjakson aikana kontrolliin verrattuna.
The OECD Guidance Document No. 23 recommends a maximum concentration of 100 μl/l.
Esimerkiksi EC50 on pitoisuus, jolla estimoidaan olevan 50 prosentin vaikutus testissä tutkittavaan ominaisuuteen altistuksen kohteeksi joutuneessa populaatiossa määritellyn altistusajan kuluessa.
To avoid potential effect of the solvent on endpoints measured (7), it is recommended to keep solvent concentration as low as possible.
IUPAC (International Union of Pure and Applied Chemistry): Kansainvälinen puhtaan ja sovelletun kemian liitto.
For a semi-static test, two different renewal procedures may be followed.
Kemikaali: Aine tai seos.
Either new test solutions are prepared in clean vessels and surviving eggs and larvae gently transferred into the new vessels, or the test organisms are retained in the test vessels whilst a proportion (at least two thirds) of the test solution / control volume is changed.
Kokonaispituus: Pituus kuonon kärjestä pyrstöevän pitemmän lohkon kärkeen; mitataan yleensä siten, että lohkot on puristettu keskilinjaa vasten.
Detailed feeding regimes are given in Appendix 3 but, as experience is gained, food and feeding regimes are continually being refined to improve survival and optimise growth.
TESTIOLOSUHTEET, TESTIN KESTO JA ELOONJÄÄMISKRITEERIT SUOSITELLUILLE LAJEILLE
Live food provides a source of environmental enrichment and therefore should be used in place of or in addition to dry or frozen food whenever appropriate to the species and life stage.
Selitykset:
Normally five concentrations of the test chemical, with a minimum of four replicates per concentration, spaced by a constant factor not exceeding 3,2 are required.
LAJIT
If available, information on the acute testing, preferable with the same species and/or a range finding test should be considered (1) when selecting the range of test concentrations.
TESTAUSOLOSUHTEET
However, all sources of information should be considered when selecting the range of test concentrations, including sources like e.g. read across, fish embryo acute toxicity test data.
TESTIN SUOSITELTAVA KESTO
A limit test, or an extended limit test, with fewer than five concentrations as the definitive test may be acceptable where empirical NOECs only are to be established.
Kontrollikalojen kokonaispituuden tyypillinen vähimmäiskeskiarvo tutkimuksen lopussa (mm) [1]
Concentrations of the test chemical higher than the 96 hour LC50 or 10 mg/l, whichever is the lower, need not be tested.
KONTROLLIEN ELOONJÄÄNEISYYS (vähintään)
Frequency of Analytical Determinations and Measurements
Suolapitoisuus (0/00)
Prior to initiation of the exposure period, proper function of the chemical delivery system across all replicates should be ensured (for example, by measuring test concentrations).
Valoisa aika (t)
Analytical methods required should be established, including an appropriate limit of quantification (LOQ) and sufficient knowledge on the substance stability in the test system.
Kuoriutuneisuus
During the test, the concentrations of the test chemical are determined at regular intervals to characterise exposure.
Kuoriutumisen jälkeinen eloonjääneisyys
A minimum of five determinations is necessary.
Makea vesi:
In flow-through systems, analytical measurements of the test chemical in one replicate per concentration should be made at least once a week changing systematically amongst replicates.
12–16 [3]
Additional analytical determinations will often improve the quality of the test outcome.
kahden viikon kuluttua siitä, kun kontrollit hakevat itse ruokansa (tai 60 vrk kuoriutumisen jälkeen)
Samples may need to be filtered to remove any particulate matter (e.g. using a 0,45 μm pore size) or centrifuged to ensure that the determinations are made on the chemical in true solution.
32 vrk testin alusta (tai 28 vrk kuoriutumisesta)
In order to reduce adsorption of the test chemical, the filters should be saturated before the use.
12–16 [4]
When the measured concentrations do not remain within 80-120 % of the nominal concentration, the effect concentrations should be determined and expressed relative to the arithmetic mean concentration for flow-through tests (see Appendix 6 of the test method C.20 for the calculation of the arithmetic mean (8)), and expressed relative to the geometric mean of the measured concentrations for semi-static tests (see Chapter 5 in the OECD Guidance Document on aquatic toxicity testing of difficult substances and mixtures (2)).
30 vrk kuoriutumisesta
During the test, dissolved oxygen, pH, and temperature should be measured in all test vessels, at least weekly, and salinity and hardness, if warranted, at the beginning and end of the test.
Medaka
Temperature should preferably be monitored continuously in at least one test vessel.
Suisto- ja merikalalajit:
Stage of embryonic development
22–25
the embryonic stage at the beginning of exposure to the test chemical should be verified as precisely as possible.
28 vrk
This can be done using a representative sample of eggs suitably preserved and cleaned.
Tyypillinen kokonaispituuden vähimmäiskeskiarvo ei ole validiteettikriteeri, mutta ilmoitetun arvon alapuolella olevat poikkeamat on huolellisesti tutkittava testin herkkyyden kannalta.
Hatching and survival
Kokonaispituuden vähimmäiskeskiarvo on johdettu nykyhetkellä käytettävissä olevien tietojen valikoimasta.
observations on hatching and survival should be made at least once daily and numbers recorded.
Testattava kirjolohikanta saattaa edellyttää muiden lämpötilojen käyttöä.
If fungus on eggs is observed early in embryonic development (e.g. at day one or two of test), those eggs should be counted and removed.
Siitoskanta on pidettävä samassa lämpötilassa kuin mätimunat.
Dead embryos, larvae and juvenile fish should be removed as soon as observed since they can decompose rapidly and may be broken up by the actions of the other fish.
Lyhyt totutus testilämpötilaan on välttämätön sen jälkeen, kun mätimunat on saatu kaupalliselta kasvattajalta (esim. 1–2 t).
Extreme care should be taken when removing dead individuals not to physically damage adjacent eggs/larvae.
Toukat on pidettävä pimeässä yhden viikon ajan kuoriutumisen jälkeen lukuun ottamatta aikoja, jolloin niitä tarkastellaan.
Signs of death vary according to species and life stage.
Sen jälkeen käytetään koko testin ajan heikkoa valaistusta (valoisa aika 12–16 tuntia) (4).
For example:
Valaistusolojen on oltava kaikissa testausolosuhteissa vakaita.
for fertilised eggs: particularly in the early stages, a marked loss of translucency and change in colouration, caused by coagulation and/or precipitation of protein, leading to a white opaque appearance;
Kaikissa testeissä ± 2 0/00.
for embryos, larvae and juvenile fish: immobility and/or absence of respiratory movement and/or absence of heartbeat and/or lack of reaction to mechanical stimulus.
SUOSITUSLAJIEN SIITOS- JA TESTIELÄINTEN RUOKINTA- JA KÄSITTELYOHJEET
Abnormal appearance
FBS pakastetut suolalehtijalkaiset; aikuiset Artemia sp
the number of larvae or juvenile fish showing abnormality of body form should be recorded at adequate intervals depending on the duration of the test and the nature of the abnormality described.
BSN suolalehtijalkaisten naplius-toukat; vasta kuoriutuneet
It should be noted that abnormal larvae and juvenile fish occur naturally and can be of the order of several percent in the control(s) in some species.
BSN48 suolalehtijalkaisten nauplius-toukat; 48 tunnin ikäiset
Where deformities and associated abnormal behaviour are considered so severe that there is considerable suffering to the organism, and it has reached a point beyond which it will not recover, it may be removed from the test.
RAVINTO [1]
Such animals should be euthanised and treated as mortalities for subsequent data analysis.
KUORIUTUMISEN JÄLKEINEN SIIRTOAIKA
Normal embryonic development has been documented for most species recommended in this test method (9) (10) (11) (12).
AIKA ENSIMMÄISEEN RUOKINTAAN
Abnormal behaviour
Siitoskalat
abnormalities, e.g. hyperventilation, uncoordinated swimming, atypical quiescence and atypical feeding behaviour should be recorded at adequate intervals depending on the duration of the test (e.g. once daily for warm water species).
Vastakuoriutuneet toukat
These effects, although difficult to quantify, can, when observed, aid in the interpretation of mortality data.
Juveniilit
Weight
Tyyppi
at the end of the test, all surviving fish are weighed at least on a replicate basis (reporting the number of animals in the replicate and the mean weight per animal): wet weight — (blotted dry) is preferred, however, dry weight data may also be reported (13).
Tiheys
Length
Kirjolohen rehu
at the end of the test, individual lengths are measured.
Ei mitään [2]
Total length is recommended, if however, caudal fin rot or fin erosion occurs, standard length can be used.
Kirjolohen aloitusrehu BSN
The same method should be used for all fish in a given test.
2–4 ruokintaa päivässä
Individual length can be measured either by e.g. callipers, digital camera, or calibrated ocular micrometer.
14–16 päivää kuoriutumisen jälkeen tai kun ne alkavat uida (ei olennaista)
Typical minimum lengths are defined in Appendix 2.
19 päivää kuoriutumisen jälkeen tai kun ne alkavat uida
It is recommended that the design of the experiment and selection of statistical test permit adequate power (80 % or higher) to detect changes of biological importance in endpoints where a NOEC is to be reported.
BSN, hiutalerehu FBS
If an ECx is to be reported, the design of the experiment and selection of regression model should permit estimation of ECx so that (i) the 95 % confidence interval reported for ECx does not contain zero and is not overly wide, (ii) the 95 % confidence interval for the predicted mean at ECx does not contain the control mean (iii) there is no significant lack-of-fit of regression model to the data.
BSN48, hiutalerehu
Either approach requires the identification of the percent change in each endpoint that is important to detect or estimate.
2–3 kertaa päivässä
The experimental design should be tailored to allow that.
Sen jälkeen, kun kuoriutuneisuus on 90 %
When the above conditions for determining the ECx are not satisfied, the NOEC approach should be used.
2 vrk kuoriutumisesta
It is not likely that the same percent change applies to all endpoints, nor is it likely that a feasible experiment can be designed that will meet these criteria for all endpoints, so it is important to focus on the endpoints, which are important for the respective experiment in designing the experiment appropriately.
BSN, hiutalerehu
Statistical flow diagrams and guidance for each approach are available in Appendixes 5 and 6 to guide in the treatment of data and in the choice of the most appropriate statistical test or model to use.
Kaupallinen toukkarehu, alkueläimiä [3], proteiinia [4]
Other statistical approaches may be used, provided they are scientifically justified.
BSN48, hiutalerehu
In order to make a multiple comparison between the results at the individual concentrations and those for the controls, the step-down Jonckheere-Terpstra or Williams' test is recommended for continuous responses and a step-down Cochran-Armitage test for quantal responses that are consistent with a monotone concentration-response and with no evidence of extra-binomial variance (14).
2 vrk kuoriutumisesta
When there is evidence of extra-binomial variance, the Rao-Scott modification of the Cochran-Armitage test is recommended (15) (16) or Williams or Dunnett's (after an arcsin-square-root transform) or Jonckheere-Terpstra test applied to replicate proportions.
hiutalerehu
Where the data are not consistent with a monotone concentration-response, Dunnett's or Dunn's or the Mann-Whitney method may be found useful for continuous responses and Fisher's Exact test for quantal responses (14) (17) (18).
BSN, hiutalerehu (tai alkueläimiä tai rataseläimiä)